GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — 5
5 Despite subsection C.08.009.2(1) of the Food and Drug Regulations , information in respect of a clinical trial that is confidential business information and that is contained in a submission or supplement with respect to which one of the following circumstances occurred before the day on which these Regulations come into force ceases to be confidential business information on the day on which these Regulations come into force: (a) the Minister issued a notice of compliance under section C.08.004 or C.08.004.01 of the Food and Drug Regulations ; (b) the Minister, after having notified the manufacturer under paragraph C.08.004(1)(b) or C.08.004.01(1)(b) of the Food and Drug Regulations that the submission or supplement did not comply with section C.08.002, C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1 of those Regulations, issued a notice to the manufacturer, in view of the omission by the manufacturer to amend the submission or supplement, that indicated that the submission or supplement was considered to have been withdrawn; (c) the Minister notified the manufacturer under paragraph C.08.004(3)(b) or C.08.004.01(3)(b) of the Food and Drug Regulations that the submission or supplement did not comply with section C.08.002, C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1 of those Regulations.
Food and Drug Regulations — 6
6 (1) This section applies to information in respect of a clinical trial that is confidential business information and that is contained in a submission or supplement (a) that was filed within 90 days before the day on which these Regulations come into force; and (b) with respect to which the Minister notified the manufacturer under paragraph C.08.004(1)(b) or C.08.004.01(b) of the Food and Drug Regulations before the day on which these Regulations come into force that the submission or supplement did not comply with section C.08.002, C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1 of the Food and Drug Regulations . (2) Despite subsection C.08.009.2(1) of the Food and Drug Regulations , information in respect of a clinical trial that is contained in a submission or supplement ceases to be confidential business information upon the expiry of whichever of the following periods applies if the manufacturer does not amend the submission or supplement within that period: (a) 90 days after the day on which these Regulations come into force; or (b) any longer period specified by the Minister.
Food and Drug Regulations — 7
7 Sections 5 and 6 do not apply to information referred to in subsection C.08.009.2(2) of the Food and Drug Regulations .
Food and Drug Regulations — 6
6 Despite these Regulations, beer may, until December 13, 2022, be sold in accordance with the Food and Drug Regulations , as they read immediately before the day on which these Regulations come into force.
Food and Drug Regulations — 2
2 Despite these Regulations, vodka may, until December 13, 2022, be sold in accordance with the Food and Drug Regulations , as they read immediately before the day on which these Regulations come into force.
Food and Drug Regulations — 18
18 (1) The following definitions apply in this section and in sections 19 to 30: authorization means an authorization that was issued under the ISAD Interim Order in respect of a new drug on the basis of (a) an application submitted under section 3 of the ISAD Interim Order other than an application that was submitted on the basis of a direct or indirect comparison of the new drug to another drug; or (b) an application submitted under section 4 of the ISAD Interim Order. ( autorisation ) supplement means a supplement to a new drug submission that is filed under section C.08.003 of the Food and Drug Regulations . ( supplément ) (2) Unless the context otherwise requires, words and expressions used in this section and in sections 19 to 30 have the meanings assigned by the Food and Drug Regulations .
