Best price levitra generic

She said best price levitra generic a major hurdle and disparities for those in rural communities is access to mental services.“For every 340 citizens, there’s only one licensed mental health professional. That number grows larger in Central Louisiana,” she said.Louisiana needs more than 200 mental health workers to meet the current professional worker shortage.(Source. HRSA)The Health Resources and Services Administration published information in July 2021, demonstrating the great need for mental health professionals.

For example, Rapides Parish is included in the dark blue category, indicating a major shortage best price levitra generic in the area.“It’s definitely hard to get access to care. It’s truly a crisis.”The effects of the mental health professional shortages also influence hiring decisions for local mental health organizations. Michael Moto, CEO and owner of Healing Hands and Hearts Behavioral Health Center, said it is challenging getting trained people into the field.

He also best price levitra generic said male mental health professionals are in dire need. His center currently employs one male case manager.“Most of the issues we see are children without the parent in the home, particularly the father,” Moto said.He said the shortage puts a strain on mental health organizations. He also believes male mental health workers play a vital role in community health.“By not having male case managers, we’re not able to help those clients that need male role models and guidance in their lives,” he said.Those role models at an early age can improve health and overall life outcomes because many in the state’s juvenile justice system experience mental illness.“Students drop out of school because they’re getting in trouble because their mental needs and mental health needs aren’t being met,” Corken said.

€œThere’s drug best price levitra generic addiction, incarceration, violence, job stability and, sadly, suicide. The rate is every 12 hours, one person in Louisiana dies by suicide.”Corken said the most important thing is breaking down stigmas and barriers like transportation and bringing services to patients.“It’s so difficult in a rural area because sometimes the closest practitioner can be easily over an hour from someone’s house, so that makes it incredibly difficult to receive continuing treatment, let alone just one treatment,” she said.She also claims the expansion of telehealth services leaves many rural families without healthcare because of the state’s broadband infrastructure. A coalition of non-profits and other groups identified 17 parishes in Louisiana as broadband deserts—a parish with 50% or less broadband coverage.“That’s definitely just another barrier,” she said.

€œIf you can’t receive these specialized behavioral health services inpatient, reach out best price levitra generic to us. We will try and connect you with a provider that’s in your area, goes into homes and treats kids and families so that they can lead productive lives.”RESOURCES:National Suicide Hotline. 1-800-273-8255Healing Hands and Hearts Behavioral Center.

1-318-625-7050Click here to contact the Rural Mental Health best price levitra generic Alliance Click here to report a typo.Copyright 2021 KALB. All rights reserved.Start Preamble Notice of amendment. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to clarify and expand the authority for certain Qualified Persons authorized to prescribe, dispense, and administer covered countermeasures under section VI of this Declaration.

This amendment best price levitra generic is effective as of August 4, 2021. Start Further Info L. Paige Ezernack, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201.

202-260-0365, paige.ezernack@hhs.gov best price levitra generic. End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant.

The PREP Act was enacted on December 30, 2005, as Public Law best price levitra generic 109-148, Division C, § 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C.

247d-6d and best price levitra generic 42 U.S.C. 247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the levitra and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013, and the erectile dysfunction Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, 2020, to expand Covered Countermeasures under the PREP Act.

On January 31, 2020, the former Secretary, Alex best price levitra generic M. Azar II, declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation's health care community to the erectile dysfunction treatment outbreak.

Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration effective best price levitra generic on April 26, 2020, July 25, 2020, October 23, 2020, January 21, 2021, April 21, 2021 and July 20, 2021. On March 10, 2020, former Secretary Azar issued a Declaration under the PREP Act for medical countermeasures against erectile dysfunction treatment (85 FR 15198, Mar. 17, 2020) (the Declaration).

On April 10, the former best price levitra generic Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020). On June 4, the former Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm erectile dysfunction treatment might otherwise cause.

(85 FR 35100, best price levitra generic June 8, 2020). On August 19, the former Secretary amended the declaration to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommended the administration or use of the Covered Countermeasures. (85 FR 52136, August 24, 2020).

On December 3, 2020, the former Secretary amended the declaration to incorporate Advisory Opinions of the General Counsel interpreting the PREP Act and the Secretary's Declaration and authorizations issued by the Department's best price levitra generic Office of the Assistant Secretary for Health as an Authority Having Jurisdiction to respond. Added an additional category of qualified persons under Section V of the Declaration. Made explicit that the Declaration covers all qualified levitra and epidemic products as defined under the PREP Act.

Added a third method of best price levitra generic distribution to provide liability protections for, among other things, private distribution channels. Made explicit that there can be Start Printed Page 41978situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and the Declaration's liability protections. Made explicit that there are substantive federal legal and policy issues and interests in having a unified whole-of-nation response to the erectile dysfunction treatment levitra among federal, state, local, and private-sector entities.

Revised the best price levitra generic effective time period of the Declaration. And republished the declaration in full. (85 FR 79190, December 9, 2020).

On February 2, 2021, the Acting Secretary Norris Cochran amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer erectile dysfunction treatment best price levitra generic treatments that are covered countermeasures under the Declaration (86 FR 7872, February 2, 2021). On February 16, 2021, the Acting Secretary amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer erectile dysfunction treatments that are covered countermeasures under the Declaration (86 FR 9516, February 16, 2021) and on February 22, 2021, the Department filed a notice of correction to the February 2 and February 16 notices correcting effective dates stated in the Declaration, and correcting the description of qualified persons added by the February 16, 2021 amendment. (86 FR 10588, February 22, 2021).

On March 11, 2021, the Acting Secretary amended the Declaration to add additional Qualified Persons authorized to prescribe, dispense, and best price levitra generic administer covered countermeasures under the Declaration. (86 FR 14462 March 16, 2021). Secretary Xavier Becerra now amends section V of the Declaration to revise subsections (d) and (f) to clarify that qualified pharmacy technicians are Qualified Persons covered by the Declaration, and to expand the scope of authority for qualified pharmacy technicians to administer seasonal influenza treatments to adults within the state where they are authorized to practice and for interns to administer seasonal influenza treatments to adults consistent with other terms and conditions of the Declaration.

Accordingly, subsection best price levitra generic V(d) authorizes. (d) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy),[] (1) treatments that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule or (2) seasonal influenza treatment administered by qualified pharmacy technicians and interns that the ACIP recommends to persons aged 19 and older according to ACIP's standard immunization schedule. Or (3) FDA authorized or FDA licensed erectile dysfunction treatment -19 treatments to persons ages three or older.

Such State-licensed pharmacists and the State-licensed or best price levitra generic registered interns or technicians under their supervision are qualified persons only if the following requirements are met. I. The treatment must be authorized, approved, or licensed by the FDA.

Ii. In the case of a erectile dysfunction treatment, the vaccination must be ordered and administered according to ACIP's erectile dysfunction treatment recommendation(s). Iii.

In the case of a childhood treatment, the vaccination must be ordered and administered according to ACIP's standard immunization schedule. Iv. In the case of seasonal influenza treatment administered by qualified pharmacy technicians and interns, the vaccination must be ordered and administered according to ACIP's standard immunization schedule.

V. In the case of pharmacy technicians, the supervising pharmacist must be readily and immediately available to the immunizing qualified pharmacy technician. Vi.

The licensed pharmacist must have completed the immunization training that the licensing State requires for pharmacists to order and administer treatments. If the State does not specify training requirements for the licensed pharmacist to order and administer treatments, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) to order and administer treatments. Such a training program must include hands on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments.

Vii. The licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments.

Viii. The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation; [] ix. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.

X. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), Start Printed Page 41979complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. Xi.

The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate. And xii. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) erectile dysfunction treatment vaccination provider agreement and any other federal requirements that apply to the administration of erectile dysfunction treatment(s).

Further, the initial phrase of subsection V(f) is revised to state authorize “Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer treatments under the law of any State as of the effective date of this amendment, or a pharmacist or pharmacy intern as authorized under the section V(d) of this Declaration. . .

.” Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under the PREP Act has been issued with respect to such countermeasure. €œQualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed.

Or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8) By this amendment to the Declaration, the Secretary clarifies and expands the authorization for a category of persons who are qualified persons under section 247d-6d(i)(8)(B).

First, the amendment clarifies that qualified pharmacy technicians are authorized to administer Childhood vaccinations and erectile dysfunction treatment vaccinations that are Covered Countermeasures under section VI of this Declaration. The Department has authorized qualified pharmacy technicians to administer these treatments under section V(a) of the Declaration through Guidance issued by the Assistant Secretary for Health.[] This amendment adds qualified pharmacy technicians to section V(d) of the Declaration, to clarify that these healthcare professionals are authorized subject to the conditions stated in that subsection. In addition, the amendment expands the authorization for qualified pharmacy technicians and interns to administer seasonal influenza treatments under the supervision of a pharmacist to persons aged 19 and older consistent with ACIP recommendations.

The Secretary anticipates that there will be a need for the adult population to receive both erectile dysfunction treatment and seasonal influenza treatments throughout the 2021-2022 influenza season. Health risks may increase for individuals who contract seasonal influenza concurrently with erectile dysfunction treatment, thus expanding the scope of authorized vaccinators for seasonal influenza lessens the harm otherwise caused by erectile dysfunction treatment. While influenza incidence was lower than anticipated last fall and winter, the same cannot be assumed for the 2021-2022 flu season, as states have largely lifted the community mitigation measures previously in place at the height of the erectile dysfunction treatment levitra.

Seasonal influenza has the potential to inflict significant burden and strain on the U.S. Healthcare system in its own right. And in conjunction with the ongoing erectile dysfunction treatment levitra, a spike in influenza cases could overwhelm healthcare providers.

Like the vaccination against erectile dysfunction treatment, the vaccination against influenza requires many people to be vaccinated within a short period of time, potentially creating a surge on the system. Concern also remains regarding the emergence of erectile dysfunction variants and their potential to cause disease both among vaccinated and unvaccinated populations. It is yet to be determined if erectile dysfunction treatment boosters will be recommended.

However, if boosters become necessary, allowing pharmacy interns and technicians to administer both erectile dysfunction treatments and influenza treatments would allow states maximum flexibility in limiting potential impacts of both illnesses. ACIP also recently voted unanimously in favor of erectile dysfunction treatment and influenza treatment co-administration.[] Like erectile dysfunction treatments, influenza treatments are administered as intramuscular (IM) injections, and would require minimal, if any, additional training to administer, and would not place any undue training burden on providers. As qualified persons, these qualified pharmacy technicians and interns will be afforded liability protections in accordance with the PREP Act and the terms of this amended Declaration.

Second, to the extent that any State law that would otherwise prohibit these healthcare professionals who are a “qualified person” from prescribing, dispensing, or administering erectile dysfunction treatments or other Covered Countermeasures, such law is preempted. On May 19, 2020, the Office of the General Counsel issued an advisory opinion concluding that, because licensed pharmacists are “qualified persons” under this declaration, the PREP Act preempts state law that would otherwise prohibit such pharmacists from ordering and administering authorized erectile dysfunction treatment diagnostic tests.[] The opinion relied in part on the fact that the Congressional delegation of authority to the Secretary under the PREP Act to specify a class of persons, beyond those who are authorized to administer a covered countermeasure under State law, as “qualified persons” would be rendered a nullity in the absence of such preemption. This opinion is incorporated by reference into this declaration.

Based on the reasoning set forth in the May 19, 2020 advisory opinion, any State law that would otherwise prohibit a member of any of the classes of “qualified persons” Start Printed Page 41980specified in this declaration from administering a covered countermeasure is likewise preempted. In accordance with section 319F-3(i)(8)(A) of the Public Health Service Act, a State remains free to expand the universe of individuals authorized to administer covered countermeasures within its jurisdiction under State law. The plain language of the PREP Act makes clear that there is preemption of state law as described above.

Furthermore, preemption of State law is justified to respond to the nation-wide public health emergency caused by erectile dysfunction treatment as it will enable States to quickly expand the vaccination workforce with additional qualified healthcare professionals where State or local requirements might otherwise inhibit or delay allowing these healthcare professionals to participate in the erectile dysfunction treatment countermeasure program. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against erectile dysfunction treatment. Section V of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against erectile dysfunction treatment, as amended April 10, 2020, June 4, 2020, August 19, 2020, as amended and republished on December 3, 2020, and as amended on February 2, 2021, and as amended March 11, 2021, is further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below.

All other sections of the Declaration remain in effect as republished at 85 FR 79190 (December 9, 2020). 1. Covered Persons, section V, delete in full and replace with.

V. Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States.

€œOrder” as used herein and in guidance issued by the Office of the Assistant Secretary for Health [] means a provider medication order, which includes prescribing of treatments, or a laboratory order, which includes prescribing laboratory orders, if required. In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an Emergency, as that term is defined in Section VII of this Declaration; [] (b) Any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act.

(c) Any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act. (d) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy),[] (1) treatments that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule or (2) seasonal influenza treatment administered by qualified pharmacy technicians and interns that the ACIP recommends to persons aged 19 and older according to ACIP's standard immunization schedule. Or (3) FDA authorized or FDA licensed erectile dysfunction treatment -19 treatments to persons ages three or older.

Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons only if the following requirements are met. I. The treatment must be authorized, approved, or licensed by the FDA.

Ii. In the case of a erectile dysfunction treatment, the vaccination must be ordered and administered according to ACIP's erectile dysfunction treatment recommendation(s). Iii.

In the case of a childhood treatment, the vaccination must be ordered and administered according to ACIP's standard immunization schedule. Iv. In the case of seasonal influenza treatment administered by qualified pharmacy technicians and interns, the vaccination must be ordered and administered according to ACIP's standard immunization schedule.

V. In the case of pharmacy technicians, the supervising pharmacist must be readily and immediately available to the immunizing qualified pharmacy technician. Vi.

The licensed pharmacist must have completed the immunization training that the licensing State requires for pharmacists to order and administer treatments. If the State does not specify training requirements for the licensed pharmacist to order and administer treatments, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) to order and administer treatments. Such a training program must include hands on injection technique, clinical evaluation of indications and contraindications of treatments, and the Start Printed Page 41981recognition and treatment of emergency reactions to treatments.

Vii. The licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments.

Viii. The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation; [] ix. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.

X. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. Xi.

The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate. And xii. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) erectile dysfunction treatment vaccination provider agreement and any other federal requirements that apply to the administration of erectile dysfunction treatment(s).

(e) Healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are licensed or otherwise permitted to practice. When ordering and administering Covered Countermeasures by means of telehealth to patients in a state where the healthcare personnel are not already permitted to practice, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients by means of telehealth in the state where the healthcare personnel are permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.[] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services.

(f) Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer treatments under the law of any State as of the effective date of this amendment, or a pharmacist or pharmacy intern as authorized under the section V(d) of this Declaration, who prescribes, dispenses, or administers erectile dysfunction treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies, other than the State in which the license or certification is held, in association with a erectile dysfunction treatment vaccination effort by a federal, State, local Tribal or territorial authority or by an institution in the State in which the erectile dysfunction treatment covered countermeasure is administered, so long as the license or certification of the healthcare professional has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General, subject to. (i) Documentation of completion of the Centers for Disease Control and Prevention erectile dysfunction treatment (CDC) treatment Training Modules [] and, for healthcare providers who are not currently practicing, documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering intramuscular injections is in their ordinary scope of practice, who confirms competency of the healthcare provider in preparation and administration of the erectile dysfunction treatment(s) to be administered. (g) Any member of a uniformed service (including members of the National Guard in a Title 32 duty status) (hereafter in this paragraph “service member”) or Federal government, employee, contractor, or volunteer who prescribes, administers, delivers, distributes or dispenses a Covered Countermeasure.

Such Federal government service members, employees, contractors, or volunteers are qualified persons if the following requirement is met. The executive department or agency by or for which the Federal service member, employee, contractor, or volunteer is employed, contracts, or volunteers has authorized or could authorize that service member, employee, contractor, or volunteer to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure as any part of the duties or responsibilities of that service member, employee, contractor, or volunteer, even if those authorized duties or responsibilities ordinarily would not extend to members of the public or otherwise would be more limited in scope than the activities such service member, employees, contractors, or volunteers are authorized to carry out under this declaration. And (h) The following healthcare professionals and students in a healthcare profession training program subject to the requirements of this paragraph.

1. Any midwife, paramedic, advanced or intermediate emergency medical technician (EMT), physician assistant, respiratory therapist, dentist, podiatrist, optometrist or veterinarian licensed or certified to practice under the law of any state who prescribes, dispenses, or administers erectile dysfunction treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a erectile dysfunction treatment vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the erectile dysfunction treatment covered countermeasure is administered. 2.

Any physician, advanced practice registered nurse, registered nurse, practical nurse, pharmacist, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, respiratory therapist, dentist, physician assistant, podiatrist, optometrist, or veterinarian who has held an active license or certification under the law of any State within the last five years, which is inactive, expired or lapsed, who prescribes, dispenses, or administers erectile dysfunction treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a erectile dysfunction treatment vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the erectile dysfunction treatment covered countermeasure is administered, so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General. 3. Any medical, nursing, pharmacy, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, physician assistant, respiratory therapy, dental, Start Printed Page 41982podiatry, optometry or veterinary student with appropriate training in administering treatments as determined by his or her school or training program and supervision by a currently practicing healthcare professional experienced in administering intramuscular injections who administers erectile dysfunction treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a erectile dysfunction treatment vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the erectile dysfunction treatment covered countermeasure is administered.

Subject to the following requirements. I. The treatment must be authorized, approved, or licensed by the FDA.

Ii. Vaccination must be ordered and administered according to ACIP's erectile dysfunction treatment recommendation(s). Iii.

The healthcare professionals and students must have documentation of completion of the Centers for Disease Control and Prevention erectile dysfunction treatment Training Modules and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering erectile dysfunction treatments. Iv. The healthcare professionals and students must have documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering vaccinations is in their ordinary scope of practice, who confirms competency of the healthcare provider or student in preparation and administration of the erectile dysfunction treatment(s) to be administered and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering erectile dysfunction treatments.

V. The healthcare professionals and students must have a current certificate in basic cardiopulmonary resuscitation; [] vi. The healthcare professionals and students must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment.

And vii. The healthcare professionals and students comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) erectile dysfunction treatment vaccination provider agreement and any other federal requirements that apply to the administration of erectile dysfunction treatment(s). Nothing in this Declaration shall be construed to affect the National treatment Injury Compensation Program, including an injured party's ability to obtain compensation under that program.

Covered countermeasures that are subject to the National treatment Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program.

All other terms and conditions of the Declaration apply to such covered countermeasures. 2. Effective Time Period, section XII, delete in full and replace with.

Liability protections for any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, through the means of distribution identified in Section VII(a) of this Declaration, begin on March 27, 2020 and extend through October 1, 2024. Liability protections for all other Covered Countermeasures identified in Section VI of this Declaration, through means of distribution identified in Section VII(a) of this Declaration, begin on February 4, 2020 and extend through October 1, 2024. Liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begin with a Declaration of Emergency as that term is defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that ACIP recommends to persons ages three through 18 according to ACIP's standard immunization schedule, liability protections began on August 24, 2020), and last through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first.

Levitra official website

	Levitra	Stendra super force	Levitra professional	Cialis oral jelly
Dosage	Cheap	No	Cheap	No
Best way to use	38	49	64	63
Free samples	Yes	Yes	No	Yes
Buy with Paypal	At cvs	At cvs	Canadian Pharmacy	At walgreens
Take with alcohol	12h	5h	24h	19h

Therapeutic creep in provision of hypothermia for hypoxic ischaemic encephalopathyThree articles relate to the changing practices of UK clinicians in the provision levitra official website of therapeutic hypothermia for hypoxic ischaemic encephalopathy http://www.tracyiperkins.com/2016/04/18/highs-lows/ (HIE). Lori Hage and colleagues report the clinical characteristics of term born infants treated with therapeutic hypothermia for a diagnosis of HIE in the UK between 2010 and 2017. The data came from the National Neonatal Research Database and include infants who were treated for 3 days or who died during this levitra official website period. There were 5201 infants who met this definition. The number of infants treated increased year on year until 2015 and then levelled out.

Markers of condition at levitra official website birth suggested inclusion over time of greater numbers of infants with less severe disease. The number of infants treated with a diagnosis of mild encephalopathy increased four-fold from 31 infants per year to 133 infants per year over the study period. There was no important change in the number of infants treated with severe levitra official website encephalopathy over the same time period. Lara Shipley and colleagues report temporal changes in the incidence of hypoxic-ischaemic encephalopathy in the UK between the time periods 2011–13 and 2014–16. The incidence of mild and of moderate or severe HIE remained stable between epochs suggesting that there has not been diagnostic creep driving the therapeutic creep.

The proportion of infants with mild HIE who were treated with therapeutic hypothermia significantly levitra official website increased over time between 2011–2013 (24.9%) and 2014–2016 (35.8%). The number of late preterm infants diagnosed with HIE also remained stable over time but again the proportion treated with hypothermia increased from 34% to 47%. This therapeutic creep, where larger numbers of infants are cooled who do not fulfil the criteria used to select infants for enrolment in the randomised controlled trials has been observed in other health systems. On the one hand it represents invasive levitra official website treatment that is not well supported by the evidence base. Further trials are called for to determine whether hypothermia is beneficial in milder cases.

The authors also point out that there is some is some subjectivity in the assessment of encephalopathy meaning that some clinicians don't cool borderline infants where others levitra official website would classify them with more severe encephalopathy. Unrelated to these articles but on the same theme we received a viewpoint from Mohamed Ali Tagin and Alastair Gunn. They argue that the criteria used to select infants for the trials were deliberately biased towards selecting infants at highest risk (and by inference not likely to have selected all infants that stand to benefit). The individual components of the inclusion criteria perform poorly and levitra official website are subjective. They encourage clinicians in doubt about whether an infant should be cooled to choose cooling because there is still an appreciable risk of adverse outcome and the treatment can be delivered safely, so that the potential benefits outweigh the potential harms.

They argue levitra official website that the limitations of the evidence should be discussed with the families involved. Perhaps therapeutic creep will push the trials out of reach. When new treatments are shown to be effective it is understandable that clinicians are keen to use them and this makes research more difficult before we know everything we want to know. This again is a situation that would become less likely if we continue to work towards inclusive research models normalising levitra official website routine involvement in enhancing the knowledge base. See pages F529, F501 and F458Methods for surfactant administrationA network meta-analysis by Ioannis Bellos and colleagues of 16 RCTs and 20 observational studies including data from more than 13 000 infants, suggests that thin catheter administration of surfactant is associated with lower rates of mortality, PVL, BPD and mechanical ventilation.

