000 02189cam  2200373zi 4500
0019.899686
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008210511e202108##onc     o    f000 0 eng d
020 |a9780660388168
040 |aCaOODSP|beng|erda|cCaOODSP
043 |an-cn---
0861 |aH164-273/2021E-PDF
24500|aGuidance document : |bregulatory requirements for drug identification numbers (DINs).
264 1|a[Ottawa] : |bHealth Canada = Santé Canada, |cAugust 2021.
264 4|c©2021
300 |a1 online resource (32 pages)
336 |atext|btxt|2rdacontent
337 |acomputer|bc|2rdamedia
338 |aonline resource|bcr|2rdacarrier
500 |aTitle from cover.
500 |aIssued also in French under title: Ligne directrice : exigences réglementaires associées à une identification numérique attribuée à une drogue (DIN).
500 |aIssued also in HTML format.
500 |a"Administrative changes date: 2021/06/28."
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 9.
650 0|aDrugs|xLabeling|zCanada.
7101 |aCanada. |bHealth Canada, |eissuing body.
77508|tLigne directrice : |w(CaOODSP)9.899687
795 |tGuidance document : |w(CaOODSP)9.874552
85640|qPDF|s1.23 MB|uhttps://publications.gc.ca/collections/collection_2021/sc-hc/H164-273-2021-eng.pdf
8564 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-requirements-drug-identification-numbers/document.html