GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — (a)
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 )
Food and Drug Regulations — 32
32 (1) Subject to section 35, the manufacturer of a food for which a Temporary Marketing Authorization Letter was issued under subsection B.01.054(1) of the Food and Drug Regulations and for which a Temporary Marketing Authorization number is set out in the TMAL Lists is exempt from the application of sections B.29.031, D.01.009, D.01.011, D.02.009 and D.03.002 of those Regulations in respect of the food if the following conditions are met: (a) when the Letter expired, the food was not the subject of an outstanding request that it be withdrawn from the market; and (b) since the expiration of the Letter, (i) [Repealed, SOR/2024-244, s. 159] (ii) the manufacturer has complied with the following conditions set out in Appendix 1 to the Letter, as applicable: (A) there are no marks, statements, labels or advertisements, including product sampling, that promote the food for consumption by children or by pregnant or breastfeeding women, (B) the food contains the substances referred to in Appendix 2 to the Letter in the amounts set out in that Appendix, (C) the statements set out in Appendix 1 to the Letter, or statements with equivalent meaning, are shown on the label of the food, (D) no claims are made on the label of the food relating to physical performance or health benefits of the food, and (E) the conditions set out in Appendix 3 to the Letter are complied with, and (iii) no substance set out in column 1 of the List of Permitted Supplemental Ingredients has been added to the food, with the exception of a substance (A) set out in Appendix 2 to the Letter, or (B) that is a permitted food additive. (2) The manufacturer may, in respect of the food referred to in subsection (1), comply with the provisions of the Food and Drug Regulations that were amended by sections 1 to 11, 13 to 48, and 57 to 75 of the Regulations Amending the Food and Drug Regulations (Nutrition Labelling, Other Labelling Provisions and Food Colours) , as they read on December 13, 2016.
Food and Drug Regulations — 33
e table to Part II of the Threshold Levels for Cautionary Statements and Other Conditions of Use for the food category set out in column 1 to which the food belongs, the applicable cautionary statements set out in the headings to columns 2 to 4 or statements with equivalent meaning; (h) with respect to a food referred to in paragraph (f) or (g), the manufacturer complies with the conditions of use set out in column 6 of the table to Part II of the Threshold Levels for Cautionary Statements and Other Conditions of Use for the food category set out in column 1 to which the food belongs; and (i) if the cautionary statement “Not recommended for children, pregnant or breastfeeding women and individuals sensitive to caffeine”, or a statement with equivalent meaning, appears on the label of the food, there are no marks, statements, labels or advertisements, including product sampling, that promote the food for consumption by children or by pregnant or breastfeeding women. (2) The Minister must provide written notification to the manufacturer that the sale of the food is authorized if (a) the manufacturer submits to the Minister (i) the information referred to in subparagraphs B.01.054(1)(a)(i) to (vii) of the Food and Drug Regulations as they read immediately before the day on which these Regulations come into force, and (ii) any other information requested by the Minister to assess the information referred to in subparagraph (i); and (b) the food belongs to a food category set out in column 1 of the List of Permitted Supplemented Food Categories; (c) in the case where a substance set out in column 1 of the table to Part I to the Threshold Levels for Cautionary Statements and Other Conditions of Use has been added to the food, the total amount of that substance contained in the food does not exceed the maximum daily level set out in column 7 or 9 of Part I of the table for that substance; and (d) in the case where caffeine has been added to the food, the total amount of caffeine contained in the food does not exceed the maximum level per serving set out in column 5 of the table to Part II to the Threshold Levels for Cautionary Statements and Other Conditions of Use for the food category to which the food belongs. (3) [Repealed, SOR/2024-244, s. 160] (4) The manufacturer may, in respect of the food referred to in subsection (1), comply with the provisions of the Food and Drug Regulations that were amended by sections 1 to 11, 13 to 48 and 57 to 75 of the Regulations Amending the Food and Drug Regulations (Nutrition Labelling, Other Labelling Provisions and Food Colours) , as they read on December 13, 2016. (5) For greater certainty, the notification referred to in paragraph (1)(a) cannot be a Temporary Marketing Authorization Letter issued under subsection B.01.054(1) of the Food and Drug Regulations .
