GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Transportation of Dangerous Goods by Rail Security Regulations — (a)
(a) UN1170, ETHANOL with more than 24% ethanol, by volume, ETHANOL SOLUTION with more than 24% ethanol, by volume, ETHYL ALCOHOL with more than 24% ethanol, by volume, or ETHYL ALCOHOL SOLUTION with more than 24% ethanol, by volume;
Transportation of Dangerous Goods by Rail Security Regulations — (b)
(b) UN1202, DIESEL FUEL, GAS OIL or HEATING OIL, LIGHT;
Transportation of Dangerous Goods by Rail Security Regulations — (d)
(d) UN1268, PETROLEUM DISTILLATES, N.O.S., or PETROLEUM PRODUCTS, N.O.S.;
Transportation of Dangerous Goods by Rail Security Regulations — (e)
(e) UN1863, FUEL, AVIATION, TURBINE ENGINE;
Transportation of Dangerous Goods by Rail Security Regulations — (h)
(h) UN3295, HYDROCARBONS, LIQUID, N.O.S.; and
Transportation of Dangerous Goods by Rail Security Regulations — (i)
(i) UN3494, PETROLEUM SOUR CRUDE OIL, FLAMMABLE, TOXIC
Transportation of Dangerous Goods by Rail Security Regulations — (a)
Any quantity of any of the following dangerous goods included in Class 3 that are desensitized explosives and for which a placard is required under Part 4 of the Transportation of Dangerous Goods Regulations : (a) UN1204, NITROGLYCERIN SOLUTION IN ALCOHOL with not more than 1% nitroglycerin; (b) UN2059, NITROCELLULOSE SOLUTION, FLAMMABLE with not more than 12.6% nitrogen, by dry mass, and not more than 55% nitrocellulose; (c) UN3064, NITROGLYCERIN, SOLUTION IN ALCOHOL with more than 1% but not more than 5% nitroglycerin; and (d) UN3379, DESENSITIZED EXPLOSIVE, LIQUID, N.O.S.
Transportation of Dangerous Goods by Rail Security Regulations — (a)
(a) UN1204, NITROGLYCERIN SOLUTION IN ALCOHOL with not more than 1% nitroglycerin;
Transportation of Dangerous Goods by Rail Security Regulations — (b)
(b) UN2059, NITROCELLULOSE SOLUTION, FLAMMABLE with not more than 12.6% nitrogen, by dry mass, and not more than 55% nitrocellulose;
Transportation of Dangerous Goods by Rail Security Regulations — (c)
(c) UN3064, NITROGLYCERIN, SOLUTION IN ALCOHOL with more than 1% but not more than 5% nitroglycerin; and
Transportation of Dangerous Goods by Rail Security Regulations — (d)
(d) UN3379, DESENSITIZED EXPLOSIVE, LIQUID, N.O.S.
Transportation of Dangerous Goods by Rail Security Regulations — (a)
Any quantity of either of the following dangerous goods included in Class 5.2: (a) UN3111, ORGANIC PEROXIDE TYPE B, LIQUID, TEMPERATURE CONTROLLED,; and (b) UN3112, ORGANIC PEROXIDE TYPE B, SOLID, TEMPERATURE CONTROLLED
Transportation of Dangerous Goods by Rail Security Regulations — (a)
(a) UN3111, ORGANIC PEROXIDE TYPE B, LIQUID, TEMPERATURE CONTROLLED,; and
Transportation of Dangerous Goods by Rail Security Regulations — (b)
(b) UN3112, ORGANIC PEROXIDE TYPE B, SOLID, TEMPERATURE CONTROLLED
Transportation of Dangerous Goods by Rail Security Regulations — (a)
More than 500 kg of either of the following dangerous goods included in Class 7: (a) UN2977, RADIOACTIVE MATERIAL, URANIUM HEXAFLUORIDE, FISSILE; and (b) UN2978, RADIOACTIVE MATERIAL, URANIUM HEXAFLUORIDE, non-fissile or fissile excepted
Transportation of Dangerous Goods by Rail Security Regulations — (a)
(a) UN2977, RADIOACTIVE MATERIAL, URANIUM HEXAFLUORIDE, FISSILE; and
Transportation of Dangerous Goods by Rail Security Regulations — (b)
(b) UN2978, RADIOACTIVE MATERIAL, URANIUM HEXAFLUORIDE, non-fissile or fissile excepted
Critical Habitat of the Western Brook Lamprey (Lampetra richardsoni) Morrison Creek Population Order — a
Whereas the Western Brook Lamprey ( Lampetra richardsoni ) Morrison Creek population is a wildlife species that is listed as an endangered species in Part 2 of Schedule 1 to the Species at Risk Act a ; a S.C. 2002, c. 29
Critical Habitat of the Western Brook Lamprey (Lampetra richardsoni) Morrison Creek Population Order — Critical Habitat of the Western Brook Lamprey (Lampetra richardsoni) Morrison Creek Population Order
Whereas the action plan that identified the critical habitat of that species has been included in the Species at Risk Public Registry;
Critical Habitat of the Western Brook Lamprey (Lampetra richardsoni) Morrison Creek Population Order — b
And whereas no portion of the critical habitat of that species that is specified in the annexed Order is in a place referred to in subsection 58(2) b of that Act; b S.C. 2015, c. 10, s. 60
Critical Habitat of the Western Brook Lamprey (Lampetra richardsoni) Morrison Creek Population Order — Critical Habitat of the Western Brook Lamprey (Lampetra richardsoni) Morrison Creek Population Order
Therefore, the Minister of Fisheries and Oceans, pursuant to subsections 58(4) and (5) of the Species at Risk Act a , makes the annexed Critical Habitat of the Western Brook Lamprey (Lampetra richardsoni) Morrison Creek Population Order .
