GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Certificate of Supplementary Protection Regulations — 1
Definition of Act 1 (1) In these Regulations, Act means the Patent Act . Definition of authorization for sale (2) In these Regulations and for the purposes of section 104 of the Act, authorization for sale means an authorization under the Food and Drugs Act , or any predecessor enactment relating to the same subject matter, that permits the sale of a drug in Canada, but does not include an interim order permitting the sale of a drug under section 30.1 of that Act, a certificate issued under section C.08.015 of the Food and Drug Regulations , an exemption under subsection C.10.002(1) or C.10.008(1) of those Regulations or an authorization under section C.05.006, C.05.008 or C.08.010 or subsection C.11.003(1) or C.11.014(1) of those Regulations, section 67 or 71 of the Natural Health Products Regulations or section 21 or subsection 24(2) of the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations . SOR/2021-199, s. 8 SOR/2022-18, s. 53 SOR/2022-18, s. 54 SOR/2023-18, s. 6
Certificate of Supplementary Protection Regulations — 2
Variations 2 For the purposes of subsections 105(3) and (4) of the Act, the prescribed variations are (a) a variation in any appendage within the molecular structure of a medicinal ingredient that causes it to be an ester, salt, complex, chelate, clathrate or any non-covalent derivative; (b) a variation that is an enantiomer, or a mixture of enantiomers, of a medicinal ingredient; (c) a variation that is a solvate or polymorph of a medicinal ingredient; (d) an in vivo or in vitro post-translational modification of a medicinal ingredient; and (e) any combination of the variations set out in paragraphs (a) to (d).
Certificate of Supplementary Protection Regulations — 3
Eligible patents — requirement 3 (1) For the purpose of paragraph 106(1)(a) of the Act, the prescribed requirement is that the patent must be in force. Eligible patents — manners of pertinence to medicinal ingredients (2) For the purpose of paragraph 106(1)(c) of the Act, the prescribed manners in which a patent may pertain to a medicinal ingredient or combination of medicinal ingredients are the following: (a) the patent contains a claim for the medicinal ingredient or combination of all the medicinal ingredients contained in a drug for which the authorization for sale set out in the application for a certificate of supplementary protection was issued; (b) the patent contains a claim for the medicinal ingredient or combination of all the medicinal ingredients as obtained by a specified process and contained in a drug for which the authorization for sale set out in the application for a certificate of supplementary protection was issued; and (c) the patent contains a claim for a use of the medicinal ingredient or combination of all the medicinal ingredients contained in a drug for which the authorization for sale set out in the application for a certificate of supplementary protection was issued.
Certificate of Supplementary Protection Regulations — 4
Authorization for sale 4 For the purpose of paragraph 106(1)(c) of the Act, the prescribed kind of authorization for sale is a notice of compliance issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations .
Certificate of Supplementary Protection Regulations — 5
Consultation with Patent Office 5 The Minister may consult with the officers or employees of the Patent Office about any matter relating to a patent that is set out in a certificate of supplementary protection or in an application for a certificate of supplementary protection.