Food and Drug Regulations — 34
34 A manufacturer that is exempted under section 32 (1) or subsection 33 (1) is also exempt from the application of paragraphs 4(1)(a) and (d) of the Food and Drugs Act in respect only of a substance set out in column 1 of the List of Permitted Supplemental Ingredients that has been added to the food.
Food and Drug Regulations — 35
35 A manufacturer is not exempted under subsection 32 (1) or subsection 33 (1) in respect of the food referred to in subsection 32 (1) or subsection 33 (1), as the case may be, if the Minister notifies the manufacturer, in writing, that the Minister has reasonable grounds to believe that the use of the food is detrimental to the health of the consumer.
Food and Drug Regulations — 36
36 Sections 32 to 35 cease to have effect on December 31, 2025.
Food and Drug Regulations — 44
44 Unless the context otherwise requires, the words and expressions used in sections 45 to 50 have the same meaning as in the Food and Drug Regulations .
Food and Drug Regulations — 45
45 (1) Terms and conditions imposed on a drug identification number under subsection C.01.014.21(1.1) of the Food and Drug Regulations , as that subsection read immediately before the day on which subsection 7 (1) of these Regulations comes into force, that are in effect immediately before that day remain in effect until the day immediately before the day on which subsection 7 (4) of these Regulations comes into force. (2) Subsection C.01.014.21(1.1) of the Food and Drug Regulations , as that subsection read immediately before the day on which subsection 7 (1) of these Regulations comes into force, continues to apply in respect of a designated COVID-19 drug , as defined in section C.08.001.1 of the Food and Drug Regulations as it read immediately before the day on which subsection 24 (1) of these Regulations comes into force, until the day immediately before the day on which subsection 7 (4) of these Regulations comes into force. (3) For the purposes of subsection C.01.014.21 (1.1) of the Food and Drug Regulations , if a condition is removed from the List of Conditions that Threaten Public Health, a public health emergency drug to which the condition relates continues to be considered a public health emergency drug until the day immediately before the day on which subsection 7 (4) of these Regulations comes into force. (4) [Not in force]
Food and Drug Regulations — 47
47 If an application for an establishment licence or to amend such a licence contains — in accordance with subsection C.01A.005(2) or C.01A.006(1.1) of the Food and Drug Regulations , as those subsections read immediately before the day on which sections 9 and 10 of these Regulations come into force — a statement that refers to COVID-19 and the application is submitted to the Minister before that day, the Minister may, on or after that day, issue or amend the licence on the basis of the application.
Food and Drug Regulations — 48
48 If, on the day on which subsections 26 (3) and (5) of these Regulations come into force the Minister has not yet issued a notice of compliance under section C.08.004 of the Food and Drug Regulations or a notice under paragraph C.08.004(3)(b) of those Regulations in respect of a new drug submission 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 these Regulations comes into force — that was filed in accordance with subsections C.08.002(2) to (2.5) and section C.08.005.1 of the Food and Drug Regulations , as those provisions read immediately before the day on which subsections 26 (3) and (5) of these Regulations come into force, subsections C.08.002(2) to (2.5) of the Food and Drug Regulations , as those subsections read immediately before that day, continue to apply until one of the notices is issued.
Food and Drug Regulations — 49
49 (1) Subsection C.08.002(2.01) of the Food and Drug Regulations does not apply in respect of a new drug submission that is filed before the day on which that subsection comes into force. (2) Subsection C.08.003(3.01) of the Food and Drug Regulations does not apply in respect of a supplement to a new drug submission if the supplement is filed before the day on which that subsection comes into force.
