GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Natural Health Products Regulations — 37
37 If the information and documents submitted in respect of an application under section 28, an application for amendment under subsection 32(2) or a request for renewal under section 36 are insufficient to enable the Minister to determine whether the licence should be issued, amended or renewed, as the case may be, the Minister may request that the applicant provide the Minister with such additional information as is necessary to make the determination.
Natural Health Products Regulations — 38
38 (1) A licensee may, by amendment of the site licence, relinquish any part of the authorization given to the licensee under this Part. (2) An application to amend the site licence for the purposes of subsection (1) shall be submitted to the Minister and shall contain the following information and documents: (a) a document, signed and dated by the licensee, that sets out the site licence number and that specifies each activity or, by address, each building, in respect of which the authorization is requested to be relinquished; and (b) an attestation, signed and dated by a quality assurance person, stating that after the relinquishment, the buildings, equipment, practices and procedures used in respect of each activity conducted by the licensee will remain in compliance with the requirements set out in Part 3. (3) The Minister shall amend the site licence as requested by the licensee in paragraph (2)(a) if the licensee provides the Minister with an application that is in accordance with subsection (2).
Natural Health Products Regulations — 39
39 (1) Subject to subsection (2), the Minister may suspend a site licence if the Minister has reasonable grounds to believe that (a) the licensee has contravened any provision of the Act or these Regulations; or (b) the licensee has made a false or misleading statement in the application submitted under section 28 or the application for amendment under subsection 32(2). (2) Subject to section 40, the Minister shall not suspend a site licence unless (a) the Minister has sent the licensee a notice that sets out the reason for the intended suspension; and (b) the licensee has not, within 90 days after the date of the notice referred to in paragraph (a), provided the Minister with information or documents demonstrating that the licence should not be suspended on the grounds that (i) the situation giving rise to the intended suspension did not exist, or (ii) the situation giving rise to the intended suspension has been corrected. SOR/2022-146, s. 7
Natural Health Products Regulations — 40
40 The Minister shall suspend a site licence before giving the licensee an opportunity to be heard if, as a result of any circumstance, the Minister has reasonable grounds to believe that it is necessary to do so to prevent injury to the health of a purchaser or consumer.
Natural Health Products Regulations — 41
41 If the Minister suspends a site licence under section 39 or 40, the Minister shall send the licensee a notice that sets out the reason for suspension and the day on which the suspension is effective, and the Minister shall (a) reinstate the licence if, within 90 days after the day on which the suspension is effective, the licensee provides the Minister with information or documents demonstrating that the situation giving rise to the suspension did not exist or that it has been corrected; or (b) cancel the licence if, within 90 days after the day on which the suspension is effective, the licensee has not provided the Minister with the information or documents referred to in paragraph (a).
Natural Health Products Regulations — 42
42 If the Minister cancels a licence under paragraph 41(b), the Minister shall send the licensee a notice that sets out the reason for the cancellation and the day on which the cancellation is effective.
Natural Health Products Regulations — 43
43 (1) Subject to subsection (2), no person shall sell a natural health product unless it is manufactured, packaged, labelled, imported, distributed or stored, as the case may be, in accordance with this Part. (2) A person may sell a natural health product that is manufactured, packaged, labelled, imported, distributed or stored, as the case may be, in accordance with requirements that are equivalent to those set out in this Part if the natural health product is imported. SOR/2021-46, s. 17(F)
Natural Health Products Regulations — 44
44 (1) Every natural health product available for sale shall comply with the specifications submitted in respect of that natural health product under paragraph 5(i) and with every change to those specifications made by the product licence holder. (2) The specifications shall contain the following information: (a) detailed information respecting the purity of the natural health product, including statements indicating its purity tolerances; (b) for each medicinal ingredient of the natural health product, detailed information respecting its quantity per dosage unit and its identity, including statements indicating its quantity and identity tolerances; (c) if a representation relating to the potency of a medicinal ingredient is to be shown on a label of the natural health product, detailed information respecting the potency of the medicinal ingredient, including statements indicating its potency tolerances; and (d) a description of the methods used for testing or examining the natural health product. (3) The specifications and every change to those specifications shall be approved by a quality assurance person.
