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Use of Patented Products for International Humanitarian Purposes Regulations (SOR/2005-143)

Regulations are current to 2020-12-28 and last amended on 2018-06-25. Previous Versions

Renewal of Authorization

 The renewal of an authorization by the Commissioner under section 21.12 of the Act shall be in the form set out in Form 11 of the schedule.

Product Price Publications

 For the purpose of paragraph (b) of the definition average price in subsection 21.17(6) of the Act, the publications reporting the prices in Canada of pharmaceutical products sold by or with the consent of the patentee that are equivalent to the pharmaceutical product to which an authorization under section 21.04 of the Act relates are the following:

  • (a) the Ontario Drug Benefit Formulary/Comparative Drug Index published by the Ministry of Health and Long-Term Care of Ontario;

  • (b) the list of insured medications set out in Schedule 1 to the Regulation respecting the List of medications covered by the basic prescription drug insurance plan, CQLR, c. A-29.01, r. 3, as is published under the title “List of Medications” on the website of the Régie de l’assurance maladie du Québec; and

  • (c) the PPS Buyers Guide published by ProActive Pharma Solutions (PPS) or the parts of its website known as PPS Centrus where those prices are set out.

  • SOR/2018-141, s. 2

Coming into Force

Footnote * These Regulations come into force on the day on which An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa), being chapter 23 of the Statutes of Canada, 2004, comes into force.

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