Guidance document : master files for veterinary products : procedures and administrative requirements.: H164-311/2021E-PDF
"The objective of this guidance document is to outline the procedures that veterinary Master File (MF) holders must follow to file confidential business information (CBI) directly with Health Canada's Veterinary Drugs Directorate (VDD) that is cross-referenced in support of an Applicant's veterinary drug submission (including DIN (Drug Identification Number) applications). A MF is a reference document that provides information about specific equipment, processes or components used in the manufacturing, processing, or packaging of a drug. The MF is a useful document for providing CBI to Health Canada that is not available to the manufacturer of the dosage form or to the Applicant of a drug submission. This guidance document provides information on filing requirements, processing and assessment procedures for veterinary MFs, and outlines the registration requirements for administrative changes, updates, withdrawals and closures. It is intended to create greater alignment with the procedures used internationally for the management of MFs"--Introduction, page 6.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.895264&sl=0
| Department/Agency | Canada. Health Canada, issuing body. |
|---|---|
| Title | Guidance document : master files for veterinary products : procedures and administrative requirements. |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| Electronic document | |
| Note(s) | Issued also in French under title: Ligne directrice : fiches maîtresses pour les produits vétérinaires : procédures et exigences administratives. "Pub.: 200401." Issued also in HTML format. Includes bibliographical references. |
| Publishing information | Ottawa, ON : Health Canada = Santé Canada, July 23, 2020. ©2020 |
| Description | 1 online resource (29 pages) |
| ISBN | 9780660371092 |
| Catalogue number |
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| Subject terms | Drug approval -- Canada. Veterinary drugs -- Canada. Veterinary drug industry -- Canada. |
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