Natural Health Products Regulations — 45
45 (1) Every natural health product shall be manufactured, packaged, labelled and stored in premises that are designed, constructed and maintained in a manner that permits the activity to be conducted under sanitary conditions, and in particular that (a) permits the premises to be kept clean and orderly; (b) permits the effective cleaning of all surfaces in the premises; (c) permits the natural health product to be stored or processed appropriately; (d) prevents the contamination of the natural health product; and (e) prevents the addition of an extraneous substance to the natural health product. (2) Every natural health product shall be stored under conditions that will maintain the quality and safety of the natural health product. SOR/2018-69, s. 49(F) SOR/2021-46, s. 17(F) SOR/2021-46, s. 18(F)
Natural Health Products Regulations — 46
46 Every natural health product shall be manufactured, packaged, labelled and stored using equipment that is designed, constructed, maintained, operated and arranged in a manner that (a) permits the effective cleaning of its surfaces; (b) permits it to function in accordance with its intended use; (c) prevents it from contaminating the natural health product; and (d) prevents it from adding an extraneous substance to the natural health product. SOR/2021-46, s. 17(F)
Natural Health Products Regulations — 47
47 Every natural health product shall be manufactured, packaged, labelled and stored by personnel who are qualified by education, training or experience to perform their respective tasks. SOR/2021-46, s. 17(F)
Natural Health Products Regulations — 48
48 Every natural health product shall be manufactured, packaged, labelled and stored in accordance with a sanitation program that sets out (a) procedures for effectively cleaning the premises in which the activity is conducted; (b) procedures for effectively cleaning the equipment used in the activity; (c) procedures for handling any substance used in the activity; and (d) all requirements, in respect of the health, the hygienic behaviour and the clothing of the personnel who are involved in the activity, that are necessary to ensure that the activity is conducted in sanitary conditions. SOR/2018-69, s. 50(F) SOR/2021-46, s. 17(F)
Natural Health Products Regulations — 49
49 Every natural health product shall be manufactured, packaged, labelled and stored in accordance with standard operating procedures that are designed to ensure that the activity is conducted in accordance with the requirements of this Part. SOR/2021-46, s. 17(F)
Natural Health Products Regulations — 50
50 Every manufacturer, packager, labeller, importer and distributor shall establish and maintain a system of control that permits the rapid and complete recall of every lot or batch of the natural health product that has been made available for sale.
Natural Health Products Regulations — 51
51 (1) Every manufacturer, packager, labeller, importer and distributor shall (a) have a quality assurance person who (i) is responsible for assuring the quality of the natural health product before it is made available for sale, and (ii) has training, experience and technical knowledge relating to the activity conducted and the requirements of this Part; and (b) investigate and record every complaint received in respect of the quality of the natural health product and, if necessary, take corrective action. (2) Every natural health product shall be manufactured, packaged and labelled using only material that, prior to its use in the activity, has been approved for that use by a quality assurance person. (3) Every natural health product shall be manufactured, packaged, labelled and stored using methods and procedures that, prior to their implementation, have been approved by a quality assurance person. (4) Every lot or batch of a natural health product shall be approved by a quality assurance person before it is made available for sale. (5) Every natural health product that is sold and subsequently returned to its manufacturer, packager, labeller, importer or distributor shall be approved by a quality assurance person before that natural health product is made available for further sale. SOR/2018-69, s. 51(E) SOR/2021-46, s. 17(F) SOR/2022-146, s. 8(E)
Natural Health Products Regulations — 52
52 Every manufacturer and every importer shall determine the period of time during which, after being packaged for sale, the natural health product will maintain its purity and physical characteristics and its medicinal ingredients will maintain their quantity per dosage unit and their potency when (a) it is stored under its recommended storage conditions; or (b) if it does not have recommended storage conditions, it is stored at room temperature. SOR/2018-69, s. 53 SOR/2021-46, s. 17(F) SOR/2021-46, s. 18(F)
Natural Health Products Regulations — 53
53 Every manufacturer who sells a natural health product shall maintain the following records at the site at which the natural health product is manufactured: (a) the master production document for the natural health product; (b) a list of all ingredients contained in each lot or batch of the natural health product; (c) records of any testing conducted in respect of a lot or batch of raw material used in the manufacture of the natural health product; (d) records of any testing conducted by or for the manufacturer in respect of a lot or batch of the natural health product; (e) a copy of the specifications for each natural health product that is being manufactured at the site; (f) records demonstrating that each lot or batch of the natural health product was manufactured in accordance with the requirements of this Part; (g) a record of each determination made by the manufacturer in accordance with section 52 and the information that supports that determination; (h) records containing sufficient information to enable the recall of every lot or batch of the natural health product that has been made available for sale; (i) a list of all natural health products that are being manufactured at the site; and (j) a copy of the sanitation program in use at the site. SOR/2022-146, s. 9
Natural Health Products Regulations — 54
54 Every packager who sells a natural health product shall maintain the following records at the site at which the natural health product is packaged: (a) records of any testing conducted by or for the packager in respect of the material used to package the natural health product; (b) records demonstrating that each lot or batch of the natural health product was packaged in accordance with the requirements of this Part; (c) records containing sufficient information to enable the recall of every lot or batch of the natural health product that has been made available for sale; (d) a list of all natural health products that are being packaged at the site; and (e) a copy of the sanitation program in use at the site. SOR/2022-146, s. 10
Natural Health Products Regulations — 55
55 Every labeller who sells a natural health product shall maintain the following records at the site at which the natural health product is labelled: (a) records demonstrating that each lot or batch of the natural health product was labelled in accordance with the requirements of this Part; (b) records containing sufficient information to enable the recall of every lot or batch of the natural health product that has been made available for sale; (c) a list of all natural health products that are being labelled at the site; and (d) a copy of the sanitation program in use at the site.
