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| 02307cam 2200409zi 4500 |
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| 001 | 9.868510 |
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| 003 | CaOODSP |
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| 005 | 20240521100943 |
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| 006 | m o d f |
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| 007 | cr mn||||||||| |
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| 008 | 190218e202405 onc ob f000 0 eng d |
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| 020 | |a9780660296517 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH164-272/2024E-PDF |
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| 245 | 00|aGuidance document : |bpreparation of regulatory activities in non-eCTD format. |
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| 246 | 17|aGuidance document : |bpreparation of RAs in non-eCTD format |
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| 264 | 1|aOttawa, ON : |bHealth Canada = Santé Canada, |cMay 2024. |
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| 264 | 4|c©2024 |
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| 300 | |a1 online resource (42 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 : préparation des activités de réglementation en format non-eCTD. |
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| 500 | |aTitle from cover. |
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| 500 | |aAt head of title: Guidance document. |
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| 500 | |a"Effective date: 2024/05/15." |
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| 500 | |a"Pub.: 240030"--Page 2. |
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| 504 | |aIncludes bibliographical references. |
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| 520 | |a"This document defines the filing requirements and provides guidance on the structure, content and transmission of regulatory transactions filed in the non-electronic common technical document (non-eCTD) format. … The objective of this document is to provide operational direction and guidance to sponsors and Health Canada staff on the requirements for the preparation of: regulatory activities for Human drugs and disinfectants pursuant to Part C - Division 1 and Division 5 of the Food and Drug Regulations; regulatory activities for Veterinary drugs pursuant to Part C - Division 1 and Division 8 of the Food and Drug Regulations; Master Files (MFs) …"--Introduction, page 6. |
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| 650 | 0|aPharmaceutical policy|zCanada. |
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| 650 | 0|aDisinfection and disinfectants|xGovernment policy|zCanada. |
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| 650 | 0|aVeterinary drugs|xGovernment policy|zCanada. |
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| 710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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| 775 | 08|tLigne directrice : |w(CaOODSP)9.868511 |
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| 795 | |tGuidance document |b(2016)|w(CaOODSP)9.848996 |
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| 856 | 40|qPDF|s1.20 MB|uhttps://publications.gc.ca/collections/collection_2024/sc-hc/H164-272-2024-eng.pdf |
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