Certificate of Supplementary Protection Regulations — 6
Countries and period 6 (1) For the purpose of paragraph 106(1)(f) of the Act, (a) the prescribed countries are (i) the European Union and any country that is a member of the European Union, (ii) the United States of America, (iii) Australia, (iv) Switzerland, (v) Japan, and (vi) the United Kingdom; and (b) the prescribed period for filing the application for the authorization for sale is (i) 24 months, if the application for a certificate of supplementary protection was filed no later than the first anniversary of the day on which section 59 of the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act comes into force, and (ii) 12 months, in any other case. Period — filing application for certificate (2) For the purpose of subsection 106(3) of the Act, the prescribed period for filing the application for a certificate of supplementary protection is 120 days. Content of application (3) An application for a certificate of supplementary protection must contain (a) the applicant’s name and contact information in Canada, including their complete address; (b) the filing date of the application for the patent, the date on which the patent was granted and the date on which the term referred to in section 44 of the Act will expire; (c) the applicant’s attestation, as the case may be, that the applicant is the patentee and is recorded as an owner of the patent in the Patent Office or that they are the manufacturer who is authorized under section 8 to file the application; (d) the applicant’s attestation that (i) when the application was filed for the authorization for sale referred to in paragraph 106(1)(c) of the Act, no application for a marketing approval, equivalent to an authorization for sale, with respect to the medicinal ingredient or combination of medicinal ingredients, as the case may be, set out in the application for the certificate of supplementary protection had been submitted in a country prescribed by paragraph (1)(a), or (ii) if one or more of those applications for a marketing approval had been submitted in one or more of those countries, the application for the authorization for sale referred to in paragraph 106(1)(c) of the Act was filed before the end of the prescribed period referred to in paragraph (1)(b) that begins on the day of submission of the first of those marketing approval applications; and (e) a description of the method of payment used to pay the fee prescribed under subsection 9(1). SOR/2020-288, s. 1 SOR/2024-241, s. 27
Certificate of Supplementary Protection Regulations — 7
Filing date 7 The filing date of an application for a certificate of supplementary protection is the date on which the information required by paragraphs 106(5)(a) and (b) of the Act and the content required by subsection 6(3) of these Regulations are received by the Minister.
Certificate of Supplementary Protection Regulations — 8
Application by manufacturer 8 A person recorded in the Patent Office as the owner of a patent may authorize a manufacturer to file on their behalf an application for a certificate of supplementary protection that sets out the patent if the authorization for sale in relation to which the certificate of supplementary protection is sought was issued to that manufacturer.
Certificate of Supplementary Protection Regulations — 9
Fee — application for certificate 9 (1) The fee payable on filing an application for a certificate of supplementary protection is $9,011. Beginning on April 1, 2018, the fee increases annually by an amount equal to 2% of the fee payable in the previous year, rounded up to the nearest dollar. Manner of payment (2) The fee must be paid in Canadian currency to the account of the Receiver General for Canada.
Certificate of Supplementary Protection Regulations — 10
Period — commencement of proceeding 10 For the purpose of subsection 110(2) of the Act, the prescribed period for commencing a proceeding referred to in that subsection is 90 days.
Certificate of Supplementary Protection Regulations — 11
Period — expiry of pending applications 11 For the purpose of subsection 111(1) of the Act, the prescribed period for the expiry of pending applications for a certificate of supplementary protection is 90 days. However, if any proceedings have been commenced under section 110 of the Act and two or more applications are pending at the end of the 90-day period, the prescribed period for the expiry of all of the pending applications is 30 days after the day on which the last of those proceedings has been finally disposed of.
Certificate of Supplementary Protection Regulations — 12
Withdrawal of application 12 An application for a certificate of supplementary protection is withdrawn on the day on which the Minister receives a notice of withdrawal from the applicant.
Certificate of Supplementary Protection Regulations — 13
Register 13 The Minister must maintain an electronic register of applications for certificates of supplementary protection and certificates of supplementary protection that contains the following information: (a) in the case of an application, the number of the patent as recorded in the Patent Office, the date on which the term referred to in section 44 of the Act expires, the medicinal ingredient or combination of medicinal ingredients and the number of the authorization for sale set out in the application, along with an indication of whether the authorization for sale relates to human use or veterinary use; and (b) in the case of a certificate of supplementary protection, the number of the patent as recorded in the Patent Office, the medicinal ingredient or combination of medicinal ingredients and the number of the authorization for sale set out in the certificate of supplementary protection, the number of the certificate of supplementary protection, the day on which its term begins and on which its term ends, along with an indication of whether it relates to human use or veterinary use. SOR/2024-241, s. 28
Certificate of Supplementary Protection Regulations — 14
Period — new patent notice 14 For the purpose of subsection 122(1) of the Act, the prescribed period that begins on the day on which a new patent is issued under section 47 of the Act is 30 days.