See page F474The cost of neonatal abstinence syndromePhilippa Rees and colleagues estimated the direct NHS costs of neonatal unit in-patient care for Neonatal Abstinence Syndrome in England between 2012 and 2017 using the National Neonatal Research Database. There were 6411 admissions with this diagnosis during the study period (1.6 levitra official website per 1000 births) and the incidence increased over time. The direct annual cost of care was £10 440 444, with a median cost of £7715 per infant. The median time to discharge was 10.2 days and this levitra official website was higher in the 49% of infants receiving pharmacotherapy. The emerging literature suggests that changes in the model of care away from neonatal unit admission could improve patient outcomes and greatly reduce costs.

See page F494Measurement of the effect of chest compressionsResuscitation council guidance advises on the depth of chest compressions during cardiopulmonary resuscitation in the newborn. Although it makes sense that compression depth is important this is based on indirect information and extrapolation levitra official website. Marlies Bruckner and colleagues developed an automated device that could deliver controlled compression depth and investigated its effect on piglets with experimental asphyxia to asystole. Compression depth made an important levitra official website difference to carotid blood flow and systolic blood pressure. See page F553Face mask versus nasal prong or nasopharyngeal tube for neonatal resuscitation in the delivery roomAvneet Magnat and colleagues performed a systematic review of evidence relating to the best interface for providing respiratory support in the delivery room.

They identified five randomised controlled trials involving 873 infants. There was no difference in mortality levitra official website between devices. Confidence intervals for most outcomes were wide indicating the need for more data. Difference in rates of intubation in the delivery room and need for chest compressions during initial stabilisation suggest that more data may uncover clinically important differences. It will be interesting to see levitra official website how this meta-analysis changes after inclusion of data from the recently completed CORSAD trial.

See page F561Ethics statementsPatient consent for publicationNot required.Clinical scenario‘Sarah is a baby girl born by an emergency caesarean section following a period of observation for non-reassuring cardiotocographic recordings. She was initially ‘flat’ and received positive pressure ventilation for 3 min before levitra official website establishing spontaneous breathing. Her Apgar scores were 1, 6 and 8 at 1, 5 and 10 min, respectively. Cord pH was 7.08 and standard base excess (sBE) was −12.1. Sarah stayed with her mother as she was breathing normally levitra official website and centrally pink despite being mildly hypotonic with minimal activity.

At 10 hours of age, she started to develop recurrent seizures. Cerebral MRI showed extensive diffusion restriction patterns compatible with acute hypoxic–ischaemic levitra official website insult.’Sarah is a composite case, developed to include real events that we and others have observed. Unfortunately, many neonatal units receive similar cases every year and they often end up not offering therapeutic hypothermia, the only available treatment with proven safety and efficacy to this condition.1 The current guidelines are not inclusive and do not consider borderline cases.2 3The simple question clinicians should ask themselves, is it unreasonable to treat a newborn with perinatal asphyxia and moderate encephalopathy?. Babies, in a situation like Sarah, may lose the opportunity to be treated with therapeutic hypothermia because they miss a single criterion from the current cooling guidelines. The selection criteria in the initial randomised controlled trials of hypothermia were developed to identify the highest risk newborns levitra official website who had been exposed to hypoxia–ischaemia.

Newborns who had lower levels of risk were pragmatically excluded. Now that the evidence for benefit is well established,1 4 we propose that those entry points ….

Therapeutic creep in provision of hypothermia for hypoxic ischaemic encephalopathyThree articles relate to the changing practices of UK clinicians best price levitra generic in the provision of therapeutic hypothermia for hypoxic ischaemic encephalopathy Going Here (HIE). Lori Hage and colleagues report the clinical characteristics of term born infants treated with therapeutic hypothermia for a diagnosis of HIE in the UK between 2010 and 2017. The data came from the National Neonatal Research Database best price levitra generic and include infants who were treated for 3 days or who died during this period.

There were 5201 infants who met this definition. The number of infants treated increased year on year until 2015 and then levelled out. Markers of condition at birth suggested inclusion best price levitra generic over time of greater numbers of infants with less severe disease.

The number of infants treated with a diagnosis of mild encephalopathy increased four-fold from 31 infants per year to 133 infants per year over the study period. There was no important change in the number of infants treated with severe encephalopathy over the same best price levitra generic time period. Lara Shipley and colleagues report temporal changes in the incidence of hypoxic-ischaemic encephalopathy in the UK between the time periods 2011–13 and 2014–16.

The incidence of mild and of moderate or severe HIE remained stable between epochs suggesting that there has not been diagnostic creep driving the therapeutic creep. The proportion of infants with mild HIE who were treated with therapeutic hypothermia significantly increased over time between 2011–2013 (24.9%) and 2014–2016 (35.8%) best price levitra generic. The number of late preterm infants diagnosed with HIE also remained stable over time but again the proportion treated with hypothermia increased from 34% to 47%.

This therapeutic creep, where larger numbers of infants are cooled who do not fulfil the criteria used to select infants for enrolment in the randomised controlled trials has been observed in other health systems. On the one hand it represents invasive treatment that best price levitra generic is not well supported by the evidence base. Further trials are called for to determine whether hypothermia is beneficial in milder cases.

The authors also point out that there is some is some subjectivity in the assessment of encephalopathy meaning that some clinicians don't best price levitra generic cool borderline infants where others would classify them with more severe encephalopathy. Unrelated to these articles but on the same theme we received a viewpoint from Mohamed Ali Tagin and Alastair Gunn. They argue that the criteria used to select infants for the trials were deliberately biased towards selecting infants at highest risk (and by inference not likely to have selected all infants that stand to benefit).

The individual components of best price levitra generic the inclusion criteria perform poorly and are subjective. They encourage clinicians in doubt about whether an infant should be cooled to choose cooling because there is still an appreciable risk of adverse outcome and the treatment can be delivered safely, so that the potential benefits outweigh the potential harms. They argue that the limitations of the evidence should be discussed with the best price levitra generic families involved.

Perhaps therapeutic creep will push the trials out of reach. When new treatments are shown to be effective it is understandable that clinicians are keen to use them and this makes research more difficult before we know everything we want to know. This again is a situation that would become less likely if we continue to work towards inclusive research best price levitra generic models normalising routine involvement in enhancing the knowledge base.

See pages F529, F501 and F458Methods for surfactant administrationA network meta-analysis by Ioannis Bellos and colleagues of 16 RCTs and 20 observational studies including data from more than 13 000 infants, suggests that thin catheter administration of surfactant is associated with lower rates of mortality, PVL, BPD and mechanical ventilation. See page F474The cost of neonatal abstinence syndromePhilippa Rees and colleagues estimated the direct NHS costs of neonatal unit in-patient care for Neonatal Abstinence Syndrome in England between 2012 and 2017 using the National Neonatal Research Database. There were best price levitra generic 6411 admissions with this diagnosis during the study period (1.6 per 1000 births) and the incidence increased over where can you buy levitra time.

The direct annual cost of care was £10 440 444, with a median cost of £7715 per infant. The median time to discharge was 10.2 days and this was higher in best price levitra generic the 49% of infants receiving pharmacotherapy. The emerging literature suggests that changes in the model of care away from neonatal unit admission could improve patient outcomes and greatly reduce costs.

See page F494Measurement of the effect of chest compressionsResuscitation council guidance advises on the depth of chest compressions during cardiopulmonary resuscitation in the newborn. Although it best price levitra generic makes sense that compression depth is important this is based on indirect information and extrapolation. Marlies Bruckner and colleagues developed an automated device that could deliver controlled compression depth and investigated its effect on piglets with experimental asphyxia to asystole.

Compression depth best price levitra generic made an important difference to carotid blood flow and systolic blood pressure. See page F553Face mask versus nasal prong or nasopharyngeal tube for neonatal resuscitation in the delivery roomAvneet Magnat and colleagues performed a systematic review of evidence relating to the best interface for providing respiratory support in the delivery room. They identified five randomised controlled trials involving 873 infants.

There was no difference in mortality between devices best price levitra generic. Confidence intervals for most outcomes were wide indicating the need for more data. Difference in rates of intubation in the delivery room and need for chest compressions during initial stabilisation suggest that more data may uncover clinically important differences.

It will best price levitra generic be interesting to see how this meta-analysis changes after inclusion of data from the recently completed CORSAD trial. See page F561Ethics statementsPatient consent for publicationNot required.Clinical scenario‘Sarah is a baby girl born by an emergency caesarean section following a period of observation for non-reassuring cardiotocographic recordings. She was initially ‘flat’ and received positive pressure ventilation for 3 min best price levitra generic before establishing spontaneous breathing.

Her Apgar scores were 1, 6 and 8 at 1, 5 and 10 min, respectively. Cord pH was 7.08 and standard base excess (sBE) was −12.1. Sarah stayed best price levitra generic with her mother as she was breathing normally and centrally pink despite being mildly hypotonic with minimal activity.

At 10 hours of age, she started to develop recurrent seizures. Cerebral MRI showed extensive diffusion restriction patterns compatible with acute hypoxic–ischaemic insult.’Sarah is best price levitra generic a composite case, developed to include real events that we and others have observed. Unfortunately, many neonatal units receive similar cases every year and they often end up not offering therapeutic hypothermia, the only available treatment with proven safety and efficacy to this condition.1 The current guidelines are not inclusive and do not consider borderline cases.2 3The simple question clinicians should ask themselves, is it unreasonable to treat a newborn with perinatal asphyxia and moderate encephalopathy?.

Babies, in a situation like Sarah, may lose the opportunity to be treated with therapeutic hypothermia because they miss a single criterion from the current cooling guidelines. The selection criteria in the initial randomised controlled trials of hypothermia were developed to identify the best price levitra generic highest risk newborns who had been exposed to hypoxia–ischaemia. Newborns who had lower levels of risk were pragmatically excluded.

Now that the evidence for benefit is well established,1 4 we propose that those entry points ….

Where can I keep Levitra?

Keep out of the reach of children. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

Compare viagra cialis levitra side effects

Over the past 20 years, a large body of research has documented a relationship between higher nurse-to-patient compare viagra cialis levitra side effects staffing ratios and better patient outcomes, including shorter hospital stays, lower rates of failure to prevent mortality after an in-hospital complication, inpatient mortality for multiple types of patients, hospital-acquired pneumonia, unplanned extubation, respiratory failure and cardiac arrest.1–5 In addition, patients report higher satisfaction when they are cared for more helpful hints in hospitals with higher staffing levels.6 7To date, most studies have not identified an ‘optimal’ nurse staffing ratio,8 which creates a challenge for determining appropriate staffing levels. If increasing nurse staffing always produces at least some improvement in the quality of care, how does one determine what staffing level is best?. This decision is ultimately an economic one, balancing the benefits of nurse staffing with the other options for which those resources compare viagra cialis levitra side effects could be used. It is in this context that hospitals develop staffing plans, generally based on historical patterns of patient acuity.Practical challenges of nurse staffingHospital staffing plans provide the structure necessary for determining hiring and scheduling, but fall short for a number of reasons.

First, there are multiple ways in which patient acuity can be measured, which can have measurable effects on the staffing levels resulting from acuity models.9 Second, patient compare viagra cialis levitra side effects volume and acuity can shift rapidly with changes in the volume of admissions, discharges and transfers between units. Third, staffing plans provide little guidance regarding the optimal mix of permanent staff, variable staff and externally contracted staff.The paper by Saville and colleagues10 in this issue of BMJ Quality &. Safety addresses the latter two issues by applying a simulation model to identify the optimal target for baseline nurse staffing in order to minimise periods of understaffing compare viagra cialis levitra side effects. Included in this model is consideration of the extent to which hospitals should leverage temporary personnel (typically obtained through an external agency) to fill gaps.

The model acknowledges the likelihood compare viagra cialis levitra side effects that a hospital cannot realistically prevent all shifts from having a shortfall of nurses at all times, as well as the reality that hospital managers lack information about the best balance between permanent and temporary staff. In addition, the analysis includes a calculation of the costs of each staffing approach, drawing from the records of 81 inpatient wards in four hospital organisations.The application of sophisticated simulation models and other advanced analyticl approaches to analysis of nurse staffing has been limited to date, and this paper is an exemplar of the value of such research. Recent studies have used machine learning methods to forecast hospital discharge volume,11 a discrete event simulation model to determine nursing staff needs in a neonatal intensive care unit,12 and a prediction model compare viagra cialis levitra side effects using machine learning and hierarchical linear regression to link variation in nurse staffing with patient outcomes.13 This new study applied a unique Monte Carlo simulation model to estimate demand for nursing care and test different strategies to meet demand.The results of the analysis are not surprising in that hospitals are much less likely to experience understaffed patient shifts if they aim to have higher baseline staffing. The data demonstrate a notable leftward skew, indicating that hospitals are more likely to have large unanticipated increases in patient volume and acuity than to have unanticipated decreases.

This results compare viagra cialis levitra side effects in hospitals being more likely to have shifts that are understaffed than shifts that are overstaffed, which inevitably places pressure on hospitals to staff at a higher level and/or have access to a larger pool of temporary nurses. It also is not surprising that hospitals will need to spend more money per patient day if they aim to reduce the percent of shifts that are understaffed. What is surprising about the results is that hospitals do not necessarily achieve cost savings by relying on temporary personnel versus setting regular staffing at a higher level.Trade-offs between permanent and temporary staffThe temporary nursing workforce enables healthcare facilities to maintain flexible yet full care teams based on patient care needs. Hospitals can use temporary nurses to address staffing gaps during leaves of absence, turnover or gaps between recruitment of permanent compare viagra cialis levitra side effects nurses, as well as during high-census periods.

Temporary personnel are typically more expensive on an hourly basis than permanent staff. In addition, compare viagra cialis levitra side effects over-reliance on temporary staff can have detrimental effects on permanent nurses’ morale and motivation. Orientations prior to shifts are often limited, which leads to a twofold concern as temporary nurses feel ill-prepared for shifts and permanent staff feel flustered when required to bring the temporary nurse up to speed while being expected to continue normal operations.14 Agency nurses may be assigned to patients and units that are incongruent with their experience and skills—either to unfamiliar units, which affects their ability to confidently deliver care, or to less complex patients where they feel as if their skills are not used adequately.14 15 These issues can create tension between temporary and permanent nursing staff, which can be compounded by the wage disparity. Permanent staff might feel demoralised and expendable when working alongside temporary staff who are not integrated into the social fabric of the staff.16Hospital managers also must be cognisant of the potential quality impact of relying heavily on compare viagra cialis levitra side effects temporary nursing staff.

Research on the impact of contingent nursing employment on costs and quality have often found negative effects on quality, including mortality, and higher costs.17 18 However, other studies have found that the association between temporary nursing staff and low quality result from general shortages of nursing staff, which make a hospital more likely to employ temporary staff, and not directly from the contingent staff.19–21 Thus, temporary nurses play an important role in alleviating staffing shortages that would otherwise lead to lower quality of care.22Charting a path forward in hospital management and healthcare researchThe maturation of electronic health records and expansion of computerised healthcare management systems provide opportunities both for improved decision making about workforce deployment and for advanced workforce research. In the compare viagra cialis levitra side effects area of workforce management, nursing and other leaders have a growing array of workforce planning tools available to them. Such tools are most effective when they display clear information about predicted patient needs and staff availability, but managers still must rely on their on-the-ground understanding of their staff and their context of patient care.23 Integration of human resources data with patient outcomes data has revealed that individual nurses and their characteristics have important discrete effects on the quality of care.24 25 Future development of workforce planning tools should translate this evidence to practice. In addition, new technology platforms are emerging to facilitate compare viagra cialis levitra side effects direct matching between temporary healthcare personnel and healthcare organisations.

One recent study tested a smartphone-based application that allowed for direct matching of locum tenens physicians with a hospital in the English National Health Service, finding that the platform generated benefits including greater transparency and lower cost.26 Similar technologies for registered nurses could facilitate better matching between hospital needs and temporary nurses’ preparedness to meet those needs.Analytical methods that fully leverage the large datasets compiled through electronic health records, human resources systems and other sources can be applied to advance research on the composition of nursing teams to improve quality of care. As noted above, prior research has applied machine learning compare viagra cialis levitra side effects and discrete event simulation to analyses of healthcare staffing. Other recent studies have leveraged natural language processing of nursing notes to identify fall risk factors27 and applied data mining of human resources records to understand the job titles held by nurses.28 Linking these rapidly advancing analytical approaches that assess the outcomes and costs of nurse staffing strategies, such as the work by Saville and colleagues published in this issue, to data on the impact of nurse staffing on the long-term costs of patient care will further advance the capacity of hospital leaders to design cost-effective policies for workforce deployment.Guidelines aim to align clinical care with best practice. However, simply publishing a guideline rarely triggers behavioural changes to match guideline recommendations.1–3 We thus transform guideline recommendations into actionable tasks by introducing interventions that promote behavioural changes meant to produce guideline-concordant care.

Unfortunately, not much has changed in the 25 years since Oxman and colleagues concluded that we have no ‘magic bullets’ when it comes to changing clinician behaviour.4 In fact, far from magic bullets, interventions aimed at increasing the degree to which patients receive care recommended in guidelines (eg, educational interventions, reminders, audit and feedback, financial incentives, computerised decision support) typically produce disappointingly small improvements in care.5–10Much improvement work aims to ‘make the right compare viagra cialis levitra side effects thing to do the easy thing to do.’ Yet, design solutions which hardwire the desired actions remain few and far between. Further, improvement interventions which ‘softwire’ such actions—not guaranteeing that they occur, but at least increasing the likelihood that clinicians will deliver the care recommended in guidelines—mostly produce small improvements.5–9 Until this situation changes, we need to acknowledge the persistent reality that guidelines themselves represent a main strategy for promoting care consistent with current evidence, which means their design should promote the desired actions.11 12In this respect, guidelines constitute a type of clinical decision support. And, like all decision support compare viagra cialis levitra side effects interventions, guidelines require. (1) user testing to assess if the content is understood as intended and (2) empirical testing to assess if the decision support provided by the guideline does in fact promote the desired behaviours.

While the processes for developing guidelines have received substantial attention over the years,13–18 surprisingly little attention has been paid compare viagra cialis levitra side effects to empirically answering basic questions about the finished product. Do users understand guidelines as intended?. And, what version of a given compare viagra cialis levitra side effects guideline engenders the desired behaviours by clinicians?. In this issue of BMJ Quality and Safety, Jones et al19 address this gap by using simulation to compare the frequency of medication errors when clinicians administer an intravenous medication using an existing guideline in the UK’s National Health Service (NHS) versus a revised and user-tested version of the guideline that more clearly promotes the desired actions.

Their findings demonstrate that changes to guideline design (through addition of compare viagra cialis levitra side effects actionable decision supports) based on user feedback does in fact trigger changes in behaviour that can improve safety. This is an exciting use of simulation, which we believe should encourage further studies in this vein.Ensuring end users understand and use guidelines as intendedJones and colleagues’ approach affords an opportunity to reflect on the benefits of user testing and simulation of guidelines. The design and evaluation of their revised guidelines provides an excellent example of a careful stepwise progression compare viagra cialis levitra side effects in the development and evaluation of a guideline as a type of decision support for clinicians. First, in a prior study,20 they user tested the original NHS guidelines to improve retrieval and comprehension of information.

The authors produced a revised guideline, which included reformatted sections as well as increased support for key calculations, such as for infusion rates. The authors again user tested the revised guideline, compare viagra cialis levitra side effects successfully showing higher rates of comprehension. Note that user testing refers to a specific approach focused on comprehension rather than behaviour21 and is distinct from usability testing. Second, in the current study, Jones et al evaluated whether compare viagra cialis levitra side effects nurse and midwife end users exhibited the desired behavioural changes when given the revised guidelines (with addition of actionable decision supports), compared with a control group working with the current version of the guidelines used in practice.

As a result, Jones and colleagues verify that end users (1) understand the content in the guideline and (2) actually change their behaviour in response to using it.Simulation can play a particularly useful role in this context, as it can help identify problems with users’ comprehension of the guideline and also empirically assess what behavioural changes occur in response to design changes in the guidelines. The level of methodological control compare viagra cialis levitra side effects and qualitative detail that simulation provides is difficult to feasibly replicate with real-world pilot studies, and therefore simulation fills a critical gap.Jones et al report successful changes in behaviour due to the revised guidelines in which they added actionable decision supports. For example, their earlier user testing found that participants using the initial guidelines did not account for displacement volume when reconstituting the powdered drug, leading to dosing errors. A second error with the initial guidelines involved participants using the shortest infusion rate provided (eg, guidelines state ‘1 to 3 hours’), without realising that the shortest rate is not appropriate for compare viagra cialis levitra side effects certain doses (eg, 1 hour is appropriate for smaller doses, but larger doses should not be infused over 1 hour because the drug would then be administered faster than the maximum allowable infusion rate of 3 mg/kg/hour).

These two issues were addressed in the revised guidelines by providing key determinants for ‘action’ such as calculation formulas that account for displacement volume and infusion duration, thereby more carefully guiding end users to avoid these dose and rate errors. These changes compare viagra cialis levitra side effects to the guideline triggered specific behaviours (eg, calculations that account for all variables) that did not occur with the initial guidelines. Therefore, the simulation testing demonstrated the value of providing determinants for action, such as specific calculation formulas to support end users, by showing a clear reduction in dose and rate errors when using the revised guidelines compared with the initial guidelines.The authors also report that other types of medication-specific errors remained unaffected by the revised guidelines (eg, incorrect technique and flush errors)—the changes made did not facilitate the desired actions. The initial guidelines indicate ‘DO NOT SHAKE’ in capital letters, and there is a section specific to ‘Flushing’ compare viagra cialis levitra side effects.

