Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
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Regulations are current to 2025-06-09 and last amended on 2025-05-31. Previous Versions
PART 2Drugs (continued)
DIVISION 3Fees for Examination of an Application for an Establishment Licence — Drugs (continued)
Fees and Remission (continued)
Marginal note:Fee — licence authorizing distribution
36 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 — but not fabricating drugs in sterile dosage form, importing drugs or fabricating drugs that are not in sterile dosage form — the fee is as follows:
(a) in respect of drugs for human use,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 5 of Schedule 3, the fee set out in item 4 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 5 of Schedule 3, the amount that is calculated in accordance with subsection 4(2); and
(b) in respect of drugs for veterinary use only,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 8 of Schedule 4, the fee set out in item 4 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 8 of Schedule 4, the amount that is calculated in accordance with subsection 4(2).
Marginal note:Fee — licence authorizing wholesaling
37 For the examination of an application for an establishment licence for each building at which one or more activities are to be conducted, including wholesaling drugs — but not fabricating drugs in sterile dosage form, importing drugs, fabricating drugs that are not in sterile dosage form or distributing drugs — the fee is as follows:
(a) in respect of drugs for human use,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 5 of Schedule 3, the fee set out in item 5 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 5 of Schedule 3, the amount that is calculated in accordance with subsection 4(2); and
(b) in respect of drugs for veterinary use only,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 8 of Schedule 4, the fee set out in item 5 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 8 of Schedule 4, the amount that is calculated in accordance with subsection 4(2).
Marginal note:Fee — licence authorizing packaging/labelling
38 For the examination of an application for an establishment licence for each building at which one or more activities are to be conducted, including packaging/labelling drugs — but not fabricating drugs in sterile dosage form, importing drugs, fabricating drugs that are not in sterile dosage form, distributing drugs or wholesaling drugs — the fee is as follows:
(a) in respect of drugs for human use,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 5 of Schedule 3, the fee set out in item 6 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 5 of Schedule 3, the amount that is calculated in accordance with subsection 4(2); and
(b) in respect of drugs for veterinary use only,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 8 of Schedule 4, the fee set out in item 6 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 8 of Schedule 4, the amount that is calculated in accordance with subsection 4(2).
Marginal note:Fee — licence authorizing testing
39 For the examination of an application for an establishment licence for each building at which one or more activities are to be conducted, including testing drugs — but not fabricating drugs in sterile dosage form, importing drugs, fabricating drugs that are not in sterile dosage form, distributing drugs, wholesaling drugs or packaging/labelling drugs — the fee is as follows:
(a) in respect of drugs for human use,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 5 of Schedule 3, the fee set out in item 7 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 5 of Schedule 3, the amount that is calculated in accordance with subsection 4(2); and
(b) in respect of drugs for veterinary use only,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 8 of Schedule 4, the fee set out in item 7 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 8 of Schedule 4, the amount that is calculated in accordance with subsection 4(2).
Marginal note:Fee — application for licence — building outside Canada
40 (1) For the examination of an application for an establishment licence referred to in section 33 or 34, the fee for each building located outside Canada that is listed on the application is
(a) in respect of drugs for human use, $918; and
(b) in respect of drugs for veterinary use only,
(i) in the case of a fee that is payable in the fiscal year 2020-2021, $765; and
(ii) in the case of a fee that is payable in any subsequent fiscal year, $918.
Marginal note:Fee — application for annual review — building outside Canada
(2) For the examination of an application for the annual review of an establishment licence referred to in section 33 or 34, the fee for each building located outside Canada that is listed on the establishment licence is the applicable fee set out in paragraph (1)(a) or (b).
Marginal note:Fee — amendment — licence authorizing sterile fabrication
41 If an application to amend an establishment licence seeks to add a building and the amendment seeks to authorize the holder to fabricate drugs in sterile dosage form at that building, the fee for the examination of the application for each building to be added is as follows:
(a) in respect of drugs for human use,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 5 of Schedule 3, the fee set out in item 1 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 5 of Schedule 3, the amount that is calculated in accordance with subsection 4(2); and
(b) in respect of drugs for veterinary use only,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 8 of Schedule 4, the fee set out in item 1 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 8 of Schedule 4, the amount that is calculated in accordance with subsection 4(2).
Marginal note:Fee — amendment — licence authorizing importation
42 If an application to amend an establishment licence seeks to add a building and the amendment seeks to authorize the holder to import drugs — but not to fabricate drugs in sterile dosage form — at that building, the fee for the examination of the application for each building to be added is as follows:
(a) in respect of drugs for human use,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 5 of Schedule 3, the fee set out in item 2 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 5 of Schedule 3, the amount that is calculated in accordance with subsection 4(2); and
(b) in respect of drugs for veterinary use only,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 8 of Schedule 4, the fee set out in item 2 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 8 of Schedule 4, the amount that is calculated in accordance with subsection 4(2).
