GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Fees in Respect of Drugs and Medical Devices Order — 76
Definitions 76 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. 6 SOR/2023-278, s. 4
Fees in Respect of Drugs and Medical Devices Order — 77
Annual fee 77 (1) The annual fee that is payable for the right to sell a licensed Class II, III or IV medical device or an authorized Class II, III or IV medical device that is not a UPHN medical device is $381. Fee payable by holder (2) The fee is payable either by the person that holds the licence for the Class II, III or IV medical device, if the licence is not suspended under section 40 or 41 of the Medical Devices Regulations , or by the person that holds the authorization. SOR/2023-21, s. 6 SOR/2023-278, s. 6
Fees in Respect of Drugs and Medical Devices Order — 78
Timing of payment 78 The fee is payable on December 20.
Fees in Respect of Drugs and Medical Devices Order — 79
Remission — small business 79 Subject to section 80, remission is granted to the person referred to in subsection 77(2) of an amount equal to 25% of the fee that is payable under subsection 77(1) if the person provides the Minister with the statement provided under subsection 43(1) or section 68.24 of the Medical Devices 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. SOR/2023-21, s. 7
Fees in Respect of Drugs and Medical Devices Order — 80
Difference payable 80 If the Minister requests under section 5 that the person referred to in subsection 77 (2) provide additional information, the difference between the fee payable under subsection 77 (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 — SOR/96-143
SOR/96-143 * 81 This Order comes into force on the day on which the Veterinary Drug Evaluation Fees Regulations are repealed but if it is registered after that day, it comes into force on the day on which it is registered. * [Note: Regulations in force April 1, 2020.]
Fees in Respect of Drugs and Medical Devices Order — (a)
Documentation to support (a) a change of manufacturer, in the case of an abbreviated new drug submission; or (b) a change to the brand name of a drug, in the case of a supplement to an abbreviated new drug submission 4
Fees in Respect of Drugs and Medical Devices Order — (a)
(a) a change of manufacturer, in the case of an abbreviated new drug submission; or
Fees in Respect of Drugs and Medical Devices Order — (b)
(b) a change to the brand name of a drug, in the case of a supplement to an abbreviated new drug submission 4
Fees in Respect of Drugs and Medical Devices Order — Note:
Note: The fee payable under subsection 30(1) of this Order is not reduced if an application is filed on or after April 1 and up to and including June 30.
Fees in Respect of Drugs and Medical Devices Order — 1
Definition of disinfectant 1 In this Schedule, disinfectant has the meaning assigned by the definition antimicrobial agent in subsection C.01A.001(1) of the Food and Drug Regulations . Item Column 1 Column 2 Column 3 Column 4 Column 5 Type of Drug Fee ($) Fee ($) Fee ($) Fee ($) Fiscal Year Fiscal Year Fiscal Year Fiscal Year 2020-2021 2021-2022 2022-2023 2023-2024 1 Disinfectant 1,285 1,344 1,403 1,462 2 Non-prescription drug 1,623 2,022 2,421 2,820 3 Drug other than one referred to in item 1 or 2 1,836 2,754 4,080 4,679
Fees in Respect of Drugs and Medical Devices Order — 1
Definition of private label medical device 1 In this Schedule, private label medical device means a medical device that is identical in every respect to a medical device in respect of which a licence has been issued, except that the device is labelled with the name and address of another manufacturer and the name and identifier of the device that the other manufacturer is proposing to sell under its own name or under a trademark, design, trade-name or other name or mark owned or controlled by it.
Fees in Respect of Drugs and Medical Devices Order — 14
14 A person that submits an application, under subsection 10(1) of the Biocides Regulations , for a market authorization for a biocide , as defined in subsection 1(1) of those Regulations, is not required to pay the fee for the examination of the application referred to in subsection 27.2 (1) of the Fees in Respect of Drugs and Medical Devices Order if the biocide is the subject of one of the exceptions set out in section 67 or 69 of those Regulations.
Fees in Respect of Drugs and Medical Devices Order — 8
8 Items 10 and 11 of Schedule 1 to the Order are repealed.
Fees in Respect of Drugs and Medical Devices Order — 9
9 The portion of item 1 of Schedule 1 to the Order in column 2 is replaced by the following: Column 2 Item Description 1 Submissions in support of a drug that contains a medicinal ingredient not previously approved in a drug for sale in Canada and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph 1
Fees in Respect of Drugs and Medical Devices Order — 11
11 Section 1 and the heading before it of Schedule 6 to the Order are repealed.
Fees in Respect of Drugs and Medical Devices Order — 12
12 Item 1 of Schedule 6 to the Order is repealed.
Fees in Respect of Drugs and Medical Devices Order — 13
13 The portion of item 3 of Schedule 6 to the Order in column 1 is replaced by the following: Column 1 Item Description 3 Drug, other than a biocide and other than one referred to in item 2
Surtax on the Importation of Certain Steel Goods Refund Order — Surtax on the Importation of Certain Steel Goods Refund Order
Her Excellency the Governor General in Council, on the recommendation of the Minister of Finance, pursuant to section 58 of the Customs Tariff a , makes the annexed Surtax on the Importation of Certain Steel Goods Refund Order .
