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.
Lien permanent pour cette publication :
publications.gc.ca/pub?id=9.906448&sl=1
| Ministère/Organisme | Canada. Health Canada, issuing body. |
|---|---|
| Titre | Guidance document : special access program for drugs : guidance document for industry and practitioners. |
| Variante du titre | Special access program for drugs : guidance document for industry and practitioners |
| Type de publication | Monographie |
| Langue | [Anglais] |
| Autres langues publiées | [Français] |
| Édition ultérieure | Guidance document : |
| Édition précédente | Guidance document : |
| Format | Électronique |
| Document électronique | |
| 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. |
| Information sur la publication | Ottawa, ON : Health Canada = Santé Canada, January 2022. ©2022 |
| Description | 1 online resource (31 pages) |
| ISBN | 9780660414782 |
| Numéro de catalogue |
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| Numéro de catalogue du ministère | Pub.: 210501 |
| Descripteurs | Drug accessibility -- Government policy -- Canada. |
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