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008190820e201906##onc     o    f000 0 eng d
020 |a9780660312880
040 |aCaOODSP|beng|erda|cCaOODSP
043 |an-cn---
0861 |aH164-273/2019E-1-PDF
24500|aGuidance document : |bregulatory requirements for drug identification numbers (DINs).
250 |a[2019/06/19 edition].
264 1|a[Ottawa] : |bHealth Canada = Santé Canada, |cJune 2019.
264 4|c©2019
300 |a1 online resource (28 pages)
336 |atext|btxt|2rdacontent
337 |acomputer|bc|2rdamedia
338 |aonline resource|bcr|2rdacarrier
500 |aCover title.
500 |a"Date adopted: 2019/05/03; effective date: 2019/05/03; administrative changes date: 2019/06/19."
500 |aIssued also in French under title: Ligne directrice : exigences réglementaires associées à une identification numérique attribuée à une drogue (DIN).
520 |a"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.
650 0|aDrugs|xLabeling|zCanada.
7101 |aCanada. |bHealth Canada.
77508|tLigne directrice : |w(CaOODSP)9.874556
794 |tGuidance document : |b[2021/06/28 edition]|w(CaOODSP)9.899686
795 |tGuidance document : |b[2019/05/03 edition]|w(CaOODSP)9.870481
85640|qPDF|s307 KB|uhttps://publications.gc.ca/collections/collection_2019/sc-hc/H164-273-2019-1-eng.pdf