Consultation - Draft Guidance Document for Industry and Practitioners on the Special Access Program (SAP) for Drugs
From Health Canada
Current status: Open
Opened on May 10, 2019 and will close to new input on July 19, 2019.
This draft guidance provides information on the interpretation of the proposed amendments to the medical emergency provisions of the Food and Drug Regulations. It also assists practitioners to comply with the proposed regulatory requirements by explaining the request and authorization process and reporting requirements when requesting a drug for use in a medical emergency, and foreign drug manufacturers requesting to store a drug in a Canadian facility.
Join in: how to participate
Send us an email
Send an email to HC.Policy.Bureau.Enquiries.SC@canada.ca with your ideas or comments to make yourself heard.
Participate by mail:
Send a letter with your ideas and input to the address in contact information below.
Who is the focus of this consultation
We will engage with Canadians:
- Drug Manufacturers
- General public
Goals of the consultation
We are seeking stakeholder comments on the draft guidance. This draft guidance should be read in conjunction with the proposed regulations posted on the Canada Gazette website. The input gathered through this consultation will be used to finalize the guidance document.
- Pre-publication of draft regulations in Canada Gazette I
Bureau of Policy, Science, and International Programs (BPSIP)
Therapeutic Products Directorate
Health Products and Food Branch
Holland Cross, Tower B
1600 Scott St
Address Locator: 3102C1
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