Surtax on the Importation of Certain Steel Goods Refund Order — 1
Refund 1 (1) A refund is granted of a surtax paid under the Order Imposing a Surtax on the Importation of Certain Steel Goods , as it read on April 28, 2019, in respect of goods of the following classes of goods, as set out in column 1 of Schedule 1 to that Order: (a) classes of goods 2 to 5 and 7 for goods originating in all countries; and (b) classes of goods 1 and 6 for goods originating in Colombia, Korea, Panama and Peru. Non-application (2) The refund referred to in subsection (1) is granted of the surtax, or portion of the surtax, for which no other claim for relief has been granted under the Customs Tariff .
Surtax on the Importation of Certain Steel Goods Refund Order — 2
Coming into force 2 This Order comes into force on the day on which it is registered.
Black Lake First Nation Water Power Regulations — a
Whereas the Black Lake First Nation has requested by resolution of its council that the Minister of Indian Affairs and Northern Development recommend to the Governor in Council the making of the annexed Regulations and, in accordance with paragraph 5(1)(a) of the First Nations Commercial and Industrial Development Act a , the Minister has received that resolution; a S.C. 2005, c. 53
Black Lake First Nation Water Power Regulations — Black Lake First Nation Water Power Regulations
Whereas the Black Lake First Nation is a first nation within the meaning of the First Nations Commercial and Industrial Development Act a ;
Black Lake First Nation Water Power Regulations — Black Lake First Nation Water Power Regulations
Whereas the purpose of the annexed Regulations is to ensure that the laws set out in Schedule 2 to the annexed Regulations apply as federal law to the project, within the limits of federal constitutional authority;
Black Lake First Nation Water Power Regulations — Black Lake First Nation Water Power Regulations
Whereas the annexed Regulations specify provincial officials by whom, and provincial bodies by which, powers may be exercised or duties are to be performed;
Black Lake First Nation Water Power Regulations — Black Lake First Nation Water Power Regulations
And whereas, in accordance with paragraph 5(1)(b) of the First Nations Commercial and Industrial Development Act a , an agreement has been concluded between the Minister of Indian Affairs and Northern Development, the Province of Saskatchewan and the council of the Black Lake First Nation for the administration and enforcement of the annexed Regulations by those provincial officials and bodies;
Black Lake First Nation Water Power Regulations — b
Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of Indian Affairs and Northern Development, pursuant to section 3 b of the First Nations Commercial and Industrial Development Act a and paragraph 15(d) of the Dominion Water Power Act c , makes the annexed Black Lake First Nation Water Power Regulations . b S.C. 2012, c. 19, s. 63 c R.S., c. W-4
Black Lake First Nation Water Power Regulations — 1
Definitions 1 The following definitions apply in these Regulations. incorporated laws means the statutes and regulations of Saskatchewan, or the portions of them, that are set out in Schedule 2, as amended from time to time and as adapted by sections 13 to 34. ( texte législatif incorporé ) project means the construction, modification, operation, decommissioning, reclamation and abandonment of hydroelectric facilities on the project lands and the generation of electricity from the water power available within those lands. ( projet ) project lands means the lands of the Black Lake First Nation Chicken Reserve No. 224 that are set out in Schedule 1. ( terres du projet )
Black Lake First Nation Water Power Regulations — Black Lake First Nation Water Power Regulations
incorporated laws means the statutes and regulations of Saskatchewan, or the portions of them, that are set out in Schedule 2, as amended from time to time and as adapted by sections 13 to 34. ( texte législatif incorporé )
Black Lake First Nation Water Power Regulations — Black Lake First Nation Water Power Regulations
project means the construction, modification, operation, decommissioning, reclamation and abandonment of hydroelectric facilities on the project lands and the generation of electricity from the water power available within those lands. ( projet )
Black Lake First Nation Water Power Regulations — Black Lake First Nation Water Power Regulations
project lands means the lands of the Black Lake First Nation Chicken Reserve No. 224 that are set out in Schedule 1. ( terres du projet )
Black Lake First Nation Water Power Regulations — 2
Provincial – The Interpretation Act, 1995 2 The incorporated laws are to be interpreted in accordance with the Saskatchewan statute The Interpretation Act, 1995 , S.S. 1995, c. I-11.2, as amended from time to time, and, for that purpose, references to “enactment” in that Act are to be read to include the incorporated laws.
