9 For the purpose of section 21.12 of the Act, an application for the renewal of an authorization shall be in the form set out in Form 10 of the schedule and shall be signed by the holder of the authorization.
Renewal of Authorization
10 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
11 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, as amended from time to time;
(b) the Drug Formulary published by the Régie de l’assurance maladie du Québec, as amended from time to time; and
(c) the PPS® Pharma Publication published by Total Pricing Systems Inc., as amended from time to time.
Coming into Force
Footnote *12 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.
Return to footnote *[Note: Regulations in force May 14, 2005, see SI/2005-46.]
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