Certificate of Supplementary Protection Regulations — 15
Correction of errors — application 15 (1) On the request of an applicant for a certificate of supplementary protection or with their consent, the Minister may, before the certificate of supplementary protection is issued, amend the application to correct any obvious error, including an obvious omission. However, after the expiry of the period prescribed by section 10, the Minister must not correct an error in the patent number that is set out in the application. Correction of errors — certificate (2) The Minister may correct any obvious error, including an obvious omission, in a certificate of supplementary protection, on the basis of information that the Minister had, or could have obtained, on the day of its issuance. However, the Minister may also correct such an error that concerns how a medicinal ingredient, or a combination of medicinal ingredients, is set out on the basis of information that the Minister obtains after that day. Effect of correction (3) A corrected application or certificate of supplementary protection has the same effect as if it were originally filed or issued in its corrected form.
Certificate of Supplementary Protection Regulations — Coming into force
Coming into force * 16 These Regulations come into force on the day on which section 59 of the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act , chapter 6 of the Statutes of Canada, 2017, comes into force but, if they are registered after that day, they come into force on the day on which they are registered. * [Note: Regulations in force September 21, 2017, see SI/2017-47.]
Certificate of Supplementary Protection Regulations — 10
10 (1) In this section and in sections 11 to 15, Exceptional Importation and Shortages Interim Order No. 2 means the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 , made by the Minister of Health on March 1, 2021 and published in Part I of the Canada Gazette on March 20, 2021. (2) In sections 11 to 15, designated biocide , designated drug , designated food for a special dietary purpose , designated hand sanitizer and designated medical device have the same meaning as in the Exceptional Importation and Shortages Interim Order No. 2.
Certificate of Supplementary Protection Regulations — 15
15 A person who, immediately before the Exceptional Importation and Shortages Interim Order No. 2 ceased to have effect, was permitted, under subsection 30(2) of that Interim Order, to conduct an activity in respect of a designated hand sanitizer may continue to do so without holding an establishment licence that authorizes them to do so until the earliest of (a) the occurrence of one of the circumstances referred to in paragraphs 30(2)(a) to (c) of that Interim Order, and (b) September 1, 2023.
Certificate of Supplementary Protection Regulations — 7
7 (1) In this section, new Regulations means the Food and Drug Regulations as they read on the day on which these Regulations come into force. (2) A letter of authorization that was issued under subsection C.08.010(1) of the Food and Drug Regulations before the day on which these Regulations come into force is deemed to be an authorization issued under subsection C.11.003(1) of the new Regulations, if the medical emergency in respect of which the letter was issued is a public or Canadian Armed Forces health emergency.
Regulations Specifying Territories and Indicating International Registers — a
His Excellency the Governor General in Council, on the recommendation of the Minister of Transport, pursuant to paragraphs 7(a) a and (b) a of the Coasting Trade Act b , makes the annexed Regulations Specifying Territories and Indicating International Registers . a S.C. 2017, c. 6, s. 94 b S.C. 1992, c. 31
Regulations Specifying Territories and Indicating International Registers — 1
Territories in Schedule 1 1 The territories set out in Schedule 1 are not referred to in the definition territory of the European Union in subsection 2(1) of the Coasting Trade Act .
Regulations Specifying Territories and Indicating International Registers — 2
International registers 2 The registers set out in Schedule 2 are international registers for the purpose of paragraph 3(2.2)(c) of the Coasting Trade Act . SOR/2020-239, s. 1
Regulations Specifying Territories and Indicating International Registers — Coming into force
Coming into force * 3 These Regulations come into force on the day on which section 94 of the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act , chapter 6 of the Statutes of Canada, 2017, comes into force but, if they are registered after that day, they come into force on the day on which they are registered. * [Note: Regulations in force September 21, 2017, see SI/2017-47.]