Critical Habitat of the Western Brook Lamprey (Lampetra richardsoni) Morrison Creek Population Order — 1
Application 1 Subsection 58(1) of the Species at Risk Act applies to the critical habitat of the Western Brook Lamprey ( Lampetra richardsoni ) Morrison Creek population, which is identified in the action plan for that species that is included in the Species at Risk Public Registry.
Critical Habitat of the Western Brook Lamprey (Lampetra richardsoni) Morrison Creek Population Order — 2
Coming into force 2 This Order comes into force on the day on which it is registered.
Fees in Respect of Drugs and Medical Devices Order — Fees in Respect of Drugs and Medical Devices Order
Whereas, pursuant to section 30.62 a of the Food and Drugs Act b , the Minister of Health has consulted with any persons that the Minister considers to be interested in the matter;
Fees in Respect of Drugs and Medical Devices Order — Fees in Respect of Drugs and Medical Devices Order
Therefore, the Minister of Health, pursuant to subsections 30.61(1) a and 30.63(1) a of the Food and Drugs Act b , makes the annexed Fees in Respect of Drugs and Medical Devices Order .
Fees in Respect of Drugs and Medical Devices Order — Fees in Respect of Drugs and Medical Devices Order
Ottawa, May 3, 2019 Ginette C. Petitpas Taylor Minister of Health
Fees in Respect of Drugs and Medical Devices Order — Fees in Respect of Drugs and Medical Devices Order
entity has the meaning assigned by the definition organization in section 2 of the Criminal Code . ( entité )
Fees in Respect of Drugs and Medical Devices Order — (a)
fiscal year means (a) for the purposes of sections 16, 17, 25, 26, 27.6, 27.7, 49, 53, 57, 58.2, 66, 67, 74 and 79, the fiscal year of a person that provides information under that section or of a person with which the person is affiliated; and (b) for the purposes of any other section, the period beginning on April 1 in one year and ending on March 31 in the next year. ( exercice )
Fees in Respect of Drugs and Medical Devices Order — Fees in Respect of Drugs and Medical Devices Order
performance standard means the document entitled Performance Standards for the Fees in Respect of Drugs and Medical Devices Order that is published by the Government of Canada on its website, dated February 16, 2024. ( norme de rendement )
Fees in Respect of Drugs and Medical Devices Order — (a)
small business means a person in respect of which either of the following criteria applies: (a) the total of the number of employees of the person and of the persons with which the person is affiliated is fewer than 100; or (b) the total of the gross revenue of the person and of the persons with which the person is affiliated is $30,000 or more but less than $5 million. ( petite entreprise )
Fees in Respect of Drugs and Medical Devices Order — 2
Purpose — fees 2 (1) The purpose of this Order is to fix the fees for the following: (a) in respect of drugs for human use and drugs for veterinary use only, the examination of a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission referred to in section C.08.002, C.08.002.1 or C.08.003 of the Food and Drug Regulations , as the case may be, an application in respect of an establishment licence filed under those Regulations or an application for a drug identification number filed under section C.01.014.1 of those Regulations; (b) in respect of drugs for veterinary use only, the examination of a notification for a veterinary health product filed under subsection C.01.615(1) of the Food and Drug Regulations , a preclinical submission filed under subsection C.08.005(1) of those Regulations, information filed under section C.08.010 of those Regulations for the purpose of obtaining a letter of authorization, information and material filed under section C.08.014 of those Regulations for the purpose of obtaining an experimental studies certificate, information and material filed with the Minister in respect of a notifiable change or a protocol filed with the Minister; (b.1) in respect of biocides, the examination of an application for a market authorization submitted under section 10 of the Biocides Regulations , an application for a notice of acceptance in respect of a major change submitted under subsection 15(2) of those Regulations, the examination of a written description of a minor change provided to the Minister 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, or the examination of 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; (b.2) the right to sell a biocide under the Biocides Regulations ; (c) the right to sell a drug under the Food and Drug Regulations ; (d) the examination of an application in respect of a medical device licence, the right to sell a medical device or the examination of an application in respect of an establishment licence under the Medical Devices Regulations ; and (e) the examination of an application to amend an authorization in respect of a Class II, III or IV medical device that is not a UPHN medical device or the right to sell such a device under the Medical Devices Regulations . Purpose — remission (2) The purpose of this Order is also to remit, in whole or in part, certain of those fees. SOR/2023-21, s. 2 SOR/2023-278, s. 6 SOR/2024-121, s. 2
