Establishment Licensing Fees (Veterinary Drugs) Regulations (SOR/98-4)

Regulations are current to 2017-11-20 and last amended on 2011-04-01. Previous Versions

Establishment Licensing Fees (Veterinary Drugs) Regulations

SOR/98-4

FINANCIAL ADMINISTRATION ACT

Registration 1997-12-17

Establishment Licensing Fees (Veterinary Drugs) Regulations

P.C. 1997-1896 1997-12-17

His Excellency the Governor General in Council, on the recommendation of the Minister of Health and the Treasury Board, pursuant to paragraph 19.1(a)Footnote a of the Financial Administration Act and, considering that it is in the public interest to remit certain debts, pursuant to subsection 23(2.1)Footnote b of that Act, hereby makes the annexed Establishment Licensing Fees Regulations (1056).

Interpretation

Marginal note:Definitions
  •  (1) The definitions in this subsection apply in these Regulations.

    activity

    activité

    activity means an activity set out in Table I to section C.01A.008 of the Food and Drug Regulations. (activité)

    category

    catégorie

    category means a category of drugs set out in Table II to section C.01A.008 of the Food and Drug Regulations. (catégorie)

    drug

    drogue

    drug has the same meaning as in subsection C.01A.001(2) of the Food and Drug Regulations. (drogue)

    establishment licence

    licence d’établissement

    establishment licence means a licence issued under section C.01A.008 of the Food and Drug Regulations. (licence d’établissement)

    site

    site

    site means

    • (a) a building specified in an establishment licence and located more than one kilometre from any other building specified in the licence; or

    • (b) more than one building specified in an establishment licence, all of which are located within one kilometre of each other. (site)

  • Marginal note:Other words and expressions

    (2) Unless the context otherwise requires, all other words and expressions used in these Regulations have the meanings assigned to them by the Food and Drugs Act, the Food and Drug Regulations, the Controlled Drugs and Substances Act or the Narcotic Control Regulations, as the case may be.

Application

Marginal note:Application

 These Regulations apply only to establishment licences for activities that relate to drugs for veterinary use only.

  • SOR/2011-84, s. 2.

Fees

Marginal note:Amount payable

 The fee that is payable for an establishment licence is the sum of the fees referred to in sections 4 to 10, as applicable.

Marginal note:Licence authorizing fabrication
  •  (1) The fee payable for each site at which one or more activities is authorized by the establishment licence including the fabrication of drugs is the basic fee, set out in column 2 of item 1 of Schedule 1, together with each of the following fees that are applicable:

    • (a) if the licence is in respect of more than one category of drugs, the fee set out in column 2 of item 2 of Schedule 1, for each additional category;

    • (b) if the licence is in respect of more than one dosage form class, the applicable fee set out in column 2 of item 3 of Schedule 1; and

    • (c) if the licence is in respect of sterile dosage forms, the fee set out in column 2 of item 4 of Schedule 1.

  • Marginal note:Importing

    (2) Despite section 6, if importing is authorized by the establishment licence at a site referred to in subsection (1), the fee referred to in paragraph 6(b) is also payable.

Marginal note:Licence authorizing packaging/labelling
  •  (1) The fee that is payable for each site at which one or more activities is authorized by the establishment licence, including packaging/labelling drugs but not including fabricating drugs, is the basic fee, set out in column 2 of item 1 of Schedule 2, together with each of the following fees that are applicable:

    • (a) if the licence is in respect of more than one category of drugs, the fee set out in column 2 of item 2 of Schedule 2, for each additional category; and

    • (b) if the licence is in respect of more than one dosage form class, the applicable fee set out in column 2 of item 3 of Schedule 2.

  • Marginal note:Importing

    (2) Despite section 6, if importing is authorized by the establishment licence at a site referred to in subsection (1), the fee referred to in paragraph 6(b) is also payable.

Marginal note:Licence authorizing importation

 The fee that is payable for one or more activities authorized by the establishment licence, including importing drugs but not including fabricating or packaging/labelling drugs, is

  • (a) for each site where those activities are so authorized, the basic fee, set out in column 2 of item 1 of Schedule 3, together with each of the following fees that are applicable:

    • (i) if the licence is in respect of more than one category of drugs, the fee set out in column 2 of item 2 of Schedule 3, for each additional category, and

    • (ii) if the licence is in respect of more than one dosage form class, the applicable fee set out in column 2 of item 3 of Schedule 3; and

  • (b) for each fabricator outside Canada of drugs that are imported, except where a certificate from a Canadian inspector indicating that the fabricator’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4 of Part C of the Food and Drug Regulations is provided by the importer, the sum of the following fees that are applicable:

    • (i) the fee set out in column 2 of item 4 of Schedule 3, and

    • (ii) if the licence is in respect of more than one dosage form class, for each additional dosage form class, the fee set out in column 2 of item 5 of Schedule 3.

Marginal note:Licence authorizing distribution

 The fee that is payable for each site at which one or more activities is authorized by the establishment licence, including distributing drugs as a distributor referred to in paragraph C.01A.003(b) of the Food and Drug Regulations but not including fabricating, packaging/labelling or importing drugs, is the basic fee, set out in column 2 of item 1 of Schedule 3, together with each of the following fees that are applicable:

  • (a) if the licence is in respect of more than one category of drugs, the fee set out in column 2 of item 2 of Schedule 3, for each additional category; and

  • (b) if the licence is in respect of more than one dosage form class, the applicable fee set out in column 2 of item 3 of Schedule 3.

Marginal note:Drug analysis fee

 In addition to the fees referred to in sections 4 to 7, the fee that is payable, if an establishment licence authorizes the holder to fabricate, package/label, import or distribute drugs as a distributor referred to in paragraph C.01A.003(b) of the Food and Drug Regulations, is for any of those activities, the highest fee set out in column 2 of Schedule 4 that corresponds to drugs described in column 1 of that Schedule

  • (a) in respect of which the licence is requested; and

  • (b) except in the case of an importer, for which the holder of the licence has obtained an identification number (DIN) or a numbered certificate of registration (GP).

Marginal note:Licence authorizing distribution or wholesaling

 The fee that is payable for each site at which one or more activities is authorized by the establishment licence, including distributing drugs as a distributor referred to in paragraph C.01A.003(a) of the Food and Drug Regulations or wholesaling drugs but not including fabricating, packaging/labelling or importing drugs or distributing drugs as a distributor referred to in paragraph C.01A.003(b) of those Regulations, is a basic fee of $1,500.

Marginal note:Licence authorizing testing

 The fee that is payable for each site at which only the testing of drugs is authorized by the establishment licence is a basic fee of $1,000.

Marginal note:Remission
  •  (1) Subject to subsection 13(2), if the total of the fees payable under sections 3 to 10 of these Regulations and the fee payable under section 3 of the Licensed Dealers for Controlled Drugs and Narcotics (Veterinary Use) Fees Regulations is greater than an amount equal to 1.5% of the applicant’s actual gross revenue from the sale, testing and packaging/labelling of drugs, as well as controlled drugs and narcotics not in dosage form, for the previous calendar year, remission is granted of the difference between those amounts if the applicant provides, with their application for the annual review of their licence, a statement signed by the individual responsible for the applicant’s financial affairs that sets out the actual gross revenue.

  • Marginal note:Statement — first year of activities

    (2) If the applicant has not completed their first calendar year of conducting activities under the licence, the applicant shall provide the statement within 90 days after the day on which that year ends in order to be eligible for the remission.

  • SOR/2011-84, s. 3.
 
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