GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drugs Act — F-27 10
Where standard prescribed for drug 10 (1) Where a standard has been prescribed for a drug, no person shall label, package, sell or advertise any substance in such a manner that it is likely to be mistaken for that drug, unless the substance complies with the prescribed standard. Trade standards (2) Where a standard has not been prescribed for a drug, but a standard for the drug is contained in any publication referred to in Schedule B, no person shall label, package, sell or advertise any substance in such a manner that it is likely to be mistaken for that drug, unless the substance complies with the standard. Where no prescribed or trade standard (3) Where a standard for a drug has not been prescribed and no standard for the drug is contained in any publication referred to in Schedule B, no person shall sell the drug unless (a) it is in accordance with the professed standard under which it is sold; and (b) it does not resemble, in a manner likely to deceive, any drug for which a standard has been prescribed or is contained in any publication referred to in Schedule B. R.S., c. F-27, s. 10
Food and Drugs Act — F-27 11
Unsanitary manufacture, etc., of drug 11 No person shall manufacture, prepare, preserve, package or store for sale any drug under unsanitary conditions. R.S., c. F-27, s. 11
Food and Drugs Act — F-27 12
Drugs not to be sold unless safe manufacture indicated 12 No person shall sell any drug described in Schedule C or D unless the Minister has, in prescribed form and manner, indicated that the premises in which the drug was manufactured and the process and conditions of manufacture therein are suitable to ensure that the drug will not be unsafe for use. R.S., c. F-27, s. 12
Food and Drugs Act — F-27 13
Drugs not to be sold unless safe batch indicated 13 No person shall sell any drug described in Schedule E unless the Minister has, in prescribed form and manner, indicated that the batch from which the drug was taken is not unsafe for use. R.S., c. F-27, s. 13
Food and Drugs Act — F-27 14
Samples 14 No person shall distribute or cause to be distributed any drug as a sample except in accordance with the regulations. R.S., 1985, c. F-27, s. 14 2020, c. 1, s. 57
Food and Drugs Act — F-27 15
Schedule F drugs not to be sold 15 No person shall sell any drug described in Schedule F. R.S., c. F-27, s. 15
Food and Drugs Act — F-27 16
Prohibited sales of cosmetics 16 No person shall sell any cosmetic that (a) has in or on it any substance that may cause injury to the health of the user when the cosmetic is used, (i) according to the directions on the label or accompanying the cosmetic, or (ii) for such purposes and by such methods of use as are customary or usual therefor; (b) consists in whole or in part of any filthy or decomposed substance or of any foreign matter; or (c) was manufactured, prepared, preserved, packaged or stored under unsanitary conditions. R.S., 1985, c. F-27, s. 16; 2016, c. 9, s. 2(F)
Food and Drugs Act — F-27 16.1
Prohibited sales — animal testing 16.1 (1) No person shall sell a cosmetic unless the person can establish the safety of the cosmetic without relying on data derived from a test conducted on an animal that could cause pain, suffering or injury, whether physical or mental, to the animal. Exceptions (2) The prohibition in subsection (1) does not apply if (a) the Government of Canada has published the data in a scientific journal or on a Government of Canada website; (b) the data is publicly available and is derived from a test that was not sponsored by or conducted by or on behalf of a person who manufactures, imports or sells the cosmetic; (c) the following conditions are met: (i) the data is derived from a test that was conducted on a substance in order to meet (A) a requirement under a provision of an Act of Parliament or any of its regulations that applied at the time that the test was conducted, except a requirement that relates only to cosmetics under a provision of this Act or the regulations, or (B) a requirement that does not relate to cosmetics under the law that applied in a foreign state at the time that the test was conducted, (ii) the substance is or has been used in a product that is not a cosmetic and that is or has been legally sold in the country where the requirement in question applied, and (iii) the test was necessary to meet the requirement in order to sell the product in that country; (d) the data is derived from a test that was conducted before the day on which this section comes into force; (e) the cosmetic was sold in Canada at any time before the day on which this section comes into force; or (f) any prescribed circumstance applies. 2023, c. 26, s. 505
Food and Drugs Act — F-27 16.2
