00000nam 2200000zi 4500 9.927743 CaOODSP 20231130151823 m o d f cr mn||||||||| 230925e202311 onc o f000 0 eng d 9780660680651 CaOODSP eng rda CaOODSP n-cn--- H164-305/2023E-1-PDF Guidance document : certificates of supplementary protection. CSP guidance document Ottawa, ON : Health Canada = Santé Canada, November 2023. ©2023 1 online resource (25 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Ligne directrice : certificats de protection supplémentaire. Cover title. "Date adopted: 2017/09/21; Revised Date: 22023/11/16; Effective date: 2023/11/16." "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. … The purpose of this Guidance Document is to outline the CSP application process for applicants, the service standard and the roles and responsibilities of applicants and Health Canada"--Introduction, page 7. Patent medicines Canada. Patent extensions Canada. Pharmaceutical policy Canada. Canada. Health Canada, issuing body. Ligne directrice : (CaOODSP)9.927744 Guidance document : (CaOODSP)9.931029 Guidance document : (CaOODSP)9.921627 PDF 467 KB https://publications.gc.ca/collections/collection_2023/sc-hc/H164-305-2023-1-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/register-certificates/certificate-supplementary-protection-regulations.html 230453