Marginal note:Fee — amendment — licence authorizing non-sterile fabrication
43 If an application to amend an establishment licence seeks to add a building and the amendment seeks to authorize the holder to fabricate drugs that are not in sterile dosage form — but not to fabricate drugs in sterile dosage form or import drugs — at that building, the fee for the examination of the application for each building to be added is as follows:
(a) in respect of drugs for human use,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 5 of Schedule 3, the fee set out in item 3 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 5 of Schedule 3, the amount that is calculated in accordance with subsection 4(2); and
(b) in respect of drugs for veterinary use only,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 8 of Schedule 4, the fee set out in item 3 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 8 of Schedule 4, the amount that is calculated in accordance with subsection 4(2).
Marginal note:Fee — amendment — licence authorizing distribution
44 If an application to amend an establishment licence seeks to add a building and the amendment seeks to authorize the holder to distribute drugs — but not to fabricate drugs in sterile dosage form, import drugs or fabricate drugs that are not in sterile dosage form — at that building, the fee for the examination of the application for each building to be added is as follows:
(a) in respect of drugs for human use,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 5 of Schedule 3, the fee set out in item 4 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 5 of Schedule 3, the amount that is calculated in accordance with subsection 4(2); and
(b) in respect of drugs for veterinary use only,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 8 of Schedule 4, the fee set out in item 4 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 8 of Schedule 4, the amount that is calculated in accordance with subsection 4(2).
Marginal note:Fee — amendment — licence authorizing wholesaling
45 If an application to amend an establishment licence seeks to add a building and the amendment seeks to authorize the holder to wholesale drugs — but not to fabricate drugs in sterile dosage form, import drugs, fabricate drugs that are not in sterile dosage form or distribute drugs — at that building, the fee for the examination of the application for each building to be added is as follows:
(a) in respect of drugs for human use,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 5 of Schedule 3, the fee set out in item 5 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 5 of Schedule 3, the amount that is calculated in accordance with subsection 4(2); and
(b) in respect of drugs for veterinary use only,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 8 of Schedule 4, the fee set out in item 5 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 8 of Schedule 4, the amount that is calculated in accordance with subsection 4(2).
Marginal note:Fee — amendment — licence authorizing packaging/labelling
46 If an application to amend an establishment licence seeks to add a building and the amendment seeks to authorize the holder to package/label drugs — but not to fabricate drugs in sterile dosage form, import drugs, fabricate drugs that are not in sterile dosage form, distribute drugs or wholesale drugs — at that building, the fee for the examination of the application for each building to be added is as follows:
(a) in respect of drugs for human use,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 5 of Schedule 3, the fee set out in item 6 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 5 Schedule 3, the amount that is calculated in accordance with subsection 4(2); and
(b) in respect of drugs for veterinary use only,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 8 of Schedule 4, the fee set out in item 6 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 8 of Schedule 4, the amount that is calculated in accordance with subsection 4(2).
Marginal note:Fee — amendment — licence authorizing testing
47 If an application to amend an establishment licence seeks to add a building and the amendment seeks to authorize the holder to test drugs — but not to fabricate drugs in sterile dosage form, import drugs, fabricate drugs that are not in sterile dosage form, distribute drugs, wholesale drugs or package/label drugs — at that building, the fee for the examination of the application for each building to be added is as follows:
(a) in respect of drugs for human use,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 5 of Schedule 3, the fee set out in item 7 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 5 of Schedule 3, the amount that is calculated in accordance with subsection 4(2); and
(b) in respect of drugs for veterinary use only,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 8 of Schedule 4, the fee set out in item 7 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 8 of Schedule 4, the amount that is calculated in accordance with subsection 4(2).
Marginal note:Prorated fee
48 The fee that is payable under subsection 29(1) is reduced by the percentage set out in column 1 of Schedule 5 if the person referred to in subsection 29(2) files, in the period set out in column 2,
(a) an application for an establishment licence and has not previously filed such an application; or
(b) an application to amend an establishment licence that seeks to add a building.
Marginal note:Remission — small business
49 Subject to section 50, remission is granted to the person referred to in subsection 29(2) of an amount equal to 25% of the fee that is payable under subsection 29(1) if the person provides with their application, in a form established by the Minister,
(a) in the case where the person has completed their first fiscal year,
(i) a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, and
(ii) the following information:
(A) a list of the persons with which the person was affiliated in the person’s last completed fiscal year,
(B) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person was affiliated in the person’s last completed fiscal year,
(C) the number of employees of the person in their last fiscal year and of the persons with which the person was affiliated in those persons’ last completed fiscal year, and
(D) the gross revenue of the person in their last fiscal year and of the persons with which the person was affiliated in those persons’ last completed fiscal year; and
(b) in the case where the person has not completed their first fiscal year,
(i) a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, and
(ii) the following information:
(A) a list of the persons with which the person is affiliated in the person’s first fiscal year,
(B) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person is affiliated in the person’s first fiscal year,
(C) the number of employees of the person in their first fiscal year and of the persons with which the person is affiliated in those persons’ last completed fiscal year, and
(D) the projected gross revenue of the person in their first fiscal year and the gross revenue of the persons with which the person is affiliated in those persons’ last completed fiscal year.
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