Food and Drug Regulations — (a)
authorization means an authorization that was issued under the ISAD Interim Order in respect of a new drug on the basis of (a) an application submitted under section 3 of the ISAD Interim Order other than an application that was submitted on the basis of a direct or indirect comparison of the new drug to another drug; or (b) an application submitted under section 4 of the ISAD Interim Order. ( autorisation )
Food and Drug Regulations — Food and Drug Regulations
supplement means a supplement to a new drug submission that is filed under section C.08.003 of the Food and Drug Regulations . ( supplément )
Food and Drug Regulations — 19
19 (1) Despite subsection 2(1) of the ISAD Interim Order, the manufacturer of a new drug who is the holder of an authorization in respect of the new drug may file a new drug submission under section C.08.002 of the Food and Drug Regulations , or a supplement, for the new drug and subsection C.01.014.1(3) and Division 8 of Part C of those Regulations apply in respect of the submission or supplement. (2) The authorization is revoked if the manufacturer does not file a new drug submission under section C.08.002 of the Food and Drug Regulations , or a supplement, for the new drug within one of the following periods, as applicable: (a) in the case of an authorization that was issued before the day on which this section comes into force, 90 days after the day on which this section comes into force; or (b) in the case of an authorization that is issued on or after the day on which this section comes into force, 90 days after the day on which the authorization is issued. (3) If the manufacturer files a new drug submission under section C.08.002 of the Food and Drug Regulations , or a supplement, for the new drug within the applicable period set out in paragraph (2)(a) or (b), the authorization is revoked when one of the following circumstances occurs: (a) the Minister issues a notice of compliance under section C.08.004 of those Regulations in respect of the submission or supplement; (b) if the Minister issues a notice to the manufacturer under paragraph C.08.004(1)(b) of those Regulations in respect of the submission or supplement and the manufacturer does not amend the submission or supplement in accordance with subsection C.08.004(2) of those Regulations, the period referred to in subsection C.08.004(2) expires; (c) the Minister issues a notice to the manufacturer under paragraph C.08.004(3)(b) of those Regulations in respect of the submission or supplement.
Food and Drug Regulations — 20
20 The Food and Drug Regulations — other than the following provisions — do not apply to a new drug in respect of which an authorization was issued to the manufacturer of the new drug if, immediately before the day on which this section comes into force, the authorization was neither suspended nor revoked: (a) sections A.01.014, A.01.015, A.01.022 to A.01.043, A.01.050, A.01.051 and A.01.060.1 to A.01.068; (b) sections C.01.004 to C.01.011, C.01.014.9, C.01.014.10, C.01.017 and C.01.019, subsection C.01.020(1) and sections C.01.020.1, C.01.040.3 to C.01.053, C.01.064 to C.01.069 and C.01.401; (c) the provisions of Divisions 1A and 2 of Part C; (d) sections C.03.202, C.03.203 and C.03.206 to C.03.209; and (e) sections C.04.004, C.04.005, C.04.007, C.04.009 and C.04.010.
Food and Drug Regulations — 21
21 (1) The drug identification number that was assigned under subsection 7(1) of the ISAD Interim Order in relation to a new drug that is referred to in section 20 continues to be assigned for the distinct combination of dosage form, strength and route of administration of the new drug. (2) A reference in Divisions 1 and 1A of Part C of the Food and Drug Regulations — other than in sections C.01.050, C.01.052, C.01.053 and C.01A.003 — to a drug identification number is deemed to include a reference to the drug identification number that is referred to in subsection (1). (3) A reference in section C.01A.003 of the Food and Drug Regulations to a distributor who holds a drug identification number is deemed to include a reference to the manufacturer who is referred to in section 20.
Food and Drug Regulations — 22
22 The manufacturer who is referred to in section 20 shall, within 15 days after the day on which the new drug is first sold in Canada, notify the Minister, in writing, of the date of that first sale, unless the manufacturer has already done so under section 8 of the ISAD Interim Order.
Food and Drug Regulations — 23
23 The manufacturer who is referred to in section 20 shall, within 15 days after the day on which the manufacturer permanently discontinues the sale in Canada of the new drug, notify the Minister, in writing, of the date on which the sale was permanently discontinued, unless the manufacturer has already done so under section 9 of the ISAD Interim order.
Food and Drug Regulations — 24
24 Despite the definition drug in section C.01.014.8 of the Food and Drug Regulations , sections C.01.014.9 and C.01.014.10 of those Regulations apply, with any necessary modifications, to the manufacturer who is referred to in section 20 in respect of the new drug.
