Update: Health Canada has prepared an overview of its special access programs, and has finalized the Guidance Document: Sale of Drugs - Public or Canadian Armed Forces Health Emergencies.
On February 15, 2023, Regulations Amending Certain Regulations Concerning the Sale of Drugs (Public or Canadian Armed Forces Health Emergencies) came into force. These Regulations amend the Food and Drug Regulations to add a new Division 11, titled "Public or Canadian Armed Forces Health Emergencies - Drugs for Immediate Use or Stockpiling."
New Division 11 will facilitate access to drugs for emergency preparedness and response activities proposed by public health officials (PHOs), including the Public Health Agency of Canada, by permitting an application to the Minister of Health to authorize the sale of a specified quantity of a drug not otherwise authorized in Canada for:
- use in an immediate public or military health emergency; and
- stockpiling in anticipation of a public or military health emergency.
Drugs that receive an authorization under new Division 11 may be approved in a foreign jurisdiction or may still be under development; the Regulations place certain labelling, reporting and monitoring obligations on the PHOs to ensure safe use and handling of the drug. The Regulations also permit distribution of a stockpiled drug authorized under Division 11 to a practitioner who has requested the drug through the Special Access Program under Division 8.
Consequent amendments are made to other regulations, including to exclude an authorization under new Division 11 from an "authorization for sale" for the purposes of the Certificate of Supplementary Protection Regulations.
As we had previously reported, Health Canada had pre-published a version of the Regulations in 2019, along with a Draft Guidance Document: Public or Canadian Armed Forces Health Emergencies - Drugs for Immediate Use or Stockpiling for consultation. A final guidance document has not been posted.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
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