FEDERAL REG

Regulations Amending the Fees in Respect of Drugs and Medical Devices Regulations

PROPOSED FEDERAL REGULATION - VIA PART I OF THE GAZETTE

Proposed
March 4, 2017


REGULATORY IMPACT ANALYSIS STATEMENT For the Regulatory Impact Analysis Statement, see the Regulations Amending the Food and Drug Regulations and the Regulations Amending the Food and Drug Regulations (Shortages of Drugs and Discontinuation of Sale of Drugs). PROPOSED REGULATORY TEXT Notice is given that the Governor in Council, on the recommendation of the Treasury Board, pursuant to subsection ... (Click for more)


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Published on March 8, 2017

Bill Summary

Regulations Amending the Fees in Respect of Drugs and Medical Devices Regulations

REGULATORY IMPACT ANALYSIS STATEMENT For the Regulatory Impact Analysis Statement, see the Regulations Amending the Food and Drug Regulations and the Regulations Amending the Food and Drug Regulations (Shortages of Drugs and Discontinuation of Sale of Drugs). PROPOSED REGULATORY TEXT Notice is given that the Governor in Council, on the recommendation of the Treasury Board, pursuant to subsection 19(1) (see footnote a) and section 19.1 (see footnote b) of the Financial Administration Act (see footnote c), proposes to make the annexed Regulations Amending the Fees in Respect of Drugs and Medical Devices 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 Bruno Rodrigue, Director, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health, Address Locator: 3105A, Holland Cross, Tower B, 5th Floor, 1600 Scott Street, Ottawa, Ontario K1A 0K9 (email: [email protected]). Ottawa, February 23, 2017 Jurica Čapkun Assistant Clerk of the Privy Council Regulations Amending the Fees in Respect of Drugs and Medical Devices Regulations 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): (e) a drug that is an active ingredient as defined in subsection C.01A.001(1) of the Food and Drug Regulations and that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Food and Drugs Act. 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: (d) if the amendment seeks to authorize the holder to distribute 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 the Food and Drug Regulations but not to fabricate, package/label or import drugs, the basic fee set out in item 1, column 2, of Schedule 4; and (e) if the amendment seeks to authorize the holder to distribute drugs as a distributor referred to in paragraph C.01A.003(a) of the Food and Drug Regulations, to distribute 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, to wholesale drugs or to conduct more than one of those activities, but not to fabricate, package/label, or import drugs or to distribute drugs (other than drugs that are listed in Schedule C to that Act and that are in dosage form) as a distributor referred to in paragraph C.01A.003(b) of those Regulations, the basic fee set out in section 23. (2) Paragraphs 28(2)(d) and (e) of the Regulations are replaced by the following: (d) if the amendment seeks to authorize the holder to distribute a drug (other than a drug that is listed in Schedule C to the Food and Drugs Act and that is in dosage form) of an additional category as a distributor referred to in paragraph C.01A.003(b) of the Food and Drug Regulations, the basic fee set out in item 1, column 2, of Schedule 4; (e) if the amendment seeks to authorize the holder to distribute a drug of an additional category as a distributor referred to in paragraph C.01A.003(a) of the Food and Drug Regulations, to distribute a drug that is listed in Schedule C to the Food and Drugs Act and that is in dosage form as a distributor referred to in paragraph C.01A.003(b) of those Regulations or to wholesale a drug of an additional category, the basic fee set out in section 23; and 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 section 2 of the Regulations Amending the Food and Drug Regulations and the Regulations Amending the Food and Drug Regulations (Shortages of Drugs and Discontinuation of Sale of Drugs) comes into force, but if they are registered after that day, they come into force on the day on which they are registered. [9-1-o] Footnote a S.C. 1991, c. 24, s. 6 Footnote b S.C. 1991, c. 24, s. 6 Footnote c R.S., c. F-11 Footnote 1 SOR/2011-79

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