ARCHIVED — Regulations Amending the Food and Drug Regulations

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Vol. 144, No. 46 — November 13, 2010

Statutory authority

Food and Drugs Act

Sponsoring department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

For the Regulatory Impact Analysis Statement, see Fees in Respect of Drugs and Medical Devices Regulations.

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act (see footnote b), proposes to make the annexed Regulations Amending the Food and Drug 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 Kendal Weber, Director General, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Health Canada, Address Locator: 2004A, Graham Spry Building, 250 Lanark Avenue, 4th Floor, Ottawa, Ontario K1A 0K9 (fax: 613-954-9981; email: cri_irc_consultations@hc-sc.gc.ca).

Ottawa, November 4, 2010

JURICA ČAPKUN
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS

AMENDMENTS

1. The heading before section C.01A.005 of the English version of the Food and Drug Regulations (see footnote 1) is replaced by the following:

Application

2. The portion of section C.01A.005 of the Regulations before paragraph (a) is replaced by the following:

C.01A.005. A person who wishes to apply for an establishment licence shall submit an application to the Minister, in a form established by the Minister, that contains the following information:

3. Subsection C.01A.006(1) of the Regulations is replaced by the following:

C.01A.006. (1) A person who wishes to amend an establishment licence shall submit an application to the Minister, in a form established by the Minister, that contains the information referred to in section C.01A.005 that relates to the amendment.

4. (1) Subsection C.01A.007(1) of the Regulations is replaced by the following:

C.01A.007 (1) The Minister may, on receipt of an application for an establishment licence, for an amendment to an establishment licence or for the review of an establishment licence, require the applicant to submit further details pertaining to the information contained in the application that are necessary to enable the Minister to make a decision.

(2) The portion of subsection C.01A.007(2) of the Regulations before paragraph (a) is replaced by the following:

(2) When considering an application, the Minister may require that

5. Section C.01A.009 of the Regulations is replaced by the following:

Annual Licence Review

C.01A.009. (1) The holder of an establishment licence that is not suspended shall file with the Minister an application for the review of their licence before April 1 in each year and include with it the information set out in section C.01A.005.

(2) The Minister shall conduct an annual review of the licence on the basis of the information filed by the holder and any other relevant information in the Minister’s possession.

6. The Regulations are amended by adding the following after section C.01A.018:

Cancellation

C.01A.018.1 The Minister shall cancel a licence in either of the following circumstances:

(a) the licence has been suspended for a period of more than 12 months; or

(b) the licensee has failed to file an application for the review of their licence in accordance with subsection C.01A.009(1).

COMING INTO FORCE

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

[46-1-o]

Footnote a
S.C. 2005, c. 42, s. 2

Footnote b
R.S., c. F-27

Footnote 1
C.R.C., c. 870