Fees in Respect of Drugs and Medical Devices Order — 3
Non-application 3 (1) This Order does not apply in respect of (a) publicly funded health care institutions; (b) branches or agencies of the Government of Canada or of the government of a province; or (c) drugs that are the subject of an extraordinary use new drug submission filed under section C.08.002.01 of the Food and Drug Regulations or of an abbreviated extraordinary use new drug submission filed under section C.08.002.1 of those Regulations. Definition of publicly funded health care institution (2) For the purposes of subsection (1), publicly funded health care institution means an institution that is funded by the Government of Canada or the government of a province and that is (a) licensed, approved or designated by a province in accordance with the laws of the province to provide care or treatment to persons or animals suffering from any form of disease or illness; or (b) owned or operated by the Government of Canada or the government of a province and that provides health services.
Fees in Respect of Drugs and Medical Devices Order — 4
Adjustment of fees 4 (1) Beginning on April 1, 2021, every fee set out in this Order is to be adjusted in each fiscal year on April 1 by the percentage change over 12 months in the April All-items Consumer Price Index for Canada, as published by Statistics Canada under the Statistics Act , for the previous fiscal year and rounded up to the nearest dollar. Formula (2) In the case of a fee that is payable under any of Divisions 1 to 5 of Part 2 or Division 1 of Part 3 in a fiscal year that is not set out in the applicable schedule, the amount of the fee is to be calculated, on April 1 of the fiscal year, in accordance with the following formula and rounded up to the nearest dollar: Fee = A + (A × B) where A is the amount of the fee that was payable in the previous fiscal year; and B is the percentage change over 12 months in the April All-items Consumer Price Index for Canada, as published by Statistics Canada under the Statistics Act , for the previous fiscal year.
Fees in Respect of Drugs and Medical Devices Order — 5
Information on request 5 If the Minister determines, in respect of a person that provided information under any of the following provisions, that additional information is necessary to demonstrate that the person met the definition small business in subsection 1(1) in the applicable fiscal year, the Minister may request that the person provide him or her with additional information within 60 days after the day on which the request is made: (a) subparagraph 16 (a)(ii) or (b)(ii); (b) clause 17 (b)(i)(B) or (ii)(B); (c) subparagraph 25 (a)(ii) or (b)(ii); (d) clause 26 (b)(i)(B) or (ii)(B); (d.1) subparagraph 27.6 (a)(ii) or (b)(ii); (d.2) clause 27.7 (b)(i)(B) or (ii)(B); (e) subparagraph 49 (a)(ii) or (b)(ii); (f) subparagraph 53 (a)(ii) or (b)(ii); (g) subparagraph 57 (a)(ii) or (b)(ii); (g.1) subparagraph 58.2 (a)(ii) or (b)(ii); (h) subparagraph 66 (a)(ii) or (b)(ii); (i) clause 67 (b)(i)(B) or (ii)(B); (j) subparagraph 74 (a)(ii) or (b)(ii); or (k) subparagraph 79 (a)(ii) or (b)(ii). SOR/2024-121, s. 3
Fees in Respect of Drugs and Medical Devices Order — 6
Remission — performance standard 6 (1) If the Minister determines that the performance standard has not been met in relation to a fee that is payable under this Order, remission is granted to the person that must pay the fee (a) of an amount equal to 25% of the fee; or (b) of an amount equal to 25% of the amount that is payable, in the case where remission is granted of part of the fee under any other provision of this Order. Exceptions (2) Subsection (1) does not apply to a fee for the examination of (a) an application or submission referred to in this Order in respect of which a joint or parallel review is conducted by the Minister and a foreign regulatory authority; (b) an application for a licence that is filed under section 32 of the Medical Devices Regulations if (i) the medical device to which the application relates includes a component that is a drug, and (ii) the Minister has made a decision in respect of the application to issue or amend a medical device licence under section 36 of those Regulations, or to refuse to issue or amend such a licence under section 38 of those Regulations; or (c) the following: (i) a new drug submission for a public health emergency drug if subsection C.08.002(2.3) of the Food and Drug Regulations applies to that submission, or (ii) a supplement to any new drug submission if subsection C.08.003(7) of those Regulations applies to that supplement. SOR/2021-47, s. 1 SOR/2023-21, s. 3(F) SOR/2024-247, s. 1
Fees in Respect of Drugs and Medical Devices Order — 7
Definition of submission 7 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 new drug submission that is filed under section C.08.002 of those Regulations; (c) an abbreviated new drug submission that is filed under section C.08.002.1 of those Regulations; or (d) a supplement to a new drug submission or abbreviated new drug submission that is filed under section C.08.003 of those Regulations.
