Guidance document : master files (MFs) - procedures and administrative requirements.: H164-267/2022E-PDF
"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.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.906439&sl=0
| Department/Agency | Canada. Health Canada, issuing body. |
|---|---|
| Title | Guidance document : master files (MFs) - procedures and administrative requirements. |
| Variant title | Master files - procedures and administrative requirements |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Earlier edition | Guidance document : |
| Format | Electronic |
| Electronic document | |
| Note(s) | Cover title. "Revised date: 2021/12/01 ; effective date: 2022/01/01." Issued also in French under title: Ligne directrice : fiches maîtresses (FM) - procédures et exigences administratives. Issued also in HTML format. Includes bibliographical references (pages 33-39). |
| Publishing information | Ottawa, ON : Health Canada = Santé Canada, January 2022. ©2022 |
| Description | 1 online resource (46 pages) |
| ISBN | 9780660414744 |
| Catalogue number |
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| Subject terms | Pharmaceutical policy -- Canada. Drug approval -- Canada. |