Description

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.

Resources

Name	Format	Description	Link
Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations	HTML		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 Regulations	HTML		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

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