ARCHIVED Interim order and guidance document to import, sell and advertise COVID-19 related drugs and vaccines: Notice
COVID-19 drugs that were authorized in Canada under the Interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19 (ISAD IO) were able to transition and file a new drug submission under the Food and Drug Regulations (FDR). The authorization of these COVID-19 drugs, under the ISAD IO, will remain valid beyond September 16, 2021, as long as a submission was filed under the Regulations and until the review is completed by Health Canada. For more information on the application status of a COVID-19 drug, please see the Drug and Health Product Submissions Under Review (SUR).
Date published: 2020-09-17
On September 16, 2020, the Minister of Health approved an interim order (IO) to import, sell and advertise drugs during COVID-19. This interim order creates a new authorization pathway that will help expedite the authorization of drugs and vaccines for COVID-19.
On this page
- Why the interim order was introduced
- Facilitating earlier access to drugs and vaccines
- Prioritizing COVID-19 applications
- Interim order guidance document
Why the interim order was introduced
Many companies and academic institutions around the world are developing potential drugs and vaccines for COVID-19. To help expedite the authorization of these products, Health Canada has created a new authorization pathway that will facilitate earlier access to COVID-19 drugs or vaccines.
Facilitating earlier access to drugs and vaccines
The new interim order introduces temporary regulatory tools to expedite the authorization for importing, selling and advertising COVID-19-related drugs and vaccines without compromising standards for patient safety.
The new tools allow the Minister of Health to:
- authorize a drug that is not yet licensed in Canada or elsewhere with a modified set of requirements
- authorize a drug based on certain elements being approved by a trusted foreign regulatory authority
- expand the use of an already-authorized drug to include a COVID-19 indication based on known evidence with or without an application from the market authorization holder
The interim order applies to:
- prescription drugs
- non-prescription professional-use drugs
- biologically-derived products, such as vaccines, blood derived products, and products produced through biotechnology
- veterinary drugs
The interim order does not apply to:
- over-the-counter non-prescription drugs
- disinfectants and hand sanitizers (antiseptic skin cleanser)
- veterinary health products
- natural health products, defined in the Natural Health Products Regulations
Learn more about drug and vaccine authorizations for COVID-19.
Pre-positioning of COVID-19 drugs and vaccines
To facilitate timely access to COVID-19 drugs and vaccines, the interim order also introduces a mechanism to import drugs and vaccines that show promise for treating or preventing COVID-19 into Canada. This mechanism, known as “pre-positioning,” allows promising treatments to be placed in Canadian facilities before their authorization to allow for quicker distribution after authorization.
The use of this pre-positioning mechanism is restricted to promising COVID-19 drugs and vaccines for which the Government of Canada has entered into a contract with the manufacturer for their procurement. The Chief Public Health Officer of the Public Health Agency of Canada must notify the Minister of Health that a drug or vaccine is to be pre-positioned. The importer of COVID-19 drugs and vaccines to be pre-positioned must have a Canadian establishment licence. Use of the drug or vaccine cannot occur until it receives a market authorization from Health Canada.
Prioritizing COVID-19 applications
We are committed to prioritizing the review of all COVID-19 drug applications. This will ensure timely access to novel drugs and vaccines without compromising their safety, efficacy and quality.
You can access:
- a list of applications received for COVID-19-related drugs and vaccines, and their status
- the drugs and vaccines that have been authorized for treating COVID-19
Interim order guidance document
Our IO to import, sell and advertise drugs during COVID-19 guidance document provides information and outlines the application requirements.
The guidance document comes into force immediately. We will be engaging with stakeholders and accepting comments on the guidance document. Please provide feedback by email to firstname.lastname@example.org by October 8, 2020.
An updated guidance document will be released following these consultations.
If you wish to apply for authorization of a COVID-19 drug, please contact Health Canada at:
- pharmaceutical drugs: email@example.com
- biologic drugs: firstname.lastname@example.org
- veterinary drugs: email@example.com
Existing regulations and guidance for all applications not covered under this interim order will continue to apply.
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