Canada Gazette, Part I, Volume 150, Number 27: Regulations Amending the Establishment Licensing Fees (Veterinary Drugs) Regulations

July 2, 2016

Statutory authority

Financial Administration Act

Sponsoring department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

For the Regulatory Impact Analysis Statement, see Regulations Amending the Food and Drug Regulations (Veterinary Drugs — Antimicrobial Resistance).

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council, pursuant to paragraph 19.1(a) (see footnote a) of the Financial Administration Act (see footnote b), proposes to make the annexed Regulations Amending the Establishment Licensing Fees (Veterinary Drugs) 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, 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 Building, Tower B, 5th Floor, 1600 Scott Street, Ottawa, Ontario K1A 0K9 (email: LRM_MLR_consultations@hc-sc.gc.ca).

Ottawa, June 16, 2016

Jurica Čapkun
Assistant Clerk of the Privy Council

Regulations Amending the Establishment Licensing Fees (Veterinary Drugs) Regulations

Amendments

1 Section 2 of the Establishment Licensing Fees (Veterinary Drugs) Regulations (see footnote 1) is replaced by the following:

Application

2 These Regulations apply to establishment licences for activities that relate to drugs for veterinary use only, with the exception of those for activities that relate to active pharmaceutical ingredients, as defined in subsection C.01A.001(1) of the Food and Drug Regulations, that are for veterinary use.

2 Subsection 11(1) of the French version of the Regulations is replaced by the following:

Remise

11 (1) Sous réserve du paragraphe 13(2), si le total du prix à payer selon les articles 3 à 10 du présent règlement et du prix à payer selon l'article 3 du Règlement sur les prix à payer pour les licences de distributeurs autorisés de drogues contrôlées et de stupéfiants (usage vétérinaire) est supérieur à un montant correspondant à 1,5 % des recettes brutes réelles du demandeur pour l'année civile précédente qui proviennent de la vente, de l'analyse et de l'emballage-étiquetage de drogues — ainsi que de drogues contrôlées et de stupéfiants qui ne sont pas sous forme posologique — et si le demandeur fournit avec la demande d'examen annuel de sa licence un état de ces recettes dûment signé par son responsable des affaires financières, remise est accordée d'une somme égale à la différence entre ce prix total et ce montant.

Coming into Force

3 These Regulations come into force on the day that, in the sixth month after the month in which they are published in the Canada Gazette, Part II, has the same calendar number as the day on which they are published or, if that sixth month has no day with that number, the last day of that sixth month.

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