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000
| 02221cam 2200385zi 4500 |
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| 001 | 9.875014 |
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| 003 | CaOODSP |
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| 005 | 20221107164339 |
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| 006 | m o d f |
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| 007 | cr ||||||||||| |
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| 008 | 190617t20192019onc o f000 0 eng d |
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| 020 | |a9780660314631|z9780660314105 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH164-281/2019E-PDF|zH149‐18/2019E‐PDF |
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| 245 | 00|aGuidance document : |bpost-notice of compliance (NOC) : changes : quality document. |
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| 246 | 17|aPost‐NOC quality |
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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 (271 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 | |aIssued also in French under title: Ligne directrice : changements survenus après l’avis de conformité (AC) : document sur la qualité. |
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| 500 | |aIncorrect catalogue number (H149‐18/2019E‐PDF) and ISBN (978‐0‐660‐31410‐5) printed in this publication. |
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| 500 | |a"Publication date: July 2019." |
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| 500 | |aIssued also in HTML format. |
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| 520 | |a"The first version of Health Canada’s Post‐Notice of Compliance Changes – Quality Document was finalised in 2009. This document has been periodically updated and has an emphasis on applying a science‐based and risk‐based approach to the pharmaceutical quality assessment of these products. As such, updated guidance documents continue to be needed on the information to support quality changes to new drugs which apply a modernized, science‐based, and risk‐based approach to this area"--Page 19. |
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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)9.875018 |
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| 856 | 40|qPDF|s1.43 MB|uhttps://publications.gc.ca/collections/collection_2021/sc-hc/H164-281-2019-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/quality-document/guidance.html |
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