Guidance on drug establishment licences and associated fees.: H14-311/2019E-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), and the Fees in Respect of Drugs and Medical Devices Regulations with regards to drug establishment licence (DEL) requirements and associated fees"--Purpose, page 6.

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Publication information
Department/Agency Canada. Health Canada.
Title Guidance on drug establishment licences and associated fees.
Publication type Monograph
Language [English]
Other language editions [French]
Later edition Guidance on drug establishment licences.
Format Electronic
Electronic document
Note(s) Issued also in French under title: Document d’orientation sur les licences d’établissement de produits pharmaceutiques et les frais associés.
Cover title.
"April 8, 2019."
Includes bibliographical references (pages 50-53).
Publishing information [Ottawa] : Health Canada = Santé Canada, 2019.
Description 1 online resource (53 pages)
ISBN 9780660299860
Catalogue number
  • H14-311/2019E-PDF
Subject terms Pharmaceutical industry -- Licenses -- Canada.
Pharmaceutical industry -- Safety regulations -- Canada.
Pharmaceutical policy -- Canada.
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