In contrast, the revised guidelines do not capitalise the warning about shaking the vial, but embed the warning with a numbered sequence in the medication preparation section, aiming to increase the likelihood of reading it at the appropriate time. The revised guidelines do not have a section specific to flushing, but embed the flushing instructions as an unnumbered step in the administration section. Thus, the value of embedding technique and flushing information within the context of use was not validated in the simulation testing (ie, no significant differences in the rates of these errors), highlighting precisely the pivotal role compare viagra cialis levitra side effects that simulation can play in assessing whether attempts to improve usability result in actual behavioural changes.Finally, simulation can identify potential unintended consequences of a guideline. For instance, Jones and colleagues observed an increase in errors (although not statistically significant) that were not medication specific (eg, non-aseptic technique such as hand washing, swabbing vials with an alcohol wipe).

Given that the revised guidelines were specific to the medication tested, it is unusual that we see a tendency toward a worsening effect on generic compare viagra cialis levitra side effects medication preparation skills. Again, this finding was not significant, but we highlight this to remind ourselves of the very real possibility that some interventions might introduce new and unexpected errors in response to changing workflow and practice6. Simulations offer an opportunity to spot these risks in advance.Now that Jones et al have seen how the revised guidelines change behaviour, they are optimally positioned compare viagra cialis levitra side effects to move forward. On one hand, they have the option of revising the guidelines further in attempts to address these resistant errors, and on the other, they can consider designing other interventions to be implemented in parallel with their user-tested guidance.

At first glance, the errors that were resistant to change appear to be mechanical tasks that end users might think of as applying uniformly to multiple medications (eg, flush errors, compare viagra cialis levitra side effects non-aseptic technique). Therefore, a second intervention that has a more general scope (rather than drug specific) might be pursued. Regardless of what they decide to pursue, we applaud their measured approach and highlight that the key takeaway is that their next steps are supported with clearer evidence of what to expect when the guidelines are released—certainly a helpful piece of information to guide decisions as to whether broad implementation of guidelines is justified.Caveats and conclusionSimulation is not a panacea—it is not able to assess longitudinal adherence, and there are limitations to how realistically clinicians behave compare viagra cialis levitra side effects when observed for a few sample procedures when under the scrutiny of observers. Further, studies where interventions are implemented to assess whether they move the needle on the outcomes we care about (eg, adverse events, length of stay, patient mortality) are needed and should continue.

However, having end users physically perform clinical tasks with the intervention in representative environments represents an important strategy to assess the degree to which guidelines and other compare viagra cialis levitra side effects decision support interventions in fact promote the desired behaviours and to spot problems in advance of implementation. Such simulation testing is not currently a routine step in intervention design. We hope it becomes a more common phenomenon, with more improvement work following the example of the approach so effectively demonstrated by Jones and colleagues..

Over the past 20 years, a large body of research has documented a relationship between higher nurse-to-patient staffing best price levitra generic ratios and better patient outcomes, including shorter hospital stays, lower rates of failure to prevent mortality after an in-hospital complication, inpatient mortality for multiple types of patients, hospital-acquired pneumonia, unplanned extubation, respiratory failure and cardiac arrest.1–5 In addition, patients report higher satisfaction when they are cared for in hospitals with higher staffing levels.6 7To date, most studies have not identified an ‘optimal’ nurse staffing ratio,8 which creates a challenge for determining appropriate staffing levels. If increasing nurse staffing always produces at least some improvement in the quality of care, how does one determine what staffing level is best?. This decision is ultimately an economic one, balancing the benefits of nurse staffing with the other options for best price levitra generic which those resources could be used. It is in this context that hospitals develop staffing plans, generally based on historical patterns of patient acuity.Practical challenges of nurse staffingHospital staffing plans provide the structure necessary for determining hiring and scheduling, but fall short for a number of reasons. First, there are multiple ways in which patient acuity can be best price levitra generic measured, which can have measurable effects on the staffing levels resulting from acuity models.9 Second, patient volume and acuity can shift rapidly with changes in the volume of admissions, discharges and transfers between units.

Third, staffing plans provide little guidance regarding the optimal mix of permanent staff, variable staff and externally contracted staff.The paper by Saville and colleagues10 in this issue of BMJ Quality &. Safety addresses the latter two issues by applying a simulation model to identify the optimal target for baseline nurse staffing in order best price levitra generic to minimise periods of understaffing. Included in this model is consideration of the extent to which hospitals should leverage temporary personnel (typically obtained through an external agency) to fill gaps. The model acknowledges the likelihood that a hospital cannot realistically prevent best price levitra generic all shifts from having a shortfall of nurses at all times, as well as the reality that hospital managers lack information about the best balance between permanent and temporary staff. In addition, the analysis includes a calculation of the costs of each staffing approach, drawing from the records of 81 inpatient wards in four hospital organisations.The application of sophisticated simulation models and other advanced analyticl approaches to analysis of nurse staffing has been limited to date, and this paper is an exemplar of the value of such research.

Recent studies have used machine learning methods to forecast hospital discharge volume,11 a discrete event simulation model to determine nursing staff needs in a neonatal intensive care unit,12 and a prediction model using machine learning and hierarchical linear regression to link variation in nurse staffing with patient outcomes.13 This new study applied a unique Monte Carlo simulation model to estimate demand for nursing care and test different strategies to meet demand.The results of the analysis are not surprising in that hospitals are much best price levitra generic less likely to experience understaffed patient shifts if they aim to have higher baseline staffing. The data demonstrate a notable leftward skew, indicating that hospitals are more likely to have large unanticipated increases in patient volume and acuity than to have unanticipated decreases. This results in hospitals being more likely to have shifts that are understaffed than shifts that are overstaffed, which inevitably places pressure on hospitals to staff at a higher level and/or best price levitra generic have access to a larger pool of temporary nurses. It also is not surprising that hospitals will need to spend more money per patient day if they aim to reduce the percent of shifts that are understaffed. What is surprising about the results is that hospitals do not necessarily achieve cost savings by relying on temporary personnel versus setting regular staffing at a higher level.Trade-offs between permanent and temporary staffThe temporary nursing workforce enables healthcare facilities to maintain flexible yet full care teams based on patient care needs.

Hospitals can use temporary nurses to address staffing gaps during leaves of absence, turnover or gaps between recruitment of best price levitra generic permanent nurses, as well as during high-census periods. Temporary personnel are typically more expensive on an hourly basis than permanent staff. In addition, over-reliance on temporary staff best price levitra generic can have detrimental effects on permanent nurses’ morale and motivation. Orientations prior to shifts are often limited, which leads to a twofold concern as temporary nurses feel ill-prepared for shifts and permanent staff feel flustered when required to bring the temporary nurse up to speed while being expected to continue normal operations.14 Agency nurses may be assigned to patients and units that are incongruent with their experience and skills—either to unfamiliar units, which affects their ability to confidently deliver care, or to less complex patients where they feel as if their skills are not used adequately.14 15 These issues can create tension between temporary and permanent nursing staff, which can be compounded by the wage disparity. Permanent staff might feel demoralised and expendable when working alongside temporary staff who are not integrated best price levitra generic into the social fabric of the staff.16Hospital managers also must be cognisant of the potential quality impact of relying heavily on temporary nursing staff.

Research on the impact of contingent nursing employment on costs and quality have often found negative effects on quality, including mortality, and higher costs.17 18 However, other studies have found that the association between temporary nursing staff and low quality result from general shortages of nursing staff, which make a hospital more likely to employ temporary staff, and not directly from the contingent staff.19–21 Thus, temporary nurses play an important role in alleviating staffing shortages that would otherwise lead to lower quality of care.22Charting a path forward in hospital management and healthcare researchThe maturation of electronic health records and expansion of computerised healthcare management systems provide opportunities both for improved decision making about workforce deployment and for advanced workforce research. In the area of workforce management, best price levitra generic nursing and other leaders have a growing array of workforce planning tools available to them. Such tools are most effective when they display clear information about predicted patient needs and staff availability, but managers still must rely on their on-the-ground understanding of their staff and their context of patient care.23 Integration of human resources data with patient outcomes data has revealed that individual nurses and their characteristics have important discrete effects on the quality of care.24 25 Future development of workforce planning tools should translate this evidence to practice. In addition, new technology platforms are best price levitra generic emerging to facilitate direct matching between temporary healthcare personnel and healthcare organisations. One recent study tested a smartphone-based application that allowed for direct matching of locum tenens physicians with a hospital in the English National Health Service, finding that the platform generated benefits including greater transparency and lower cost.26 Similar technologies for registered nurses could facilitate better matching between hospital needs and temporary nurses’ preparedness to meet those needs.Analytical methods that fully leverage the large datasets compiled through electronic health records, human resources systems and other sources can be applied to advance research on the composition of nursing teams to improve quality of care.

As noted above, prior research has applied machine learning and discrete event simulation best price levitra generic to analyses of healthcare staffing. Other recent studies have leveraged natural language processing of nursing notes to identify fall risk factors27 and applied data mining of human resources records to understand the job titles held by nurses.28 Linking these rapidly advancing analytical approaches that assess the outcomes and costs of nurse staffing strategies, such as the work by Saville and colleagues published in this issue, to data on the impact of nurse staffing on the long-term costs of patient care will further advance the capacity of hospital leaders to design cost-effective policies for workforce deployment.Guidelines aim to align clinical care with best practice. However, simply publishing a guideline rarely triggers behavioural changes to match guideline recommendations.1–3 We thus transform guideline recommendations into actionable tasks by introducing interventions that promote behavioural changes meant to produce guideline-concordant care. Unfortunately, not much has changed in the 25 years since Oxman and colleagues concluded that we have best price levitra generic no ‘magic bullets’ when it comes to changing clinician behaviour.4 In fact, far from magic bullets, interventions aimed at increasing the degree to which patients receive care recommended in guidelines (eg, educational interventions, reminders, audit and feedback, financial incentives, computerised decision support) typically produce disappointingly small improvements in care.5–10Much improvement work aims to ‘make the right thing to do the easy thing to do.’ Yet, design solutions which hardwire the desired actions remain few and far between. Further, improvement interventions which ‘softwire’ such actions—not guaranteeing that they occur, but at least increasing the likelihood that clinicians will deliver the care recommended in guidelines—mostly produce small improvements.5–9 Until this situation changes, we need to acknowledge the persistent reality that guidelines themselves represent a main strategy for promoting care consistent with current evidence, which means their design should promote the desired actions.11 12In this respect, guidelines constitute a type of clinical decision support.

And, like best price levitra generic all decision support interventions, guidelines require. (1) user testing to assess if the content is understood as intended and (2) empirical testing to assess if the decision support provided by the guideline does in fact promote the desired behaviours. While the processes for developing guidelines have received substantial attention over the years,13–18 surprisingly little attention has been paid to empirically answering basic questions about the best price levitra generic finished product. Do users understand guidelines as intended?. And, what version of a given guideline engenders the desired behaviours by best price levitra generic clinicians?.

In this issue of BMJ Quality and Safety, Jones et al19 address this gap by using simulation to compare the frequency of medication errors when clinicians administer an intravenous medication using an existing guideline in the UK’s National Health Service (NHS) versus a revised and user-tested version of the guideline that more clearly promotes the desired actions. Their findings demonstrate that changes to guideline design (through addition of best price levitra generic actionable decision supports) based on user feedback does in fact trigger changes in behaviour that can improve safety. This is an exciting use of simulation, which we believe should encourage further studies in this vein.Ensuring end users understand and use guidelines as intendedJones and colleagues’ approach affords an opportunity to reflect on the benefits of user testing and simulation of guidelines. The design and evaluation of their revised guidelines provides an excellent example of a careful stepwise best price levitra generic progression in the development and evaluation of a guideline as a type of decision support for clinicians. First, in a prior study,20 they user tested the original NHS guidelines to improve retrieval and comprehension of information.

The authors produced a revised guideline, which included reformatted sections as well as increased support for key calculations, such as for infusion rates. The authors best price levitra generic again user tested the revised guideline, successfully showing higher rates of comprehension. Note that user testing refers to a specific approach focused on comprehension rather than behaviour21 and is distinct from usability testing. Second, in the current study, Jones et al best price levitra generic evaluated whether nurse and midwife end users exhibited the desired behavioural changes when given the revised guidelines (with addition of actionable decision supports), compared with a control group working with the current version of the guidelines used in practice. As a result, Jones and colleagues verify that end users (1) understand the content in the guideline and (2) actually change their behaviour in response to using it.Simulation can play a particularly useful role in this context, as it can help identify problems with users’ comprehension of the guideline and also empirically assess what behavioural changes occur in response to design changes in the guidelines.

The level of methodological control and qualitative detail that simulation provides is best price levitra generic difficult to feasibly replicate with real-world pilot studies, and therefore simulation fills a critical gap.Jones et al report successful changes in behaviour due to the revised guidelines in which they added actionable decision supports. For example, their earlier user testing found that participants using the initial guidelines did not account for displacement volume when reconstituting the powdered drug, leading to dosing errors. A second error with the initial guidelines involved participants using the shortest infusion rate provided (eg, guidelines state ‘1 to 3 hours’), without realising that the shortest rate is not best price levitra generic appropriate for certain doses (eg, 1 hour is appropriate for smaller doses, but larger doses should not be infused over 1 hour because the drug would then be administered faster than the maximum allowable infusion rate of 3 mg/kg/hour). These two issues were addressed in the revised guidelines by providing key determinants for ‘action’ such as calculation formulas that account for displacement volume and infusion duration, thereby more carefully guiding end users to avoid these dose and rate errors. These changes to the guideline triggered specific behaviours (eg, calculations best price levitra generic that account for all variables) that did not occur with the initial guidelines.

Therefore, the simulation testing demonstrated the value of providing determinants for action, such as specific calculation formulas to support end users, by showing a clear reduction in dose and rate errors when using the revised guidelines compared with the initial guidelines.The authors also report that other types of medication-specific errors remained unaffected by the revised guidelines (eg, incorrect technique and flush errors)—the changes made did not facilitate the desired actions. The initial best price levitra generic guidelines indicate ‘DO NOT SHAKE’ in capital letters, and there is a section specific to ‘Flushing’. In contrast, the revised guidelines do not capitalise the warning about shaking the vial, but embed the warning with a numbered sequence in the medication preparation section, aiming to increase the likelihood of reading it at the appropriate time. The revised guidelines do not have a section specific to flushing, but embed the flushing instructions as an unnumbered step in the administration section. Thus, the value of embedding technique and flushing information within the context of use was not validated in the simulation testing (ie, no significant differences in the rates of these errors), highlighting precisely the pivotal role that simulation can play in assessing whether attempts best price levitra generic to improve usability result in actual behavioural changes.Finally, simulation can identify potential unintended consequences of a guideline.

For instance, Jones and colleagues observed an increase in errors (although not statistically significant) that were not medication specific (eg, non-aseptic technique such as hand washing, swabbing vials with an alcohol wipe). Given that the revised guidelines were specific to best price levitra generic the medication tested, it is unusual that we see a tendency toward a worsening effect on generic medication preparation skills. Again, this finding was not significant, but we highlight this to remind ourselves of the very real possibility that some interventions might introduce new and unexpected errors in response to changing workflow and practice6. Simulations offer an opportunity to spot these risks in advance.Now that Jones et al have seen how the revised guidelines change behaviour, they are best price levitra generic optimally positioned to move forward. On one hand, they have the option of revising the guidelines further in attempts to address these resistant errors, and on the other, they can consider designing other interventions to be implemented in parallel with their user-tested guidance.

At first glance, the errors that were resistant to change appear to be mechanical tasks that end users might think of as applying uniformly to multiple medications (eg, best price levitra generic flush errors, non-aseptic technique). Therefore, a second intervention that has a more general scope (rather than drug specific) might be pursued. Regardless of best price levitra generic what they decide to pursue, we applaud their measured approach and highlight that the key takeaway is that their next steps are supported with clearer evidence of what to expect when the guidelines are released—certainly a helpful piece of information to guide decisions as to whether broad implementation of guidelines is justified.Caveats and conclusionSimulation is not a panacea—it is not able to assess longitudinal adherence, and there are limitations to how realistically clinicians behave when observed for a few sample procedures when under the scrutiny of observers. Further, studies where interventions are implemented to assess whether they move the needle on the outcomes we care about (eg, adverse events, length of stay, patient mortality) are needed and should continue. However, having end users physically perform clinical tasks with the intervention in representative environments represents an important strategy best price levitra generic to assess the degree to which guidelines and other decision support interventions in fact promote the desired behaviours and to spot problems in advance of implementation.

Such simulation testing is not currently a routine step in intervention design. We hope it becomes a more common phenomenon, with more improvement work following the example of the approach so effectively demonstrated by Jones and colleagues..

Images of levitra

Abemaciclib 215268 Verzenio Eli prices of levitra Lilly images of levitra Canada Inc. N/A 2019-04-08 2025-04-08 N/A 2027-04-08 acalabrutinib 214504 Calquence AstraZeneca Canada Inc. N/A 2019-08-23 2025-08-23 images of levitra N/A 2027-08-23 aclidinium bromide 157598 Tudorza Genuair AstraZeneca Canada Inc. Duaklir Genuair 2013-07-29 2019-07-29 N/A 2021-07-29 afatinib dimaleate 158730 Giotrif Boehringer Ingelheim (Canada) Ltd. N/A 2013-11-01 2019-11-01 N/A 2021-11-01 aflibercept 149321 Eylea Bayer Inc.

N/A 2013-11-08 2019-11-08 N/A images of levitra 2021-11-08 albiglutide 165145 Eperzan GlaxoSmithKline Inc. N/A 2015-07-15 2021-07-15 N/A 2023-07-15 alectinib hydrochloride 189442 Alecensaro Hoffmann-La Roche Limited N/A 2016-09-29 2022-09-29 N/A 2024-09-29 alirocumab 183116 Praluent Sanofi-aventis Canada Inc. N/A 2016-04-11 2022-04-11 N/A 2024-04-11 alogliptin benzoate 158335 Nesina Takeda Canada Inc. KazanoOseni 2013-11-27 2019-11-27 N/A 2021-11-27 alpelisib 226941 Piqray images of levitra Novartis Pharmaceuticals Canada Inc. N/A 2020-03-11 2026-03-11 N/A 2028-03-11 amifampridine (supplied as amifampridine phosphate) 232685 Firdapse Kye Pharmaceuticals Inc.

N/A 2020-07-31 2026-07-31 N/A 2028-07-31 anthrax immune globulin (human) images of levitra 200446 Anthrasil Emergent BioSolutions Canada Inc. N/A 2017-11-06 2023-11-06 Yes 2026-05-06 antihemophilic factor (recombinant BDD), Fc fusion protein 163447 Eloctate Sanofi-Aventis Canada Inc. N/A 2014-08-22 2020-08-22 Yes 2023-02-22 antihemophilic factor (recombinant), pegylated 189709 Adynovate Takeda Canada Inc. N/A 2016-11-17 2022-11-17 Yes images of levitra 2025-05-17 antihemophilic factor (recombinant, B-domain deleted, pegylated) (also known as damoctocog alfa pegol) 210935 Jivi Bayer Inc. N/A 2018-10-18 2024-10-18 Yes 2027-04-18 antihemophilic factor (recombinant, B-domain deleted) (also known as simoctocog alfa) 169551 Nuwiq Octapharma Pharmazeutika Produktionsges.m.b.H N/A 2014-10-23 2020-10-23 Yes 2023-04-23 antihemophilic factor VIII (recombinant), singlechain (also known as lonoctocog alfa) 190891 Afstyla CSL Behring Canada Inc.

N/A 2016-12-12 2022-12-12 Yes 2025-06-12 anthrax antigen fiate 212387 Biothrax Emergent Biodefense Operations Lansing LLC N/A 2018-12-13 2024-12-13 N/A 2026-12-13 antihemophilic factor VIII (recombinant, B-domain truncated), PEGylated (turoctocog alfa pegol) 218531 Esperoct Novo Nordisk Canada Inc. N/A 2019-07-04 images of levitra 2025-07-04 Yes 2028-01-04 apalutamide 211942 Erleada Janssen Inc. N/A 2018-07-03 2024-07-03 N/A 2026-07-03 apremilast 169862 Otezla Amgen Canada Inc. N/A 2014-11-12 2020-11-12 N/A 2022-11-12 asfotase alfa 179340 Strensiq Alexion Pharma International Sàrl N/A 2015-08-14 2021-08-14 Yes 2024-02-14 asunaprevir 172617 Sunvepra Bristol-Myers Squibb Canada N/A 2016-03-09 2022-03-09 N/A 2024-03-09 atezolizumab 196843 Tecentriq Hoffmann-La Roche Limited N/A 2017-04-12 2023-04-12 N/A 2025-04-12 avelumab 204052 Bavencio EMD Serono, a Division of EMD Inc., Canada N/A 2017-12-18 2023-12-18 N/A 2025-12-18 axicabtagene ciloleucel 218389 Yescarta Gilead Sciences Canada Inc N/A 2019-02-13 2025-02-13 N/A 2027-02-13 azelastine hydrochloride 169604 Dymista Meda Pharmaceuticals Ltd. N/A 2014-10-23 2020-10-23 Yes 2023-04-23 baloxavir marboxil 227361 Xofluza Hoffmann-La Roche Limited N/A 2020-02-19 images of levitra 2026-02-19 Yes 2028-08-19 baricitinib 193687 Olumiant Eli Lilly Canada Inc.

N/A 2018-08-17 2024-08-17 N/A 2026-08-17 bazedoxifene acetate 160681 Duavive Pfizer Canada Inc. N/A 2014-10-23 2020-10-23 N/A 2022-10-23 benralizumab 204008 Fasenra images of levitra AstraZeneca Canada Inc. N/A 2018-02-22 2024-02-22 Yes 2026-08-22 bepotastine besilate 179294 Bepreve Bausch and Lomb Incorporated N/A 2016-07-27 2022-07-27 Yes 2025-01-27 bictegravir 203718 Biktarvy Gilead Sciences Canada, Inc. N/A 2018-07-10 2024-07-10 Yes 2027-01-10 bilastine 184231 Blexten Aralez Pharmaceutials Canada Inc. N/A 2016-04-21 2022-04-21 Yes 2024-10-21 binimetinib 237410 Mektovi Pfizer Canada ULC N/A 2021-03-02 2027-03-02 N/A 2029-03-02 blinatumomab 181723 images of levitra Blincyto Amgen Canada Incorporated N/A 2015-12-22 2021-12-22 Yes 2024-06-22 bosutinib 152211 Bosulif Pfizer Canada Inc.

