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008250307e202506##onc     o    f000 0 eng d
020 |a9780660763040
040 |aCaOODSP|beng|erda|cCaOODSP
043 |an-cn---
0861 |aH164-319/2025E-PDF
24500|aGuidance document : |bdata protection under C.08.004.1 of the Food and Drug Regulations.
250 |a[June 2025 edition].
264 1|aOttawa, ON : |bHealth Canada = Santé Canada, |cJune 2025.
264 4|c©2025
300 |a1 online resource (19 pages)
336 |atext|btxt|2rdacontent
337 |acomputer|bc|2rdamedia
338 |aonline resource|bcr|2rdacarrier
500 |aIssued 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.
500 |a"Date adopted: 2009/03/11. Revised date: 2025/06/16. Effective date: 2025/06/16."
500 |a"Pub.: 240952"--Page 2.
520 |a"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.
650 0|aDrug approval|zCanada.
650 0|aData protection|zCanada.
7101 |aCanada. |bHealth Canada, |eissuing body.
77508|tLigne directrice : |w(CaOODSP)9.948928
795 |tGuidance document : |b[May 2021 edition]|w(CaOODSP)9.899805
85640|qPDF|s454 KB|uhttps://publications.gc.ca/collections/collection_2025/sc-hc/H164-319-2025-eng.pdf
8564 |qHTML|sN/A|uhttps://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
986 |a240952