Food and Drug Regulations — 171
171 (1) The following definitions apply in this section. former Regulations means the Food and Drug Regulations , as they read immediately before the day on which these Regulations come into force. ( ancien règlement ) prepackaged product has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations . ( produit préemballé ) (2) Subject to subsection (3) and for the period that begins on the day on which these Regulations come into force and ends on December 31, 2027, section B.16.014 of the Food and Drug Regulations , as enacted by section 112, does not apply to a pre-mix that is referred to in section B.16.004 of those Regulations if it is labelled in accordance with the former Regulations. (3) For the period that begins on the day on which these Regulations come into force and ends on December 31, 2025, a pre-mix referred to in section B.16.004 of the Food and Drug Regulations , as enacted by section 112, does not need to be labelled in accordance with section B.01.014 of the former Regulations if the pre-mix is a prepackaged product containing aspartame and is labelled in accordance with section B.01.014 of the Food and Drug Regulations as it read on December 13, 2016.
Food and Drug Regulations — Food and Drug Regulations
former Regulations means the Food and Drug Regulations , as they read immediately before the day on which these Regulations come into force. ( ancien règlement )
Food and Drug Regulations — 77
77 Subsection C.01.004.02(6) of the Regulations is amended by adding “and” at the end of paragraph (a), by striking out “and” at the end of paragraph (b) and by repealing paragraph (c).
Food and Drug Regulations — 78
78 Paragraphs C.01.014.1(2)(c) and (d) of the Regulations are replaced by the following: (c) the recommended route of administration;
Food and Drug Regulations — 79
79 Subsection C.01.040.2(5) of the Regulations is repealed.
Food and Drug Regulations — 80
80 The definition antimicrobial agent in subsection C.01A.001(1) of the Regulations is repealed.
Food and Drug Regulations — 81
81 Subsection C.01A.002(1) of the Regulations is amended by adding “and” at the end of paragraph (c), by striking out “and” at the end of paragraph (d) and by repealing paragraph (e).
Food and Drug Regulations — 82
82 Section C.02.002.1 of the Regulations is repealed.
Food and Drug Regulations — 5
5 Section C.01.014.1 of the Regulations is amended by adding the following after subsection (3): (4) The Minister may request that a manufacturer of a drug for human use, other than a new drug, who has made an application under subsection (1) provide the Minister, within a period specified by the Minister that is reasonable in the circumstances, with a risk management plan for the drug that meets the requirements set out in section C.01.701, if the Minister has reasonable grounds to believe that (a) there is a significant degree of uncertainty respecting the risks associated with the drug; or (b) the drug presents a serious risk of injury to human health that warrants that measures, other than labelling, be taken to reduce the probability or severity of such an injury.
Food and Drug Regulations — 6
6 Subsection C.01.014.2(2) of the Regulations is replaced by the following: (2) The Minister may refuse to issue the document if (a) the Minister has reasonable grounds to believe that the product to which the application for the drug identification number relates is not a drug; (b) the Minister has reasonable grounds to believe that the sale of the drug would (i) cause injury to the health of the purchaser or consumer, or (ii) contravene a provision of the Act or these Regulations; or (c) the Minister has requested a risk management plan for the drug under subsection C.01.014.1(4) and the manufacturer (i) fails to provide the risk management plan within the specified period; or (ii) provides the Minister with a risk management plan that does not meet the requirements set out in section C.01.701.
Food and Drug Regulations — 7
7 (4) Section C.01.014.21 of the Regulations is replaced by the following: C.01.014.21 (1) The Minister may, at any time, impose terms and conditions on a drug identification number assigned for a drug or amend such terms and conditions after considering (a) whether there are significant uncertainties relating to the benefits or risks associated with the drug; (b) whether the requirements under the Act are sufficient for the following objectives to be met: (i) optimizing the benefits and managing the risks associated with the drug, (ii) managing the uncertainties relating to the benefits and risks, and (iii) collecting information to enable the continuous assessment of the benefits and risks, the identification of any changes to them and the management of the uncertainties; (c) whether the proposed terms and conditions may contribute to those objectives being met; (d) whether compliance with the proposed terms and conditions is technically feasible; and (e) whether there are less burdensome ways for those objectives to be met. (2) The Minister shall notify, in writing, the manufacturer who was issued a document under subsection C.01.014.2(1) that sets out the drug identification number, of any terms and conditions imposed on the drug identification number and of any amendment to those terms and conditions.
