Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations

Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations Canada’s obligations under the North American Free Trade Agreement and the Agreement on Trade-Related Aspects of Intellectual Property Rights require the granting of protection for undisclosed test or other data necessary to determine the safety and effectiveness of a pharmaceutical product which utilizes a new chemical entity, the origination of which involved considerable effort. 2021-07-05 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyData protectionFood and Drug RegulationsNorth American Free Trade Agreementagreementtradeintellectual property rightsundisclosed testsafety and effectivenesspharmaceutical producta new chemical entity Guidance Document: Data Protection under C.08.004.1 of the Food and Drug RegulationsHTML 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#a11 Guidance Document: Data Protection under C.08.004.1 of the Food and Drug RegulationsHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/protection-donnees-vertu-article-08-004-1-reglement-aliments-drogues.html

Canada’s obligations under the North American Free Trade Agreement and the Agreement on Trade-Related Aspects of Intellectual Property Rights require the granting of protection for undisclosed test or other data necessary to determine the safety and effectiveness of a pharmaceutical product which utilizes a new chemical entity, the origination of which involved considerable effort.

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