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.
Lien permanent pour cette publication :
publications.gc.ca/pub?id=9.874552&sl=1
Ministère/Organisme | Canada. Health Canada. |
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Titre | Guidance document : regulatory requirements for drug identification numbers (DINs). |
Type de publication | Monographie |
Langue | [Anglais] |
Autres langues publiées | [Français] |
Édition ultérieure | Guidance document : |
Édition précédente | Guidance document : |
Format | Électronique |
Document électronique | |
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). "Date adopted: 2019/05/03; effective date: 2019/05/03; administrative changes date: 2019/06/19." Issued also in HTML format. |
Information sur la publication | [Ottawa] : Health Canada = Santé Canada,June 2019. ©2019 |
Description | 1 online resource (28 pages) |
ISBN | 9780660312880 |
Numéro de catalogue |
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Numéro de catalogue du ministère | 190110 |
Descripteurs | Drug labelling |