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| 02378nam 2200397zi 4500 |
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001 | 9.939764 |
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003 | CaOODSP |
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005 | 20240823104011 |
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006 | m o d f |
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007 | cr cn||||||||| |
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008 | 240624t20242024onc o f000 0 eng d |
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020 | |a9780660725031 |
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040 | |aCaOODSP|beng|erda|cCaOODSP |
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043 | |an-cn--- |
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086 | 1 |aH164-273/1-2024E-PDF |
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245 | 00|aGuidance document : |bregulatory requirements for drug identification numbers (DINs). |
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246 | 17|aRegulatory requirements for drug identification numbers (DINs) |
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250 | |a[2024/07/15 edition]. |
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264 | 1|aOttawa, Ontario : |bHealth Canada = Santé Canada, |c2024. |
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264 | 4|c©2024 |
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300 | |a1 online resource (35 pages) |
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336 | |atext|btxt|2rdacontent |
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337 | |acomputer|bc|2rdamedia |
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338 | |aonline resource|bcr|2rdacarrier |
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500 | |aCover title. |
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500 | |a"Publication date: July 2024." |
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500 | |a"Date adopted: 2019/05/03 ; Effective date: 2019/05/03 ; Administrative changes date: 2024/07/15." |
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500 | |aIssued also in French under title: Ligne directrice : exigences réglementaires associées à une identification numérique attribuée à une drogue (DIN). |
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520 | |a"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. |
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650 | 0|aDrugs|xLabeling|zCanada. |
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710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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775 | 08|tLigne directrice : |w(CaOODSP)9.939767 |
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795 | |tGuidance document : |b[2024/05/01 edition]|w9.936452 |
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856 | 40|qPDF|s501 KB|uhttps://publications.gc.ca/collections/collection_2024/sc-hc/H164-273-1-2024-eng.pdf |
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856 | 4 |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 |
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