Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)

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.

Marginal note:Difference payable

50 If the Minister requests under section 5 that the person referred to in subsection 29(2) provide additional information, the difference between the fee payable under subsection 29(1) and the amount already paid is immediately payable if

• (a) the person has not provided, within the period specified in section 5, the Minister with additional information for the purpose of demonstrating that the person met the definition small business in subsection 1(1) in the applicable fiscal year; or

• (b) the person has provided, within the period specified in section 5, the Minister with additional information for the purpose of demonstrating that the person met the definition in the applicable fiscal year but the Minister determines, after the period ends, that the person has not provided sufficient information to demonstrate that they met that definition in the applicable fiscal year.

DIVISION 4Fees for Right to Sell Drugs for Human Use

Non-application

Marginal note:Non-application

51 This Division does not apply to drugs for veterinary use only.

Fees and Remission

Marginal note:Annual fee

• 52 (1) The annual fee that is payable for the right to sell a drug for which a drug identification number has been assigned under subsection C.01.014.2(1) of the Food and Drug Regulations is, in respect of the type of drug set out in column 1 of Schedule 6, as follows:

  • (a) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 5 of Schedule 6, the fee set out in that column; and

  • (b) 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 6, the amount that is calculated in accordance with subsection 4(2).

• Marginal note:Fee payable by person after first sale

  (2) The fee is payable by the person to which a document was issued under subsection C.01.014.2(1) of the Food and Drug Regulations that sets out the drug identification number assigned for the drug if the person has sold the drug following the issuance of the document.

• Marginal note:Timing of payment

  (3) The fee is payable on October 1.

• Marginal note:Non-application — interruption of sale

  (4) Subject to subsection (5), subsection (1) does not apply to the person if they notified the Minister in accordance with section C.01.014.71 of the Food and Drug Regulations in the 12 months preceding October 1.

• Marginal note:Resumption of sale

  (5) Subsection (4) ceases to apply on the day on which the person notifies the Minister in accordance with section C.01.014.72 of the Food and Drug Regulations.

Marginal note:Remission — small business

53 Subject to section 54, remission is granted to the person referred to in subsection 52(2) of an amount equal to 25% of the fee that is payable under subsection 52(1) if the person provides with the notification provided under subsection C.01.014.5(1) of the Food and Drug Regulations, 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.