N/A 2014-03-07 2020-03-07 N/A 2022-03-07 botulism antitoxin heptavalen C/ D/ F/ G - (equine) 190645 Bat Emergent BioSolutions Inc. N/A 2016-12-08 2022-12-08 Yes 2025-06-08 brexpiprazole 192684 Rexulti Otsuka Pharmaceutical Co. Ltd. N/A 2017-02-16 2023-02-16 Yes 2025-08-16 brigatinib 210369 Alunbrig Takeda Canada Incorporated N/A 2018-07-26 2024-07-26 N/A 2026-07-26 brivaracetam 183355 Brivlera UCB Canada Incorporated N/A 2016-03-09 2022-03-09 Yes 2024-09-09 brodalumab 195317 Siliq Bausch Health, Canada Inc. N/A 2018-03-06 2024-03-06 N/A 2026-03-06 brolucizumab 226224 Beovu Novartis Pharmaceuticals Canada Inc.

N/A 2020-03-12 2026-03-12 N/A 2028-03-12 bromfenac sodium sesquihydrate 171657 Prolensa Bausch &. Lomb Incorporated N/A 2015-03-26 2021-03-26 N/A 2023-03-26 burosumab 216239 Crysvita Kyowa Kirin Limited N/A 2018-12-05 2024-12-05 Yes 2027-06-05 cabotegravir sodium 227315 Vocabria ViiV Healthcare ULC N/A 2020-03-18 2026-03-18 N/A 2028-03-18 cabotegravir 227315 Cabenuva ViiV Healthcare ULC N/A 2020-03-18 2026-03-18 N/A 2028-03-18 cabozantinib (supplied as cabozantinib (S)-malate) 206230 Cabometyx Ipsen Biopharmaceuticals Canada Inc. N/A 2018-09-14 2024-09-14 N/A 2026-09-14 calcifediol 205392 Rayaldee Vifor Fresenius Medical Care Renal Pharma Ltd N/A 2018-07-10 2024-07-10 N/A 2026-07-10 canagliflozin 157505 Invokana Janssen Inc. InvokametInvokamet XR 2014-05-23 2020-05-23 N/A 2022-05-23 caplacizumab 230001 Cablivi Sanofi-Aventis Canada Inc. N/A 2020-02-28 2026-02-28 N/A 2028-02-28 carfilzomib 184479 Kyprolis Amgen Canada Inc.

N/A 2016-01-15 2022-01-15 N/A 2024-01-15 carglumic acid 171358 Carbaglu Recordati Rare Diseases N/A 2015-04-10 2021-04-10 Yes 2023-10-10 cedazuridine 234610 Inqovi Otsuka Pharmaceutical Co., Ltd. N/A 2020-07-07 2026-07-07 N/A 2028-07-07 ceftolozane 178006 Zerbaxa Merck Canada Inc. N/A 2015-09-30 2021-09-30 N/A 2023-09-30 cemiplimab 218718 Libtayo Sanofi-Aventis Canada Inc. N/A 2019-04-10 2025-04-10 N/A 2027-04-10 cenegermin 218145 Oxervate Dompé farmaceutici S.p.A. N/A 2019-02-08 2025-02-08 N/A 2027-02-08 ceritinib 175702 Zykadia Novartis Pharmaceuticals Canada Inc.

N/A 2015-03-27 2021-03-27 N/A 2023-03-27 cerliponase alfa 216539 Brineura Biomarin International Limited N/A 2018-12-19 2024-12-19 Yes 2027-06-19 coagulation factor IX (recombinant), albumin fusion protein (rIX-FP) 180793 Idelvion CSL Behring Canada Inc. N/A 2016-01-26 2022-01-26 Yes 2024-07-26 coagulation factor IX (recombinant), pegylated (nonacog beta pegol) 201114 Rebinyn Novo Nordisk Canada Inc. N/A 2017-11-29 2023-11-29 Yes 2026-05-29 coagulation factor IX, Fc fusion protein 163614 Alprolix Sanofi-Aventis Canada Inc. N/A 2014-03-20 2020-03-20 Yes 2022-09-20 cobimetinib 182788 Cotellic Hoffmann-La Roche Limited N/A 2016-02-22 2022-02-22 N/A 2024-02-22 crisaborole 206906 Eucrisa Pfizer Canada Inc. N/A 2018-06-07 2024-06-07 Yes 2026-12-07 cysteamine bitartrate 191347 Procysbi Horizon Pharma Ireland Ltd.

N/A 2017-06-13 2023-06-13 Yes 2025-12-13 dabrafenib mesylate 157590 Tafinlar Novartis Pharmaceuticals Canada Inc. N/A 2013-07-16 2019-07-16 N/A 2021-07-16 daclatasvir 172616 Daklinza Bristol-Myers Squibb Canada N/A 2015-08-13 2021-08-13 N/A 2023-08-13 daclizumab beta 190458 Zinbryta Biogen Canada Inc. N/A 2016-12-08 2022-12-08 N/A 2024-12-08 dacomitinib 214572 Vizimpro Pfizer Canada Inc. N/A 2019-02-26 2025-02-26 N/A 2027-02-26 dalbavancin (supplied as dalbavancin hydrochloride) 212390 Xydalba Cipher Pharmaceuticals Inc. N/A 2018-09-04 2024-09-04 N/A 2026-09-04 dapagliflozin propanediol 160877 Forxiga AstraZeneca Canada Inc.

XigduoQtern 2014-12-12 2020-12-12 N/A 2022-12-12 daratumumab 187648 Darzalex Janssen Inc. Darzalex SC 2016-06-29 2022-06-29 N/A 2024-06-29 darolutamide 226146 Nubeqa Bayer Inc. N/A 2020-02-20 2026-02-20 N/A 2028-02-20 deferiprone 162924 Ferriprox Chiesi Canada Corp. N/A 2015-02-13 2021-02-13 Yes 2023-08-13 defibrotide sodium 200808 Defitelio Jazz Pharmaceuticals Ireland Limited N/A 2017-07-10 2023-07-10 Yes 2026-01-10 difluprednate 154517 Durezol Novartis Pharmaceuticals Canada Inc. N/A 2013-11-04 2019-11-04 Yes 2022-05-04 dimethyl fumarate 154776 Tecfidera Biogen Idec Canada Inc.

N/A 2013-04-03 2019-04-03 Yes 2021-10-03 dinutuximab 212066 Unituxin United Therapeutics Corporation N/A 2018-11-28 2024-11-28 Yes 2027-05-28 dolutegravir sodium 161084 Tivicay ViiV Healthcare ULC TriumeqJulucaDovato 2013-10-31 2019-10-31 Yes 2022-05-01 doravirine 211293 Pifeo Merck Canada Inc. Delstrigo 2018-10-12 2024-10-12 N/A 2026-10-12 dulaglutide 168671 Trulicity Eli Lilly Canada Inc. N/A 2015-11-10 2021-11-10 N/A 2023-11-10 dupilumab 201285 Dupixent Sanofi-Aventis Canada Inc. N/A 2017-11-30 2023-11-30 Yes 2026-05-30 durvalumab 202953 Imfinzi AstraZeneca Canada Inc. N/A 2017-11-03 2023-11-03 N/A 2025-11-03 edaravone 214391 Radicava Mitsubishi Tanabe Pharma Corporation N/A 2018-10-03 2024-10-03 N/A 2026-10-03 edoxaban 187363 Lixiana Servier Canada Inc.

N/A 2016-11-04 2022-11-04 N/A 2024-11-04 efinaconazole 159416 Jublia Bausch Health, Canada Inc. N/A 2013-10-02 2019-10-02 N/A 2021-10-02 elagolix 209513 Orilissa AbbVie Corporation N/A 2018-10-05 2024-10-05 N/A 2026-10-05 eliglustat tartrate 183050 Cerdelga Genzyme Canada, A division of Sanofi-aventis Canada Inc. N/A 2017-04-21 2023-04-21 N/A 2025-04-21 elosulfase alfa 170340 Vimizim Biomarin International Limited N/A 2014-07-02 2020-07-02 Yes 2023-01-02 elotuzumab 188144 Empliciti Bristol-Myers Squibb Canada N/A 2016-06-21 2022-06-21 N/A 2024-06-21 eluxadoline 190162 Viberzi Allergan inc. N/A 2017-01-26 2023-01-26 N/A 2025-01-26 emicizumab 212635 Hemlibra Hoffmann-La Roche Limited N/A 2018-08-02 2024-08-02 Yes 2027-02-02 empagliflozin 162552 Jardiance Boehringer Ingelheim (Canada) Ltd. SynjardyGlyxambi 2015-07-23 2021-07-23 N/A 2023-07-23 enasidenib mesylate 217033 Idhifa Celgene Inc.

N/A 2019-02-06 2025-02-06 N/A 2027-02-06 encorafenib 237413 Braftovi Pfizer Canada ULC N/A 2021-03-02 2027-03-02 N/A 2029-03-02 entrectinib 227517 Rozlytrek Hoffmann-La Roche Limited N/A 2020-02-10 2026-02-10 Yes 2028-08-10 enzalutamide 159678 Xtandi Astellas Pharma Canada Inc. N/A 2013-05-29 2019-05-29 N/A 2021-05-29 eptinezumab 233288 Vyepti Lundbeck Canada Inc. N/A 2021-01-11 2027-01-11 N/A 2029-01-11 erdafitinib 224529 Balversa Janssen Inc. N/A 2019-10-25 2025-10-25 N/A 2027-10-25 erenumab 208607 Aimovig Novartis Pharmaceuticals Canada Inc. N/A 2018-08-01 2024-08-01 N/A 2026-08-01 ertugliflozin 204724 Steglatro Merck Canada Inc.

SteglujanSegluromet 2018-05-09 2024-05-09 N/A 2026-05-09 eslicarbazepine acetate 165665 Aptiom Sunovion Pharmaceuticals Canada Inc. N/A 2014-07-08 2020-07-08 Yes 2023-01-08 estetrol monohydrate 236197 Nextstellis Searchlight Pharma Inc. N/A 2021-03-05 2027-03-05 N/A 2029-03-05 evolocumab 178234 Repatha Amgen Canada Inc. N/A 2015-09-10 2021-09-10 Yes 2024-03-10 fedratinib (supplied as fedratinib hydrochloride) 229866 Inrebic Celgene Inc. N/A 2020-07-27 2026-07-27 N/A 2028-07-27 ferric pyrophosphate citrate 239850 Triferic Avnu Rockwell Medical Inc.

N/A 2021-04-22 2027-04-22 Yes 2029-10-22 finafloxacin 172450 Xtoro MerLion Pharmaceuticals GmbH N/A 2016-03-11 2022-03-11 Yes 2024-09-11 flibanserin 189352 Addyi Searchlight Pharma Inc. N/A 2018-02-27 2024-02-27 N/A 2026-02-27 florbetaben (18F) 193105 Neuraceq Isologic Innovative Radiopharmaceuticals Ltd. N/A 2017-02-22 2023-02-22 N/A 2025-02-22 follitropin delta 188743 Rekovelle Ferring Inc. N/A 2018-03-22 2024-03-22 N/A 2026-03-22 fostamatinib (supplied as fostamatinib disodium) 232078 Tavalisse Rigel Pharmaceuticals Inc. N/A 2020-11-19 2026-11-19 N/A 2028-11-19 fremanezumab 226828 Ajovy Teva Canada Limited N/A 2020-04-09 2026-04-09 N/A 2028-04-09 gadoterate meglumine 186333 Dotarem Guerbet N/A 2016-11-26 2022-11-26 Yes 2025-05-26 galcanezumab 219521 Emgality Eli Lilly Canada Inc.

N/A 2019-07-30 2025-07-30 N/A 2027-07-30 galsulfase 159020 Naglazyme BioMarin Pharmaceutical Inc. N/A 2013-09-16 2019-09-16 Yes 2022-03-16 gemtuzumab ozogamicin 223091 Mylotarg Pfizer Canada ULC N/A 2019-11-28 2025-11-28 Yes 2028-05-28 gilteritinib fumarate 227918 Xospata Astellas Pharma Canada Inc. N/A 2019-12-23 2025-12-23 N/A 2027-12-23 givosiran (supplied as givosiran sodium) 237194 Givlaari Alnylam Netherlands B.V.. N/A 2020-10-09 2026-10-09 N/A 2028-10-09 glasdegib 225793 Daurismo Pfizer Canada ULC N/A 2020-04-28 2026-04-28 N/A 2028-04-28 glecaprevir, pibrentasvir 202233 Maviret AbbVie Corporation N/A 2017-08-16 2023-08-16 Yes 2026-02-16 glycerol phenylbutyrate 174219 Ravicti Horizon Pharma Ireland Ltd. N/A 2016-03-18 2022-03-18 Yes 2024-09-18 grazoprevir, elbasvir 185866 Zepatier Merck Canada Inc.

N/A 2016-01-19 2022-01-19 N/A 2024-01-19 guanfacine hydrochloride 150741 Intuniv XR Takeda Canada Inc. N/A 2013-07-05 2019-07-05 Yes 2022-01-05 guselkumab 200590 Tremfya Janssen Inc. N/A 2017-11-10 2023-11-10 N/A 2025-11-10 haemagglutinin strain A (H5N1) 115398 Arepanrix H5N1 ID Biomedical Corporation of Quebec N/A 2013-02-13 2019-02-13 Yes 2021-08-13 hemin 212276 Panhematin Recordati Rare Diseases Canada Inc. N/A 2018-07-13 2024-07-13 N/A 2026-07-13 ibrutinib 174029 Imbruvica Janssen Inc. N/A 2014-11-17 2020-11-17 Yes 2023-05-17 icatibant acetate 162918 Firazyr Takeda Canada Inc.

N/A 2014-06-04 2020-06-04 Yes 2022-12-04 icosapent ethyl 227235 Vascepa HLS Therapeutics Inc. N/A 2019-12-30 2025-12-30 N/A 2027-12-30 idarucizumab 182503 Praxbind Boehringer Ingelheim (Canada) Ltd N/A 2016-04-29 2022-04-29 N/A 2024-04-29 idelalisib 172652 Zydelig Gilead Sciences Canada Inc. N/A 2015-03-27 2021-03-27 N/A 2023-03-27 inotersen sodium 214274 Tegsedi Akcea Therapeutics Inc. N/A 2018-10-03 2024-10-03 N/A 2026-10-03 inotuzumab ozogamicin 204077 Besponsa Pfizer Canada Inc. N/A 2018-03-15 2024-03-15 N/A 2026-03-15 insulin degludec 198124 Tresiba Novo Nordisk Canada Inc.

Xultophy 2017-08-25 2023-08-25 Yes 2026-02-25 ioflupane (123I) 201481 Datscan GE Healthcare Canada Inc. N/A 2017-12-07 2023-12-07 N/A 2025-12-07 iron isomaltoside 1000 193890 Monoferric Pharmacosmos A/S N/A 2018-06-22 2024-06-22 N/A 2026-06-22 isatuximab 229245 Sarclisa Sanofi-Aventis Canada Inc. N/A 2020-04-29 2026-04-29 N/A 2028-04-29 isavuconazole (supplied as isavuconazonium sulfate) 208919 Cresemba Avir Pharma Inc. N/A 2018-12-19 2024-12-19 N/A 2026-12-19 ivabradine hydrochloride 166949 Lancora Servier Canada Inc. N/A 2016-12-23 2022-12-23 Yes 2025-06-23 ivermectin 172733 Rosiver Galderma Canada Inc.

N/A 2015-04-22 2021-04-22 N/A 2023-04-22 ixazomib (supplied as ixazomib citrate) 190498 Ninlaro Takeda Canada Inc. N/A 2016-08-04 2022-08-04 N/A 2024-08-04 ixekizumab 184993 Taltz Eli Lilly Canada Inc. N/A 2016-05-25 2022-05-25 Yes 2024-11-25 lanadelumab 213920 Takhzyro Takeda Canada Inc. N/A 2018-09-19 2024-09-19 Yes 2027-03-19 larotrectinib (supplied as larotrectinib sulfate) 219998 Vitrakvi Bayer Inc. N/A 2019-07-10 2025-07-10 Yes 2028-01-10 latanoprostene bunod 211732 Vyzulta Bausch &.

Lomb Incorporated N/A 2018-12-27 2024-12-27 N/A 2026-12-27 ledipasvir 173180 Harvoni Gilead Sciences Canada Inc. N/A 2014-10-15 2020-10-15 Yes 2023-04-15 lefamulin acetate 233292 Xenleta Sunovion Pharmaceuticals Canada Inc. N/A 2020-07-10 2026-07-10 N/A 2028-07-10 lemborexant 231286 Dayvigo Eisai Limited N/A 2020-11-04 2026-11-04 N/A 2028-11-04 lenvatinib mesylate 180877 Lenvima Eisai Limited N/A 2015-12-22 2021-12-22 N/A 2023-12-22 letermovir 204165 Prevymis Merck Canada Inc. N/A 2017-11-01 2023-11-01 N/A 2025-11-01 levomilnacipran hydrochloride 167319 Fetzima Allergan Inc. N/A 2015-05-08 2021-05-08 N/A 2023-05-08 lifitegrast 199810 Xiidra Novartis Pharmaceuticals Canada Inc.

N/A 2017-12-22 2023-12-22 N/A 2025-12-22 linaclotide 161056 Constella Forest Laboratories Canada Inc. N/A 2013-12-02 2019-12-02 N/A 2021-12-02 lixisenatide 193862 Adlyxine Sanofi-aventis Canada Inc. Soliqua 2017-05-25 2023-05-25 N/A 2025-05-25 lomitapide mesylate 160385 Juxtapid Aegerion Pharmaceuticals Canada Ltd. N/A 2014-02-04 2020-02-04 N/A 2022-02-04 lorlatinib 215733 Lorbrena Pfizer Canada ULC N/A 2019-02-22 2025-02-22 N/A 2027-02-22 lubiprostone 179333 Amitiza Sucampo Pharma Americas LLC N/A 2015-10-14 2021-10-14 N/A 2023-10-14 lumacaftor 181715 Orkambi Vertex Pharmaceuticals (Canada) Incorporated N/A 2016-01-26 2022-01-26 Yes 2024-07-26 luspatercept 236441 Reblozyl Celgene Inc. N/A 2020-09-25 2026-09-25 N/A 2028-09-25 lutetium177 Lu oxodotreotide 217184 Lutathera Advanced Accelerator Applications USA, Inc.

N/A 2019-01-09 2025-01-09 N/A 2027-01-09 macitentan 161372 Opsumit Janssen Inc. N/A 2013-11-06 2019-11-06 Yes 2022-05-06 mecasermin 235023 Increlex Ipsen Biopharmaceuticals Canada Inc. N/A 2020-12-17 2026-12-17 Yes 2029-06-17 mepolizumab 179850 Nucala GlaxoSmithKline Inc. N/A 2015-12-03 2021-12-03 Yes 2024-06-03 midostaurin 201101 Rydapt Novartis Pharmaceuticals Canada Inc. N/A 2017-07-21 2023-07-21 Yes 2026-01-21 mifepristone 160063 Mifegymiso Linepharma International Limited N/A 2015-07-29 2021-07-29 Yes 2024-01-29 migalastat hydrochloride 196956 Galafold Amicus Therapeutics UK LTD N/A 2017-09-05 2023-09-05 N/A 2025-09-05 modified vaccinia levitra (ankara-bavarian nordic) 144762 Imvamune Bavarian Nordic A/S N/A 2013-11-21 2019-11-21 N/A 2021-11-21 naloxegol oxalate 167790 Movantik Knight Therapeutics Inc.

N/A 2015-06-02 2021-06-02 N/A 2023-06-02 necitumumab 193689 Portrazza Eli Lilly Canada Inc. N/A 2017-03-16 2023-03-16 N/A 2025-03-16 neisseria meningitidis serogroup A polysaccharide, neisseria meningitidis serogroup C polysaccharide, neisseria meningitidis serogroup W-135 polysaccharide, neisseria meningitidis serogroup Y polysaccharide, conjugated to tetanus toxoid carrier protein 154290 Nimenrix Pfizer Canada Inc. N/A 2013-03-05 2019-03-05 Yes 2021-09-05 neisseria meningitidis serogroup B recombinant lipoprotein 2086 (rLP2086) subfamily A and Neisseria meningitidis serogroup B recombinant lipoprotein 2086 (rLP2086) subfamily B 195550 Trumenba Pfizer Canada Inc. N/A 2017-10-05 2023-10-05 Yes 2026-04-05 neratinib maleate 218224 Nerlynx Knight Therapeutics Inc. N/A 2019-07-16 2025-07-16 N/A 2027-07-16 netupitant 196495 Akynzeo Elvium Life Sciences N/A 2017-09-28 2023-09-28 N/A 2025-09-28 nintedanib (supplied as nintedanib esilate) 176043 Ofev Boehringer Ingelheim (Canada) Ltd N/A 2015-06-25 2021-06-25 N/A 2023-06-25 niraparib 216792 Zejula GlaxoSmithKline Inc.

N/A 2019-06-27 2025-06-27 N/A 2027-06-27 nivolumab 180828 Opdivo Bristol-Myers-Squibb Canada N/A 2015-09-25 2021-09-25 Yes 2024-03-25 nusinersen 200070 Spinraza Biogen Canada Inc. N/A 2017-06-29 2023-06-29 Yes 2025-12-29 obeticholic acid 198418 Ocaliva Intercept Pharmaceuticals Inc. N/A 2017-05-24 2023-05-24 N/A 2025-05-24 obiltoxaximab 230825 Anthim Elusys Therapeutics, Inc. N/A 2020-07-30 2026-07-30 N/A 2028-07-30 obinutuzumab 168227 Gazyva Hoffmann-La Roche Limited N/A 2014-11-25 2020-11-25 N/A 2022-11-25 ocrelizumab 198094 Ocrevus Hoffmann-La Roche Limited N/A 2017-08-14 2023-08-14 N/A 2025-08-14 ocriplasmin 161356 Jetrea ThromboGenics N.V. N/A 2013-08-13 2019-08-13 N/A 2021-08-13 olaparib 182823 Lynparza AstraZeneca Canada Inc.

