00000nam 2200000zi 4500 9.939764 CaOODSP 20250122155427 m o d f cr cn||||||||| 240624t20242024onc o f000 0 eng d 9780660725031 CaOODSP eng rda CaOODSP n-cn--- H164-273/1-2024E-PDF Guidance document : regulatory requirements for drug identification numbers (DINs). Regulatory requirements for drug identification numbers (DINs) [2024/07/15 edition]. Ottawa, Ontario : Health Canada = Santé Canada, 2024. ©2024 1 online resource (35 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier 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). "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. Drugs Labeling Canada. Canada. Health Canada, issuing body. Ligne directrice : (CaOODSP)9.939767 Guidance document : (CaOODSP)9.947279 Guidance document : [2024/05/01 edition] (CaOODSP)9.936452 PDF 501 KB https://publications.gc.ca/collections/collection_2024/sc-hc/H164-273-1-2024-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-requirements-drug-identification-numbers/document.html 240307