Guidance document : master files (MFs) - procedures and administrative requirements. : H164-267/2019E-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.
Lien permanent pour cette publication :
publications.gc.ca/pub?id=9.867638&sl=1
| Ministère/Organisme | Canada. Health Canada, issuing body. |
|---|---|
| Titre | Guidance document : master files (MFs) - procedures and administrative requirements. |
| Variante du titre | Master files - procedures and administrative requirements |
| Type de publication | Monographie |
| Langue | [Anglais] |
| Autres langues publiées | [Français] |
| Édition ultérieure | Guidance document : |
| Format | Électronique |
| Document électronique | |
| Note(s) | Issued also in French under title: Ligne directrice : fiches maîtresses (FM) - procédures et exigences administratives. The PDF copy has been replaced (18/05/2021) with an amended version as requested by the publisher. "Pub.: 180762." Issued also in HTML format. Includes bibliographical references (pages 28-35). |
| Information sur la publication | Ottawa, ON : Health Canada = Santé Canada, February 2019. ©2019 |
| Description | 1 online resource (40 pages) |
| ISBN | 9780660294087 |
| Numéro de catalogue |
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| Descripteurs | Pharmaceutical policy -- Canada. Drug approval -- Canada. |
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