N/A 2016-04-29 2022-04-29 N/A 2024-04-29 olaratumab 203478 Lartruvo Eli Lilly Canada Inc. N/A 2017-11-23 2023-11-23 N/A 2025-11-23 olodaterol hydrochloride 155649 Striverdi Respimat Boehringer Ingelheim (Canada) Ltd. Inspiolto Respimat 2013-06-11 2019-06-11 N/A 2021-06-11 ombitasvir, paritaprevir, dasabuvir sodium 174739 Holkira Pak Abbvie Corporation Technivie 2014-12-22 2020-12-22 N/A 2022-12-22 onasemnogene abeparvovec 239719 Zolgensma Novartis Pharmaceuticals Canada Inc. N/A 2020-12-15 2026-12-15 Yes 2029-06-15 osimertinib mesylate 188171 Tagrisso AstraZeneca Canada Inc. N/A 2016-07-05 2022-07-05 N/A 2024-07-05 ozanimod (supplied as ozanimod hydrochloride) 232761 Zeposia Celgene Inc.

N/A 2020-10-02 2026-10-02 N/A 2028-10-02 ozenoxacin 192925 Ozanex Ferrer Internacional, S.A. N/A 2017-05-01 2023-05-01 Yes 2025-11-01 palbociclib 182048 Ibrance Pfizer Canada Inc. N/A 2016-03-16 2022-03-16 N/A 2024-03-16 pasireotide diaspartate 145005 Signifor Novartis Pharmaceuticals Canada Inc. Signifor Lar 2013-09-23 2019-09-23 N/A 2021-09-23 patiromer sorbitex calcium 210368 Veltassa Vifor Fresenius Medical Care Renal Pharma Ltd. N/A 2018-10-03 2024-10-03 N/A 2026-10-03 patisiran (as patisiran sodium) 221896 Onpattro Alnylam Netherlands B.V.

N/A 2019-06-07 2025-06-07 N/A 2027-06-07 peginterferon beta-1a 166974 Plegridy Biogen Idec Canada Inc. N/A 2015-08-10 2021-08-10 N/A 2023-08-10 pembrolizumab 175884 Keytruda Merck Canada Inc. N/A 2015-05-19 2021-05-19 Yes 2023-11-19 peramivir 191280 Rapivab BioCryst Pharmaceuticals Inc. N/A 2017-01-05 2023-01-05 N/A 2025-01-05 perampanel 153747 Fycompa Eisai Limited N/A 2013-04-04 2019-04-04 Yes 2021-10-04 plecanatide 215288 Trulance Cipher Pharmaceuticals Inc. N/A 2019-10-10 2025-10-10 N/A 2027-10-10 polatuzumab vedotin 232303 Polivy Hoffmann-La Roche Limited N/A 2020-07-09 2026-07-09 N/A 2028-07-09 polidocanol 177359 Varithena Provensis Ltd.

N/A 2015-08-04 2021-08-04 N/A 2023-08-04 pomalidomide 165891 Pomalyst Celgene Inc. N/A 2014-01-20 2020-01-20 Yes 2022-07-20 pralatrexate 207545 Folotyn Servier Canada Inc. N/A 2018-10-26 2024-10-26 N/A 2026-10-26 prasterone 198822 Intrarosa Endoceutics Inc. N/A 2019-11-01 2025-11-01 N/A 2027-11-01 ponatinib hydrochloride 165121 Iclusig Ariad Pharmaceuticals Inc. N/A 2015-04-02 2021-04-02 N/A 2023-04-02 ponesimod 239537 Ponvory Janssen Inc.

N/A 2021-04-28 2027-04-28 N/A 2029-04-28 propiverine hydrochloride 188323 Mictoryl / Mictoryl Pediatric Duchesnay Inc. N/A 2017-01-05 2023-01-05 Yes 2025-07-05 radium - 223 dichloride 161312 Xofigo Bayer Inc. N/A 2013-12-12 2019-12-12 N/A 2021-12-12 ramucirumab 176810 Cyramza Eli Lilly Canada Inc. N/A 2015-07-16 2021-07-16 N/A 2023-07-16 ravulizumab 217955 Ultomiris Alexion Pharma GmbH N/A 2019-08-28 2025-08-28 N/A 2027-08-28 recombinant haemagglutinin protein-strain A (H1N1) recombinant haemagglutinin protein-strain A (H3N2) recombinant haemagglutinin protein-strain B (Victoria) recombinant haemagglutinin protein-strain B (Yamagata) 235672 Supemtek Sanofi Pasteur Limited N/A 2021-01-14 2027-01-14 N/A 2029-01-14 recombinant human papillomalevitra types 31, 33, 45, 52 and 58 170006 Gardasil 9 Merck Canada Inc. N/A 2015-02-05 2021-02-05 Yes 2023-08-05 recombinant neisseria meningitidis group B NHBA fusion protein, recombinant neisseria meningitidis group B NadA protein, recombinant neisseria meningitidis group B FHBP fusion protein, outer membrane vesicle (neisseria meningitidis group B NZ98/254 strain) 147275 Bexsero GlaxoSmithKline Inc.

N/A 2013-12-06 2019-12-06 Yes 2022-06-06 recombinant porcine factor VIII (antihemophilic factor (recombinant), porcine sequence) 177290 Obizur Takeda Canada Inc. N/A 2015-10-14 2021-10-14 N/A 2023-10-14 regorafenib monohydrate 157970 Stivarga Bayer Inc. N/A 2013-03-11 2019-03-11 Yes 2021-09-11 remdesivir 240551 Veklury Gilead Sciences Canada, Inc. N/A 2020-07-27 2026-07-27 N/A 2028-07-27 reslizumab 185873 Cinqair Teva Canada Limited N/A 2016-07-20 2022-07-20 Yes 2025-01-20 ribociclib (supplied as ribociclib succinate) 203884 Kisqali Novartis Pharmaceuticals Canada Inc. N/A 2018-03-02 2024-03-02 N/A 2026-03-02 rifaximin 161256 Zaxine Salix Pharmaceuticals http://www.sc-zwickl.zwettl.at/?p=305 Inc.

N/A 2013-08-13 2019-08-13 N/A 2021-08-13 riociguat 162761 Adempas Bayer Inc. N/A 2013-09-19 2019-09-19 N/A 2021-09-19 ripretinib 234688 Qinlock Deciphera Pharmaceuticals, LLC N/A 2020-06-19 2026-06-19 N/A 2028-06-19 risankizumab 215753 Skyrizi AbbVie Corporation N/A 2019-04-17 2025-04-17 N/A 2027-04-17 risdiplam 242373 Evrysdi Hoffman-La Roche Limited N/A 2021-04-14 2027-04-14 Yes 2029-10-14 romidepsin 152293 Istodax Celgene Inc. N/A 2013-10-16 2019-10-16 N/A 2021-10-16 romosozumab 197713 Evenity Amgen Canada Inc. N/A 2019-06-17 2025-06-17 N/A 2027-06-17 rupatadine (supplied as rupatadine fumarate) 186488 Rupall Medexus Pharmaceuticals Inc. N/A 2016-07-20 2022-07-20 Yes 2025-01-20 sacubitril 182734 Entresto Novartis Pharmaceuticals Canada Inc.

N/A 2015-10-02 2021-10-02 N/A 2023-10-02 safinamide (as safinamide mesylate) 207115 Onstryv Valeo Pharma Inc. N/A 2019-01-10 2025-01-10 N/A 2027-01-10 sarilumab 191745 Kevzara Sanofi-aventis Canada Inc. N/A 2017-01-12 2023-01-12 N/A 2025-01-12 satralizumab 233642 Enspryng Hoffmann-La Roche Limited N/A 2020-06-01 2026-06-01 Yes 2028-12-01 sebelipase alfa 204085 Kanuma Alexion Pharma GmbH N/A 2017-12-15 2023-12-15 Yes 2026-06-15 secukinumab 170732 Cosentyx Novartis Pharmaceuticals Canada Inc. N/A 2015-02-27 2021-02-27 Yes 2023-08-27 selexipag 182114 Uptravi Janssen Inc. N/A 2016-01-20 2022-01-20 N/A 2024-01-20 semaglutide 202059 Ozempic Novo Nordisk Canada Inc.

Rybelsus 2018-01-04 2024-01-04 N/A 2026-01-04 siltuximab 174291 Sylvant EUSA Pharma (UK) Limited N/A 2014-12-03 2020-12-03 N/A 2022-12-03 simeprevir 164021 Galexos Janssen Inc. N/A 2013-11-18 2019-11-18 N/A 2021-11-18 siponimod 223225 Mayzent Novartis Pharmaceuticals Canada Inc. N/A 2020-02-20 2026-02-20 N/A 2028-02-20 sodium zirconium cyclosilicate 218799 Lokelma AstraZeneca Canada Inc. N/A 2019-07-25 2025-07-25 N/A 2027-07-25 sofosbuvir 165043 Sovaldi Gilead Sciences Canada Inc. HarvoniEpclusaVosevi 2013-12-13 2019-12-13 N/A 2021-12-13 solriamfetol hydrochloride 237511 Sunosi Jazz Pharmaceuticals Ireland Ltd.

N/A 2021-05-13 2027-05-13 N/A 2029-11-13 sonidegib phosphate 229407 Odomzo Sun Pharma Global FZE N/A 2020-06-12 2026-06-12 N/A 2028-06-12 stiripentol 142417 Diacomit Biocodex SA N/A 2012-12-21 2018-12-21 Yes 2021-06-21 sucroferric oxyhydroxide 201492 Velphoro Vifor Fresenius Medical Care Renal Pharma Ltd. N/A 2018-01-05 2024-01-05 N/A 2026-01-05 sugammadex sodium 180385 Bridion Merck Canada Inc. N/A 2016-02-05 2022-02-05 N/A 2024-02-05 suvorexant 196367 Belsomra Merck Canada Inc. N/A 2018-11-29 2024-11-29 N/A 2026-11-29 tafamidis meglumine 228368 Vyndaqel Pfizer Canada ULC N/A 2020-01-20 2026-01-20 N/A 2028-01-20 tafluprost 165596 Saflutan Purdue Pharma N/A 2014-05-26 2020-05-26 N/A 2022-05-26 talazoparib (supplied as talazoparib tosylate) 220584 Talzenna Pfizer Canada ULC N/A 2019-09-06 2025-09-06 N/A 2027-09-06 taliglucerase alfa 140854 Elelyso Pfizer Canada Inc. N/A 2014-05-29 2020-05-29 Yes 2022-11-29 tedizolid phosphate 173603 Sivextro Merck Canada Inc.

N/A 2015-03-17 2021-03-17 N/A 2023-03-17 teduglutide 180223 Revestive Takeda Canada Inc. N/A 2015-09-04 2021-09-04 Yes 2024-03-04 telotristat ethyl (as telotristat etiprate) 208730 Xermelo Ipsen Biopharmaceuticals Canada Inc. N/A 2018-10-10 2024-10-10 N/A 2026-10-10 tenapanor hydrochloride 224850 Ibsrela Knight Therapeutics Inc. N/A 2020-04-15 2026-04-15 N/A 2028-04-15 tenofovir alafenamide hemifumarate 181399 Genvoya Gilead Sciences Canada Inc. DescovyOdefseyVemlidySymtuzaBiktarvy 2015-11-27 2021-11-27 Yes 2024-05-27 teriflunomide 160646 Aubagio Genzyme Canada a division of Sanofi-aventis Canada Inc.

N/A 2013-11-14 2019-11-14 Yes 2022-05-14 tesamorelin 131836 Egrifta Theratechnologies Inc. N/A 2014-04-29 2020-04-29 N/A 2022-04-29 tezacaftor 211292 Symdeko Vertex Pharmaceuticals (Canada) Incorporated N/A 2018-06-27 2024-06-27 Yes 2026-12-27 tildrakizumab 224036 Ilumya Sun Pharma Global FZE N/A 2021-05-19 2027-05-19 N/A 2029-05-19 tisagenlecleucel 213547 / 213698 Kymriah Novartis Pharmaceuticals Canada Inc. N/A 2018-09-05 2024-09-05 Yes 2027-03-05 tofacitinib 154642 Xeljanz Pfizer Canada Inc. N/A 2014-04-17 2020-04-17 Yes 2022-10-17 trametinib 157665 Mekinist Novartis Pharmaceuticals Canada Inc. N/A 2013-07-18 2019-07-18 N/A 2021-07-18 trastuzumab deruxtecan 242104 Enhertu AstraZeneca Canada Inc.

N/A 2021-04-15 2027-04-15 N/A 2029-04-15 trastuzumab emtansine 162414 Kadcyla Hoffmann-La Roche Limited N/A 2013-09-11 2019-09-11 N/A 2021-09-11 trifarotene 221945 Aklief Galderma Canada Inc. N/A 2019-11-25 2025-11-25 Yes 2028-05-25 tipiracil hydrochloride 205852 Lonsurf Taiho Pharma Canada Inc. N/A 2018-01-25 2024-01-25 N/A 2026-01-25 triheptanoin 242196 Dojolvi Uagenyx Pharmaceutical Inc. N/A 2021-02-15 2027-02-15 Yes 2029-08-15 tucatinib 235295 Tukysa Seattle Genetics Inc. N/A 2020-06-05 2026-06-05 N/A 2028-06-05 turoctocog alfa 170796 Zonovate Novo Nordisk Canada Inc.

N/A 2014-12-08 2020-12-08 Yes 2023-06-08 ulipristal acetate 156861 Fibristal Allergan Inc. N/A 2013-06-24 2019-06-24 N/A 2021-06-24 umeclidinium bromide 161585 Anoro Ellipta GlaxoSmithKline Inc. Incruse Ellipta 2013-12-23 2019-12-23 N/A 2021-12-23 upadacitinib 223734 Rinvoq AbbVie Corporation N/A 2019-12-23 2025-12-23 N/A 2027-12-23 varicella-zoster levitra glycoprotein E (gE) 200244 Shingrix GlaxoSmithKline Inc. N/A 2017-10-13 2023-10-13 N/A 2025-10-13 vedolizumab 169414 Entyvio Takeda Canada Inc. N/A 2015-01-29 2021-01-29 Yes 2023-07-29 velpatasvir 190521 Epclusa Gilead Sciences Canada Inc.

Vosevi 2016-07-11 2022-07-11 Yes 2025-01-11 venetoclax 190761 Venclexta AbbVie Corporation N/A 2016-09-30 2022-09-30 N/A 2024-09-30 vernakalant hydrochloride 190817 Brinavess Cipher Pharmaceuticals Inc. N/A 2017-03-13 2023-03-13 N/A 2025-03-13 vilanterol trifenatate 157301 Breo Ellipta GlaxoSmithKline Inc. Anoro ElliptaTrelegy Ellipta 2013-07-03 2019-07-03 Yes 2022-01-03 vilazodone hydrochloride 176820 Viibryd Allergan Inc. N/A 2015-07-16 2021-07-16 Yes 2024-01-16 vismodegib 154608 Erivedge Hoffmann-La Roche Ltd. N/A 2013-07-12 2019-07-12 N/A 2021-07-12 von willebrand factor (recombinant) (vonicog alfa) 213188 Vonvendi Takeda Canada Inc.

N/A 2019-01-10 2025-01-10 N/A 2027-01-10 vorapaxar sulfate 179320 Zontivity Toprol Acquisition LLC N/A 2016-05-13 2022-05-13 N/A 2024-05-13 voretigene neparvovec 233097 Luxturna Novartis Pharmaceuticals Canada Inc. N/A 2020-10-13 2026-10-13 Yes 2029-04-13 vortioxetine hydrobromide 159019 Trintellix Lundbeck Canada Inc. N/A 2014-10-22 2020-10-22 Yes 2023-04-22 voxilaprevir 202324 Vosevi Gilead Sciences Canada Inc. N/A 2017-08-16 2023-08-16 N/A 2025-08-16 zanubrutinib 242748 Brukinsa BeiGene Switzerland GmbH N/A 2021-03-01 2027-03-01 N/A 2029-03-01Important. This updated Notice replaces the previous version that was published on September 18, 2020.

May 31, 2021Our file number. 21-109448-84 Health Canada is issuing this Notice to clinical trial sponsors to clarify the approach to various types of clinical research with cannabis. Health Canada recognizes that conducting clinical research (i.e., research carried out on humans) with cannabis is critical to generating high-quality evidence that can be used to better understand the health risks and benefits of cannabis use, inform health policies and protect the health and safety of Canadians. Clinical research also supports the development of cannabis-based drug products that are safe, effective and of high quality. Sponsors interested in conducting research with cannabis must meet certain requirements under the Cannabis Act and its regulations.

Authorization to conduct research with cannabis must be obtained by applying for a federal cannabis research licence from the Controlled Substances and Cannabis Branch of Health Canada. The Application requirements for cannabis research licences webpage provides more information on how to obtain a research licence from Health Canada under the Cannabis Act and its regulations. Table of contents General requirements for research with cannabis - Food and Drugs Act (FDA) and Cannabis Act Any research with cannabis that meets the definition of a clinical trial in the Food and Drug Regulations (FDR) is subject to Part C, Division 5 of those regulations. Under Part C, Division 5 of the FDR, a clinical trial means. "An investigation in respect of a drug for use in humans that involves human subjects and that is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug, identify any adverse events in respect of the drug, study the absorption, distribution, metabolism and excretion of the drug, or ascertain the safety or efficacy of the drug." This definition only applies to clinical trials that are interventional and not observational (see section below on observational studies).

The application of this definition does not depend on how data generated from a clinical trial will be used. This means that research that is not intended to support the development of an authorized drug product could still meet the definition of a clinical trial, if any of the criteria set out in the definition above are met. Division 5 is a set of internationally aligned regulations under the FDR that govern the sale and importation of drugs for use in clinical trials. These regulations are designed to support research and innovation in an ethical manner to ensure the protection of clinical trial participants, as well as the integrity of the data generated. They also ensure that the same level of scrutiny is applied to all clinical trials, regardless of the drug substance being tested.

Under Division 5, sponsors must file a clinical trial application (CTA) to conduct a clinical trial. A CTA does not need to be submitted to Health Canada if a clinical trial is investigating an authorized drug product (i.e., one that has received a Notice of Compliance (NOC) or a Drug Identification Number (DIN)) and is used within the parameters authorized under the NOC or DIN (e.g., indication, dosage, formulation, route of administration, etc.). A CTA to investigate cannabis, or any other drug substance, must contain standard information and documentation to ensure that the trial is properly designed and that participants (and other implicated persons) are not exposed to undue risk. This includes, but is not limited to, a study protocol, informed consent forms, an Investigator's Brochure (IB), chemistry and manufacturing information, along with other pertinent information. Sponsors who are considering undertaking a clinical trial to investigate cannabis are encouraged to request a pre-application meeting with the Office of Clinical Trials to discuss their specific circumstances and requirements.

Approval from a Research Ethics Board (REB) must also be obtained before starting a clinical trial. More information on CTA requirements for drug products can be found in the Guidance Document For Clinical Trial Sponsors. Clinical Trial Applications. Quality (chemistry and manufacturing) requirements for CTAs involving cannabis are the same as for any pharmaceutical product used in a clinical trial. The scope and detail of information submitted in support of the quality portion of a CTA should be sufficient to enable Health Canada to make an adequate assessment of the characteristics of the drug.

Sponsors are expected to submit progressively more detailed quality information through subsequent clinical trial phases. More information on quality requirements can be found in the Guidance Document - Quality (Chemistry and Manufacturing) Guidance. Clinical Trial Applications (CTAs) for Pharmaceuticals. In addition to CTA requirements, clinical trials in Canada are conducted in accordance with internationally accepted principles of Good Clinical Practices (GCP). As part of GCP, drugs used in clinical trials must meet Good Manufacturing Practices (GMP), which is a requirement under Part C, Division 5 of the FDR.

Health Canada is aware that it may be challenging for some sponsors to obtain GMP-grade cannabis for research, but this requirement is necessary to ensure the consistency of the investigational product throughout the clinical trial(s). Sponsors must also report to Health Canada any serious and unexpected adverse drug reactions (ADRs) that occur during a clinical trial. For more information on ADR reporting, please visit the following webpage. Clinical Trials - Adverse Drug Reaction (ADR) Reporting. Clinical trials with cannabis for therapeutic purposes, or with intent to market as a drug under the Food and Drug Regulations Clinical research is essential to understanding the effects of cannabis in a therapeutic context, as well as for the development of drug products that are safe and effective.

An increased availability of authorized drugs containing cannabis provides Canadians with a greater selection of therapeutic options to meet their health needs. High-quality research also helps guide practitioners in making evidence-based decisions when prescribing and managing patients using these drugs. When a clinical trial with cannabis is conducted for therapeutic purposes, standard clinical trial requirements apply (as described above). In addition, sponsors are reminded that, should they plan to seek market authorization under the FDR, studies that do not meet the requirements of Division 5 may not be accepted. In particular, the IB (which is a regulatory requirement described in C.05.005(e) of the FDR) should be prepared in accordance with the Health Canada / ICH Guidance Document E6.

Good Clinical Practice. Consolidated Guideline. This means that the data contained in the IB should be specific to the product being investigated, include the results of any pre-clinical studies, and any relevant clinical studies, and be updated annually. Researchers have informed Health Canada that a product-specific IB is not always feasible for cannabis, and acts as an impediment to cannabis research in Canada. In early phase trials, Health Canada may consider that the absence of the full set of product-specific pre-clinical studies in the IB is acceptable if the clinical trial involves a cannabis product that is produced under GMP conditions, and for which there is sufficient evidence of safe human use.

Health Canada expects that the sponsor will be developing a product-specific IB, aligned with the requirements of ICH M3(R2), for trials designed to confirm the efficacy and safety of the cannabis product for use in the treatment of a specific disease/condition, and that the IB will be updated as new information accumulates. Some flexibility may be acceptable for cannabis products where a similar product has received market authorization either in Canada or another member state of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). In this situation, Health Canada may consider the absence of a full set of product-specific pre-clinical studies acceptable in early phase trials if the sponsor can provide information that establishes the similarity of the chemical and physical properties of the investigational product to the marketed product. Synthetic products that are not duplicates of naturally occurring phytocannabinoids, or where a similar product has not received market authorization either in Canada or in an ICH member state, require product-specific pre-clinical studies, even for early phase trials. The sponsor also needs to provide an attestation that the investigational product is manufactured in a facility that is compliant with GMP.