Prohibition — animal testing 16.2 No person shall conduct a test on an animal that could cause pain, suffering or injury, whether physical or mental, to the animal if the purpose of the test is to meet, with respect to a cosmetic, a requirement under a provision of this Act or the regulations or to meet a requirement that relates to the safety of cosmetics under the law that applies in a foreign state. 2023, c. 26, s. 505
Food and Drugs Act — F-27 16.3
Prohibited claims — animal testing 16.3 (1) No person shall make a claim on the label of or in an advertisement for a cosmetic that is likely to create an impression that the cosmetic was not tested on animals after the day on which this section comes into force unless the person has evidence that no such testing occurred after that day. Provision of evidence (2) A person who makes a claim described in subsection (1) shall, on the request of the Minister, provide the Minister with the evidence referred to in that subsection. 2023, c. 26, s. 505
Food and Drugs Act — F-27 17
Where standard prescribed for cosmetic 17 Where a standard has been prescribed for a cosmetic, no person shall label, package, sell or advertise any article in such a manner that it is likely to be mistaken for that cosmetic, unless the article complies with the prescribed standard. R.S., c. F-27, s. 17
Food and Drugs Act — F-27 18
Unsanitary conditions 18 No person shall manufacture, prepare, preserve, package or store for sale any cosmetic under unsanitary conditions. R.S., c. F-27, s. 18
Food and Drugs Act — F-27 19
Prohibited sales of devices 19 No person shall sell any device that, when used according to directions or under such conditions as are customary or usual, may cause injury to the health of the purchaser or user thereof. R.S., c. F-27, s. 19
Food and Drugs Act — F-27 20
Deception, etc., regarding devices 20 (1) No person shall label, package, treat, process, sell or advertise any device in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its design, construction, performance, intended use, quantity, character, value, composition, merit or safety. Devices labelled or packaged in contravention of regulations (2) A device that is not labelled or packaged as required by, or is labelled or packaged contrary to, the regulations shall be deemed to be labelled or packaged contrary to subsection (1). R.S., c. F-27, s. 20; 1976-77, c. 28, s. 16
Food and Drugs Act — F-27 21
Where standard prescribed for device 21 Where a standard has been prescribed for a device, no person shall label, package, sell or advertise any article in such a manner that it is likely to be mistaken for that device, unless the article complies with the prescribed standard. R.S., c. F-27, s. 21
Food and Drugs Act — F-27 21.1
Power to require information — serious risk 21.1 (1) If the Minister believes that a therapeutic product may present a serious risk of injury to human health, the Minister may order a person to provide the Minister with information that is in the person’s control and that the Minister believes is necessary to determine whether the product presents such a risk. Disclosure —  serious risk (2) The Minister may disclose confidential business information about a therapeutic prod­uct without notifying the person to whose business or affairs the information relates or obtaining their consent, if the Minister believes that the product may present a serious risk of injury to human health. Disclosure —  health or safety (3) The Minister may disclose confidential business information about a therapeutic prod­uct without notifying the person to whose business or affairs the information relates or obtaining their consent, if the purpose of the disclosure is related to the protection or promotion of human health or the safety of the public and the disclosure is to (a) a government; (b) a person from whom the Minister seeks advice; or (c) a person who carries out functions relating to the protection or promotion of human health or the safety of the public. Definition of government (4) In this section, government means any of the following or their institutions: (a) the federal government; (b) a corporation named in Schedule III to the Financial Administration Act ; (c) a provincial government or a public body established under an Act of the legislature of a province; (d) an aboriginal government as defined in subsection 13(3) of the Access to Information Act ; (e) a government of a foreign state or of a subdivision of a foreign state; or (f) an international organization of states. 2014, c. 24, s. 3
Food and Drugs Act — F-27 21.2
Modification or replacement — labelling or packaging 21.2 The Minister may, if he or she believes that doing so is necessary to prevent injury to health, order the holder of a therapeutic product authorization that authorizes the import or sale of a therapeutic product to modify the product’s label or to modify or replace its package. 2014, c. 24, s. 3
