Vol. 144, No. 14 — April 3, 2010

Regulations Amending the Patented Medicines (Notice of Compliance) Regulations

Statutory authority

Patent Act

Sponsoring department

Department of Industry

REGULATORY IMPACT ANALYSIS STATEMENT

For the Regulatory Impact Analysis Statement, see Regulations Amending the Food and Drug Regulations (1319 — New Drugs for Extraordinary Use).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 55.2(4) (see footnote a) of the Patent Act (see footnote b), proposes to make the annexed Regulations Amending the Patented Medicines (Notice of Compliance) Regulations.

Interested persons may make representations concerning the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Colette Downie, Director General, Marketplace Framework Policy Branch, Industry Canada, C.D. Howe Building, 10th Floor, East Tower, Room 1046A, 235 Queen Street, Ottawa, Ontario K1A 0H5 (fax: 613-948-6393; e-mail: colette.downie@ic.gc.ca).

Ottawa, March 25, 2010

JURICA ČAPKUN
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE PATENTED MEDICINES
(NOTICE OF COMPLIANCE) REGULATIONS

AMENDMENTS

1. The definition “notice of compliance” in section 2 of the Patented Medicines (Notice of Compliance) Regulations (see footnote 1) is replaced by the following:

“notice of compliance” means a notice issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations; (avis de conformité)

2. The definitions “new drug submission” and “supplement to a new drug submission” in subsection 3(1) of the Regulations are replaced by the following:

“new drug submission” means a new drug submission or an extraordinary use new drug submission as those terms are used in Division 8 of Part C of the Food and Drug Regulations, but excludes such a submission that is based solely on the change of name of the manufacturer. (présentation de drogue nouvelle)

“supplement to a new drug submission” means a supplement to a new drug submission or a supplement to an extraordinary use new drug submission as those terms are used in Division 8 of Part C of the Food and Drug Regulations, but excludes such a supplement 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)

3. Subsection 4.1(1) of the Regulations is replaced by the following:

4.1 (1) In this section, “supplement to the new drug submission” means a supplement to a new drug submission or a supplement to an extraordinary use new drug submission as those terms are used in Division 8 of Part C of the Food and Drug Regulations.

4. Paragraph 5(6)(a) of the Regulations is replaced by the following:

(a) the date on which the Minister notifies the second person under paragraph C.08.004(3)(b) or C.08.004.01(3)(b), as the case may be, of the Food and Drug Regulations of their non-compliance with the requirements of section C.08.002, C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1 of those Regulations; or

COMING INTO FORCE

5. These Regulations come into force on the day on which they are registered.

[14-1-o]

Footnote a
S.C. 2001, c. 10, s. 2(2)

Footnote b
R.S., c. P-4

Footnote 1
SOR/93-133

NOTICE:
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