GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Fees in Respect of Drugs and Medical Devices Order — 54
Difference payable 54 If the Minister requests under section 5 that the person referred to in subsection 52 (2) provide additional information, the difference between the fee payable under subsection 52 (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.
Fees in Respect of Drugs and Medical Devices Order — 55
Application 55 This Division applies to drug for veterinary use only.
Fees in Respect of Drugs and Medical Devices Order — 56
Annual fee 56 (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 as follows: (a) in the case of a fee that is payable in a fiscal year set out in any of columns 1 to 4 of Schedule 7, 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 1 to 4 of Schedule 7, the amount that is calculated in accordance with subsection 4 (2). 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. Timing of payment (3) The fee is payable on October 1. 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. 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 .
Fees in Respect of Drugs and Medical Devices Order — 57
Remission — small business 57 Subject to section 58 , remission is granted to the person referred to in subsection 56 (2) of an amount equal to 25% of the fee that is payable under subsection 56 (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.
Fees in Respect of Drugs and Medical Devices Order — 58
Difference payable 58 If the Minister requests under section 5 that the person referred to in subsection 56 (2) provide additional information, the difference between the fee payable under subsection 56 (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.
Fees in Respect of Drugs and Medical Devices Order — 58.1
Annual fee 58.1 (1) The annual fee that is payable for the right to sell a biocide for which a market authorization has been issued under section 11 of the Biocides Regulations is $1,535. Fee payable by person that sold biocide (2) The fee is payable by the person to which a market authorization was issued if the person has sold the biocide in the 12 months preceding October 1. Timing of payment (3) The fee is payable on October 1. Non-application — permanent discontinuance of sale (4) Subsection (1) does not apply to the person if they have informed the Minister, in accordance with section 47 of the Biocides Regulations , that they permanently discontinued the sale of the biocide in Canada in the 12 months preceding October 1. SOR/2024-121, s. 7
Fees in Respect of Drugs and Medical Devices Order — 58.2
Remission — small business 58.2 Subject to section 58.3 , remission is granted to the person referred to in subsection 58.1 (2) of an amount equal to 25% of the fee that is payable under subsection 58.1 (1) if the person provides, with the information referred to in section 46 of the Biocides 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 the gross revenue 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 person’s 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. SOR/2024-121, s. 7
Fees in Respect of Drugs and Medical Devices Order — 58.3
Difference payable 58.3 If the Minister requests under section 5 that the person referred to in subsection 58.1 (2) provide additional information, the difference between the fee payable under subsection 58.1 (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. SOR/2024-121, s. 7
Fees in Respect of Drugs and Medical Devices Order — 59
Definitions 59 The following definitions apply in this Division. authorization means an authorization for a medical device issued under section 68.12 of the Medical Devices Regulations , if the device (a) is a Class II, III or IV device; and (b) is not a UPHN medical device. ( autorisation ) licence means a medical device licence issued under paragraph 36(1)(a) of the Medical Devices Regulations . ( homologation ) SOR/2023-21, s. 4 SOR/2023-278, s. 2
Fees in Respect of Drugs and Medical Devices Order — (a)
authorization means an authorization for a medical device issued under section 68.12 of the Medical Devices Regulations , if the device (a) is a Class II, III or IV device; and (b) is not a UPHN medical device. ( autorisation )
Fees in Respect of Drugs and Medical Devices Order — Fees in Respect of Drugs and Medical Devices Order
licence means a medical device licence issued under paragraph 36(1)(a) of the Medical Devices Regulations . ( homologation )
Fees in Respect of Drugs and Medical Devices Order — 60
Fee for examination 60 (1) Subject to paragraph 62(b) and section 64, the fee for the examination of an application for a licence that is filed under section 32 of the Medical Devices Regulations , an application for a licence amendment that is filed under section 34 or an application to amend an authorization filed under section 68.14 of those Regulations is, in respect of the applicable category set out in column 1 of Schedule 8 and described in column 2, as follows: (a) in the case of a fee that is payable in a fiscal year set out in any of columns 3 to 6 of Schedule 8, 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 3 to 6 of Schedule 8, the amount that is calculated in accordance with subsection 4 (2). Exception (1.1) Subsection (1) does not apply in respect of an application to amend an authorization for a medical device if the purpose of the application is to authorize the device in relation to a medical condition that qualified it as a UPHN medical device when the application was submitted. Fee payable by person that files application (2) The fee is payable by the person that files the application. SOR/2023-21, s. 5 SOR/2023-278, s. 3
Fees in Respect of Drugs and Medical Devices Order — 61
Reinstatement 61 Every provision of this Division that applies to an application for a licence for a Class II, III or IV medical device filed under section 32 of the Medical Devices Regulations also applies to a request to have such a licence reinstated following the correction of the situation that gave rise to its suspension.
