Fees in Respect of Drugs and Medical Devices Regulations (SOR/2011-79)

Regulations are current to 2016-06-21 and last amended on 2013-12-19. Previous Versions

Marginal note:Remission — actual gross revenue

 If the amount already paid is greater than 10% of the actual gross revenue of the person referred to in section 6, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the person.

Marginal note:Audited sales records
  •  (1) If the Minister determines, on the basis of any information available to the Minister, that the records provided in accordance with subsection 11(3) are not adequate to determine the actual gross revenue of the person referred to in section 6, the Minister may require, for the purpose of determining the fee payable or the amount of the remission, the person to provide sales records that have been audited by a qualified independent auditor.

  • Marginal note:Omission

    (2) If, within 60 days after the day of the Minister’s request for the audited sales records, the person has not provided the Minister with them, the difference between the fee payable under section 6 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 10% of the person’s actual gross revenue, the amount by which the lesser of the fee payable under section 6 and 10% of the person’s actual gross revenue exceeds the amount paid is immediately payable.

  • Marginal note:Difference remitted

    (4) If the audited sales records establish that the amount already paid is greater than 10% of the person’s actual gross revenue, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the person.

Marginal note:Remission

 Remission is granted to the person referred to in section 6 of the amount of the fee referred to in that section in respect of a drug if the manufacturer has received an authorization under section 21.04 of the Patent Act.

DIVISION 2Fees for the Examination of an Application for a Drug Establishment Licence

Interpretation

Marginal note:Definitions
  •  (1) The following definitions apply in this Division.

    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)

    controlled drug

    drogue contrôlée

    controlled drug has the same meaning as in subsection G.01.001(1) of the Food and Drug Regulations. (drogue contrôlée)

    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)

    health care facility

    établissement de santé

    health care facility means a facility that provides diagnostic or therapeutic services to patients. It includes a group of such facilities that report to one common management that has responsibility for the activities carried out in those facilities. (établissement de santé)

    narcotic

    stupéfiant

    narcotic has the same meaning as in section 2 of the Narcotic Control Regulations. (stupéfiant)

  • Marginal note:Words and expressions

    (2) Unless the context otherwise requires, all other words and expressions used in this Division have the meanings assigned to them by the Food and Drugs Act or the Food and Drug Regulations.

  • SOR/2013-122, s. 20.

Application

Marginal note:Non-application

 This Division does not apply to any publicly funded health care facility or any branch or agency of the Government of Canada or of the government of a province.

Fee

Marginal note:Fee
  •  (1) The fee payable by an applicant for the examination of an application for an establishment licence or for the annual review of an establishment licence is the sum of the applicable fees referred to in sections 19 to 25 and the fee payable by an applicant for the examination of an application for the amendment of an establishment licence is the sum of the fees referred to in sections 27 and 28.

  • Marginal note:Remission

    (2) Subject to subsection 26(2), if the fee is greater than an amount equal to 1% of the applicant’s actual gross revenue from activities conducted under an establishment licence during the previous calendar year, remission is granted of the difference between those amounts if the applicant provides with their application a statement signed by the individual responsible for the applicant’s financial affairs that sets out the actual gross revenue.

  • Marginal note:Timing of payment

    (3) Subject to subsection (4), the fee is payable at the time the applicant submits an application for an establishment licence or for the annual review of an establishment licence under section C.01A.005 or C.01A.009 of the Food and Drug Regulations or an application for the amendment of an establishment licence under section C.01A.006 of those Regulations.

  • Marginal note:First year of activities

    (4) If the applicant has not completed their first calendar year of conducting activities under the establishment licence, the payment of the fee is deferred until the end of that year.

  • Marginal note:Reinstatement

    (5) Every provision of this Division that applies to an application for an establishment licence also applies to a request to have such a licence reinstated.

Marginal note:Interpretation

 In sections 19 to 25, a reference to the examination of an application for an establishment licence includes an examination of an application for the annual review of an establishment licence.

Marginal note:Licence authorizing fabrication
  •  (1) For the examination of an application for an establishment licence for each building at which one or more activities, including fabricating drugs, are to be conducted, the fee is the basic fee, set out in item 1, column 2, of Schedule 2, and any of the following fees that are applicable:

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

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

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

  • Marginal note:Importing

    (2) Despite section 21, if the importing of drugs is to be authorized by the establishment licence at a building referred to in subsection (1), the fee referred to in paragraph 21(b) is also payable.

Marginal note:Licence authorizing packaging/labelling
  •  (1) Subject to subsection (3), for the examination of an application for an establishment licence for each building at which one or more activities, including packaging/labelling drugs but not including fabricating drugs, are to be conducted, the fee is the basic fee, set out in item 1, column 2, of Schedule 3, and any of the following fees that are applicable:

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

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

  • Marginal note:Importing

    (2) Despite section 21, if the importing of drugs is to be authorized by the establishment licence at a building referred to in subsection (1), the fee referred to in paragraph 21(b) is also payable.

  • Marginal note:Medical gas

    (3) If the applicant for an establishment licence proposes to conduct activities only in regard to drugs in the dosage form class of medical gas at more than one building, the fee is the sum of the following fees:

    • (a) in regard to packaging/labelling, the basic fee set out in item 1, column 2, of Schedule 3, as if only one building were authorized under the licence;

    • (b) in regard to all other activities, the fee that would be payable under subsection 17(1) if packaging/labelling activities were not referred to in the application.

 
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