Black Lake First Nation Water Power Regulations — 3
Other expressions 3 For greater certainty, the adaptations in sections 13 to 34 are to be interpreted to be part of the incorporated laws to which they apply.
Black Lake First Nation Water Power Regulations — 4
Incorporation by reference 4 Subject to section 5, the incorporated laws apply to the project.
Black Lake First Nation Water Power Regulations — 5
Restriction – laws in force 5 (1) A provision of an incorporated law applies only if the provision of the law of Saskatchewan that it incorporates is in force. Restriction – limits of authority (2) For greater certainty, an incorporated law applies only to the extent that it is within the limits of federal constitutional authority.
Black Lake First Nation Water Power Regulations — 6
Incorporation of procedural matters 6 (1) Unless otherwise provided and subject to any adaptations set out in sections 13 to 34, the following are to conform to the laws of Saskatchewan, whether or not those laws have been set out in Schedule 2: (a) the enforcement of incorporated laws; (b) the prosecution of an offence, or any other proceedings, in relation to the contravention of an incorporated law; (c) the review or appeal of an action or decision taken, or of a failure to take an action that could have been taken, under an incorporated law; and (d) the delivery of notices or the service of documents in relation to an action to be taken under an incorporated law. Related powers (2) For the purposes of subsection (1), a person or body that has a power, duty or function under a law of Saskatchewan has the same power, duty or function in respect of any actions taken under that subsection.
Black Lake First Nation Water Power Regulations — 7
Offences and penalties 7 (1) If contravention of a law of Saskatchewan that is incorporated in these Regulations is an offence under the laws of Saskatchewan, contravention of the incorporated law is also an offence and is subject to the same penalties as under the laws of Saskatchewan. Violations and administrative monetary penalties (2) If contravention of a law of Saskatchewan that is incorporated in these Regulations is a violation under the laws of Saskatchewan, contravention of the incorporated law is also a violation and is subject to the same administrative monetary penalties as under the laws of Saskatchewan.
Black Lake First Nation Water Power Regulations — 8
Financial requirements under lease 8 If the incorporated laws require a cash deposit or other financial security to be given, those requirements do not displace, but instead apply in addition to, the requirements of any lease of the project lands in relation to cash deposits or other financial security.
Black Lake First Nation Water Power Regulations — 9
Exclusion 9 The Dominion Water Power Regulations , the Indian Reserve Waste Disposal Regulations and the Indian Timber Regulations do not apply to the project.
Black Lake First Nation Water Power Regulations — 10
Lease, permit or easement 10 The Minister of Indian Affairs and Northern Development may issue leases or permits or grant easements for the purpose of carrying out the project.
Black Lake First Nation Water Power Regulations — 11
Payment 11 (1) The water rentals required to be paid in respect of the project under The Water Power Rental Regulations , as incorporated and adapted by these Regulations, are to be paid in the following proportions: (a) 50% to the Water Security Agency or its successor; and (b) 50% to Her Majesty in right of Canada. Use and benefit (2) The water rentals paid to Her Majesty in right of Canada are to be for the use and benefit of the Black Lake First Nation.
Black Lake First Nation Water Power Regulations — 12
Survival of rights 12 Any licences, permits, authorizations, orders or exemptions — including any amendments to them — issued by a provincial official in relation to the project before the day on which these Regulations come into force are to be considered to have been issued under these Regulations and to be valid for the purposes of these Regulations.
Black Lake First Nation Water Power Regulations — 13
Statutes and regulations of Saskatchewan 13 Unless otherwise indicated, the statutes and regulations referred to in sections 18 to 34 are statutes and regulations of Saskatchewan.
Black Lake First Nation Water Power Regulations — 14
Reference to Crown 14 For greater certainty, in the incorporated laws, (a) “Crown” does not include Her Majesty in right of Canada; (b) “Crown lands” and “Crown mineral lands” do not include the project lands; and (c) a “Crown disposition” does not include a disposition by Her Majesty in right of Canada.
