Guidance document : special access program for drugs : guidance document for industry and practitioners.: H164-303/2020E-PDF
"Health Canada’s Special Access Program for drugs (SAP) enables drugs that are not marketed in Canada to be requested by practitioners for the treatment, diagnosis, or prevention of serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. Non-marketed drugs may be unauthorized if they have not been approved by Health Canada. This means they have not been assessed for safety, effectiveness and quality. It may also mean that the sale of the drug has not commenced in Canada, or the product has been discontinued or removed from the market due to regulatory actions under the Food and Drug Regulations (FDR)"--Introduction, page 6.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.893231&sl=0
| Department/Agency |
|
|---|---|
| Title | Guidance document : special access program for drugs : guidance document for industry and practitioners. |
| Variant title |
|
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Later edition | Guidance document : |
| Format | Digital text |
| Electronic document | |
| Note(s) |
|
| Publishing information |
|
| Description | 1 online resource (29 pages) |
| ISBN | 9780660365572 |
| Catalogue number |
|
| Departmental catalogue number | 200275 |
| Subject terms |
Request alternate formats
To request an alternate format of a publication, complete the Government of Canada Publications email form. Use the form’s “question or comment” field to specify the requested publication.Page details
- Date modified: