Guidance Document - Certificates of Supplementary Protection

Guidance Document - Certificates of Supplementary Protection In agreeing to apply the Canada-European Union Comprehensive Economic and Trade Agreement (CETA), Canada has committed to provide up to two years of sui generis (of its own kind) protection for new pharmaceutical products protected by an eligible patent, from the expiry of the patent. Canada has implemented this commitment by introducing Certificates of Supplementary Protection (CSPs) for medicinal ingredients, applicable for Canadian pharmaceuticals, biologics and veterinary drugs. 2023-12-02 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetyguidance documentcertificates of supplementary-protectionnew pharmaceutical productseligible patentpharmaceuticalsbiologicsveterinary drugs Guidance Document - Certificates of Supplementary ProtectionHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/register-certificates/certificate-supplementary-protection-regulations.html Guidance Document - Certificates of Supplementary ProtectionHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/registre-certificats/reglement-certificats-protection-supplementaire.html

In agreeing to apply the Canada-European Union Comprehensive Economic and Trade Agreement (CETA), Canada has committed to provide up to two years of sui generis (of its own kind) protection for new pharmaceutical products protected by an eligible patent, from the expiry of the patent. Canada has implemented this commitment by introducing Certificates of Supplementary Protection (CSPs) for medicinal ingredients, applicable for Canadian pharmaceuticals, biologics and veterinary drugs.

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