00000nam 2200000zi 4500 9.869653 CaOODSP 20221107162916 m o d f cr ||||||||||| 190311s2019 onc |ob f000 0 eng d 9780660299860 CaOODSP eng rda CaOODSP n-cn--- H14-311/2019E-PDF Guidance on drug establishment licences and associated fees. [Ottawa] : Health Canada = Santé Canada, 2019. 1 online resource (53 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 et les frais associés. Cover title. "GUI-0002." "April 8, 2019." Includes bibliographical references (pages 50-53). "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. Pharmaceutical industry Licenses Canada. Pharmaceutical industry Safety regulations Canada. Pharmaceutical policy Canada. Canada. Health Canada. Document d’orientation sur les licences d’établissement de produits pharmaceutiques et les frais associés. (CaOODSP)9.869656 Guidance on drug establishment licences. (CaOODSP)9.884429 PDF 571 KB https://publications.gc.ca/collections/collection_2019/sc-hc/H14-311-2019-eng.pdf