Guidance document : regulatory requirements for drug identification numbers (DINs).: H164-273/2021E-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 9.

Permanent link to this Catalogue record:
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Publication information
Department/Agency Canada. Health Canada, issuing body.
Title Guidance document : regulatory requirements for drug identification numbers (DINs).
Publication type Monograph
Language [English]
Other language editions [French]
Earlier edition Guidance document :
Format Electronic
Electronic document
Note(s) Title from cover.
Issued also in French under title: Ligne directrice : exigences réglementaires associées à une identification numérique attribuée à une drogue (DIN).
Issued also in HTML format.
"Administrative changes date: 2021/06/28."
Publishing information [Ottawa] : Health Canada = Santé Canada, August 2021.
©2021
Description 1 online resource (32 pages)
ISBN 9780660388168
Catalogue number
  • H164-273/2021E-PDF
Departmental catalogue number 210083
Subject terms Drugs -- Labeling -- Canada.
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