Guidance document : certificates of supplementary protection.: H164-305/2023E-PDF

"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.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.921627&sl=0

Publication information
Department/Agency Canada. Health Canada, issuing body.
Title Guidance document : certificates of supplementary protection.
Variant title CSP guidance document
Publication type Monograph
Language [English]
Other language editions [French]
Later edition Guidance document :
Earlier edition Guidance document :
Format Electronic
Electronic document
Note(s) Issued also in French under title: Ligne directrice : certificats de protection supplémentaire.
Cover title.
"Date adopted: 2017/09/21; Revised Date: 2023/04/04; Effective date: 2023/05/12."
"Pub.: 230040."
Publishing information Ottawa, ON : Health Canada = Santé Canada, May 2023.
©2023
Description 1 online resource (25 pages)
ISBN 9780660483467
Catalogue number
  • H164-305/2023E-PDF
Departmental catalogue number 230040
Subject terms Patent medicines -- Canada.
Patent extensions -- Canada.
Pharmaceutical policy -- Canada.
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