Sponsors who are considering undertaking a clinical trial to investigate cannabis are encouraged to request a pre-application meeting with the Office of Clinical Trials to discuss their specific circumstances and requirements. Clinical trials with cannabis for non-therapeutic purposes Clinical research is also needed to better understand the psychological and physiological effects of cannabis for non-therapeutic purposes. For example, this can include investigating the time to onset or duration of effects of a cannabis product, the impact of cannabis use on driving performance, or various types of public health research. For the purposes of this document only, non-therapeutic cannabis research can be considered to be an interventional investigation aimed at. Increasing the knowledge on cannabis and its effects in a healthy user population.

Generating knowledge on cannabis to inform public health and public safety measures, public education, and policy. And/or Furthering research and development of cannabis products aimed for sale under the cannabis legal framework. It would exclude studies that have the following objectives. Assessing potential therapeutic effects/outcomes/indications. And/ or Assessing the efficacy in treating a disease state, symptoms or conditions.

Clinical trials with cannabis for non-therapeutic purposes are currently subject to Part C, Division 5 of the FDR and require the submission of a CTA to Health Canada. However, the Department recognizes that Division 5 may not be ideally suited to regulate research for non-therapeutic purposes using commercially available products containing cannabis sold under the cannabis legal framework. In order to facilitate non-therapeutic cannabis research, it is Health Canada's intention to exempt cannabis used in these studies from the application of the FDA/FDR, and to create a framework under the Cannabis Regulations for non-therapeutic cannabis research. More information regarding this regulatory initiative can be found in this Notice of Intent and this Forward Regulatory Plan.In the interim, for clinical trials with cannabis for non-therapeutic purposes, the Department may consider the absence of product specific pre-clinical and clinical information acceptable for these studies, provided there is sufficient information on the product's main active ingredient(s) - for example, cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC). However, the IB must continue to include all the types of information listed under C.05.005(e) on these active ingredients, and must contain sufficient information to support the specific study.

The information must be relevant to the product under investigation in terms of route of administration, dosage regimen (dose and frequency) and product form or class (e.g., cannabis extract, edible cannabis, cannabis topicals, dried cannabis or fresh cannabis). The information must also be updated annually, and include recent and relevant clinical trial results. If sponsors wish to be eligible for this approach, their clinical trials must be conducted on healthy adults who are currently using cannabis, using the same product form/class that participants have normally used and the same route of administration. The dosage regimen of cannabis administered in the trial is not to exceed what the participant would normally have consumed within a similar period of time. Additionally, although the investigational product does not have to be available for retail sale on the legal market (i.e.

It may be under development), it must meet the requirements of the Cannabis Regulations for legal retail sale and meet GMP quality requirements. If dried cannabis is administered through smoking or vaping, adequate measures to prevent exposure of other individuals (e.g., research staff or other participants) to second-hand smoke or vapour is to be included in the protocol. All other aspects of Division 5, including (but not limited to) the requirement for REB approval, a qualified investigator at each site, submission of chemistry and manufacturing information, adherence to GCP and adverse reaction reporting requirements, continue to apply. Sponsors who are considering undertaking a clinical trial to investigate cannabis are encouraged to request a pre-application meeting with the Office of Clinical Trials to discuss their specific circumstances and requirements. When submitting a CTA, sponsors are to indicate in their cover letter whether the clinical trial is for therapeutic purposes or for non-therapeutic purposes.

Please see below for a tabular summary of these scenarios. Type of cannabis product Type of clinical trial Eligibility for a non-product-specific IB Yes No Cannabis products of botanical origin† and synthetics that are duplicates of naturally occurring cannabinoids Non-therapeutic purpose trial √†† Therapeutic purpose early phase trial √†† Therapeutic purpose confirmatory trial √ Synthetics that are not duplicates of naturally occurring cannabinoids Non-therapeutic purpose trial √ Therapeutic purpose early phase trial √ Therapeutic purpose confirmatory trial √ Cannabis products††† where a similar product has received market authorization either in Canada or in an ICH member state Non-therapeutic purpose trial √†††† Therapeutic purpose early phase trial √†††† Therapeutic purpose confirmatory trial √ † Dried cannabis, fresh cannabis, edible cannabis, cannabis topicals, cannabis extracts (including cannabis oil) †† Information on the main active ingredients and on human use may be considered acceptable ††† Cannabis products of botanical origin or synthetics that are duplicates of naturally occurring cannabinoids †††† Information that establishes similarity of the chemical and physical properties of the investigational product to the marketed product may be considered acceptable Other types of cannabis-based research that are not considered clinical trials Sponsors should consult the definition of a clinical trial in Part C, Division 5 of the FDR to determine whether their study protocol meets the criteria for a clinical trial. When in doubt, sponsors should consult the Office of Clinical Trials. Observational studies Sponsors who intend to conduct an observational study using cannabis do not need to submit a CTA to Health Canada. A study is considered observational if it meets all of the following criteria.

The protocol does not assign to the participants a specific intervention. The prescription of a drug containing cannabis or authorization of cannabis for medical purposes is clearly separated from the decision to include the patient in the study. The investigator has no control over the prescribing, authorization or administration of the cannabis product. The cannabis product being used must be sourced from the legal regulated Canadian market. The number of inclusion criteria must be very limited (e.g., adults using cannabis and the ability to provide consent).

And The collection of data should involve no to minimal health risks. For observational studies, the sponsors are reminded to consult with their Research Ethics Boards regarding applicable ethics requirements.Serious adverse reactions observed during the course of an observational study should be reported to Canada Vigilance. Information on cannabis adverse reaction reporting can be found in the Cannabis adverse reaction reporting guide. Organoleptic testing, and testing of detection devices Although the Department cannot, in advance, provide a complete list of study protocols that would not meet the definition of a clinical trial, two examples include. Organoleptic testing (e.g., assessment of consumer preference with respect to taste or smell) of products containing cannabis, provided that the cannabis is in its final form and meets the requirements in the Cannabis Regulations for retail sale.

Research on the verification, validation or standardization of a device detecting cannabis for judicial or forensic use (e.g., roadside testing devices), provided that the study focuses on the device and not on the properties or effects of cannabis. Clinical research involving parts of the cannabis plant permitted in natural health products The requirements of the Natural Health Products Regulations apply to clinical trials for natural health products, including those containing permitted parts of the cannabis plant (see section 3.4 of Health Canada's Health products containing cannabis or for use with cannabis. Guidance for the Cannabis Act, the Food and Drugs Act, and related regulations document for more details on permitted parts). More information about these requirements can be found in the Clinical Trials for Natural Health Products guidance document. Veterinary research In order to conduct veterinary drug research or studies using drugs containing cannabis, the investigator or the sponsor is required to submit either an Experimental Studies Certificate (ESC) or a veterinary Investigational New Drug (IND) application to Health Canada's Veterinary Drugs Directorate (VDD).

For all research or studies to be conducted using a veterinary drug, the objective is to ensure that there is appropriate oversight to cover the overall health and safety of study animals. If the study includes food-producing animals, Health Canada also considers relevant information to address food safety. Sponsors are strongly urged to request a pre-submission meeting with VDD before submitting an ESC or IND application for research involving cannabis. More information can be found on the veterinary drugs forms and applications page. Compliance and enforcement As part of its regulatory responsibilities, Health Canada promotes, monitors and enforces compliance.

As such, Health Canada Inspectors may conduct inspections of clinical trials under the authority of Section 23 of the FDA. The purpose of these inspections is to verify compliance with Part C, Division 5 of the FDR, which include the requirement to comply with GCP. For more information on compliance and enforcement, please refer to the Compliance and Enforcement Policy for Health Products (POL-0001) and to the various guidance documents available on the Health Canada Good Clinical Practices webpage. Contact Information. Office of Clinical Trials - Therapeutic Products DirectorateHealth Products and Food BranchE-mail.

Hc.oct.enquiries-requetes.bec.sc@canada.ca Natural and Non-prescription Health Products DirectorateHealth Products and Food BranchE-mail. Nhpd-cta.dec-dpsn@hc-sc.gc.ca Veterinary Drugs DirectorateHealth Products and Food BranchE-mail:hc.vdd.skmd.so-dgps.dmv.cp.sc@canada.ca Licensing and Medical Access DirectorateControlled Substances and Cannabis BranchE-mail:hc.sp-licensing-cannabis-licences-sp.sc@canada.ca Clinical Trial Compliance ProgramRegulatory Operations and Enforcement BranchE-mail. Gcp_bpc@hc-sc.gc.ca.

Abemaciclib 215268 Verzenio Eli http://ravenwoodforestarts.com/?page_id=150 Lilly Canada best price levitra generic Inc. N/A 2019-04-08 2025-04-08 N/A 2027-04-08 acalabrutinib 214504 Calquence AstraZeneca Canada Inc. N/A 2019-08-23 2025-08-23 best price levitra generic N/A 2027-08-23 aclidinium bromide 157598 Tudorza Genuair AstraZeneca Canada Inc. Duaklir Genuair 2013-07-29 2019-07-29 N/A 2021-07-29 afatinib dimaleate 158730 Giotrif Boehringer Ingelheim (Canada) Ltd.

N/A 2013-11-01 2019-11-01 N/A 2021-11-01 aflibercept 149321 Eylea Bayer Inc. N/A 2013-11-08 2019-11-08 N/A best price levitra generic 2021-11-08 albiglutide 165145 Eperzan GlaxoSmithKline Inc. N/A 2015-07-15 2021-07-15 N/A 2023-07-15 alectinib hydrochloride 189442 Alecensaro Hoffmann-La Roche Limited N/A 2016-09-29 2022-09-29 N/A 2024-09-29 alirocumab 183116 Praluent Sanofi-aventis Canada Inc. N/A 2016-04-11 2022-04-11 N/A 2024-04-11 alogliptin benzoate 158335 Nesina Takeda Canada Inc.

KazanoOseni 2013-11-27 2019-11-27 N/A 2021-11-27 alpelisib 226941 best price levitra generic Piqray Novartis Pharmaceuticals Canada Inc. N/A 2020-03-11 2026-03-11 N/A 2028-03-11 amifampridine (supplied as amifampridine phosphate) 232685 Firdapse Kye Pharmaceuticals Inc. N/A 2020-07-31 2026-07-31 N/A 2028-07-31 anthrax immune globulin (human) 200446 Anthrasil Emergent best price levitra generic BioSolutions Canada Inc. N/A 2017-11-06 2023-11-06 Yes 2026-05-06 antihemophilic factor (recombinant BDD), Fc fusion protein 163447 Eloctate Sanofi-Aventis Canada Inc.

N/A 2014-08-22 2020-08-22 Yes 2023-02-22 antihemophilic factor (recombinant), pegylated 189709 Adynovate Takeda Canada Inc. N/A 2016-11-17 2022-11-17 Yes 2025-05-17 best price levitra generic antihemophilic factor (recombinant, B-domain deleted, pegylated) (also known as damoctocog alfa pegol) 210935 Jivi Bayer Inc. N/A 2018-10-18 2024-10-18 Yes 2027-04-18 antihemophilic factor (recombinant, B-domain deleted) (also known as simoctocog alfa) 169551 Nuwiq Octapharma Pharmazeutika Produktionsges.m.b.H N/A 2014-10-23 2020-10-23 Yes 2023-04-23 antihemophilic factor VIII (recombinant), singlechain (also known as lonoctocog alfa) 190891 Afstyla CSL Behring Canada Inc. N/A 2016-12-12 2022-12-12 Yes 2025-06-12 anthrax antigen fiate 212387 Biothrax Emergent Biodefense Operations Lansing LLC N/A 2018-12-13 2024-12-13 N/A 2026-12-13 antihemophilic factor VIII (recombinant, B-domain truncated), PEGylated (turoctocog alfa pegol) 218531 Esperoct Novo Nordisk Canada Inc.

N/A 2019-07-04 2025-07-04 Yes 2028-01-04 apalutamide 211942 Erleada Janssen best price levitra generic Inc. N/A 2018-07-03 2024-07-03 N/A 2026-07-03 apremilast 169862 Otezla Amgen Canada Inc. N/A 2014-11-12 2020-11-12 N/A 2022-11-12 asfotase alfa 179340 Strensiq Alexion Pharma International Sàrl N/A 2015-08-14 2021-08-14 Yes 2024-02-14 asunaprevir 172617 Sunvepra Bristol-Myers Squibb Canada N/A 2016-03-09 2022-03-09 N/A 2024-03-09 atezolizumab 196843 Tecentriq Hoffmann-La Roche Limited N/A 2017-04-12 2023-04-12 N/A 2025-04-12 avelumab 204052 Bavencio EMD Serono, a Division of EMD Inc., Canada N/A 2017-12-18 2023-12-18 N/A 2025-12-18 axicabtagene ciloleucel 218389 Yescarta Gilead Sciences Canada Inc N/A 2019-02-13 2025-02-13 N/A 2027-02-13 azelastine hydrochloride 169604 Dymista Meda Pharmaceuticals Ltd. N/A 2014-10-23 2020-10-23 Yes 2023-04-23 baloxavir marboxil 227361 Xofluza Hoffmann-La Roche Limited N/A 2020-02-19 2026-02-19 Yes 2028-08-19 best price levitra generic baricitinib 193687 Olumiant Eli Lilly Canada Inc.

N/A 2018-08-17 2024-08-17 N/A 2026-08-17 bazedoxifene acetate 160681 Duavive Pfizer Canada Inc. N/A 2014-10-23 best price levitra generic 2020-10-23 N/A 2022-10-23 benralizumab 204008 Fasenra AstraZeneca Canada Inc. N/A 2018-02-22 2024-02-22 Yes 2026-08-22 bepotastine besilate 179294 Bepreve Bausch and Lomb Incorporated N/A 2016-07-27 2022-07-27 Yes 2025-01-27 bictegravir 203718 Biktarvy Gilead Sciences Canada, Inc. N/A 2018-07-10 2024-07-10 Yes 2027-01-10 bilastine 184231 Blexten Aralez Pharmaceutials Canada Inc.

N/A 2016-04-21 2022-04-21 Yes 2024-10-21 binimetinib 237410 Mektovi Pfizer Canada ULC best price levitra generic N/A 2021-03-02 2027-03-02 N/A 2029-03-02 blinatumomab 181723 Blincyto Amgen Canada Incorporated N/A 2015-12-22 2021-12-22 Yes 2024-06-22 bosutinib 152211 Bosulif Pfizer Canada Inc. N/A 2014-03-07 2020-03-07 N/A 2022-03-07 botulism antitoxin heptavalen C/ D/ F/ G - (equine) 190645 Bat Emergent BioSolutions Inc. N/A 2016-12-08 2022-12-08 Yes 2025-06-08 brexpiprazole 192684 Rexulti Otsuka Pharmaceutical Co. Ltd.

N/A 2017-02-16 2023-02-16 Yes 2025-08-16 brigatinib 210369 Alunbrig Takeda Canada Incorporated N/A 2018-07-26 2024-07-26 N/A 2026-07-26 brivaracetam 183355 Brivlera UCB Canada Incorporated N/A 2016-03-09 2022-03-09 Yes 2024-09-09 brodalumab 195317 Siliq Bausch Health, Canada Inc. N/A 2018-03-06 2024-03-06 N/A 2026-03-06 brolucizumab 226224 Beovu Novartis Pharmaceuticals Canada Inc. N/A 2020-03-12 2026-03-12 N/A 2028-03-12 bromfenac sodium sesquihydrate 171657 Prolensa Bausch &. Lomb Incorporated N/A 2015-03-26 2021-03-26 N/A 2023-03-26 burosumab 216239 Crysvita Kyowa Kirin Limited N/A 2018-12-05 2024-12-05 Yes 2027-06-05 cabotegravir sodium 227315 Vocabria ViiV Healthcare ULC N/A 2020-03-18 2026-03-18 N/A 2028-03-18 cabotegravir 227315 Cabenuva ViiV Healthcare ULC N/A 2020-03-18 2026-03-18 N/A 2028-03-18 cabozantinib (supplied as cabozantinib (S)-malate) 206230 Cabometyx Ipsen Biopharmaceuticals Canada Inc.

N/A 2018-09-14 2024-09-14 N/A 2026-09-14 calcifediol 205392 Rayaldee Vifor Fresenius Medical Care Renal Pharma Ltd N/A 2018-07-10 2024-07-10 N/A 2026-07-10 canagliflozin 157505 Invokana Janssen Inc. InvokametInvokamet XR 2014-05-23 2020-05-23 N/A 2022-05-23 caplacizumab 230001 Cablivi Sanofi-Aventis Canada Inc. N/A 2020-02-28 2026-02-28 N/A 2028-02-28 carfilzomib 184479 Kyprolis Amgen Canada Inc. N/A 2016-01-15 2022-01-15 N/A 2024-01-15 carglumic acid 171358 Carbaglu Recordati Rare Diseases N/A 2015-04-10 2021-04-10 Yes 2023-10-10 cedazuridine 234610 Inqovi Otsuka Pharmaceutical Co., Ltd.

N/A 2020-07-07 2026-07-07 N/A 2028-07-07 ceftolozane 178006 Zerbaxa Merck Canada Inc. N/A 2015-09-30 2021-09-30 N/A 2023-09-30 cemiplimab 218718 Libtayo Sanofi-Aventis Canada Inc. N/A 2019-04-10 2025-04-10 N/A 2027-04-10 cenegermin 218145 Oxervate Dompé farmaceutici S.p.A. N/A 2019-02-08 2025-02-08 N/A 2027-02-08 ceritinib 175702 Zykadia Novartis Pharmaceuticals Canada Inc.

N/A 2015-03-27 2021-03-27 N/A 2023-03-27 cerliponase alfa 216539 Brineura Biomarin International Limited N/A 2018-12-19 2024-12-19 Yes 2027-06-19 coagulation factor IX (recombinant), albumin fusion protein (rIX-FP) 180793 Idelvion CSL Behring Canada Inc. N/A 2016-01-26 2022-01-26 Yes 2024-07-26 coagulation factor IX (recombinant), pegylated (nonacog beta pegol) 201114 Rebinyn Novo Nordisk Canada Inc. N/A 2017-11-29 2023-11-29 Yes 2026-05-29 coagulation factor IX, Fc fusion protein 163614 Alprolix Sanofi-Aventis Canada Inc. N/A 2014-03-20 2020-03-20 Yes 2022-09-20 cobimetinib 182788 Cotellic Hoffmann-La Roche Limited N/A 2016-02-22 2022-02-22 N/A 2024-02-22 crisaborole 206906 Eucrisa Pfizer Canada Inc.

N/A 2018-06-07 2024-06-07 Yes 2026-12-07 cysteamine bitartrate 191347 Procysbi Horizon Pharma Ireland Ltd. N/A 2017-06-13 2023-06-13 Yes 2025-12-13 dabrafenib mesylate 157590 Tafinlar Novartis Pharmaceuticals Canada Inc. N/A 2013-07-16 2019-07-16 N/A 2021-07-16 daclatasvir 172616 Daklinza Bristol-Myers Squibb Canada N/A 2015-08-13 2021-08-13 N/A 2023-08-13 daclizumab beta 190458 Zinbryta Biogen Canada Inc. N/A 2016-12-08 2022-12-08 N/A 2024-12-08 dacomitinib 214572 Vizimpro Pfizer Canada Inc.

N/A 2019-02-26 2025-02-26 N/A 2027-02-26 dalbavancin (supplied as dalbavancin hydrochloride) 212390 Xydalba Cipher Pharmaceuticals Inc. N/A 2018-09-04 2024-09-04 N/A 2026-09-04 dapagliflozin propanediol 160877 Forxiga AstraZeneca Canada Inc. XigduoQtern 2014-12-12 2020-12-12 N/A 2022-12-12 daratumumab 187648 Darzalex Janssen Inc. Darzalex SC 2016-06-29 2022-06-29 N/A 2024-06-29 darolutamide 226146 Nubeqa Bayer Inc.

N/A 2020-02-20 2026-02-20 N/A 2028-02-20 deferiprone 162924 Ferriprox Chiesi Canada Corp. N/A 2015-02-13 2021-02-13 Yes 2023-08-13 defibrotide sodium 200808 Defitelio Jazz Pharmaceuticals Ireland Limited N/A 2017-07-10 2023-07-10 Yes 2026-01-10 difluprednate 154517 Durezol Novartis Pharmaceuticals Canada Inc. N/A 2013-11-04 2019-11-04 Yes 2022-05-04 dimethyl fumarate 154776 Tecfidera Biogen Idec Canada Inc. N/A 2013-04-03 2019-04-03 Yes 2021-10-03 dinutuximab 212066 Unituxin United Therapeutics Corporation N/A 2018-11-28 2024-11-28 Yes 2027-05-28 dolutegravir sodium 161084 Tivicay ViiV Healthcare ULC TriumeqJulucaDovato 2013-10-31 2019-10-31 Yes 2022-05-01 doravirine 211293 Pifeo Merck Canada Inc.

Delstrigo 2018-10-12 2024-10-12 N/A 2026-10-12 dulaglutide 168671 Trulicity Eli Lilly Canada Inc. N/A 2015-11-10 2021-11-10 N/A 2023-11-10 dupilumab 201285 Dupixent Sanofi-Aventis Canada Inc. N/A 2017-11-30 2023-11-30 Yes 2026-05-30 durvalumab 202953 Imfinzi AstraZeneca Canada Inc. N/A 2017-11-03 2023-11-03 N/A 2025-11-03 edaravone 214391 Radicava Mitsubishi Tanabe Pharma Corporation N/A 2018-10-03 2024-10-03 N/A 2026-10-03 edoxaban 187363 Lixiana Servier Canada Inc.

N/A 2016-11-04 2022-11-04 N/A 2024-11-04 efinaconazole 159416 Jublia Bausch Health, Canada Inc. N/A 2013-10-02 2019-10-02 N/A 2021-10-02 elagolix 209513 Orilissa AbbVie Corporation N/A 2018-10-05 2024-10-05 N/A 2026-10-05 eliglustat tartrate 183050 Cerdelga Genzyme Canada, A division of Sanofi-aventis Canada Inc. N/A 2017-04-21 2023-04-21 N/A 2025-04-21 elosulfase alfa 170340 Vimizim Biomarin International Limited N/A 2014-07-02 2020-07-02 Yes 2023-01-02 elotuzumab 188144 Empliciti Bristol-Myers Squibb Canada N/A 2016-06-21 2022-06-21 N/A 2024-06-21 eluxadoline 190162 Viberzi Allergan inc. N/A 2017-01-26 2023-01-26 N/A 2025-01-26 emicizumab 212635 Hemlibra Hoffmann-La Roche Limited N/A 2018-08-02 2024-08-02 Yes 2027-02-02 empagliflozin 162552 Jardiance Boehringer Ingelheim (Canada) Ltd.

