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Guidance document : regulatory requirements for drug identification numbers (DINs).H164-273/2019E-1-PDF

"When Health Canada authorizes a drug to be marketed in Canada, a Drug Identification Number (DIN) is issued to the manufacturer and printed on the package labels. A DIN indicates that the evaluation of the drug determined that it met the relevant requirements of the Food and Drugs Act and its regulations and the drug has a favourable risk/benefit profile. Manufacturers of prescription and non‐prescription drugs must obtain a DIN before they are marketed in Canada. Market authorization of a drug may require the additional issuance of a Notice of Compliance (NOC)"--Introduction, page 8.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.874552&sl=0

Publication information
Department/Agency
  • Canada. Health Canada.
TitleGuidance document : regulatory requirements for drug identification numbers (DINs).
Publication typeMonograph
Language[English]
Other language editions[French]
Later editionGuidance document : [2021/06/28 edition]
Earlier editionGuidance document : [2019/05/03 edition]
FormatDigital text
Electronic document
Note(s)
  • Cover title.
  • "Date adopted: 2019/05/03; effective date: 2019/05/03; administrative changes date: 2019/06/19."
  • Issued also in French under title: Ligne directrice : exigences réglementaires associées à une identification numérique attribuée à une drogue (DIN).
Publishing information
  • [Ottawa] : Health Canada = Santé Canada, June 2019.
  • ©2019
Description1 online resource (28 pages)
ISBN9780660312880
Catalogue number
  • H164-273/2019E-1-PDF
Departmental catalogue number190110
Edition
  • [2019/06/19 edition].
Subject terms
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