Food and Drug Regulations — 25
25 (1) Subject to subsection (2), sections 20 to 24 cease to apply to a new drug that is referred to in section 20 90 days after the day on which this section comes into force. (2) If the manufacturer who is referred to in section 20 files, for the new drug, a new drug submission under section C.08.002 of the Food and Drug Regulations or a supplement, within the period referred to in subsection (1) or has filed such a submission or supplement before the day on which this section comes into force, sections 20 to 24 cease to apply to the new drug when one of the circumstances referred to in paragraphs 19(3)(a) to (c) occurs.
Food and Drug Regulations — 26
26 (1) Despite subsection 1(3) of the ISAD Interim Order, for the purposes of the definition innovative drug in subsection C.08.004.1(1) of the Food and Drug Regulations , a medicinal ingredient is not considered to be approved in a drug by reason of the Minister having issued or amended an authorization under the ISAD Interim Order in respect of a COVID-19 drug that contains the medicinal ingredient. (2) Subsection (1) ceases to apply on the day on which the ISAD Interim Order ceases to have effect.
Food and Drug Regulations — 27
27 (1) Any terms and conditions of an establishment licence — other than those that are imposed by the Minister under the ISAD Interim Order — are deemed to be imposed by the Minister under subsection C.01A.008(4) of the Food and Drug Regulations . (2) Any terms and conditions of an establishment licence that are imposed by the Minister under the ISAD Interim Order are deemed to be imposed by the Minister under section C.01A.012.1 of the Food and Drug Regulations .
Food and Drug Regulations — 28
28 (1) Despite subsection 26(1) of the ISAD Interim Order, any establishment licence that is referred to in that subsection is not cancelled immediately before the ISAD Interim Order ceases to have effect if the holder of the establishment licence notifies the Minister in writing, before the day on which the ISAD Interim Order ceases to have effect, of their intention to continue to conduct activities in respect of the COVID-19 drug under the establishment licence. (2) Despite subsection 26(2) of the ISAD Interim Order, any amendment that is referred to in that subsection to an establishment licence continues to have effect after the ISAD Interim Order ceases to have effect if the holder of the establishment licence notifies the Minister in writing, before the day on which the ISAD Interim Order ceases to have effect, of their intention to continue to conduct activities in respect of the COVID-19 drug under the amended establishment licence.
Food and Drug Regulations — 29
29 Information and material in respect of a designated COVID-19 drug that were provided under paragraphs 28(1)(a) and (b) or 30(a) of the ISAD Interim Order are deemed to have been provided under, as the case may be, paragraphs C.08.009.03(1)(a) and (b) or C.08.009.05(a) of the Food and Drug Regulations .
Food and Drug Regulations — 30
30 Section C.08.009.05 of the Food and Drug Regulations applies, with any necessary modifications, in respect of a designated COVID-19 drug that was imported under section 28 of the ISAD Interim Order.
Food and Drug Regulations — 25
25 (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 human milk fortifier , as defined in section B.25.001 of the new Regulations, that is set out in the List of Human Milk Fortifiers Sold in Canada as of March 25, 2021 that is published on a Government of Canada website does not need to be labelled in accordance with the new Regulations if it is labelled in the same way as it was labelled immediately before the day on which these Regulations come into force. (3) Subsections (1) and (2) cease to have effect on the second anniversary of the day on which these Regulations come into force.
Food and Drug Regulations — 9
9 A person who holds an establishment licence and who created a record in accordance with the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) , made by the Minister of Health on November 27, 2020 and published in Part I of the Canada Gazette on December 12, 2020, must retain the record in accordance with subsection C.01.014.14(2) of the Food and Drug Regulations .
Food and Drug 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.
Food and Drug Regulations — 11
11 (1) Section C.10.008 of the Food and Drug Regulations applies in respect of a designated drug that was imported under the Exceptional Importation and Shortages Interim Order No. 2. (2) Sections C.10.009 to C.10.011 of those Regulations apply to a person that holds an establishment licence in respect of a designated drug that they imported under that Interim Order.