Black Lake First Nation Water Power Regulations — 15
Interpretation of incorporated laws 15 (1) Incorporated laws are to be read without reference to any of the following: (a) spent provisions; (b) provisions appointing a person, providing for the remuneration of a person, or establishing or continuing a provincial body, program, fund or registry; (c) provisions relating to the internal management of a provincial body; (d) provisions requiring or authorizing money to be spent from the General Revenue Fund of Saskatchewan or from other funds administered by Saskatchewan; (e) provisions authorizing the Lieutenant-Governor in Council, a provincial Minister or a provincial body to make regulations of general application except to the extent required to make the regulations set out in Schedule 2; (f) provisions authorizing any person or provincial official or body to expropriate any interest in lands; and (g) provisions authorizing or imposing a tax or granting or authorizing a tax credit. Interpretation of incorporated laws (2) Despite paragraph (1)(b), (a) a person appointed to a position under a law of Saskatchewan that has been incorporated by reference in these Regulations is considered to have been appointed to the same position for the purposes of these Regulations for as long as that person remains in that position under the law of Saskatchewan; and (b) a provincial body, program, fund or registry established or continued under a law of Saskatchewan that has been incorporated by reference in these Regulations is considered to have been established or continued for the purposes of these Regulations. Specified persons, officials and bodies (3) For greater certainty, a person, provincial official or provincial body that has a power, duty or function under a law of Saskatchewan incorporated by reference in these Regulations has the same power, duty or function under these Regulations, subject to the adaptations set out in sections 18 to 34. Interpretation of incorporated laws (4) For greater certainty, if a law of Saskatchewan is adapted by these Regulations, a reference to that law in an incorporated law, or in any notice, form, instrument or other document issued under an incorporated law, is to be read as a reference to that law as adapted by these Regulations.
Black Lake First Nation Water Power Regulations — 16
Limitation on searches and inspections 16 A power to conduct searches or inspections under an incorporated law, including the power to enter a place, does not include a power to enter or search, or to inspect anything in, a federal government office, without the consent of the person who is or appears to be in charge of that office.
Black Lake First Nation Water Power Regulations — 17
Limitation on production of documents 17 A power to seize, remove or compel the production of documents under an incorporated law does not include a power to seize, remove or compel the production of a document in the possession of the federal government, without the consent of the person in possession of the document.
Black Lake First Nation Water Power Regulations — 18
Adaptation to subsection 13(2) 18 In subsection 13(2) of The Environmental Management and Protection Act, 2010 , a reference to “owner” is to be read as a reference to Her Majesty in right of Canada and the Black Lake First Nation.
Black Lake First Nation Water Power Regulations — 19
Adaptation to subsection 34(2) 19 (1) Subsection 34(2) of the Act is to be read as follows: (2) If the minister is satisfied that any sewage works will adversely affect any land other than the project lands, the minister shall provide a written request to the permit holder requiring the permit holder to: (a) in respect of lands other than reserve lands, (i) obtain from the registered owner of the other land, an easement, in the prescribed form, (ii) obtain from any other person having a registered interest in the land mentioned in subclause (i) a consent to the granting of the easement, (iii) apply to the Registrar of Titles to register the easement against the titles to the affected lands; and (b) in respect of reserve lands situated outside the project lands, obtain an easement pursuant to the Indian Act . Adaptation to subsection 34(4) (2) In subsection 34(4) of the Act, a reference to “subsection (2)” is to be read as a reference to “clause (2)(a)”.
Black Lake First Nation Water Power Regulations — 20
Adaptation to paragraph 50(1)(a) 20 Paragraph 50(1)(a) of the Act is to be read as follows: (a) on any land that is owned by another person or the Crown or on the project lands or any other Black Lake reserve lands; or
Black Lake First Nation Water Power Regulations — 21
Adaptation to paragraph 1-7(1)(a) 21 (1) In paragraph 1-7(1)(a) of Chapter B.1.1 of the Appendix to The Environmental Management and Protection (Saskatchewan Environmental Code Adoption) Regulations , a reference to “owner ” is to be read as a reference to Her Majesty in right of Canada and the Black Lake First Nation. Adaptation to paragraph 1-7(2)(a) (2) In paragraph 1-7(2)(a) of Chapter B.1.1 of the Appendix to the Regulations, a reference to “owner of adjacent land” is to be read as a reference to Her Majesty in right of Canada and the Black Lake First Nation.
Black Lake First Nation Water Power Regulations — 22
Adaptation to paragraph 1-8(2)(a) 22 In paragraph 1-8(2)(a) of Part 1 of Chapter B.1.2 of the Appendix to the Regulations, a reference to “owner” is to be read to include Her Majesty in right of Canada and the Black Lake First Nation.
Black Lake First Nation Water Power Regulations — 23
Adaptation to paragraphs 3-2(a) and 3-3(b) 23 In paragraphs 3-2(a) and 3-3(b) of Part 3 of Chapter C.3.1 of the Appendix to the Regulations, a reference to “landowner” is to be read to include Her Majesty in right of Canada and the Black Lake First Nation.
Black Lake First Nation Water Power Regulations — 24
Adaptation to subsection 26(1) 24 In subsection 26(1) of The Ground Water Regulations , a reference to “landowner” is to be read to include Her Majesty in right of Canada.