Consultation - Draft Guidance Document for Industry and Practitioners on the Special Access Program (SAP) for Drugs

From Health Canada

Current status: Closed

This consultation ran from May 10, 2019 to 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This draft guidance provides information on the interpretation of the proposed amendments to the medical emergency provisions of the Food and Drug Regulations.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:

• Practitioners
• 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We are seeking stakeholder comments on the draft guidance. This draft guidance should be read in conjunction with the proposed regulations posted on the Canada Gazette website.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.

Related information

• Pre-publication of draft regulations in Canada Gazette I

Contact us

Bureau of Policy, Science, and International Programs (BPSIP)
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Tower B
1600 Scott St
Address Locator: 3102C1
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-4623
Email: HC.Policy.Bureau.Enquiries.SC@canada.ca