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| 02760nam 2200409zi 4500 |
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| 001 | 9.867638 |
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| 003 | CaOODSP |
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| 005 | 20221107162352 |
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| 006 | m o b f |
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| 007 | cr cn||||||||| |
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| 008 | 190125e201902 onc ob f000 0 eng d |
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| 020 | |a9780660294087 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH164-267/2019E-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, |cFebruary 2019. |
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| 264 | 4|c©2019 |
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| 300 | |a1 online resource (40 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 : fiches maîtresses (FM) - procédures et exigences administratives. |
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| 500 | |aThe PDF copy has been replaced (18/05/2021) with an amended version as requested by the publisher. |
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| 500 | |a"Pub.: 180762." |
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| 500 | |aIssued also in HTML format. |
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| 504 | |aIncludes bibliographical references (pages 28-35). |
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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)9.867639 |
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| 794 | |tGuidance document : |w(CaOODSP)9.906439 |
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| 856 | 40|qPDF|s401 KB|uhttps://publications.gc.ca/collections/collection_2019/sc-hc/H164-267-2019-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/guidance-document-master-files-procedures-administrative-requirements.html |
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