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| 02234nam 22003978i 4500 |
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| 001 | 9.890884 |
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| 003 | CaOODSP |
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| 005 | 20221107172728 |
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| 006 | m o d f |
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| 007 | cr ||||||||||| |
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| 008 | 200825t20202020onc ob f00| 0 eng d |
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| 020 | |a9780660358901 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH13-9/25-2020E-PDF |
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| 245 | 00|aGuidance document : |badministrative processing of submissions and applications involving human or disinfectant drugs. |
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| 264 | 1|aOttawa, ON : |bHealth Canada = Santé Canada, |c2020. |
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| 264 | 4|c©2020 |
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| 300 | |a1 online resource (24 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"Date posted: 2020/10/01." |
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| 500 | |a"Pub.: 200167." |
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| 500 | |aIssued also in HTML format. |
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| 500 | |aIssued also in French under title: Traitement administratif des présentations et des demandes concernant les médicaments destinés aux humains ou les désinfectants. |
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| 504 | |aIncludes bibliographical references. |
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| 520 | |a"Pursuant to Part C, Division 1 and Division 8 of the Food and Drug Regulations (hereafter the Regulations), no manufacturer shall sell a drug in Canada unless a Drug Identification Number (DIN) [C.01.014 (1)] or DIN and Notice of Compliance (NOC) [C.08.002 (1)] have been issued by Health Canada, which grants market authorization for that product. Manufacturers must notify Health Canada of information changes pertaining to the manufacturer and drug product as set out by paragraph C.01.014.4 (b) of the Regulations"--Introduction, page 7. |
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| 650 | 0|aDrug approval|zCanada. |
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| 710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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| 775 | 08|tLigne directrice : |w(CaOODSP)9.890886 |
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| 795 | |tGuidance document : |w9.860041 |
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| 856 | 40|qPDF|s312 KB|uhttps://publications.gc.ca/collections/collection_2020/sc-hc/H13-9-25-2020-eng.pdf |
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| 856 | 40|qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/administrative-processing-human-disinfectant-drugs-2019/document.html |
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