| 000 | 00000nam 2200000zi 4500 |
| 001 | 9.945564 |
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| 003 | CaOODSP |
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| 005 | 20251006164304 |
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| 006 | m o d f |
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| 007 | cr mn||||||||| |
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| 008 | 241126e202510##onc ob f000 0 eng d |
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| 020 | |a9780660746609 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH164-277/2025E-PDF |
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| 245 | 00|aGuidance document : |bthe management of drug submissions and applications. |
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| 264 | 1|aOttawa, ON : |bHealth Canada = Santé Canada, |cOctober 2025. |
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| 264 | 4|c©2025 |
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| 300 | |a1 online resource (52 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 : gestion des présentations et des demandes de drogue. |
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| 504 | |aIncludes bibliographical references (pages 44-45). |
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| 520 | |a"This guidance document gives direction and guidance when managing information submitted in accordance with the Food and Drugs Act and its regulations. This guidance is for sponsors and Health Canada staff from the following directorates and divisions: Medical Devices Directorate (MDD); Pharmaceutical Drugs Directorate (PDD); Marketed Health Products Directorate (MHPD); Business Facilitation and Modernization Directorate (BFMD); Biologic and Radiopharmaceutical Drugs Directorate (BRDD); Office of Submissions and Intellectual Property (OSIP) within MHPD; Non-Prescription Drug Evaluation Division (NDED) of the Natural and Non-prescription Health Products Directorate (NNHPD)"--Overview, page 1. |
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| 650 | 0|aDrug approval|zCanada. |
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| 650 | 0|aPharmaceutical policy|zCanada. |
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| 710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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| 775 | 08|tLigne directrice : |w(CaOODSP)9.945565 |
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| 795 | |tGuidance document : |b2022|w(CaOODSP)9.912786 |
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| 856 | 40|qPDF|s1.30 MB|uhttps://publications.gc.ca/collections/collection_2025/sc-hc/H164-277-2025-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/management-drug-submissions-applications.html |
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| 986 | |aPub.: 240651 |
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