Food and Drug Regulations — C.01.014.21
C.01.014.21 (1) The Minister may, at any time, impose terms and conditions on a drug identification number assigned for a drug or amend such terms and conditions after considering (a) whether there are significant uncertainties relating to the benefits or risks associated with the drug; (b) whether the requirements under the Act are sufficient for the following objectives to be met: (i) optimizing the benefits and managing the risks associated with the drug, (ii) managing the uncertainties relating to the benefits and risks, and (iii) collecting information to enable the continuous assessment of the benefits and risks, the identification of any changes to them and the management of the uncertainties; (c) whether the proposed terms and conditions may contribute to those objectives being met; (d) whether compliance with the proposed terms and conditions is technically feasible; and (e) whether there are less burdensome ways for those objectives to be met. (2) The Minister shall notify, in writing, the manufacturer who was issued a document under subsection C.01.014.2(1) that sets out the drug identification number, of any terms and conditions imposed on the drug identification number and of any amendment to those terms and conditions.
Food and Drug Regulations — 8
ing risk management plan, the Minister may request that the manufacturer of a drug for human use for which a drug identification number has been assigned and not been cancelled provide the Minister, within a period specified by the Minister that is reasonable in the circumstances, with an updated risk management plan for the drug that meets the requirements set out in section C.01.701, if the Minister, on the basis of information obtained after the existing risk management plan was provided, has reasonable grounds to believe that (a) the risks associated with the drug, or the uncertainties relating to those risks, are significantly different than those that are described in the existing risk management plan; or (b) the drug presents a serious risk of injury to human health that warrants that measures that are significantly different than those that are described in the existing risk management plan be taken to reduce the probability or severity of such an injury. (2) The manufacturer must provide the updated risk management plan within the specified period.
Food and Drug Regulations — C.01.700
C.01.700 For the purposes of sections C.01.703 and C.01.704, existing risk management plan means the most recent risk management plan for a drug that the drug’s manufacturer has provided to the Minister under these Regulations.
Food and Drug Regulations — C.01.701
C.01.701 (1) A risk management plan for a drug that the drug’s manufacturer provides to the Minister under these Regulations must, taking into account the Canadian context, contain sufficient information to enable the Minister to identify and characterize the risks associated with the drug and to conclude that the plan, if implemented, would prevent or reduce those risks or address uncertainties associated with the drug and must include (a) a description of the drug and the uses of the drug; (b) a detailed description of the risks associated with the drug and the uncertainties relating to those risks; (c) a detailed description of the measures that the manufacturer intends to take to address those uncertainties and monitor the situation with respect to them; (d) a detailed description of the measures that the manufacturer intends to take to prevent or reduce those risks; (e) a detailed description of how the manufacturer intends to evaluate the effectiveness of the measures referred to in paragraph (d); and (f) a summary of the plan’s contents in English and French. (2) Despite paragraph (1)(f), for the purposes of subsection C.01.014.1(4), paragraph C.08.002(2)(p), subparagraph C.08.002.01(2)(b)(xi), paragraph C.08.002.1(2)(a.1) and subsection C.08.003(3.2), the manufacturer may initially provide the summary of the risk management plan in either English or French if the manufacturer then provides a summary of the plan in the other language before the document that sets out the drug identification number assigned for the drug is issued under subsection C.01.014.2(1) or the notice of compliance is issued under section C.08.004 or C.08.004.01.