Fees in Respect of Drugs and Medical Devices Order — 62
Fee and timing of payment — preliminary examination 62 If a preliminary examination is conducted in respect of an application, (a) the full fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 60 (2) stating that the application has been found to be complete and has been accepted for further examination; or (b) 10% of the fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 60 (2) stating that the application has been found to be incomplete.
Fees in Respect of Drugs and Medical Devices Order — 63
Fee and timing of payment — no preliminary examination 63 If a preliminary examination is not conducted in respect of an application, the fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 60 (2) stating that the application has been received.
Fees in Respect of Drugs and Medical Devices Order — 64
Fee — filing in previous fiscal year 64 For the purposes of subsection 60 (1), if the Minister issues a notice referred to in section 62 or 63 in the fiscal year that follows the fiscal year in which the application was filed, the fee that is payable is the fee that was payable in the fiscal year in which the application was filed.
Fees in Respect of Drugs and Medical Devices Order — 65
Remission — General Council Decision 65 Remission is granted to the person referred to in subsection 60 (2) of an amount equal to the fee that is payable under subsection 60 (1) if the person has received an authorization under section 21.04 of the Patent Act in respect of the medical device.
Fees in Respect of Drugs and Medical Devices Order — 66
Remission — small business 66 Subject to section 68 , remission is granted to the person referred to in subsection 60 (2) of an amount equal to 50% of the fee that is payable under subsection 60 (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.
Fees in Respect of Drugs and Medical Devices Order — 67
Remission — first application by small business 67 Subject to section 68 , remission is granted to the person referred to in subsection 60 (2) of an amount equal to the fee that is payable under subsection 60 (1) if the following conditions are met: (a) the person has not previously filed an application for a licence under section 32 of the Medical Devices Regulations ; and (b) the person provides with their application, in a form established by the Minister, (i) in the case where the person has completed their first fiscal year, (A) a statement indicating that the person met the definition small business in subsection 1 (1) in their last completed fiscal year, and (B) the following information: (I) a list of the persons with which the person was affiliated in the person’s last completed fiscal year, (II) 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, (III) 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 (IV) 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 (ii) in the case where the person has not completed their first fiscal year, (A) a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, and (B) the following information: (I) a list of the persons with which the person is affiliated in the person’s first fiscal year, (II) 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, (III) 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 (IV) 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.
Fees in Respect of Drugs and Medical Devices Order — 68
Fee or difference payable 68 If the Minister requests under section 5 that the person referred to in subsection 60 (2) provide additional information, the fee — or the difference between the fee payable under subsection 60 (1) and the amount already paid, as the case may be — 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.
Fees in Respect of Drugs and Medical Devices Order — 69
Definition of establishment licence 69 In this Division, establishment licence means a licence issued under section 46 of the Medical Devices Regulations .
Fees in Respect of Drugs and Medical Devices Order — 70
Applicable classes 70 This Division applies to persons that import or sell medical devices that are subject to the Medical Devices Regulations , other than persons that import or sell only medical devices that are subject to Part 2 or 3 of those Regulations.
Fees in Respect of Drugs and Medical Devices Order — 71
Fee for examination 71 (1) The fee that is payable for the examination of an application for an establishment licence filed under section 45 of the Medical Devices Regulations or for the annual review of such a licence filed under section 46.1 of those Regulations is $4,590. Fee paid by person that files application (2) The fee is payable by the person that files the application.
Fees in Respect of Drugs and Medical Devices Order — 72
Timing of payment 72 The fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 71 (2) stating that the application has been accepted for further examination.
Fees in Respect of Drugs and Medical Devices Order — 73
Reinstatement 73 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 following the correction of the situation that gave rise to its suspension.
Fees in Respect of Drugs and Medical Devices Order — 74
Remission — small business 74 Subject to section 75 , remission is granted to the person referred to in subsection 71 (2) of an amount equal to 25% of the fee that is payable under subsection 71 (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.
Fees in Respect of Drugs and Medical Devices Order — 75
Difference payable 75 If the Minister requests under section 5 that the person referred to in subsection 71 (2) provide additional information, the difference between the fee payable under subsection 71 (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.