Food and Drugs Act — F-27 21.3
Minister’s powers — risk of injury to health 21.3 (1) If the Minister believes that a therapeutic product presents a serious or imminent risk of injury to health, he or she may order a person who sells the product to (a) recall the product; or (b) send the product, or cause it to be sent, to a place specified in the order. Recall order — corrective action (2) For greater certainty, if the Minister makes an order under paragraph (1)(a) and believes that corrective action is an effective means of dealing with the risk, the order may require the person who sells the product to, instead of requesting the product’s return, request the product’s owner or user to allow corrective action to be taken in respect of the product and then take that corrective action, or cause it to be taken, if the request is accepted. Prohibition — selling (3) Subject to subsection (5), no person shall sell a therapeutic product that the Minister orders them, or another person, to recall. Power to authorize sale (4) The Minister may authorize a person to sell a therapeutic product, with or without conditions, even if the Minister has ordered them, or another person, to recall it. Exception (5) A person does not contravene subsection (3) if they sell a therapeutic product that they have been authorized under subsection (4) to sell, provided that they sell it in accordance with any conditions that the Minister establishes. Contravention of unpublished order (6) No person shall be convicted of an offence for the contravention of subsection (3) unless it is proved that, at the time of the alleged contravention, the person had been notified of the recall order or reasonable steps had been taken to bring the purport of the recall order to the notice of those persons likely to be affected by it. 2014, c. 24, s. 3
Food and Drugs Act — F-27 21.301
Information — serious environmental risk 21.301 (1) If the Minister believes that a therapeutic product may present a serious risk to the environment, the Minister may order a person to provide the Minister with information that is in the person’s control and that the Minister believes is necessary to determine whether the product presents such a risk. Disclosure — serious environmental risk (2) The Minister may disclose confidential business information about a therapeutic product without notifying the person to whose business or affairs the information relates or obtaining their consent, if the Minister believes that the product may present a serious risk to the environment. Disclosure —  protection of the environment (3) The Minister may disclose confidential business information about a therapeutic product without notifying the person to whose business or affairs the information relates or obtaining their consent, if the purpose of the disclosure is related to the protection of the environment and the disclosure is to (a) a government; (b) a person from whom the Minister seeks advice; or (c) a person who carries out functions relating to the protection of the environment, including the assessment and management of risks to the environment. Definition of government (4) In this section, government has the same meaning as in subsection 21.1(4). 2023, c. 12, s. 65
Food and Drugs Act — F-27 21.302
Labelling or packaging — serious risk to environment 21.302 The Minister may, if he or she believes that doing so is necessary to prevent a serious risk to the environment, order the holder of a therapeutic product authorization that authorizes the import or sale of a therapeutic product to modify the product’s label or to modify or replace its package. 2023, c. 12, s. 65
Food and Drugs Act — F-27 21.303
Minister’s powers — serious risk to environment 21.303 (1) If the Minister believes that a therapeutic product presents a serious or imminent risk to the environment, he or she may order a person who sells the product to (a) recall the product; or (b) send the product, or cause it to be sent, to a place specified in the order. Subsections 21.3(2) to (6) apply (2) Subsections 21.3(2) to (6) apply, with any modifications that the circumstances require, in respect of any order made under subsection (1). 2023, c. 12, s. 65
Food and Drugs Act — F-27 21.31
Power to require assessment 21.31 Subject to the regulations, the Minister may order the holder of a therapeutic product authorization to conduct an assessment of the therapeutic product to which the authorization relates and provide the Minister with the results of the assessment. 2014, c. 24, s. 4
Food and Drugs Act — F-27 21.32
