Patented Medicines Regulations (SOR/94-688)

Regulations are current to 2012-05-14 and last amended on 2008-07-01. Previous Versions

Patented Medicines Regulations

SOR/94-688

PATENT ACT

Registration 1994-11-07

Patented Medicines Regulations

P.C. 1994-1819  1994-11-01

His Excellency the Governor General in Council, on the recommendation of the Minister of National Health and Welfare, pursuant to section 101Footnote * of the Patent Act, is pleased hereby to revoke the Patented Medicines Regulations, made by Order in Council P.C. 1988-2013 of September 15, 1988Footnote **, and to make the annexed Regulations specifying the information to be provided relating to patented medicines and patentees’ revenues and research and development expenditures, in substitution therefor.

1. [Repealed, SOR/2008-70, s. 2]

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INTERPRETATION

[SOR/98-105, s. 1(F)]

2. The definitions in this section apply in these Regulations.

“Act”

“Act” means the Patent Act. (Loi)

“notice of compliance”

“notice of compliance” means a notice of compliance that is issued under section C.08.004 of the Food and Drug Regulations. (avis de conformité)

  • SOR/98-105, s. 1.

INFORMATION RESPECTING THE IDENTITY AND PRICE OF MEDICINES

  • 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

    • (a) the name and address of the patentee or former patentee and the address for correspondence in Canada;

    • (b) whether the reporting patentee referred to in paragraph (a) is the patent holder, a person holding a licence other than a licence continued by subsection 11(1) of the Patent Act Amendment Act, 1992, or any other person referred to in the definition “patentee” in subsection 79(1) of the Act;

    • (c) the generic name and brand name of the medicine;

    • (d) whether the medicine is for human or veterinary use;

    • (e) the therapeutic use of the medicine approved by the Minister of Health;

    • (f) the date on which the first notice of compliance was issued to the patentee or former patentee in respect of the medicine;

    • (g) the drug identification number assigned to each strength and dosage form of the medicine under the Food and Drug Regulations;

    • (h) the patent number of each invention of the patentee or former patentee pertaining to the medicine, the date on which each patent was granted and the date on which each patent will expire.

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

    • (a) a notice of compliance has been issued in respect of the medicine; or

    • (b) the medicine is being offered for sale in Canada.

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

    • (a) seven days after the day on which the first notice of compliance is issued in respect of the medicine; and

    • (b) seven days after the day on which the medicine is first offered for sale in Canada.

  • (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.

  • SOR/98-105, s. 2(E);
  • SOR/2008-70, s. 3.
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