Food and Drug Regulations — C.01.702
C.01.702 (1) The Minister may request that the manufacturer of a drug for human use for which a drug identification number has been assigned and not been cancelled provide the Minister, within a period specified by the Minister that is reasonable in the circumstances, with a risk management plan for the drug that meets the requirements set out in section C.01.701, if (a) a risk management plan for the drug has not yet been provided to the Minister; and (b) the Minister has reasonable grounds to believe that (i) there is a significant degree of uncertainty respecting the risks associated with the drug, or (ii) the drug presents a serious risk of injury to human health that warrants that measures, other than labelling, be taken to reduce the probability or severity of such an injury. (2) The manufacturer must provide the risk management plan within the specified period.
Food and Drug Regulations — C.01.703
C.01.703 In cases where there is already an existing risk management plan, the manufacturer of a drug for human use for which a drug identification number has been assigned and not been cancelled must, as soon as feasible, provide the Minister with an updated risk management plan for the drug that meets the requirements set out in section C.01.701 if (a) the risks associated with the drug, or the uncertainties relating to those risks, are significantly different than those that are described in the existing risk management plan; or (b) the measures that the manufacturer intends to take to prevent or reduce the risks associated with the drug, or to address the uncertainties relating to those risks and to monitor the situation with respect to those uncertainties, are significantly different than those that are described in the existing risk management plan.
Food and Drug Regulations — C.01.704
C.01.704 (1) In cases where there is already an existing risk management plan, the Minister may request that the manufacturer of a drug for human use for which a drug identification number has been assigned and not been cancelled provide the Minister, within a period specified by the Minister that is reasonable in the circumstances, with an updated risk management plan for the drug that meets the requirements set out in section C.01.701, if the Minister, on the basis of information obtained after the existing risk management plan was provided, has reasonable grounds to believe that (a) the risks associated with the drug, or the uncertainties relating to those risks, are significantly different than those that are described in the existing risk management plan; or (b) the drug presents a serious risk of injury to human health that warrants that measures that are significantly different than those that are described in the existing risk management plan be taken to reduce the probability or severity of such an injury. (2) The manufacturer must provide the updated risk management plan within the specified period.
Food and Drug Regulations — 26
26 (2) Subsection C.08.002(2) of the Regulations is amended by striking out “and” at the end of paragraph (n), by adding “and” at the end of paragraph (o) and by adding the following after paragraph (o): (p) in the case of a new drug for human use, a risk management plan for the new drug that meets the requirements set out in section C.01.701, if (i) there is a significant degree of uncertainty respecting the risks associated with the new drug, or (ii) the new drug presents a serious risk of injury to human health that warrants that measures, other than labelling, be taken to reduce the probability or severity of such an injury. (4) Subsection C.08.002(2.3) of the Regulations is replaced by the following: (2.3) If, at the time a new drug submission is filed for a public health emergency drug, the manufacturer is unable to provide the Minister with information or material that is referred to in any of paragraphs (2)(e) to (k), (m), (n) and (p) and (2.1)(b) and subsection (2.2) — and, as applicable, the corresponding material referred to in paragraphs C.08.005.1(1)(b) to (d) — or any of that information or material is incomplete, the manufacturer must provide the Minister, at that time, with a plan that specifies how and when they will provide the Minister with the missing information or material.
Food and Drug Regulations — 27
27 Paragraph C.08.002.01(2)(b) of the Regulations is amended by striking out “and” at the end of subparagraph (ix), by adding “and” at the end of subparagraph (x) and by adding the following after subparagraph (x): (xi) a risk management plan for the new drug that meets the requirements set out in section C.01.701.
Food and Drug Regulations — 28
28 Subsection C.08.002.1(2) of the Regulations is amended by adding the following after paragraph (a): (a.1) in the case of a new drug for human use, a risk management plan for the new drug that meets the requirements set out in section C.01.701, if one of the circumstances set out in subparagraphs C.08.002(2)(p)(i) and (ii) is met;