Power to require tests, studies, etc. 21.32 Subject to the regulations, the Minister may, for the purpose of obtaining additional information about a therapeutic product’s effects on health or safety, order the holder of a therapeutic product authorization to (a) compile information, conduct tests or studies or monitor experience in respect of the therapeutic product; and (b) provide the Minister with the information or the results of the tests, studies or monitoring. 2014, c. 24, s. 4
Food and Drugs Act — F-27 21.321
Definition of therapeutic product 21.321 Despite the definition therapeutic product in section 2, in sections 21.31 and 21.32 therapeutic product means a drug or device or any combination of drugs and devices, but does not include a natural health product within the meaning of the Natural Health Products Regulations . 2023, c. 26, s. 501
Food and Drugs Act — F-27 21.33
Power — information relating to environmental effects 21.33 Subject to the regulations, the Minister may, for the purpose of obtaining additional information about a therapeutic product’s effects on the environment, order the holder of a therapeutic product authorization to (a) compile information or conduct tests, studies or monitoring in respect of the therapeutic product; and (b) provide the Minister with the information or the results of the tests, studies or monitoring. 2023, c. 12, s. 66
Food and Drugs Act — F-27 21.4
Statutory Instruments Act 21.4 (1) For greater certainty, orders made under any of sections 21.1 to 21.33 are not statutory instruments within the meaning of the Statutory Instruments Act . Availability of orders (2) The Minister shall ensure that any order made under any of sections 21.1 to 21.33 is publicly available. 2014, c. 24, ss. 3, 4 2023, c. 12, s. 66
Food and Drugs Act — F-27 21.5
Injunction 21.5 (1) If, on the application of the Minister, it appears to a court of competent jurisdiction that a person has done, is about to do or is likely to do anything that constitutes or is directed toward the commission of an offence under this Act in respect of a therapeutic product, the court may issue an injunction ordering the person, who is to be named in the application, to (a) refrain from doing anything that it appears to the court may constitute or be directed toward the commission of the offence; or (b) do anything that it appears to the court may prevent the commission of the offence. Notice (2) No injunction is to be issued under subsection (1) unless 48 hours’ notice is served on the party or parties who are named in the application or unless the urgency of the situation is such that service of notice would not be in the public interest. 2014, c. 24, s. 3
Food and Drugs Act — F-27 21.6
False or misleading information — therapeutic products 21.6 No person shall knowingly make a false or misleading statement to the Minister  —  or knowingly provide him or her with false or misleading information  —  in connection with any matter under this Act concerning a therapeutic product. 2014, c. 24, s. 3
Food and Drugs Act — F-27 21.7
Terms and conditions of authorizations 21.7 The holder of a therapeutic product authorization shall comply with any terms and conditions of the authorization that are imposed by the Minister under subsection 21.92(3) or under regulations made under paragraph 30(1.2)(b). 2014, c. 24, s. 3 2019, c. 29, s. 167
Food and Drugs Act — F-27 21.71
Duty to publicize clinical trial information 21.71 The holder of a therapeutic product authorization referred to in paragraph 30(1.2)(c) shall ensure that prescribed information concerning the clinical trial is made public within the prescribed time and in the prescribed manner. 2014, c. 24, s. 3 2019, c. 29, s. 168
Food and Drugs Act — F-27 21.8
Health care institutions to provide information 21.8 (1) A prescribed health care institution shall provide the Minister, within the prescribed time and in the prescribed manner, with prescribed information that is in its control about a serious adverse drug reaction that involves a therapeutic product or a medical device incident that involves a therapeutic product. Definition of therapeutic product (2) Despite the definition therapeutic product in section 2, in subsection (1) therapeutic product means a drug or device or any combination of drugs and devices, but does not include a natural health product within the meaning of the Natural Health Products Regulations . 2014, c. 24, s. 5 2023, c. 26, s. 502
Food and Drugs Act — F-27 21.9
Prohibited activities 21.9 (1) No person shall import, sell, advertise, manufacture, prepare, preserve, package, label, store or test an advanced therapeutic product unless the person (a) holds a licence in respect of that product that was issued under subsection 21.92(1) and that authorizes the activity in question; (b) is authorized under an order made under subsection 21.95(1) to conduct the activity in question in respect of the product; or (c) conducts the activity in question in accordance with the regulations. Clarification (2) For greater certainty, the prohibition applies in respect of an activity regardless of whether the activity is conducted for the purpose of the sale or use of the advanced therapeutic product. 2019, c. 29, s. 169
