00000nam 2200000zi 4500 9.893231 CaOODSP 20221107173405 m o d f cr cn||||||||| 201104t20202020onc o f000 0 eng d 9780660365572 CaOODSP eng rda CaOODSP n-cn--- H164-303/2020E-PDF Guidance document : special access program for drugs : guidance document for industry and practitioners. Special access program for drugs : guidance document for industry and practitioners Ottawa, ON : Health Canada = Santé Canada, 2020. ©2020 1 online resource (29 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Cover title. Issued also in HTML format. "Effective date: 2020/09/30." 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. "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. Drug accessibility Government policy Canada. Canada. Health Canada, issuing body. Ligne directrice : (CaOODSP)9.893233 Guidance document : (CaOODSP)9.906448 PDF 387 KB https://publications.gc.ca/collections/collection_2021/sc-hc/H164-303-2020-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/drugs/guidance.html 200275