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| 02715cam 22004098i 4500 |
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| 001 | 9.906439 |
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| 003 | CaOODSP |
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| 005 | 20221107181121 |
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| 006 | m o b f |
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| 007 | cr cn||||||||| |
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| 008 | 211223e202201 onc ob f000 0 eng d |
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| 020 | |a9780660414744 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH164-267/2022E-PDF |
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| 245 | 00|aGuidance document : |bmaster files (MFs) - procedures and administrative requirements. |
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| 246 | 17|aMaster files - procedures and administrative requirements |
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| 264 | 1|aOttawa, ON : |bHealth Canada = Santé Canada, |cJanuary 2022. |
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| 264 | 4|c©2022 |
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| 300 | |a1 online resource (46 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"Revised date: 2021/12/01 ; effective date: 2022/01/01." |
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| 500 | |aIssued also in French under title: Ligne directrice : fiches maîtresses (FM) - procédures et exigences administratives. |
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| 500 | |aIssued also in HTML format. |
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| 504 | |aIncludes bibliographical references (pages 33-39). |
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| 520 | |a"A Master File (MF) is a reference that provides information about specific processes or components used in the manufacturing, processing, or packaging of a drug. The MF is a useful vehicle for providing information to Health Canada, where that information is confidential business information (CBI) and is not available to the manufacturer of the dosage form or to the sponsors of a drug submission, DIN (Drug Identification Number) application or clinical trial application (CTA) (hereafter referred to as the Applicants). Health Canada must protect confidential business information in accordance with the law. This guidance document provides MF related-definitions, information on filing requirements, processing and assessment procedures for Type I to IV MFs, and outlines the registration requirements for new MFs as well as other MFs transactions including administrative changes, updates, withdrawals and closures"--Introduction, page 7. |
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| 650 | 0|aPharmaceutical policy|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)9.906440 |
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| 795 | |tGuidance document : |w(CaOODSP)9.867638 |
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| 856 | 40|qPDF|s477 KB|uhttps://publications.gc.ca/collections/collection_2022/sc-hc/H164-267-2022-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/guidance-document-master-files-procedures-administrative-requirements.html |
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