Food and Drugs Act — F-27 21.91
Additions to Schedule G 21.91 (1) For the purpose of preventing injury to health or preventing a person from being deceived or misled, the Minister may, by order, add a description of a therapeutic product or a class of therapeutic products to Schedule G if the Minister believes that the therapeutic product or products represent an emerging or innovative technological, scientific or medical development. Factors (2) Before adding a description of a therapeutic product or a class of therapeutic products to Schedule G, the Minister shall consider the following factors: (a) the degree of uncertainty respecting the risks and benefits associated with the therapeutic product or products and the measures that are available to adequately manage and control those risks; (b) the extent to which the therapeutic product or products are different from therapeutic products for which therapeutic product authorizations have been issued under the regulations; (c) the extent to which existing legal frameworks are adequate to prevent injury to health or to prevent persons from being deceived or misled; and (d) the prescribed factors, if any. Deletion from Schedule G (3) The Minister may, by order, delete the description of a therapeutic product or a class of therapeutic products from Schedule G. 2019, c. 29, s. 169
Food and Drugs Act — F-27 21.92
Advanced therapeutic product licence 21.92 (1) Subject to the regulations, the Minister may, on application, issue or amend an advanced therapeutic product licence that authorizes a person to import, sell, advertise, manufacture, prepare, preserve, package, label, store or test an advanced therapeutic product if the Minister believes that the applicant has provided sufficient evidence to support the conclusion that (a) the benefits associated with the product outweigh the risks; and (b) the risks associated with the product and the activity will be adequately managed and controlled. Application (2) An application for an advanced therapeutic product licence, or for its amendment, shall be filed with the Minister in the form and manner specified by the Minister and shall set out the information required by the Minister as well as any prescribed information. Terms and conditions (3) The Minister may impose terms and conditions on an advanced therapeutic product licence, including an existing licence, or amend them. 2019, c. 29, s. 169
Food and Drugs Act — F-27 21.93
Suspension and revocation 21.93 (1) Subject to the regulations, the Minister may suspend or revoke an advanced therapeutic product licence, in whole or in part, if (a) the Minister believes that the risks that are associated with the advanced therapeutic product outweigh the benefits; (b) the Minister believes that the risks associated with the product or any authorized activity are not being adequately managed or controlled; (c) in the case of a suspension, any prescribed circumstance exists; or (d) in the case of a revocation, any prescribed circumstance exists. Suspension without prior notice (2) If the Minister believes that an immediate suspension is necessary to prevent injury to health, the Minister may suspend an advanced therapeutic product licence, in whole or in part, without prior notice to its holder and regardless of whether any of the circumstances referred to in subsection (1) exists. 2019, c. 29, s. 169
Food and Drugs Act — F-27 21.94
Exemption 21.94 The holder of an advanced therapeutic product licence is, in respect of the activities authorized under the licence, exempt from the provisions of the regulations other than any provisions that are specified in regulations made under paragraph 30(1.2)(b.2). 2019, c. 29, s. 169
Food and Drugs Act — F-27 21.95
Order — advanced therapeutic products 21.95 (1) The Minister may make an order, with or without terms and conditions, that authorizes any person within a class of persons that is specified in the order to import, sell, advertise, manufacture, prepare, preserve, package, label, store or test an advanced therapeutic product. Additional content (2) The Minister may, in the order, (a) specify provisions of the regulations that are excluded from the scope of the exemption provided for in section 21.96; and (b) establish classes and distinguish among those classes. Compliance with terms and conditions (3) A person that conducts an activity under the order shall comply with any applicable terms and conditions. 2019, c. 29, s. 169