Patented Medicines Regulations

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 rights holder or former rights holder and their address for correspondence in Canada;

• (b) whether the reporting rights holder referred to in paragraph (a) is a patent holder, a holder of a certificate of supplementary protection, 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 rights holder 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 rights holder or former rights holder 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; and

• (i) for each certificate of supplementary protection that has been issued in respect of each invention pertaining to the medicine of the rights holder or former rights holder:

  • (i) the number of the certificate of supplementary protection,

  • (ii) the date on which the certificate takes effect and the date on which it expires, and

  • (iii) the number of the patent set out in the application for the certificate of supplementary protection.

(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.

(3.1) Despite subsection (3), in each of the following cases, the information referred to in subsection (1) shall be provided within 30 days after the day on which the Board sends a request for the rights holder to provide that information:

• (a) the medicine is not a prescription drug as defined in section A.01.010 of the Food and Drug Regulations and is not a drug described in Schedule D to the Food and Drugs Act;

• (b) the medicine contains a controlled substance as defined in subsection 2(1) of the Controlled Drugs and Substances Act, the sale or provision of which does not require a prescription under that Act;

• (c) a notice of compliance has been issued in respect of the medicine on the basis of information and material contained in a submission filed under section C.08.002.1 of the Food and Drug Regulations;

• (d) the medicine is for veterinary use.

(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.