00000nam 2200000zi 4500 9.884429 CaOODSP 20221107170850 m o d f cr cn||||||||| 200207t20202020onc ob f000 0 eng d 9780660339962 9780660339979 (incorrect) CaOODSP eng rda CaOODSP n-cn--- H14-311/2020E-PDF Guidance on drug establishment licences. Guidance on drug establishment licences, version 8 (GUI-0002) Ottawa, ON : Health Canada = Santé Canada, 2020. ©2020 1 online resource (45 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier 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). "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. Pharmaceutical industry Licenses Canada. Pharmaceutical industry Safety regulations Canada. Pharmaceutical policy Canada. Canada. Health Canada, issuing body. Document d'orientation sur les licences d'établissement de produits pharmaceutiques. (CaOODSP)9.884432 Guidance on drug establishment licences and associated fees. (CaOODSP)9.869653 PDF 1.51 MB https://publications.gc.ca/collections/collection_2020/sc-hc/H14-311-2020-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-drug-establishment-licences-drug-establishment-licensing-fees-0002/document.html