GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Fees in Respect of Drugs and Medical Devices Order — 17
Remission — first submission by small business 17 Subject to section 18 , remission is granted to the person referred to in subsection 9 (2) of an amount equal to the fee that is payable under subsection 9 (1) if the following conditions are met: (a) the person has not previously filed (i) a submission in respect of a drug; or (ii) an application as defined in section 27.1 in respect of a biocide; and (b) the person provides with their submission, 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. SOR/2024-121, s. 4
Fees in Respect of Drugs and Medical Devices Order — 18
Fee or difference payable 18 If the Minister requests under section 5 that the person referred to in subsection 9 (2) provide additional information, the fee — or the difference between the fee payable under subsection 9 (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 — 19
Definition of submission 19 In this Division, submission means any of the following: (a) an application for a drug identification number that is filed under section C.01.014.1 of the Food and Drug Regulations ; (b) a notification that is filed under subsection C.01.615(1) of those Regulations in respect of a veterinary health product; (c) a new drug submission that is filed under section C.08.002 of those Regulations; (d) an abbreviated new drug submission that is filed under section C.08.002.1 of those Regulations; (e) a supplement to a new drug submission or an abbreviated new drug submission that is filed under section C.08.003 of those Regulations; (f) a preclinical submission that is filed under subsection C.08.005(1) of those Regulations; (g) information that is filed under section C.08.010 of those Regulations for the purpose of obtaining a letter of authorization; (h) information and material that is filed under section C.08.014 of those Regulations for the purpose of obtaining an experimental studies certificate; (i) information and material that is filed with the Minister in respect of a notifiable change; or (j) a protocol that is filed with the Minister and may support any of the matters referred to in paragraphs (c) to (f) or (h).
Fees in Respect of Drugs and Medical Devices Order — 20
Application 20 This Division applies to drugs for veterinary use only.
Fees in Respect of Drugs and Medical Devices Order — 21
Fee for examination 21 (1) Subject to paragraph 22 (b) and section 24 , the fee that is payable in respect of a submission that is of a type set out in column 1 of Schedule 2, for the examination of each component set out in column 2 that is included in the submission, is as follows: (a) in the case of a fee that is payable in a fiscal year set out in any of columns 3 to 9 of Schedule 2, the applicable 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 9 of Schedule 2, the amount that is calculated in accordance with subsection 4 (2). Fee paid by person that files submission (2) The fee is payable by the person that files the submission.
Fees in Respect of Drugs and Medical Devices Order — 22
Fee and timing of payment — preliminary examination 22 If a preliminary examination is conducted in respect of a submission, (a) the full fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 21 (2) stating that the submission 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 21 (2) stating that the submission has been found to be incomplete.
Fees in Respect of Drugs and Medical Devices Order — 23
Fee and timing of payment — no preliminary examination 23 If a preliminary examination is not conducted in respect of a submission, the fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 21 (2) stating that the submission has been received.
Fees in Respect of Drugs and Medical Devices Order — 24
Fee — filing in previous fiscal year 24 For the purposes of subsection 21 (1), if the Minister issues a notice referred to in section 22 or 23 in the fiscal year that follows the fiscal year in which the submission was filed, the fee that is payable is the fee that was payable in the fiscal year in which the submission was filed.