Fees in Respect of Drugs and Medical Devices Order — 8
Non-application 8 This Division does not apply to drugs for veterinary use only.
Fees in Respect of Drugs and Medical Devices Order — 9
Fee for examination 9 (1) Subject to paragraph 10 (b) and section 12 , the fee for the examination of a submission is, in respect of the applicable submission class set out in column 1 of Schedule 1 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 1, 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 1, 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 — 10
Fee and timing of payment — preliminary examination 10 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 9 (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 9 (2) stating that the submission has been found to be incomplete.
Fees in Respect of Drugs and Medical Devices Order — 11
Fee and timing of payment — no preliminary examination 11 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 9 (2) stating that the submission has been received.
Fees in Respect of Drugs and Medical Devices Order — 12
Fee — filing in previous fiscal year 12 For the purposes of subsection 9 (1), if the Minister issues a notice referred to in section 10 or 11 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 — 13
Deferred payment — notice of compliance 13 Despite sections 10 and 11 , if the person referred to in subsection 9 (2) files an application for authorization under section C.07.003 of the Food and Drug Regulations at the same time that the person files the submission, payment of the fee is deferred until the issuance to the person of a notice of compliance under section C.08.004 of those Regulations or of a document setting out the drug identification number assigned for the drug under subsection C.01.014.2(1) of those Regulations.
Fees in Respect of Drugs and Medical Devices Order — 14
Remission — urgent public health need 14 Remission is granted to a person referred to in subsection 9 (2) that files a new drug submission under section C.08.002 of the Food and Drug Regulations or an application for a drug identification number under section C.01.014.1 of those Regulations of the amount of the fee that is payable under subsection 9 (1) if, as of the day on which the person filed the new drug submission or application, (a) the drug has the same medicinal ingredient, strength and route of administration and is in a comparable dosage form as a drug that may be imported under subsection C.10.001(2) of those Regulations; (b) a drug identification number has not been assigned under subsection C.01.014.2(1) of those Regulations for the drug or for another drug that has the same medicinal ingredient, strength and route of administration and is in a comparable dosage form; and (c) a notice of compliance has not been issued under section C.08.004 of those Regulations in respect of the drug or another drug that has the same medicinal ingredient, strength and route of administration and is in a comparable dosage form. SOR/2021-47, s. 2(F)
Fees in Respect of Drugs and Medical Devices Order — 14.1
Remission — designated COVID-19 drug 14.1 (1) Remission is granted to the person referred to in subsection 9(2) of the amount of the fee that is payable under subsection 9(1) if the person has (a) filed, under the ISAD Interim Order, an application for a designated COVID-19 drug , as defined in section C.08.001.1 of the Food and Drug Regulations as that section read immediately before the day on which subsection 24 (1) of the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) comes into force; and (b) subsequently filed a submission for that drug. Remission — no previous submission (2) The remission referred to in subsection (1) is granted if the person has not previously filed a submission for that designated COVID-19 drug. SOR/2021-47, s. 3 SOR/2024-247, s. 2
Fees in Respect of Drugs and Medical Devices Order — 15
Remission — General Council Decision 15 Remission is granted to the person referred to in subsection 9 (2) of the amount of the fee that is payable under subsection 9 (1) if the person has received an authorization under section 21.04 of the Patent Act in respect of the drug.
Fees in Respect of Drugs and Medical Devices Order — 16
Remission — small business 16 Subject to section 18 , remission is granted to the person referred to in subsection 9 (2) of an amount equal to 50% of the fee that is payable under subsection 9 (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.