SynjardyGlyxambi 2015-07-23 2021-07-23 N/A 2023-07-23 enasidenib mesylate 217033 Idhifa Celgene Inc. N/A 2019-02-06 2025-02-06 N/A 2027-02-06 encorafenib 237413 Braftovi Pfizer Canada ULC N/A 2021-03-02 2027-03-02 N/A 2029-03-02 entrectinib 227517 Rozlytrek Hoffmann-La Roche Limited N/A 2020-02-10 2026-02-10 Yes 2028-08-10 enzalutamide 159678 Xtandi Astellas Pharma Canada Inc. N/A 2013-05-29 2019-05-29 N/A 2021-05-29 eptinezumab 233288 Vyepti Lundbeck Canada Inc. N/A 2021-01-11 2027-01-11 N/A 2029-01-11 erdafitinib 224529 Balversa Janssen Inc.

N/A 2019-10-25 2025-10-25 N/A 2027-10-25 erenumab 208607 Aimovig Novartis Pharmaceuticals Canada Inc. N/A 2018-08-01 2024-08-01 N/A 2026-08-01 ertugliflozin 204724 Steglatro Merck Canada Inc. SteglujanSegluromet 2018-05-09 2024-05-09 N/A 2026-05-09 eslicarbazepine acetate 165665 Aptiom Sunovion Pharmaceuticals Canada Inc. N/A 2014-07-08 2020-07-08 Yes 2023-01-08 estetrol monohydrate 236197 Nextstellis Searchlight Pharma Inc.

N/A 2021-03-05 2027-03-05 N/A 2029-03-05 evolocumab 178234 Repatha Amgen Canada Inc. N/A 2015-09-10 2021-09-10 Yes 2024-03-10 fedratinib (supplied as fedratinib hydrochloride) 229866 Inrebic Celgene Inc. N/A 2020-07-27 2026-07-27 N/A 2028-07-27 ferric pyrophosphate citrate 239850 Triferic Avnu Rockwell Medical Inc. N/A 2021-04-22 2027-04-22 Yes 2029-10-22 finafloxacin 172450 Xtoro MerLion Pharmaceuticals GmbH N/A 2016-03-11 2022-03-11 Yes 2024-09-11 flibanserin 189352 Addyi Searchlight Pharma Inc.

N/A 2018-02-27 2024-02-27 N/A 2026-02-27 florbetaben (18F) 193105 Neuraceq Isologic Innovative Radiopharmaceuticals Ltd. N/A 2017-02-22 2023-02-22 N/A 2025-02-22 follitropin delta 188743 Rekovelle Ferring Inc. N/A 2018-03-22 2024-03-22 N/A 2026-03-22 fostamatinib (supplied as fostamatinib disodium) 232078 Tavalisse Rigel Pharmaceuticals Inc. N/A 2020-11-19 2026-11-19 N/A 2028-11-19 fremanezumab 226828 Ajovy Teva Canada Limited N/A 2020-04-09 2026-04-09 N/A 2028-04-09 gadoterate meglumine 186333 Dotarem Guerbet N/A 2016-11-26 2022-11-26 Yes 2025-05-26 galcanezumab 219521 Emgality Eli Lilly Canada Inc.

N/A 2019-07-30 2025-07-30 N/A 2027-07-30 galsulfase 159020 Naglazyme BioMarin Pharmaceutical Inc. N/A 2013-09-16 2019-09-16 Yes 2022-03-16 gemtuzumab ozogamicin 223091 Mylotarg Pfizer Canada ULC N/A 2019-11-28 2025-11-28 Yes 2028-05-28 gilteritinib fumarate 227918 Xospata Astellas Pharma Canada Inc. N/A 2019-12-23 2025-12-23 N/A 2027-12-23 givosiran (supplied as givosiran sodium) 237194 Givlaari Alnylam Netherlands B.V.. N/A 2020-10-09 2026-10-09 N/A 2028-10-09 glasdegib 225793 Daurismo Pfizer Canada ULC N/A 2020-04-28 2026-04-28 N/A 2028-04-28 glecaprevir, pibrentasvir 202233 Maviret AbbVie Corporation N/A 2017-08-16 2023-08-16 Yes 2026-02-16 glycerol phenylbutyrate 174219 Ravicti Horizon Pharma Ireland Ltd.

N/A 2016-03-18 2022-03-18 Yes 2024-09-18 grazoprevir, elbasvir 185866 Zepatier Merck Canada Inc. N/A 2016-01-19 2022-01-19 N/A 2024-01-19 guanfacine hydrochloride 150741 Intuniv XR Takeda Canada Inc. N/A 2013-07-05 2019-07-05 Yes 2022-01-05 guselkumab 200590 Tremfya Janssen Inc. N/A 2017-11-10 2023-11-10 N/A 2025-11-10 haemagglutinin strain A (H5N1) 115398 Arepanrix H5N1 ID Biomedical Corporation of Quebec N/A 2013-02-13 2019-02-13 Yes 2021-08-13 hemin 212276 Panhematin Recordati Rare Diseases Canada Inc.

N/A 2018-07-13 2024-07-13 N/A 2026-07-13 ibrutinib 174029 Imbruvica Janssen Inc. N/A 2014-11-17 2020-11-17 Yes 2023-05-17 icatibant acetate 162918 Firazyr Takeda Canada Inc. N/A 2014-06-04 2020-06-04 Yes 2022-12-04 icosapent ethyl 227235 Vascepa HLS Therapeutics Inc. N/A 2019-12-30 2025-12-30 N/A 2027-12-30 idarucizumab 182503 Praxbind Boehringer Ingelheim (Canada) Ltd N/A 2016-04-29 2022-04-29 N/A 2024-04-29 idelalisib 172652 Zydelig Gilead Sciences Canada Inc.

N/A 2015-03-27 2021-03-27 N/A 2023-03-27 inotersen sodium 214274 Tegsedi Akcea Therapeutics Inc. N/A 2018-10-03 2024-10-03 N/A 2026-10-03 inotuzumab ozogamicin 204077 Besponsa Pfizer Canada Inc. N/A 2018-03-15 2024-03-15 N/A 2026-03-15 insulin degludec 198124 Tresiba Novo Nordisk Canada Inc. Xultophy 2017-08-25 2023-08-25 Yes 2026-02-25 ioflupane (123I) 201481 Datscan GE Healthcare Canada Inc.

N/A 2017-12-07 2023-12-07 N/A 2025-12-07 iron isomaltoside 1000 193890 Monoferric Pharmacosmos A/S N/A 2018-06-22 2024-06-22 N/A 2026-06-22 isatuximab 229245 Sarclisa Sanofi-Aventis Canada Inc. N/A 2020-04-29 2026-04-29 N/A 2028-04-29 isavuconazole (supplied as isavuconazonium sulfate) 208919 Cresemba Avir Pharma Inc. N/A 2018-12-19 2024-12-19 N/A 2026-12-19 ivabradine hydrochloride 166949 Lancora Servier Canada Inc. N/A 2016-12-23 2022-12-23 Yes 2025-06-23 ivermectin 172733 Rosiver Galderma Canada Inc.

N/A 2015-04-22 2021-04-22 N/A 2023-04-22 ixazomib (supplied as ixazomib citrate) 190498 Ninlaro Takeda Canada Inc. N/A 2016-08-04 2022-08-04 N/A 2024-08-04 ixekizumab 184993 Taltz Eli Lilly Canada Inc. N/A 2016-05-25 2022-05-25 Yes 2024-11-25 lanadelumab 213920 Takhzyro Takeda Canada Inc. N/A 2018-09-19 2024-09-19 Yes 2027-03-19 larotrectinib (supplied as larotrectinib sulfate) 219998 Vitrakvi Bayer Inc.

N/A 2019-07-10 2025-07-10 Yes 2028-01-10 latanoprostene bunod 211732 Vyzulta Bausch &. Lomb Incorporated N/A 2018-12-27 2024-12-27 N/A 2026-12-27 ledipasvir 173180 Harvoni Gilead Sciences Canada Inc. N/A 2014-10-15 2020-10-15 Yes 2023-04-15 lefamulin acetate 233292 Xenleta Sunovion Pharmaceuticals Canada Inc. N/A 2020-07-10 2026-07-10 N/A 2028-07-10 lemborexant 231286 Dayvigo Eisai Limited N/A 2020-11-04 2026-11-04 N/A 2028-11-04 lenvatinib mesylate 180877 Lenvima Eisai Limited N/A 2015-12-22 2021-12-22 N/A 2023-12-22 letermovir 204165 Prevymis Merck Canada Inc.

N/A 2017-11-01 2023-11-01 N/A 2025-11-01 levomilnacipran hydrochloride 167319 Fetzima Allergan Inc. N/A 2015-05-08 2021-05-08 N/A 2023-05-08 lifitegrast 199810 Xiidra Novartis Pharmaceuticals Canada Inc. N/A 2017-12-22 2023-12-22 N/A 2025-12-22 linaclotide 161056 Constella Forest Laboratories Canada Inc. N/A 2013-12-02 2019-12-02 N/A 2021-12-02 lixisenatide 193862 Adlyxine Sanofi-aventis Canada Inc.

Soliqua 2017-05-25 2023-05-25 N/A 2025-05-25 lomitapide mesylate 160385 Juxtapid Aegerion Pharmaceuticals Canada Ltd. N/A 2014-02-04 2020-02-04 N/A 2022-02-04 lorlatinib 215733 Lorbrena Pfizer Canada ULC N/A 2019-02-22 2025-02-22 N/A 2027-02-22 lubiprostone 179333 Amitiza Sucampo Pharma Americas LLC N/A 2015-10-14 2021-10-14 N/A 2023-10-14 lumacaftor 181715 Orkambi Vertex Pharmaceuticals (Canada) Incorporated N/A 2016-01-26 2022-01-26 Yes 2024-07-26 luspatercept 236441 Reblozyl Celgene Inc. N/A 2020-09-25 2026-09-25 N/A 2028-09-25 lutetium177 Lu oxodotreotide 217184 Lutathera Advanced Accelerator Applications USA, Inc. N/A 2019-01-09 2025-01-09 N/A 2027-01-09 macitentan 161372 Opsumit Janssen Inc.

N/A 2013-11-06 2019-11-06 Yes 2022-05-06 mecasermin 235023 Increlex Ipsen Biopharmaceuticals Canada Inc. N/A 2020-12-17 2026-12-17 Yes 2029-06-17 mepolizumab 179850 Nucala GlaxoSmithKline Inc. N/A 2015-12-03 2021-12-03 Yes 2024-06-03 midostaurin 201101 Rydapt Novartis Pharmaceuticals Canada Inc. N/A 2017-07-21 2023-07-21 Yes 2026-01-21 mifepristone 160063 Mifegymiso Linepharma International Limited N/A 2015-07-29 2021-07-29 Yes 2024-01-29 migalastat hydrochloride 196956 Galafold Amicus Therapeutics UK LTD N/A 2017-09-05 2023-09-05 N/A 2025-09-05 modified vaccinia levitra (ankara-bavarian nordic) 144762 Imvamune Bavarian Nordic A/S N/A 2013-11-21 2019-11-21 N/A 2021-11-21 naloxegol oxalate 167790 Movantik Knight Therapeutics Inc.

N/A 2015-06-02 2021-06-02 N/A 2023-06-02 necitumumab 193689 Portrazza Eli Lilly Canada Inc. N/A 2017-03-16 2023-03-16 N/A 2025-03-16 neisseria meningitidis serogroup A polysaccharide, neisseria meningitidis serogroup C polysaccharide, neisseria meningitidis serogroup W-135 polysaccharide, neisseria meningitidis serogroup Y polysaccharide, conjugated to tetanus toxoid carrier protein 154290 Nimenrix Pfizer Canada Inc. N/A 2013-03-05 2019-03-05 Yes 2021-09-05 neisseria meningitidis serogroup B recombinant lipoprotein 2086 (rLP2086) subfamily A and Neisseria meningitidis serogroup B recombinant lipoprotein 2086 (rLP2086) subfamily B 195550 Trumenba Pfizer Canada Inc. N/A 2017-10-05 2023-10-05 Yes 2026-04-05 neratinib maleate 218224 Nerlynx Knight Therapeutics Inc.

N/A 2019-07-16 2025-07-16 N/A 2027-07-16 netupitant 196495 Akynzeo Elvium Life Sciences N/A 2017-09-28 2023-09-28 N/A 2025-09-28 nintedanib (supplied as nintedanib esilate) 176043 Ofev Boehringer Ingelheim (Canada) Ltd N/A 2015-06-25 2021-06-25 N/A 2023-06-25 niraparib 216792 Zejula GlaxoSmithKline Inc. N/A 2019-06-27 2025-06-27 N/A 2027-06-27 nivolumab 180828 Opdivo Bristol-Myers-Squibb Canada N/A 2015-09-25 2021-09-25 Yes 2024-03-25 nusinersen 200070 Spinraza Biogen Canada Inc. N/A 2017-06-29 2023-06-29 Yes 2025-12-29 obeticholic acid 198418 Ocaliva Intercept Pharmaceuticals Inc. N/A 2017-05-24 2023-05-24 N/A 2025-05-24 obiltoxaximab 230825 Anthim Elusys Therapeutics, Inc.

N/A 2020-07-30 2026-07-30 N/A 2028-07-30 obinutuzumab 168227 Gazyva Hoffmann-La Roche Limited N/A 2014-11-25 2020-11-25 N/A 2022-11-25 ocrelizumab 198094 Ocrevus Hoffmann-La Roche Limited N/A 2017-08-14 2023-08-14 N/A 2025-08-14 ocriplasmin 161356 Jetrea ThromboGenics N.V. N/A 2013-08-13 2019-08-13 N/A 2021-08-13 olaparib 182823 Lynparza AstraZeneca Canada Inc. N/A 2016-04-29 2022-04-29 N/A 2024-04-29 olaratumab 203478 Lartruvo Eli Lilly Canada Inc. N/A 2017-11-23 2023-11-23 N/A 2025-11-23 olodaterol hydrochloride 155649 Striverdi Respimat Boehringer Ingelheim (Canada) Ltd.

Inspiolto Respimat 2013-06-11 2019-06-11 N/A 2021-06-11 ombitasvir, paritaprevir, dasabuvir sodium 174739 Holkira Pak Abbvie Corporation Technivie 2014-12-22 2020-12-22 N/A 2022-12-22 onasemnogene abeparvovec 239719 Zolgensma Novartis Pharmaceuticals Canada Inc. N/A 2020-12-15 2026-12-15 Yes 2029-06-15 osimertinib mesylate 188171 Tagrisso AstraZeneca Canada Inc. N/A 2016-07-05 2022-07-05 N/A 2024-07-05 ozanimod (supplied as ozanimod hydrochloride) 232761 Zeposia Celgene Inc. N/A 2020-10-02 2026-10-02 N/A 2028-10-02 ozenoxacin 192925 Ozanex Ferrer Internacional, S.A.

N/A 2017-05-01 2023-05-01 Yes 2025-11-01 palbociclib 182048 Ibrance Pfizer Canada Inc. N/A 2016-03-16 2022-03-16 N/A 2024-03-16 pasireotide diaspartate 145005 Signifor Novartis Pharmaceuticals Canada Inc. Signifor Lar 2013-09-23 2019-09-23 N/A 2021-09-23 patiromer sorbitex calcium 210368 Veltassa Vifor Fresenius Medical Care Renal Pharma Ltd. N/A 2018-10-03 2024-10-03 N/A 2026-10-03 patisiran (as patisiran sodium) 221896 Onpattro Alnylam Netherlands B.V.

N/A 2019-06-07 2025-06-07 N/A 2027-06-07 peginterferon beta-1a 166974 Plegridy Biogen Idec Canada Inc. N/A 2015-08-10 2021-08-10 N/A 2023-08-10 pembrolizumab 175884 Keytruda Merck Canada Inc. N/A 2015-05-19 2021-05-19 Yes 2023-11-19 peramivir 191280 Rapivab BioCryst Pharmaceuticals Inc. N/A 2017-01-05 2023-01-05 N/A 2025-01-05 perampanel 153747 Fycompa Eisai Limited N/A 2013-04-04 2019-04-04 Yes 2021-10-04 plecanatide 215288 Trulance Cipher Pharmaceuticals Inc.

N/A 2019-10-10 2025-10-10 N/A 2027-10-10 polatuzumab vedotin 232303 Polivy Hoffmann-La Roche Limited N/A 2020-07-09 2026-07-09 N/A 2028-07-09 polidocanol 177359 Varithena Provensis Ltd. N/A 2015-08-04 2021-08-04 N/A 2023-08-04 pomalidomide 165891 Pomalyst Celgene Inc. N/A 2014-01-20 2020-01-20 Yes 2022-07-20 pralatrexate 207545 Folotyn Servier Canada Inc. N/A 2018-10-26 2024-10-26 N/A 2026-10-26 prasterone 198822 Intrarosa Endoceutics Inc.

N/A 2019-11-01 2025-11-01 N/A 2027-11-01 ponatinib hydrochloride 165121 Iclusig Ariad Pharmaceuticals Inc. N/A 2015-04-02 2021-04-02 N/A 2023-04-02 ponesimod 239537 Ponvory Janssen Inc. N/A 2021-04-28 2027-04-28 N/A 2029-04-28 propiverine hydrochloride 188323 Mictoryl / Mictoryl Pediatric Duchesnay Inc. N/A 2017-01-05 2023-01-05 Yes 2025-07-05 radium - 223 dichloride 161312 Xofigo Bayer Inc.

N/A 2013-12-12 2019-12-12 N/A 2021-12-12 ramucirumab 176810 Cyramza Eli Lilly Canada Inc. N/A 2015-07-16 2021-07-16 N/A 2023-07-16 ravulizumab 217955 Ultomiris Alexion Pharma GmbH N/A 2019-08-28 2025-08-28 N/A 2027-08-28 recombinant haemagglutinin protein-strain A (H1N1) recombinant haemagglutinin protein-strain A (H3N2) recombinant haemagglutinin protein-strain B (Victoria) recombinant haemagglutinin protein-strain B (Yamagata) 235672 Supemtek Sanofi Pasteur Limited N/A 2021-01-14 2027-01-14 N/A 2029-01-14 recombinant human papillomalevitra types 31, 33, 45, 52 and 58 170006 Gardasil 9 Merck Canada Inc. N/A 2015-02-05 2021-02-05 Yes 2023-08-05 recombinant neisseria meningitidis group B NHBA fusion protein, recombinant neisseria meningitidis group B NadA protein, recombinant neisseria meningitidis group B FHBP fusion protein, outer membrane vesicle (neisseria meningitidis group B NZ98/254 strain) 147275 Bexsero GlaxoSmithKline Inc. N/A 2013-12-06 2019-12-06 Yes 2022-06-06 recombinant porcine factor VIII (antihemophilic factor (recombinant), porcine sequence) 177290 Obizur Takeda Canada Inc.

N/A 2015-10-14 2021-10-14 N/A 2023-10-14 regorafenib monohydrate 157970 Stivarga Bayer Inc. N/A 2013-03-11 2019-03-11 Yes 2021-09-11 remdesivir 240551 Veklury Gilead Sciences Canada, Inc. N/A 2020-07-27 2026-07-27 N/A 2028-07-27 reslizumab 185873 Cinqair Teva Canada Limited N/A 2016-07-20 2022-07-20 Yes 2025-01-20 ribociclib (supplied as ribociclib succinate) 203884 Kisqali Novartis Pharmaceuticals Canada Inc. N/A 2018-03-02 2024-03-02 N/A 2026-03-02 rifaximin 161256 Zaxine Salix http://www.ec-sud-illkirch-graffenstaden.ac-strasbourg.fr/?page_id=2262 Pharmaceuticals Inc.

N/A 2013-08-13 2019-08-13 N/A 2021-08-13 riociguat 162761 Adempas Bayer Inc. N/A 2013-09-19 2019-09-19 N/A 2021-09-19 ripretinib 234688 Qinlock Deciphera Pharmaceuticals, LLC N/A 2020-06-19 2026-06-19 N/A 2028-06-19 risankizumab 215753 Skyrizi AbbVie Corporation N/A 2019-04-17 2025-04-17 N/A 2027-04-17 risdiplam 242373 Evrysdi Hoffman-La Roche Limited N/A 2021-04-14 2027-04-14 Yes 2029-10-14 romidepsin 152293 Istodax Celgene Inc. N/A 2013-10-16 2019-10-16 N/A 2021-10-16 romosozumab 197713 Evenity Amgen Canada Inc. N/A 2019-06-17 2025-06-17 N/A 2027-06-17 rupatadine (supplied as rupatadine fumarate) 186488 Rupall Medexus Pharmaceuticals Inc.

N/A 2016-07-20 2022-07-20 Yes 2025-01-20 sacubitril 182734 Entresto Novartis Pharmaceuticals Canada Inc. N/A 2015-10-02 2021-10-02 N/A 2023-10-02 safinamide (as safinamide mesylate) 207115 Onstryv Valeo Pharma Inc. N/A 2019-01-10 2025-01-10 N/A 2027-01-10 sarilumab 191745 Kevzara Sanofi-aventis Canada Inc. N/A 2017-01-12 2023-01-12 N/A 2025-01-12 satralizumab 233642 Enspryng Hoffmann-La Roche Limited N/A 2020-06-01 2026-06-01 Yes 2028-12-01 sebelipase alfa 204085 Kanuma Alexion Pharma GmbH N/A 2017-12-15 2023-12-15 Yes 2026-06-15 secukinumab 170732 Cosentyx Novartis Pharmaceuticals Canada Inc.

N/A 2015-02-27 2021-02-27 Yes 2023-08-27 selexipag 182114 Uptravi Janssen Inc. N/A 2016-01-20 2022-01-20 N/A 2024-01-20 semaglutide 202059 Ozempic Novo Nordisk Canada Inc. Rybelsus 2018-01-04 2024-01-04 N/A 2026-01-04 siltuximab 174291 Sylvant EUSA Pharma (UK) Limited N/A 2014-12-03 2020-12-03 N/A 2022-12-03 simeprevir 164021 Galexos Janssen Inc. N/A 2013-11-18 2019-11-18 N/A 2021-11-18 siponimod 223225 Mayzent Novartis Pharmaceuticals Canada Inc.

