00000nam 2200000za 4500 9.854770 CaOODSP 20221107155136 cr ||||||||||| 180405s2018 onc ob f000 0 eng d 9780660261539 CaOODSP eng n-cn--- H13-9/11-2018E-PDF Guidance document [electronic resource] : Patented Medicines (Notice of Compliance) Regulations. Patented Medicines (Notice of Compliance) Regulations Ottawa : Health Canada, 2018. 29 p. Issued also in French under title: Ligne directrice : Règlement sur les médicaments brevetés (avis de conformité). Cover title. "Date adopted: 2000/02/14. Revised date: 2018/04/05. Effective date: 2018/05/11." "Publication date: May 2018." Issued also in HTML format. Includes bibliographical references. "The early working exception of subsection 55.2(1) of the Patent Act allows a subsequent manufacturer to use a patented invention for the purpose of seeking regulatory approval of that product. The provision, therefore, provides an exception from infringement. The Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) provide the balance, through a patent enforcement mechanism, to ensure that the early working exception is not abused by linking the regulatory approval of a generic drug to the patent status of the innovative product. This guidance document provides information regarding the administration of the PM(NOC) Regulations by the Office of Patented Medicines and Liaison (OPML) within the Office of Submissions and Intellectual Property (OSIP), Therapeutic Products Directorate (TPD), Health Canada. It is applicable to drugs that receive a notice of compliance (NOC), including pharmaceutical, biological, radiopharmaceutical and veterinary drugs"--Introd., p. 7. Patented medicines Generic drugs Government policy Canada. Health Canada. Ligne directrice (CaOODSP)9.854772 Guidance document : (CaOODSP)9.899807 PDF 363 KB https://publications.gc.ca/collections/collection_2018/sc-hc/H13-9-11-2018-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/patented-medicines/notice-compliance-regulations.html 170559