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

Regulations are current to 2017-10-13 and last amended on 2011-04-01. Previous Versions

Marginal note:Timing of payment
  •  (1) Subject to subsection (2), the fee is payable on the day on which the establishment licence is issued or the application for the annual review of the licence is submitted.

  • Marginal note:Timing of deferred payment

    (2) In the case of an applicant referred to in subsection 11(2), the fee for an application for the annual review of their licence is payable upon the expiry of the 90–day period.

  • SOR/2011-84, s. 3.
Marginal note:Audited records
  •  (1) If the Minister determines that, on the basis of any information available to the Minister, the statement provided under subsection 11(1) is not adequate to determine the actual gross revenue referred to in that subsection, the Minister may require, for the purpose of determining the fee payable or the amount of the remission, the applicant to provide sales records that have been audited by a qualified independent auditor.

  • Marginal note:Omission

    (2) If the applicant fails to provide the Minister with the audited sales records within 90 days after the day on which the Minister requested those records, the difference between the fee and the amount already paid is immediately payable.

  • Marginal note:Difference payable

    (3) If the audited sales records establish that the amount already paid is less than the amount payable, the difference between those amounts is immediately payable.

  • Marginal note:Difference remitted

    (4) If the audited sales records establish that the amount already paid is greater than the amount payable, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the applicant.

  • SOR/2011-84, s. 3.

 [Repealed, SOR/2011-84, s. 3]

 [Repealed, SOR/2011-84, s. 3]

Licence Amendments

Marginal note:Amendment to add sterile dosage forms

 If an establishment licence authorizing the holder to carry out one or more activities including fabricating drugs is amended to authorize sterile dosage forms of drugs for the first time at a site, the fee payable for each site at which those forms are so authorized is the basic fee set out in column 2 of item 1 of Schedule 1.

Marginal note:Amendment to add activity
  •  (1) If an establishment licence is amended to add an activity at a site, the fee payable for the amendment to the licence is, for each site at which the activity is added,

    • (a) if the amendment authorizes the holder to fabricate drugs, the basic fee set out in column 2 of item 1 of Schedule 1;

    • (b) if the amendment authorizes the holder to package/label drugs but the amended licence does not authorize the holder to fabricate drugs, the basic fee set out in column 2 of item 1 of Schedule 2;

    • (c) if the amendment authorizes the holder to import drugs but the amended licence does not authorize the holder to fabricate or package/label drugs, the basic fee set out in column 2 of item 1 of Schedule 3;

    • (d) if the amendment authorizes the holder to distribute drugs as a distributor referred to in paragraph C.01A.003(b) of the Food and Drug Regulations, but the amended licence does not authorize the holder to fabricate, package/label or import drugs, the basic fee set out in column 2 of item 1 of Schedule 3; and

    • (e) if the amendment authorizes the holder to distribute drugs as a distributor referred to in paragraph C.01A.003(a) of the Food and Drug Regulations, or to wholesale drugs or to carry out both activities, but the amended licence does not authorize the holder to fabricate, package/label or import drugs or distribute drugs as a distributor referred to in paragraph C.01A.003(b) of those Regulations, the basic fee set out in section 9.

  • Marginal note:Amendment to add category

    (2) Subject to subsection (3), if an establishment licence is amended to add a category of drugs for an activity that is authorized by the licence at a site, the fee payable for the amendment to the licence is, for each site at which the category of drugs is added for the authorized activity,

    • (a) if the amendment authorizes the holder to fabricate an additional category of drugs, the basic fee set out in column 2 of item 1 of Schedule 1;

    • (b) if the amendment authorizes the holder to package/label an additional category of drugs, the basic fee set out in column 2 of item 1 of Schedule 2;

    • (c) if the amendment authorizes the holder to import an additional category of drugs, the basic fee set out in column 2 of item 1 of Schedule 3;

    • (d) if the amendment authorizes the holder to distribute an additional category of drugs as a distributor referred to in paragraph C.01A.003(b) of the Food and Drug Regulations, the basic fee set out in column 2 of item 1 of Schedule 3;

    • (e) if the amendment authorizes the holder to distribute an additional category of drugs as a distributor referred to in paragraph C.01A.003(a) of the Food and Drug Regulations, or to wholesale an additional category of drugs, the basic fee set out in section 9; and

    • (f) if the amendment authorizes the holder to test an additional category of drugs, the basic fee set out in section 10.

  • Marginal note:Included categories

    (3) If an establishment licence is amended to add a category of drugs in respect of more than one activity referred to in paragraphs (2)(a) to (f), the fee payable under subsection (2) is the highest applicable fee for those activities.

Marginal note:Fee exemption

 If a remission has been granted under section 11 or 13, no fee is payable under section 16 or 17 for the amendment of the establishment licence.

  • SOR/2011-84, s. 4.
Marginal note:Time of payment

 The fees determined in accordance with sections 16 and 17 are payable on the day on which the amended licence is issued.

Suspended Licences

Marginal note:Fee for reinstated licence
  •  (1) Subject to subsection (2), if an establishment licence has been suspended by the Minister of Health in respect of any or all matters indicated in subsection C.01A.008(2) of the Food and Drug Regulations, the fee payable for a reinstated licence is

    • (a) if it authorizes the holder to carry out one or more activities, including fabricating drugs, for each site in respect of which the matter is reinstated, the basic fee set out in column 2 of item 1 of Schedule 1;

    • (b) if it authorizes the holder to carry out one or more activities, including packaging/labelling drugs but not including fabricating drugs, for each site in respect of which the matter is reinstated, the basic fee set out in column 2 of item 1 of Schedule 2;

    • (c) if it authorizes the holder to carry out one or more activities, including importing drugs but not including fabricating or packaging/labelling drugs, for each site in respect of which the matter is reinstated, the basic fee set out in column 2 of item 1 of Schedule 3;

    • (d) if it authorizes the holder to carry out one or more activities, 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, for each site in respect of which the matter is reinstated, the basic fee set out in column 2 of item 1 of Schedule 3;

    • (e) if it authorizes the holder to carry out one or more activities, 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, for each site in respect of which the matter is reinstated, the basic fee set out in section 9; and

    • (f) if it authorizes the holder only to test drugs, for each site in respect of which the matter is reinstated, the basic fee set out in section 10.

  • Marginal note:Remission

    (2) If a remission has been granted under section 11 or 13, the fee payable for a reinstated establishment licence is the lesser of

    • (a) the fee determined in accordance with section 11 or 13, and

    • (b) the fee determined in accordance with subsection (1).

  • Marginal note:Time of payment

    (3) The fee determined in accordance with this section is payable on the day on which the establishment licence is reinstated.

  • SOR/2011-84, s. 5.
 
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