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.

Lien permanent pour cette publication :
publications.gc.ca/pub?id=9.895264&sl=1

Renseignements sur la publication
Ministère/Organisme Canada. Health Canada, issuing body.
Titre Guidance document : master files for veterinary products : procedures and administrative requirements.
Type de publication Monographie
Langue [Anglais]
Autres langues publiées [Français]
Format Électronique
Document électronique
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.
Information sur la publication Ottawa, ON : Health Canada = Santé Canada, July 23, 2020.
©2020
Description 1 online resource (29 pages)
ISBN 9780660371092
Numéro de catalogue
  • H164-311/2021E-PDF
Descripteurs Drug approval -- Canada.
Veterinary drugs -- Canada.
Veterinary drug industry -- Canada.
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