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Guidance on drug establishment licences.: H14-311/2020E-PDF

"This guide is for companies in the drug manufacturing industry. It will help to facilitate understanding and compliance with Part C, Division 1A of the Food and Drug Regulations (FDR with regards to drug establishment licence (DEL) requirements"--Purpose, page 6.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.884429&sl=0

Publication information
Department/Agency
  • Canada. Health Canada, issuing body.
TitleGuidance on drug establishment licences.
Variant title
  • Guidance on drug establishment licences, version 8 (GUI-0002)
Publication typeMonograph
Language[English]
Other language editions[French]
Earlier editionGuidance on drug establishment licences and associated fees.
FormatDigital text
Electronic document
Note(s)
  • Issued also in French under title: Document d'orientation sur les licences d'établissement de produits pharmaceutiques.
  • "GUI-0002."
  • "April 1, 2020."
  • "Pub.: 190596."
  • Issued also in HTML format.
  • Includes bibliographical references (pages 42-45).
Publishing information
  • Ottawa, ON : Health Canada = Santé Canada, 2020.
  • ©2020
Description1 online resource (45 pages)
ISBN9780660339962
Catalogue number
  • H14-311/2020E-PDF
Subject terms
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