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008211224e202201##onc     o    f000 0 eng d
020 |a9780660414782
040 |aCaOODSP|beng|erda|cCaOODSP
043 |an-cn---
0861 |aH164-303/2022E-PDF
24500|aGuidance document : |bspecial access program for drugs : guidance document for industry and practitioners.
24610|aSpecial access program for drugs : |bguidance document for industry and practitioners
264 1|aOttawa, ON : |bHealth Canada = Santé Canada, |cJanuary 2022.
264 4|c©2022
300 |a1 online resource (31 pages)
336 |atext|btxt|2rdacontent
337 |acomputer|bc|2rdamedia
338 |aonline resource|bcr|2rdacarrier
500 |aCover title.
500 |a"Effective date: 2020/09/30 ; revised date: 2022/01/05."
500 |aIssued also in French under title: Ligne directrice : programme d’accès spécial aux médicaments : ligne directrice à l’intention de l’industrie et des praticiens.
520 |a"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.
650 0|aDrug accessibility|xGovernment policy|zCanada.
7101 |aCanada. |bHealth Canada, |eissuing body.
77508|tLigne directrice : |w(CaOODSP)9.906449
794 |tGuidance document : |w(CaOODSP)9.909644
795 |tGuidance document : |w(CaOODSP)9.893231
85640|qPDF|s405 KB|uhttps://publications.gc.ca/collections/collection_2022/sc-hc/H164-303-2022-eng.pdf