Patented Medicines Regulations

SOR/94-688

INTERPRETATION

Section 2.  

The definitions in this section apply in these Regulations.

Act means the Patent .

notice of compliance means a that is issued under section C.08.004 of the Food and Drug Regulations.

INFORMATION RESPECTING THE IDENTITY AND PRICE OF MEDICINES

Section 3.  

(1) For the purposes of paragraphs 80(1)(a) and (2)(a) of the Act, information identifying the medicine shall be accompanied by the product monograph for the medicine or, if a notice of compliance has not been issued in respect of the medicine, by information similar to that contained in a product monograph, and shall indicate

(2) The information required under subsection (1) shall be provided if

(3) The information referred to in subsection (1) shall be provided no later than the earlier of

(4) The information referred to in subsection (1) shall be up to date and any modification of that information shall be reported within 30 days after the modification.

Section 4.  

(1) For the purposes of paragraphs 80(1)(b) and (2)(b) of the Act, information identifying the medicine and concerning the price of the medicine shall indicate

(2) If the medicine is for human use and contains a controlled substance as defined in the Controlled Drugs and Substances Act or a substance listed or described in Schedule C or D to the Food and Drugs Act or Schedule F to the Food and Drug Regulations, the information referred to in subsection (1) shall be provided

(3) If the medicine is for human use and does not contain a controlled substance as defined in the Controlled Drugs and Substances Act or does not contain a substance listed or described in Schedule C or D to the Food and Drugs Act or in Schedule F to the Food and Drug Regulations or is a medicine for veterinary use, the information referred to in subsection (1), for each six-month period beginning on January 1 and July 1 of each year, shall be provided to the Board within 30 days after the date on which the Board sends a request in response to a complaint respecting the price of the medicine, and during the two years following the request, within 30 days after each six-month period.

(4) For the purposes of subparagraph (1)(f)(i),

(5) Subject to subsection (6), this section does not apply to medicine sold by a patentee or former patentee to a person with whom they do not deal at arm’s length or to another patentee or former patentee.

(6) If the patentee or former patentee sells the medicine to a person with whom they do not deal at arm’s length and who is not required to provide information under paragraphs 80(1)(a) or (2)(a) of the Act, the patentee or former patentee shall provide the information required under paragraph (1)(f) in respect of any resale of the medicine by the person.

(7) For the purposes of subparagraph (1)(f)(iii), the price at which a medicine was sold in a country other than Canada shall be expressed in the currency of that country.

(8) For the purposes of this section, the Income Tax Act, as that Act read on December 1, 1987, applies, with any modifications that the circumstances require, in determining whether a patentee or former patentee is dealing at arm’s length with another person.

(9) For the purposes of this section, publicly available ex-factory price includes any price of a patented medicine that is agreed on by the patentee or former patentee and the appropriate regulatory authority of the country in which the medicine is sold by the patentee.

REVENUES AND RESEARCH AND DEVELOPMENT EXPENDITURES

Section 5.  

(1) For the purposes of subsection 88(1) of the Act, information concerning the identity of any licensee in Canada of the patentee and the revenues and research and development expenditures of the patentee shall indicate

(2) The information referred to in subsection (1) shall be provided for each calendar year and shall be submitted within 60 days after the end of each calendar year.

(3) The total gross revenues referred to in paragraph (1)(c) shall comprise revenues from sales of medicine

(4) For the purposes of paragraph (1)(d), the patentee shall specify

Section 6.  

For the purposes of subsection 88(1) of the Act, the expression research and development means those activities for which expenditures qualify, or would qualify if the expenditures were made by a taxpayer in Canada, for an investment tax credit in respect of scientific research and experimental development under the Income Tax Act as that Act read on December 1, 1987.

GENERAL

Section 7.  

(1) Every person required by these Regulations to provide information to the Board shall do so by using the appropriate electronic document made available on the Board’s website and by sending the completed electronic document, in its original format and file type, to the email address specified by the Board on its website.

(2) The electronic document shall bear the electronic signature of an authorized individual, certifying that the information set out in the document is true and complete.

SCHEDULE – (Subparagraph 4(1)(f)(iii))

ItemCountry
1.France
2.Germany
3.Italy
4.Sweden
5.Switzerland
6.United Kingdom
7.United States



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