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.
Lien permanent pour cette publication :
publications.gc.ca/pub?id=9.869653&sl=1
| Ministère/Organisme | Canada. Health Canada. |
|---|---|
| Titre | Guidance on drug establishment licences and associated fees. |
| Type de publication | Monographie |
| Langue | [Anglais] |
| Autres langues publiées | [Français] |
| Édition ultérieure | Guidance on drug establishment licences. |
| Format | Électronique |
| Document électronique | |
| 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. "GUI-0002." "April 8, 2019." Includes bibliographical references (pages 50-53). |
| Information sur la publication | [Ottawa] : Health Canada = Santé Canada, 2019. |
| Description | 1 online resource (53 pages) |
| ISBN | 9780660299860 |
| Numéro de catalogue |
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| Descripteurs | Pharmaceutical industry -- Licenses -- Canada. Pharmaceutical industry -- Safety regulations -- Canada. Pharmaceutical policy -- Canada. |