00000nam 2200000zi 4500 9.874552 CaOODSP 20240823090126 m o d f cr ||||||||||| 190820e201906##onc o f000 0 eng d 9780660312880 CaOODSP eng rda CaOODSP n-cn--- H164-273/2019E-1-PDF Guidance document : regulatory requirements for drug identification numbers (DINs). [2019/06/19 edition]. [Ottawa] : Health Canada = Santé Canada, June 2019. ©2019 1 online resource (28 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Cover title. "Date adopted: 2019/05/03; effective date: 2019/05/03; administrative changes date: 2019/06/19." 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 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. Drugs Labeling Canada. Canada. Health Canada. Ligne directrice : (CaOODSP)9.874556 Guidance document : [2021/06/28 edition] (CaOODSP)9.899686 Guidance document : [2019/05/03 edition] (CaOODSP)9.870481 PDF 307 KB https://publications.gc.ca/collections/collection_2019/sc-hc/H164-273-2019-1-eng.pdf 190110