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| 02148nam 2200385zi 4500 |
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| 001 | 9.867837 |
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| 003 | CaOODSP |
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| 005 | 20221107162423 |
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| 006 | m o d f |
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| 007 | cr ||||||||||| |
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| 008 | 190131t20192019onc |o f000 0 eng d |
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| 020 | |a9780660294506 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH164-271/2019E-PDF |
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| 245 | 00|aGuidance document : |bpost-notice of compliance (NOC) changes : safety and efficacy document. |
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| 246 | 17|aPost‐NOC changes: safety & efficacy |
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| 264 | 1|aOttawa, ON : |bHealth Canada = Santé Canada, |c2019. |
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| 264 | 4|c©2019 |
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| 300 | |a1 online resource (20 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 | |a"Publication date: July 2019." |
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| 500 | |a"Date adopted: 2009/09/02; revised date: 2019/08/12; effective date: 2019/08/12." |
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| 500 | |aIssued also in HTML format. |
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| 500 | |aIssued also in French under title: Changements survenus après l’avis de conformité (AC) : document sur l’innocuité et l’efficacité. |
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| 520 | |a"This guidance document applies to sponsors intending to make changes to new drugs that have received a NOC pursuant to section C.08.004 of the Food and Drug Regulations. These new drugs may include pharmaceuticals, biologics, and radiopharmaceuticals for human use and pharmaceutical and certain biotechnological products for veterinary use1, including those submissions for which a NOC has been recommended but issuance of the NOC has been placed on hold"--Introduction, page 6. |
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| 650 | 0|aDrugs|xLabeling|zCanada. |
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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)9.867839 |
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| 856 | 40|qPDF|s357 KB|uhttps://publications.gc.ca/collections/collection_2021/sc-hc/H164-271-2019-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/post-notice-compliance-changes/safety-efficacy-document.html |
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