Guidance document : regulatory requirements for drug identification numbers (DINs).: H164-273/1-2024E-PDF
"When Health Canada authorizes a drug to be marketed in Canada, a Drug Identification Number (DIN) is assigned 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 10.
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| Department/Agency | Canada. Health Canada, issuing body. |
|---|---|
| Title | Guidance document : regulatory requirements for drug identification numbers (DINs). |
| Variant title | Regulatory requirements for drug identification numbers (DINs) |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Earlier edition | Guidance document : [2024/05/01 edition] |
| Format | Electronic |
| Electronic document | |
| Note(s) | Cover title. "Publication date: July 2024." "Date adopted: 2019/05/03 ; Effective date: 2019/05/03 ; Administrative changes date: 2024/07/15." Issued also in French under title: Ligne directrice : exigences réglementaires associées à une identification numérique attribuée à une drogue (DIN). |
| Publishing information | Ottawa, Ontario : Health Canada = Santé Canada, 2024. ©2024 |
| Description | 1 online resource (35 pages) |
| ISBN | 9780660725031 |
| Catalogue number |
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| Departmental catalogue number | 240307 |
| Edition | [2024/07/15 edition]. |
| Subject terms | Drugs -- Labeling -- Canada. |
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