00000nam 2200000zi 4500 9.948927 CaOODSP 20250707072216 m o d f cr mn||||||||| 250307e202506##onc o f000 0 eng d 9780660763040 CaOODSP eng rda CaOODSP n-cn--- H164-319/2025E-PDF Guidance document : data protection under C.08.004.1 of the Food and Drug Regulations. [June 2025 edition]. Ottawa, ON : Health Canada = Santé Canada, June 2025. ©2025 1 online resource (19 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Ligne directrice : la protection des données en vertu de l'article C.08.004.1 du Règlement sur les aliments et drogues. "Date adopted: 2009/03/11. Revised date: 2025/06/16. Effective date: 2025/06/16." "Pub.: 240952"--Page 2. "Health Canada is pleased to announce an update to the Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations. The Office of Patented Medicines and Liaison (OPML), within the Office of Submissions and Intellectual Property, administers the data protection scheme under section C.08.004.1 of the Food and Drug Regulations. The Guidance Document has been amended to align with existing Health Products and Food Branch policies and to record the OPML's ongoing practices as they relate to the administration of the data protection scheme"--Supplied from publisher. Drug approval Canada. Data protection Canada. Canada. Health Canada, issuing body. Ligne directrice : (CaOODSP)9.948928 Guidance document : [May 2021 edition] (CaOODSP)9.899805 PDF 454 KB https://publications.gc.ca/collections/collection_2025/sc-hc/H164-319-2025-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/guidance-document-data-protection-under-08-004-1-food-drug-regulations.html 240952