Food and Drug Regulations — 12
12 (1) Subject to subsection (2), subsections C.10.008(1) and (2) of the Food and Drug Regulations apply in respect of a designated biocide that was imported under the Exceptional Importation and Shortages Interim Order No. 2. (2) For the purposes of subsection (1), that subsection C.10.008(1) is to be read without reference to (a) sections A.01.015 and A.01.017 in paragraph C.10.008(1)(a); (b) sections C.01.040.3 to C.01.049.1 in subparagraph C.10.008(1)(b)(i); (c) subparagraph C.10.008(1)(b)(ii); and (d) sections C.10.009 to C.10.011 in subparagraph C.10.008(1)(b)(iii). (3) Subsection (1) ceases to apply on December 31, 2022 in respect of the sale of a designated biocide, other than at retail sale, that was imported under the Exceptional Importation and Shortages Interim Order No. 2. (4) An importer must not sell a designated biocide that they imported under that Interim Order unless they ensure that the information referred to in paragraph 12(2)(d) of that Interim Order is available in English and French and in a manner that permits the safe use of the biocide. (5) The importer must ensure that the information is available in accordance with subsection (4) until at least the expiration of the period that corresponds to the useful life of whichever of the designated biocides that they imported has the latest useful life.
Food and Drug Regulations — 14
14 (1) Sections A.01.014 and A.01.016 of the Food and Drug Regulations , the provisions of Part B of those Regulations — other than sections B.24.100 and B.24.300 — and the provisions of Part D of those Regulations do not apply in respect of the sale of a designated food for a special dietary purpose that was imported under the Exceptional Importation and Shortages Interim Order No. 2. (2) A sale of a designated food for a special dietary purpose that was imported under the Interim Order is exempt from paragraphs 4(1)(a) and (d) of the Food and Drugs Act in respect of the use or presence of any of the substances or materials referred to in paragraphs 24(2)(a) to (g) of that Interim Order. (3) Subsections (1) and (2) cease to apply in respect of the sale of a designated food for a special dietary purpose on the food’s expiration date. (4) An importer must not sell a designated food for a special dietary purpose that they imported under the Exceptional Importation and Shortages Interim Order No. 2 No. 2 unless they ensure that the information referred to in subparagraphs 25(2)(e)(ii) to (vii) of that Interim Order is available in English and French and in a manner that permits the safe preparation and use of the food. (5) The importer shall ensure that the information is available in accordance with subsection (4) until at least the end of the day on the latest expiration date of the designated food for a special dietary purpose that they imported. (6) In this section, expiration date has the same meaning as in section B.25.001 of the Food and Drug Regulations .
Food and Drug 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.
Food and Drug Regulations — 10
10 (1) Unless the context requires otherwise, words and expressions used in this section have the same meaning as in subsection C.01A.001(1) of the Food and Drug Regulations . (2) Subject to subsection (3), during the three-month period that begins on the day on which these Regulations come into force, a drug that has, until that day, been exempt, under subsection 37(1) of the Act, from the provisions prescribed in section A.01.048 of the Food and Drug Regulations and that continues to meet the conditions set out in subsection 37(1) (a) may, despite section C.01A.004 of those Regulations, continue to be fabricated, packaged/labelled, tested, distributed or wholesaled by a person that conducted the activity before that day and that does not hold an establishment licence that authorizes the activity in respect of the drug; and (b) is exempt from the provisions of Divisions 2 to 4 of Part C of those Regulations that are prescribed in section A.01.048. (3) If, before the end of the three-month period, a person referred to in paragraph (2)(a) submits — in accordance with section C.01A.005 or C.01A.006 of the Food and Drug Regulations — an application for, or to amend, an establishment licence to authorize the activity that they have been conducting in respect of the drug, the person is, in respect of the activity, exempt from the requirement to hold an establishment licence and from the provisions referred to in paragraph (2)(b) until the Minister of Health (a) issues the licence or amends it to authorize the activity; or (b) notifies the person, after giving them the opportunity to be heard, that the licence will not be issued or amended. (4) The exemptions referred to in subsection (3) cease to apply if the person withdraws the application.
