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
| Department/Agency | Canada. Health Canada, issuing body. |
|---|---|
| Title | Guidance on drug establishment licences. |
| Variant title | Guidance on drug establishment licences, version 8 (GUI-0002) |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Earlier edition | Guidance on drug establishment licences and associated fees. |
| Format | Electronic |
| 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 |
| Description | 1 online resource (45 pages) |
| ISBN | 9780660339962 |
| Catalogue number |
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| Subject terms | Pharmaceutical industry -- Licenses -- Canada. Pharmaceutical industry -- Safety regulations -- Canada. Pharmaceutical policy -- Canada. |