00000nam 22000008i 4500 9.890884 CaOODSP 20221107172728 m o d f cr ||||||||||| 200825t20202020onc ob f00| 0 eng d 9780660358901 CaOODSP eng rda CaOODSP n-cn--- H13-9/25-2020E-PDF Guidance document : administrative processing of submissions and applications involving human or disinfectant drugs. Ottawa, ON : Health Canada = Santé Canada, 2020. ©2020 1 online resource (24 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Cover title. "Date posted: 2020/10/01." "Pub.: 200167." Issued also in HTML format. Issued also in French under title: Traitement administratif des présentations et des demandes concernant les médicaments destinés aux humains ou les désinfectants. Includes bibliographical references. "Pursuant to Part C, Division 1 and Division 8 of the Food and Drug Regulations (hereafter the Regulations), no manufacturer shall sell a drug in Canada unless a Drug Identification Number (DIN) [C.01.014 (1)] or DIN and Notice of Compliance (NOC) [C.08.002 (1)] have been issued by Health Canada, which grants market authorization for that product. Manufacturers must notify Health Canada of information changes pertaining to the manufacturer and drug product as set out by paragraph C.01.014.4 (b) of the Regulations"--Introduction, page 7. Drug approval Canada. Canada. Health Canada, issuing body. Ligne directrice : (CaOODSP)9.890886 Guidance document : (CaOODSP)9.860041 PDF 312 KB https://publications.gc.ca/collections/collection_2020/sc-hc/H13-9-25-2020-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/administrative-processing-human-disinfectant-drugs-2019/document.html