Food and Drug Regulations — 53
paragraph B.08.010(d) of the former Regulations; (f) paragraph B.08.011(c), the corresponding provisions being paragraphs B.08.011(e) or B.08.012(f), as the case may be, of the former Regulations; (g) section B.08.004, the corresponding provision being paragraph B.08.013(c) of the former Regulations; (h) paragraph B.08.006(b), the corresponding provision being paragraph B.08.014(d) of the former Regulations; (i) paragraph B.08.003(c), the corresponding provision being paragraph B.08.016(c) of the former Regulations; (j) paragraphs B.08.005(1)(b) and B.08.005(2)(c), the corresponding provision being paragraph B.08.017(d) of the former Regulations; (k) paragraphs B.08.005(1)(b) and B.08.005(2)(d), the corresponding provision being paragraph B.08.018(d) of the former Regulations; (l) paragraphs B.08.005(1)(b) and B.08.005(2)(e), the corresponding provision being paragraph B.08.019(e) of the former Regulations; (m) paragraphs B.08.005(1)(b) and B.08.005(2)(f), the corresponding provision being paragraph B.08.020(d) of the former Regulations; (n) paragraphs B.08.005(1)(b) and B.08.005(2)(g), the corresponding provision being paragraph B.08.023(e) of the former Regulations; (o) paragraphs B.08.005(1)(b) and B.08.005(2)(h), the corresponding provision being paragraph B.08.026(e) of the former Regulations; and (p) paragraph B.09.016(1)(b), the corresponding provision being subparagraph B.09.016(b)(iii) of the former Regulations. (6) For the purposes of the prohibitions set out in section B.08.029 of the Food and Drug Regulations , a food is not required to contain the amount of vitamin D set out in the applicable subsection of that section if the food contains an amount of vitamin D that falls within the range set out in the subsection of the former Regulations. (7) This section ceases to have effect on December 31, 2025.
Food and Drug Regulations — 31
31 (1) The following definitions apply in this section and sections 32 to 36 . permitted food additive means a food additive that is set out in, and used in accordance with, the Lists of Permitted Food Additives. ( additif alimentaire autorisé ) Threshold Levels for Cautionary Statements and Other Conditions of Use means the document entitled Threshold Levels for Cautionary Statements and Other Conditions of Use , published by the Government of Canada on its website, as it reads on the day on which these Regulations come into force. ( Seuils maximaux relatifs aux mises en garde et autres conditions d’utilisation ) TMAL Lists means one or more of the following lists, published by the Government of Canada on its website, as they read on the day on which these Regulations come into force: (a) the List of beverages, beverage mixes and concentrates ; (b) the List of caffeinated energy drinks ; and (c) the List of conventional foods . ( Listes LAMT ) (2) Unless the context requires otherwise, words and expressions used in this section and sections 32 to 36 have the same meaning as in the Food and Drugs Act and the Food and Drug Regulations . (3) A food referred to in section 32 or 33 is deemed not to be a supplemented food and a substance referred to in clause 32(1)(b)(ii)(B) or in subparagraph 33(1)(c)(i) is deemed not to be a supplemental ingredient unless a change to the label of the food has been made to bring the food into compliance with any provision of the Food and Drug Regulations respecting the supplemented food facts table, list of cautionary statements or supplemented food caution identifier.
Food and Drug Regulations — Food and Drug Regulations
permitted food additive means a food additive that is set out in, and used in accordance with, the Lists of Permitted Food Additives. ( additif alimentaire autorisé )
Food and Drug Regulations — Food and Drug Regulations
Threshold Levels for Cautionary Statements and Other Conditions of Use means the document entitled Threshold Levels for Cautionary Statements and Other Conditions of Use , published by the Government of Canada on its website, as it reads on the day on which these Regulations come into force. ( Seuils maximaux relatifs aux mises en garde et autres conditions d’utilisation )