Patented Medicines (Notice of Compliance) Regulations

3 (1) The following definitions apply in this section and in section 4.

identification number

identification number means a number, preceded by the letters DIN, that is assigned for a drug in accordance with subsection C.01.014.2(1) of the Food and Drug Regulations. (identification numérique)

new drug submission

new drug submission means a new drug submission as that term is used in Division 8 of Part C of the Food and Drug Regulations, but excludes a new drug submission that is based solely on the change of name of the manufacturer. (présentation de drogue nouvelle)

supplement to a new drug submission

supplement to a new drug submission means a supplement to a new drug submission as that term is used in Division 8 of Part C of the Food and Drug Regulations, but excludes a supplement to a new drug submission that is based solely on one or more of the matters mentioned in any of paragraphs C.08.003(2)(b) and (d) to (g) and subparagraphs C.08.003(2)(h)(iv) and (v) of those Regulations. (supplément à une présentation de drogue nouvelle)

(2) The Minister shall maintain a register of patents and other information submitted under section 4. To maintain the register, the Minister may refuse to add or may delete any patent or other information that does not meet the requirements of that section.

(3) If a patent is listed on the register in respect of a new drug submission or supplement to a new drug submission for a drug for which the identification number has been cancelled under paragraph C.01.014.6(1)(a) of the Food and Drug Regulations, the Minister shall delete the patent from the register 90 days after the date of cancellation.

(4) Subsection (3) does not apply if the identification number is cancelled under paragraph C.01.014.6(1)(a) of the Food and Drug Regulations because of a change in manufacturer.

(5) If, after an identification number is cancelled under paragraph C.01.014.6(1)(a) of the Food and Drug Regulations, an identification number is assigned for the same drug, the Minister shall add to the register the patent that was deleted under subsection (3) when the Minister receives the document required by section C.01.014.3 of the Food and Drug Regulations in respect of the drug.

(6) The register shall be open to public inspection during business hours.

(7) No patent on a patent list or other information submitted under section 4 shall be added to the register until after the Minister has issued a notice of compliance in respect of the new drug submission or the supplement to a new drug submission, as the case may be, to which the patent or information relates.

(8) For the purpose of deciding whether a patent, patent list or other information will be added to or deleted from the register, the Minister may consult with officers or employees of the Patent Office.