Vol. 151, No. 25 — December 13, 2017

Registration

SOR/2017-260 December 1, 2017

FINANCIAL ADMINISTRATION ACT

P.C. 2017-1502 December 1, 2017

Her Excellency the Governor General in Council, on the recommendation of the Treasury Board and the Minister of Health, pursuant to subsection 19(1) (see footnote a) and section 19.1 (see footnote b) of the Financial Administration Act (see footnote c), makes the annexed Regulations Amending the Fees in Respect of Drugs and Medical Devices Regulations (DIN Requirements for Drugs Listed in Schedule C to the Food and Drugs Act that are in Dosage Form).

Regulations Amending the Fees in Respect of Drugs and Medical Devices Regulations (DIN Requirements for Drugs Listed in Schedule C to the Food and Drugs Act that are in Dosage Form)

Amendments

1 Section 3 of the Fees in Respect of Drugs and Medical Devices Regulations (see footnote 1) is amended by striking out “or” at the end of paragraph (c), by adding “or” at the end of paragraph (d) and by adding the following after paragraph (d):

2 The Regulations are amended by adding the following after section 6:

Non-application

6.1 Section 6 does not apply to an application for a drug identification number under section C.01.014.1 of the Food and Drug Regulations that is made in respect of a drug that is listed in Schedule C to the Food and Drugs Act and that is in dosage form.

3 The portion of section 22 of the French version of the Regulations before paragraph (a) is replaced by the following:

Autorisation de distribuer

22 Pour l’examen d’une demande de licence d’établissement pour chaque bâtiment où une ou plusieurs activités doivent être menées, y compris la distribution de drogues à titre de distributeur visé à l’alinéa C.01A.003b) du Règlement sur les aliments et drogues mais non leur manufacture, leur emballage-étiquetage ou leur importation, le prix à payer correspond à la somme du prix de base prévu à la colonne 2 de l’article 1 de l’annexe 4, et des prix applicables suivants :

4 Section 23 of the Regulations is replaced by the following:

Non-application

22.1 Section 22 does not apply to an application for an establishment licence that is made in respect of a drug that is listed in Schedule C to the Food and Drugs Act and that is in dosage form.

Licence authorizing distribution or wholesaling

23 For the examination of an application for an establishment licence for each building at which one or more activities are to be conducted, including distributing drugs as a distributor referred to in paragraph C.01A.003(a) of the Food and Drug Regulations, distributing drugs that are listed in Schedule C to the Food and Drugs Act and that are in dosage form as a distributor referred to in paragraph C.01A.003(b) of those Regulations or wholesaling drugs but not including fabricating, packaging/labelling or importing drugs or distributing drugs (other than drugs that are listed in Schedule C to the Food and Drugs Act and that are in dosage form) as a distributor referred to in paragraph C.01A.003(b) of those Regulations, the fee is a basic fee of $3,870.

5 The Regulations are amended by adding the following after section 25:

Non-application

25.1 Section 25 does not apply to an application for an establishment licence that is made in respect of a drug that is listed in Schedule C to the Food and Drugs Act and that is in dosage form.

6 (1) Paragraphs 28(1)(d) and (e) of the Regulations are replaced by the following:

(2) Paragraphs 28(2)(d) and (e) of the Regulations are replaced by the following:

7 The Regulations are amended by adding the following after section 35:

Non-application

35.1 Section 35 does not apply to a drug that is listed in Schedule C to the Food and Drugs Act and that is in dosage form.

Coming into Force

8 These Regulations come into force on the day on which the Regulations Amending the Food and Drug Regulations (DIN Requirements for Drugs Listed in Schedule C to the Food and Drugs Act that are in Dosage Form) come into force, but if these Regulations 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/2017-259, Regulations Amending the Food and Drug Regulations (DIN Requirements for Drugs Listed in Schedule C to the Food and Drugs Act that are in Dosage Form).