Export Allocations Regulations — Export Allocations Regulations
His Excellency the Governor General in Council, on the recommendation of the Minister of Foreign Affairs, pursuant to section 12 a of the Export and Import Permits Act b , makes the annexed Export Allocations Regulations .
Export Allocations Regulations — 1
Definition of product 1 In these Regulations, product means any product referred to in items 5200 to 5210 of Group 5 of the schedule to the Export Control List . SOR/2020-71, s. 4
Export Allocations Regulations — 2
Application 2 An application under paragraph 6.2(2)(b) of the Export and Import Permits Act for an export allocation with respect to a product shall include, in the form provided by the Minister, (a) the name, address, telephone number and email address of the exporter and of any agent or mandatary applying on the exporter’s behalf; (b) if the exporter or agent or mandatary is a corporation, the name of a contact person for the corporation; (c) the official language selected for communications with the agent or mandatary and the exporter; (d) a description of the product, including the item number assigned to the product in the Export Control List ; (e) an indication of whether the exporter and, if applicable, the agent or mandatary are residents of Canada; and (f) any other information requested by the Minister for clarification purposes related to the application.
Export Allocations Regulations — 3
Considerations to be taken into account 3 The Minister shall take the following considerations into account when deciding whether to issue an export allocation: (a) whether the exporter or, if applicable, the agent or mandatary has furnished the information required by these Regulations; (b) whether the exporter has complied with the provisions of the Act, or the regulations made under the Export and Import Permits Act , or any condition of an export allocation or export permit; and (c) whether the exporter has furnished false or misleading information in connection with any reports required by the Act, or the regulations made under the Act, or in connection with any term or condition of an export allocation or export permit.
Export Allocations Regulations — 4
Information to be supplied 4 Every person to whom an export allocation has been issued shall provide the Minister with the following information: (a) any information required by the Minister for clarification purposes related to the export allocation; and (b) a detailed report of the circumstances of the person or of any other person who has failed or will likely fail to comply with the requirements of these Regulations with respect to a product to which the allocation relates or with the terms or conditions of the allocation as soon as the holder becomes aware of those circumstances.
Export Allocations Regulations — 5
Issuance of export allocation 5 When an application for an export allocation has been approved by the Minister, the written approval of the Minister becomes a valid export allocation.
Export Allocations Regulations — Export Allocations Regulations
* 6 These Regulations come into force on the day on which section 15 of the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act , chapter 6 of the Statutes of Canada, 2017, comes into force, but if they are registered after that day, they come into force on the day on which they are registered. * [Note: Regulations in force September 21, 2017, see SI/2017-47.]
Export Permits Regulations (Non-strategic Products) — Export Permits Regulations (Non-strategic Products)
His Excellency the Governor General in Council, on the recommendation of the Minister of Foreign Affairs, pursuant to section 12 a of the Export and Import Permits Act b , makes the annexed Export Permits Regulations (Non-strategic Products) .
