ARCHIVED — Regulations Amending the Food and Drug Regulations

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Vol. 145, No. 8 — April 13, 2011

Registration

SOR/2011-81 March 25, 2011

FOOD AND DRUGS ACT

P.C. 2011-443 March 25, 2011

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act (see footnote b), hereby makes the annexed Regulations Amending the Food and Drug Regulations.

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 and documents:

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 and documents referred to in section C.01A.005 that relate 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, an amendment to an establishment licence or 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 submit an application for the review of their licence to the Minister before April 1 of each year and include with it the information and documents referrred to in section C.01A.005.

(2) The Minister shall conduct an annual review of the licence on the basis of the information and documents submitted 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 an establishment licence in either of the following circumstances:

  1. (a) the licence has been suspended for a period of more than 12 months, or
  2. (b) the licence holder has failed to submit 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 April 1, 2011, but if they are registered after that day, they come into force on the day on which they are registered.

N.B. The Regulatory Impact Analysis Statement for these Regulations appears, following SOR/2011-79, Fees in Respect of Drugs and Medical Devices Regulations.

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

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

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