N/A 2020-02-20 2026-02-20 N/A 2028-02-20 sodium zirconium cyclosilicate 218799 Lokelma AstraZeneca Canada Inc. N/A 2019-07-25 2025-07-25 N/A 2027-07-25 sofosbuvir 165043 Sovaldi Gilead Sciences Canada Inc. HarvoniEpclusaVosevi 2013-12-13 2019-12-13 N/A 2021-12-13 solriamfetol hydrochloride 237511 Sunosi Jazz Pharmaceuticals Ireland Ltd. N/A 2021-05-13 2027-05-13 N/A 2029-11-13 sonidegib phosphate 229407 Odomzo Sun Pharma Global FZE N/A 2020-06-12 2026-06-12 N/A 2028-06-12 stiripentol 142417 Diacomit Biocodex SA N/A 2012-12-21 2018-12-21 Yes 2021-06-21 sucroferric oxyhydroxide 201492 Velphoro Vifor Fresenius Medical Care Renal Pharma Ltd.

N/A 2018-01-05 2024-01-05 N/A 2026-01-05 sugammadex sodium 180385 Bridion Merck Canada Inc. N/A 2016-02-05 2022-02-05 N/A 2024-02-05 suvorexant 196367 Belsomra Merck Canada Inc. N/A 2018-11-29 2024-11-29 N/A 2026-11-29 tafamidis meglumine 228368 Vyndaqel Pfizer Canada ULC N/A 2020-01-20 2026-01-20 N/A 2028-01-20 tafluprost 165596 Saflutan Purdue Pharma N/A 2014-05-26 2020-05-26 N/A 2022-05-26 talazoparib (supplied as talazoparib tosylate) 220584 Talzenna Pfizer Canada ULC N/A 2019-09-06 2025-09-06 N/A 2027-09-06 taliglucerase alfa 140854 Elelyso Pfizer Canada Inc. N/A 2014-05-29 2020-05-29 Yes 2022-11-29 tedizolid phosphate 173603 Sivextro Merck Canada Inc.

N/A 2015-03-17 2021-03-17 N/A 2023-03-17 teduglutide 180223 Revestive Takeda Canada Inc. N/A 2015-09-04 2021-09-04 Yes 2024-03-04 telotristat ethyl (as telotristat etiprate) 208730 Xermelo Ipsen Biopharmaceuticals Canada Inc. N/A 2018-10-10 2024-10-10 N/A 2026-10-10 tenapanor hydrochloride 224850 Ibsrela Knight Therapeutics Inc. N/A 2020-04-15 2026-04-15 N/A 2028-04-15 tenofovir alafenamide hemifumarate 181399 Genvoya Gilead Sciences Canada Inc.

DescovyOdefseyVemlidySymtuzaBiktarvy 2015-11-27 2021-11-27 Yes 2024-05-27 teriflunomide 160646 Aubagio Genzyme Canada a division of Sanofi-aventis Canada Inc. N/A 2013-11-14 2019-11-14 Yes 2022-05-14 tesamorelin 131836 Egrifta Theratechnologies Inc. N/A 2014-04-29 2020-04-29 N/A 2022-04-29 tezacaftor 211292 Symdeko Vertex Pharmaceuticals (Canada) Incorporated N/A 2018-06-27 2024-06-27 Yes 2026-12-27 tildrakizumab 224036 Ilumya Sun Pharma Global FZE N/A 2021-05-19 2027-05-19 N/A 2029-05-19 tisagenlecleucel 213547 / 213698 Kymriah Novartis Pharmaceuticals Canada Inc. N/A 2018-09-05 2024-09-05 Yes 2027-03-05 tofacitinib 154642 Xeljanz Pfizer Canada Inc.

N/A 2014-04-17 2020-04-17 Yes 2022-10-17 trametinib 157665 Mekinist Novartis Pharmaceuticals Canada Inc. N/A 2013-07-18 2019-07-18 N/A 2021-07-18 trastuzumab deruxtecan 242104 Enhertu AstraZeneca Canada Inc. N/A 2021-04-15 2027-04-15 N/A 2029-04-15 trastuzumab emtansine 162414 Kadcyla Hoffmann-La Roche Limited N/A 2013-09-11 2019-09-11 N/A 2021-09-11 trifarotene 221945 Aklief Galderma Canada Inc. N/A 2019-11-25 2025-11-25 Yes 2028-05-25 tipiracil hydrochloride 205852 Lonsurf Taiho Pharma Canada Inc.

N/A 2018-01-25 2024-01-25 N/A 2026-01-25 triheptanoin 242196 Dojolvi Uagenyx Pharmaceutical Inc. N/A 2021-02-15 2027-02-15 Yes 2029-08-15 tucatinib 235295 Tukysa Seattle Genetics Inc. N/A 2020-06-05 2026-06-05 N/A 2028-06-05 turoctocog alfa 170796 Zonovate Novo Nordisk Canada Inc. N/A 2014-12-08 2020-12-08 Yes 2023-06-08 ulipristal acetate 156861 Fibristal Allergan Inc.

N/A 2013-06-24 2019-06-24 N/A 2021-06-24 umeclidinium bromide 161585 Anoro Ellipta GlaxoSmithKline Inc. Incruse Ellipta 2013-12-23 2019-12-23 N/A 2021-12-23 upadacitinib 223734 Rinvoq AbbVie Corporation N/A 2019-12-23 2025-12-23 N/A 2027-12-23 varicella-zoster levitra glycoprotein E (gE) 200244 Shingrix GlaxoSmithKline Inc. N/A 2017-10-13 2023-10-13 N/A 2025-10-13 vedolizumab 169414 Entyvio Takeda Canada Inc. N/A 2015-01-29 2021-01-29 Yes 2023-07-29 velpatasvir 190521 Epclusa Gilead Sciences Canada Inc.

Vosevi 2016-07-11 2022-07-11 Yes 2025-01-11 venetoclax 190761 Venclexta AbbVie Corporation N/A 2016-09-30 2022-09-30 N/A 2024-09-30 vernakalant hydrochloride 190817 Brinavess Cipher Pharmaceuticals Inc. N/A 2017-03-13 2023-03-13 N/A 2025-03-13 vilanterol trifenatate 157301 Breo Ellipta GlaxoSmithKline Inc. Anoro ElliptaTrelegy Ellipta 2013-07-03 2019-07-03 Yes 2022-01-03 vilazodone hydrochloride 176820 Viibryd Allergan Inc. N/A 2015-07-16 2021-07-16 Yes 2024-01-16 vismodegib 154608 Erivedge Hoffmann-La Roche Ltd.

N/A 2013-07-12 2019-07-12 N/A 2021-07-12 von willebrand factor (recombinant) (vonicog alfa) 213188 Vonvendi Takeda Canada Inc. N/A 2019-01-10 2025-01-10 N/A 2027-01-10 vorapaxar sulfate 179320 Zontivity Toprol Acquisition LLC N/A 2016-05-13 2022-05-13 N/A 2024-05-13 voretigene neparvovec 233097 Luxturna Novartis Pharmaceuticals Canada Inc. N/A 2020-10-13 2026-10-13 Yes 2029-04-13 vortioxetine hydrobromide 159019 Trintellix Lundbeck Canada Inc. N/A 2014-10-22 2020-10-22 Yes 2023-04-22 voxilaprevir 202324 Vosevi Gilead Sciences Canada Inc.

N/A 2017-08-16 2023-08-16 N/A 2025-08-16 zanubrutinib 242748 Brukinsa BeiGene Switzerland GmbH N/A 2021-03-01 2027-03-01 N/A 2029-03-01Important. This updated Notice replaces the previous version that was published on September 18, 2020. May 31, 2021Our file number. 21-109448-84 Health Canada is issuing this Notice to clinical trial sponsors to clarify the approach to various types of clinical research with cannabis.

Health Canada recognizes that conducting clinical research (i.e., research carried out on humans) with cannabis is critical to generating high-quality evidence that can be used to better understand the health risks and benefits of cannabis use, inform health policies and protect the health and safety of Canadians. Clinical research also supports the development of cannabis-based drug products that are safe, effective and of high quality. Sponsors interested in conducting research with cannabis must meet certain requirements under the Cannabis Act and its regulations. Authorization to conduct research with cannabis must be obtained by applying for a federal cannabis research licence from the Controlled Substances and Cannabis Branch of Health Canada.

The Application requirements for cannabis research licences webpage provides more information on how to obtain a research licence from Health Canada under the Cannabis Act and its regulations. Table of contents General requirements for research with cannabis - Food and Drugs Act (FDA) and Cannabis Act Any research with cannabis that meets the definition of a clinical trial in the Food and Drug Regulations (FDR) is subject to Part C, Division 5 of those regulations. Under Part C, Division 5 of the FDR, a clinical trial means. "An investigation in respect of a drug for use in humans that involves human subjects and that is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug, identify any adverse events in respect of the drug, study the absorption, distribution, metabolism and excretion of the drug, or ascertain the safety or efficacy of the drug." This definition only applies to clinical trials that are interventional and not observational (see section below on observational studies).

The application of this definition does not depend on how data generated from a clinical trial will be used. This means that research that is not intended to support the development of an authorized drug product could still meet the definition of a clinical trial, if any of the criteria set out in the definition above are met. Division 5 is a set of internationally aligned regulations under the FDR that govern the sale and importation of drugs for use in clinical trials. These regulations are designed to support research and innovation in an ethical manner to ensure the protection of clinical trial participants, as well as the integrity of the data generated.

They also ensure that the same level of scrutiny is applied to all clinical trials, regardless of the drug substance being tested. Under Division 5, sponsors must file a clinical trial application (CTA) to conduct a clinical trial. A CTA does not need to be submitted to Health Canada if a clinical trial is investigating an authorized drug product (i.e., one that has received a Notice of Compliance (NOC) or a Drug Identification Number (DIN)) and is used within the parameters authorized under the NOC or DIN (e.g., indication, dosage, formulation, route of administration, etc.). A CTA to investigate cannabis, or any other drug substance, must contain standard information and documentation to ensure that the trial is properly designed and that participants (and other implicated persons) are not exposed to undue risk.

This includes, but is not limited to, a study protocol, informed consent forms, an Investigator's Brochure (IB), chemistry and manufacturing information, along with other pertinent information. Sponsors who are considering undertaking a clinical trial to investigate cannabis are encouraged to request a pre-application meeting with the Office of Clinical Trials to discuss their specific circumstances and requirements. Approval from a Research Ethics Board (REB) must also be obtained before starting a clinical trial. More information on CTA requirements for drug products can be found in the Guidance Document For Clinical Trial Sponsors.

Clinical Trial Applications. Quality (chemistry and manufacturing) requirements for CTAs involving cannabis are the same as for any pharmaceutical product used in a clinical trial. The scope and detail of information submitted in support of the quality portion of a CTA should be sufficient to enable Health Canada to make an adequate assessment of the characteristics of the drug. Sponsors are expected to submit progressively more detailed quality information through subsequent clinical trial phases.

More information on quality requirements can be found in the Guidance Document - Quality (Chemistry and Manufacturing) Guidance. Clinical Trial Applications (CTAs) for Pharmaceuticals. In addition to CTA requirements, clinical trials in Canada are conducted in accordance with internationally accepted principles of Good Clinical Practices (GCP). As part of GCP, drugs used in clinical trials must meet Good Manufacturing Practices (GMP), which is a requirement under Part C, Division 5 of the FDR.

Health Canada is aware that it may be challenging for some sponsors to obtain GMP-grade cannabis for research, but this requirement is necessary to ensure the consistency of the investigational product throughout the clinical trial(s). Sponsors must also report to Health Canada any serious and unexpected adverse drug reactions (ADRs) that occur during a clinical trial. For more information on ADR reporting, please visit the following webpage. Clinical Trials - Adverse Drug Reaction (ADR) Reporting.

Clinical trials with cannabis for therapeutic purposes, or with intent to market as a drug under the Food and Drug Regulations Clinical research is essential to understanding the effects of cannabis in a therapeutic context, as well as for the development of drug products that are safe and effective. An increased availability of authorized drugs containing cannabis provides Canadians with a greater selection of therapeutic options to meet their health needs. High-quality research also helps guide practitioners in making evidence-based decisions when prescribing and managing patients using these drugs. When a clinical trial with cannabis is conducted for therapeutic purposes, standard clinical trial requirements apply (as described above).

In addition, sponsors are reminded that, should they plan to seek market authorization under the FDR, studies that do not meet the requirements of Division 5 may not be accepted. In particular, the IB (which is a regulatory requirement described in C.05.005(e) of the FDR) should be prepared in accordance with the Health Canada / ICH Guidance Document E6. Good Clinical Practice. Consolidated Guideline.

This means that the data contained in the IB should be specific to the product being investigated, include the results of any pre-clinical studies, and any relevant clinical studies, and be updated annually. Researchers have informed Health Canada that a product-specific IB is not always feasible for cannabis, and acts as an impediment to cannabis research in Canada. In early phase trials, Health Canada may consider that the absence of the full set of product-specific pre-clinical studies in the IB is acceptable if the clinical trial involves a cannabis product that is produced under GMP conditions, and for which there is sufficient evidence of safe human use. Health Canada expects that the sponsor will be developing a product-specific IB, aligned with the requirements of ICH M3(R2), for trials designed to confirm the efficacy and safety of the cannabis product for use in the treatment of a specific disease/condition, and that the IB will be updated as new information accumulates.

Some flexibility may be acceptable for cannabis products where a similar product has received market authorization either in Canada or another member state of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). In this situation, Health Canada may consider the absence of a full set of product-specific pre-clinical studies acceptable in early phase trials if the sponsor can provide information that establishes the similarity of the chemical and physical properties of the investigational product to the marketed product. Synthetic products that are not duplicates of naturally occurring phytocannabinoids, or where a similar product has not received market authorization either in Canada or in an ICH member state, require product-specific pre-clinical studies, even for early phase trials. The sponsor also needs to provide an attestation that the investigational product is manufactured in a facility that is compliant with GMP.

Sponsors who are considering undertaking a clinical trial to investigate cannabis are encouraged to request a pre-application meeting with the Office of Clinical Trials to discuss their specific circumstances and requirements. Clinical trials with cannabis for non-therapeutic purposes Clinical research is also needed to better understand the psychological and physiological effects of cannabis for non-therapeutic purposes. For example, this can include investigating the time to onset or duration of effects of a cannabis product, the impact of cannabis use on driving performance, or various types of public health research. For the purposes of this document only, non-therapeutic cannabis research can be considered to be an interventional investigation aimed at.

Increasing the knowledge on cannabis and its effects in a healthy user population. Generating knowledge on cannabis to inform public health and public safety measures, public education, and policy. And/or Furthering research and development of cannabis products aimed for sale under the cannabis legal framework. It would exclude studies that have the following objectives.

Assessing potential therapeutic effects/outcomes/indications. And/ or Assessing the efficacy in treating a disease state, symptoms or conditions. Clinical trials with cannabis for non-therapeutic purposes are currently subject to Part C, Division 5 of the FDR and require the submission of a CTA to Health Canada. However, the Department recognizes that Division 5 may not be ideally suited to regulate research for non-therapeutic purposes using commercially available products containing cannabis sold under the cannabis legal framework.

In order to facilitate non-therapeutic cannabis research, it is Health Canada's intention to exempt cannabis used in these studies from the application of the FDA/FDR, and to create a framework under the Cannabis Regulations for non-therapeutic cannabis research. More information regarding this regulatory initiative can be found in this Notice of Intent and this Forward Regulatory Plan.In the interim, for clinical trials with cannabis for non-therapeutic purposes, the Department may consider the absence of product specific pre-clinical and clinical information acceptable for these studies, provided there is sufficient information on the product's main active ingredient(s) - for example, cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC). However, the IB must continue to include all the types of information listed under C.05.005(e) on these active ingredients, and must contain sufficient information to support the specific study. The information must be relevant to the product under investigation in terms of route of administration, dosage regimen (dose and frequency) and product form or class (e.g., cannabis extract, edible cannabis, cannabis topicals, dried cannabis or fresh cannabis).

The information must also be updated annually, and include recent and relevant clinical trial results. If sponsors wish to be eligible for this approach, their clinical trials must be conducted on healthy adults who are currently using cannabis, using the same product form/class that participants have normally used and the same route of administration. The dosage regimen of cannabis administered in the trial is not to exceed what the participant would normally have consumed within a similar period of time. Additionally, although the investigational product does not have to be available for retail sale on the legal market (i.e.

It may be under development), it must meet the requirements of the Cannabis Regulations for legal retail sale and meet GMP quality requirements. If dried cannabis is administered through smoking or vaping, adequate measures to prevent exposure of other individuals (e.g., research staff or other participants) to second-hand smoke or vapour is to be included in the protocol. All other aspects of Division 5, including (but not limited to) the requirement for REB approval, a qualified investigator at each site, submission of chemistry and manufacturing information, adherence to GCP and adverse reaction reporting requirements, continue to apply. Sponsors who are considering undertaking a clinical trial to investigate cannabis are encouraged to request a pre-application meeting with the Office of Clinical Trials to discuss their specific circumstances and requirements.

When submitting a CTA, sponsors are to indicate in their cover letter whether the clinical trial is for therapeutic purposes or for non-therapeutic purposes. Please see below for a tabular summary of these scenarios. Type of cannabis product Type of clinical trial Eligibility for a non-product-specific IB Yes No Cannabis products of botanical origin† and synthetics that are duplicates of naturally occurring cannabinoids Non-therapeutic purpose trial √†† Therapeutic purpose early phase trial √†† Therapeutic purpose confirmatory trial √ Synthetics that are not duplicates of naturally occurring cannabinoids Non-therapeutic purpose trial √ Therapeutic purpose early phase trial √ Therapeutic purpose confirmatory trial √ Cannabis products††† where a similar product has received market authorization either in Canada or in an ICH member state Non-therapeutic purpose trial √†††† Therapeutic purpose early phase trial √†††† Therapeutic purpose confirmatory trial √ † Dried cannabis, fresh cannabis, edible cannabis, cannabis topicals, cannabis extracts (including cannabis oil) †† Information on the main active ingredients and on human use may be considered acceptable ††† Cannabis products of botanical origin or synthetics that are duplicates of naturally occurring cannabinoids †††† Information that establishes similarity of the chemical and physical properties of the investigational product to the marketed product may be considered acceptable Other types of cannabis-based research that are not considered clinical trials Sponsors should consult the definition of a clinical trial in Part C, Division 5 of the FDR to determine whether their study protocol meets the criteria for a clinical trial. When in doubt, sponsors should consult the Office of Clinical Trials.

Observational studies Sponsors who intend to conduct an observational study using cannabis do not need to submit a CTA to Health Canada. A study is considered observational if it meets all of the following criteria. The protocol does not assign to the participants a specific intervention. The prescription of a drug containing cannabis or authorization of cannabis for medical purposes is clearly separated from the decision to include the patient in the study.

The investigator has no control over the prescribing, authorization or administration of the cannabis product. The cannabis product being used must be sourced from the legal regulated Canadian market. The number of inclusion criteria must be very limited (e.g., adults using cannabis and the ability to provide consent). And The collection of data should involve no to minimal health risks.

For observational studies, the sponsors are reminded to consult with their Research Ethics Boards regarding applicable ethics requirements.Serious adverse reactions observed during the course of an observational study should be reported to Canada Vigilance. Information on cannabis adverse reaction reporting can be found in the Cannabis adverse reaction reporting guide. Organoleptic testing, and testing of detection devices Although the Department cannot, in advance, provide a complete list of study protocols that would not meet the definition of a clinical trial, two examples include. Organoleptic testing (e.g., assessment of consumer preference with respect to taste or smell) of products containing cannabis, provided that the cannabis is in its final form and meets the requirements in the Cannabis Regulations for retail sale.

Research on the verification, validation or standardization of a device detecting cannabis for judicial or forensic use (e.g., roadside testing devices), provided that the study focuses on the device and not on the properties or effects of cannabis. Clinical research involving parts of the cannabis plant permitted in natural health products The requirements of the Natural Health Products Regulations apply to clinical trials for natural health products, including those containing permitted parts of the cannabis plant (see section 3.4 of Health Canada's Health products containing cannabis or for use with cannabis. Guidance for the Cannabis Act, the Food and Drugs Act, and related regulations document for more details on permitted parts). More information about these requirements can be found in the Clinical Trials for Natural Health Products guidance document.

Veterinary research In order to conduct veterinary drug research or studies using drugs containing cannabis, the investigator or the sponsor is required to submit either an Experimental Studies Certificate (ESC) or a veterinary Investigational New Drug (IND) application to Health Canada's Veterinary Drugs Directorate (VDD). For all research or studies to be conducted using a veterinary drug, the objective is to ensure that there is appropriate oversight to cover the overall health and safety of study animals. If the study includes food-producing animals, Health Canada also considers relevant information to address food safety. Sponsors are strongly urged to request a pre-submission meeting with VDD before submitting an ESC or IND application for research involving cannabis.

More information can be found on the veterinary drugs forms and applications page. Compliance and enforcement As part of its regulatory responsibilities, Health Canada promotes, monitors and enforces compliance. As such, Health Canada Inspectors may conduct inspections of clinical trials under the authority of Section 23 of the FDA. The purpose of these inspections is to verify compliance with Part C, Division 5 of the FDR, which include the requirement to comply with GCP.

For more information on compliance and enforcement, please refer to the Compliance and Enforcement Policy for Health Products (POL-0001) and to the various guidance documents available on the Health Canada Good Clinical Practices webpage. Contact Information. Office of Clinical Trials - Therapeutic Products DirectorateHealth Products and Food BranchE-mail. Hc.oct.enquiries-requetes.bec.sc@canada.ca Natural and Non-prescription Health Products DirectorateHealth Products and Food BranchE-mail.

Nhpd-cta.dec-dpsn@hc-sc.gc.ca Veterinary Drugs DirectorateHealth Products and Food BranchE-mail:hc.vdd.skmd.so-dgps.dmv.cp.sc@canada.ca Licensing and Medical Access DirectorateControlled Substances and Cannabis BranchE-mail:hc.sp-licensing-cannabis-licences-sp.sc@canada.ca Clinical Trial Compliance ProgramRegulatory Operations and Enforcement BranchE-mail. Gcp_bpc@hc-sc.gc.ca.