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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Department/Agency | Canada. Health Canada, issuing body. |
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Title | Guidance document : regulatory requirements for drug identification numbers (DINs). |
Publication type | Monograph |
Language | [English] |
Other language editions | [French] |
Later edition | Guidance document : |
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 |
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Departmental catalogue number | 210083 |
Subject terms | Drugs -- Labeling -- Canada. |
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