Guidance document : special access program for drugs : guidance document for industry and practitioners.: H164-303/2022E-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 7.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.906448&sl=0
| Department/Agency | Canada. Health Canada, issuing body. |
|---|---|
| Title | Guidance document : special access program for drugs : guidance document for industry and practitioners. |
| Variant title | Special access program for drugs : guidance document for industry and practitioners |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Later edition | Guidance document : |
| Earlier edition | Guidance document : |
| Format | Electronic |
| Electronic document | |
| Note(s) | Cover title. "Effective date: 2020/09/30 ; revised date: 2022/01/05." Issued also in French under title: Ligne directrice : programme d’accès spécial aux médicaments : ligne directrice à l’intention de l’industrie et des praticiens. |
| Publishing information | Ottawa, ON : Health Canada = Santé Canada, January 2022. ©2022 |
| Description | 1 online resource (31 pages) |
| ISBN | 9780660414782 |
| Catalogue number |
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| Departmental catalogue number | Pub.: 210501 |
| Subject terms | Drug accessibility -- Government policy -- Canada. |
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