Export Permits Regulations (Non-strategic Products) — 1
Definition of product 1 In these Regulations, product means any product referred to in items 5200 to 5210 of Group 5 of the schedule to the Export Control List . SOR/2020-71, s. 5
Export Permits Regulations (Non-strategic Products) — 2
Application 2 An application under subsection 7(1) of the Export and Import Permits Act or a request under section 8.31 of that Act for a permit to export a product shall include, in the form provided by the Minister, (a) the name, address, telephone number and email address of the exporter and of any agent or mandatary applying on the exporter’s behalf; (b) if the exporter or agent or mandatary is a corporation, the name of a contact person for the corporation; (c) the exporter’s identifier number assigned by the Minister; (d) the official language selected for communications with the agent or mandatary and the exporter; (e) an indication of whether the exporter and, if applicable, the agent or mandatary are residents of Canada; (f) a detailed description of the product; (g) the tariff classification of the product set out in, (i) for a product referred to in item 5201 of Group 5 of the schedule to the Export Control List , the List of Tariff Provisions set out in the schedule to the Customs Tariff , (ii) for a product referred to in item 5203 or 5204 of Group 5 of the schedule to the Export Control List , the Harmonized Tariff Schedule of the United States (1999) (United States International Trade Commission Pub. 2831, 19 U.S.C. § 1202 (1988)), and (iii) for a product referred to in any of items 5205 to 5210 of Group 5 of the schedule to the Export Control List , Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff , made by the European Union, or the Tariff of the United Kingdom , established by regulations made under section 8 of the Taxation (Cross-border Trade) Act 2018 , c. 22, of the United Kingdom; (h) the quantity of the product and the unit of measurement; (i) the value in Canadian dollars of the product; (j) the date of shipment of the product; (k) the port of entry of the product; (l) the date of entry of the product; (m) the name and address of the importer or consignee; (n) the product’s country of origin; and (o) any other information requested by the Minister for clarification purposes related to the application or request. SOR/2021-71, s. 1
Export Permits Regulations (Non-strategic Products) — 3
Amendments 3 (1) An export permit holder may, in writing, before the expiry date of the permit, make a request to the Minister to amend the permit. The request must state the terms and conditions of the permit in respect of which the amendment is being requested and the reasons for the amendment. Approval (2) If the request is approved, the letter of the Minister amending the permit, together with the original permit, becomes a valid permit.
CETA Rules of Origin Regulations — CETA Rules of Origin Regulations
His Excellency the Governor General in Council, on the recommendation of the Minister of Finance, pursuant to subsection 16(2) a of the Customs Tariff b , makes the annexed CETA Rules of Origin Regulations .
CETA Rules of Origin Regulations — 1
1 The following provisions of the Protocol on Rules of Origin and Origin Procedures of the Canada–European Union Comprehensive Economic and Trade Agreement have the force of law in Canada: (a) Articles 1 and 2; (b) paragraphs 1 to 3 of Article 3; (c) Articles 4 to 17; and (d) Annexes 1, 4, 5, 5‑A and 7.
CETA Rules of Origin Regulations — CETA Rules of Origin Regulations
* 2 These Regulations come into force on the day on which section 97 of the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act , chapter 6 of the Statutes of Canada, 2017, comes into force, but if they are registered after that day, they come into force on the day on which they are registered. * [Note: Regulations in force September 21, 2017, see SI/2017-47.]
CETA Rules of Origin for Casual Goods Regulations — CETA Rules of Origin for Casual Goods Regulations
His Excellency the Governor General in Council, on the recommendation of the Minister of Finance, pursuant to subsection 16(2) a of the Customs Tariff b , makes the annexed CETA Rules of Origin for Casual Goods Regulations .
CETA Rules of Origin for Casual Goods Regulations — 1
1 In these Regulations, casual goods means goods other than goods imported for sale or for an industrial, occupational, commercial or institutional or other like use.
CETA Rules of Origin for Casual Goods Regulations — 2
2 Casual goods that are acquired in an EU country or other CETA beneficiary are considered to originate in that country and are entitled to the benefit of the Canada-European Union Tariff if (a) the marking of the goods is in accordance with the marking laws of an EU country or other CETA beneficiary and indicates that the goods are the product of an EU country or other CETA beneficiary or of Canada; or (b) the goods do not bear a mark and nothing indicates that the goods are neither the product of an EU country or other CETA beneficiary nor the product of Canada.
CETA Rules of Origin for Casual Goods Regulations — CETA Rules of Origin for Casual Goods Regulations
* 3 These Regulations come into force on the day on which section 97 of the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act , chapter 6 of the Statutes of Canada, 2017, comes into force, but if they are registered after that day, they come into force on the day on which they are registered. * [Note: Regulations in force September 21, 2017, see SI/2017-47.]