Fees in Respect of Drugs and Medical Devices Order — 25
Remission — small business 25 Subject to section 27 , remission is granted to the person referred to in subsection 21 (2) of an amount equal to 50% of the fee that is payable under subsection 21 (1) if the person provides with their submission, 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 — 26
Remission — first submission by small business 26 Subject to section 27 , remission is granted to the person referred to in subsection 21 (2) of an amount equal to the fee that is payable under subsection 21 (1) if the following conditions are met: (a) the person has not previously filed (i) a submission in respect of a drug; or (ii) an application as defined in section 27.1 in respect of a biocide; and (b) the person provides with their submission, 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. SOR/2024-121, s. 5
Fees in Respect of Drugs and Medical Devices Order — 27
Fee or difference payable 27 If the Minister requests under section 5 that the person referred to in subsection 21 (2) provide additional information, the fee — or the difference between the fee payable under subsection 21 (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 — 27.1
Definition of application 27.1 In this Division, application means any of the following: (a) an application for a market authorization for a biocide submitted under section 10 of the Biocides Regulations ; (b) an application for a notice of acceptance in respect of a major change submitted under subsection 15(2) of those Regulations; (c) a written description of a minor change provided under subsection 17(1) of those Regulations, other than a change to contact information referred to in paragraph (a) of the definition of minor change in subsection 1(1) of those Regulations, or a change referred to in paragraph (f) of that definition; (d) an application for a market authorization for a biocide that is based on a comparison to a biocide that is authorized for sale by a foreign regulatory authority submitted under section 26 of those Regulations. SOR/2024-121, s. 6
Fees in Respect of Drugs and Medical Devices Order — 27.2
Fee for examination 27.2 (1) Subject to paragraph 27.3 (b) and section 27.5 , the fee for the examination of an application in respect of a class set out in column 1 of Schedule 2.1 and described in column 2 is the fee set out in column 3 of that Schedule. Fee paid by Person that files application (2) The fee is payable by the person that files the application. SOR/2024-121, s. 6
Fees in Respect of Drugs and Medical Devices Order — 27.3
Fee and timing of payment — Preliminary examination 27.3 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 27.2 (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 27.2 (2) stating that the application has been found to be incomplete. SOR/2024-121, s. 6
Fees in Respect of Drugs and Medical Devices Order — 27.4
Fee and timing of payment — No preliminary examination 27.4 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 27.2 (2) stating that the application has been received. SOR/2024-121, s. 6
Fees in Respect of Drugs and Medical Devices Order — 27.5
Fee — filing in previous fiscal year 27.5 For the purposes of subsection 27.2 (1), if the Minister issues a notice referred to in section 27.3 or 27.4 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. SOR/2024-121, s. 6
Fees in Respect of Drugs and Medical Devices Order — 27.6
Remission — small business 27.6 Subject to section 27.8 , remission is granted to the person referred to in subsection 27.2 (2) of an amount equal to 50% of the fee that is payable under subsection 27.2 (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. SOR/2024-121, s. 6
Fees in Respect of Drugs and Medical Devices Order — 27.7
Remission — first application by small business 27.7 Subject to section 27.8 , remission is granted to the person referred to in subsection 27.2 (2) of an amount equal to the fee that is payable under subsection 27.2 (1) if the following conditions are met: (a) the person has not previously filed (i) an application in respect of a biocide; (ii) a submission as defined in section 7 in respect of a drug; or (iii) a submission as defined in section 19 in respect of a drug; 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. SOR/2024-121, s. 6
Fees in Respect of Drugs and Medical Devices Order — 27.8
Fee or difference payable 27.8 If the Minister requests under section 5 that the person referred to in subsection 27.2 (2) provide additional information, the fee — or the difference between the fee payable under subsection 27.2 (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. SOR/2024-121, s. 6
Fees in Respect of Drugs and Medical Devices Order — 28
Definitions 28 The following definitions apply in this Division. activity means an activity set out in Table I to section C.01A.008 of the Food and Drug Regulations . ( activité ) drug has the same meaning as in subsection C.01A.001(2) of the Food and Drug Regulations . ( drogue ) establishment licence means a licence issued under section C.01A.008 of the Food and Drug Regulations . ( licence d’établissement )
Fees in Respect of Drugs and Medical Devices Order — Fees in Respect of Drugs and Medical Devices Order
activity means an activity set out in Table I to section C.01A.008 of the Food and Drug Regulations . ( activité )
Fees in Respect of Drugs and Medical Devices Order — Fees in Respect of Drugs and Medical Devices Order
drug has the same meaning as in subsection C.01A.001(2) of the Food and Drug Regulations . ( drogue )
Fees in Respect of Drugs and Medical Devices Order — Fees in Respect of Drugs and Medical Devices Order
establishment licence means a licence issued under section C.01A.008 of the Food and Drug Regulations . ( licence d’établissement )
Fees in Respect of Drugs and Medical Devices Order — 29
Fee for examination 29 (1) Subject to section 48 , the fee 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 33 to 40 and the fee payable for the examination of an application to amend an establishment licence to add a building is the sum of the applicable fees referred to in sections 41 to 47 . 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 — 30
Timing of payment 30 The fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 29 (2) stating that the application has been accepted for further examination.
Fees in Respect of Drugs and Medical Devices Order — 31
Reinstatement 31 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 — 32
Interpretation 32 In sections 33 to 39 , 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.
Fees in Respect of Drugs and Medical Devices Order — 33
Fee — licence authorizing sterile fabrication 33 For the examination of an application for an establishment licence for each building at which one or more activities are to be conducted, including fabricating drugs 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 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).