Natural Health Products Regulations — 56
56 Every importer who sells a natural health product shall maintain the following records: (a) the master production document for the natural health product; (b) a list of all ingredients contained in each lot or batch of the natural health product; (c) records of any testing conducted by or for the importer in respect of a lot or batch of the natural health product; (d) a copy of the specifications for the natural health product; (e) a record of each determination made by the importer in accordance with section 52 and the information that supports that determination; (f) records containing sufficient information to enable the recall of every lot or batch of the natural health product that has been made available for sale; and (g) a copy of the sanitation program in use by the importer. SOR/2022-146, s. 11
Natural Health Products Regulations — 57
57 Every distributor shall maintain the following records at the site at which the natural health product is stored: (a) records containing sufficient information to enable the recall of every lot or batch of the natural health product that has been made available for sale; (b) a list of all natural health products that are being stored at the site; and (c) a copy of the sanitation program in use at the site. SOR/2021-46, s. 17(F)
Natural Health Products Regulations — 58
58 Every person required under this Part to maintain a record that relates to a lot or batch of a natural health product shall maintain that record for a period of one year following the expiry date of the natural health product to which that record relates.
Natural Health Products Regulations — 59
59 Every natural health product that is intended to be sterile shall be manufactured and packaged (a) in a separate and enclosed area; (b) under the supervision of a person trained in microbiology; and (c) using a method scientifically proven to ensure its sterility.
Natural Health Products Regulations — 60
60 (1) Section C.01.064 of the Food and Drug Regulations applies in respect of natural health products except that it shall be read without reference to the words “or parenteral”. (2) Section C.01.065 of the Food and Drug Regulations applies in respect of natural health products except that it shall be read without reference to (a) the words “or parenteral”; and (b) the words “or to its common name if there is no proper name”.
Natural Health Products Regulations — 61
61 (1) Subject to subsection (3), if the Minister has reasonable grounds to believe that a lot or batch of a natural health product made available for sale may result in injury to the health of a purchaser or consumer, the Minister may require the manufacturer, importer or distributor to provide a sample of that lot or batch. (2) The sample shall be of sufficient quantity to enable a determination of whether the lot or batch of the natural health product complies with the specifications for that natural health product. (3) The Minister shall not require a sample of a lot or batch referred to in subsection (1) to be provided if more than one year has elapsed since the expiry date of that natural health product.
Natural Health Products Regulations — 62
62 Every manufacturer, importer or distributor who commences a recall of a natural health product shall, within three days after the day on which the recall is commenced, provide the Minister with the following information in respect of the natural health product: (a) the proper name and the common name of each medicinal ingredient that it contains; (b) each brand name under which it is sold; (c) its product number; (d) the number of each lot or batch recalled; (e) the name and address of the manufacturer, importer or distributor who commenced the recall; (f) the reasons for commencing the recall; (g) the name and address of each person to whom the recalled product was sold by the manufacturer, importer or distributor who commenced the recall; (h) the quantity of the recalled product that was sold by the manufacturer, importer or distributor who commenced the recall; (i) the quantity of the recalled product remaining in the possession of the manufacturer, importer or distributor who commenced the recall; (j) if the recall was commenced by a manufacturer, the quantity of the recalled product that they manufactured; (k) if the recall was commenced by an importer, the quantity of the recalled product that they imported and the name and address of each person that sold it to them; (l) if the recall was commenced by a distributor, the quantity of the recalled product that was sold to them and the name and address of each person that sold it to them; and (m) a description of any other action, in respect of the recall, that the manufacturer, importer or distributor who commenced the recall is taking. SOR/2022-146, s. 12
Natural Health Products Regulations — Natural Health Products Regulations
adverse event means any adverse occurrence in the health of a clinical trial subject who is administered a natural health product, that may or may not be caused by the administration of the natural health product, and includes an adverse reaction, a serious adverse reaction and a serious unexpected adverse reaction. ( incident thérapeutique )
Natural Health Products Regulations — Natural Health Products Regulations
clinical trial means an investigation in respect of a natural health product that involves human subjects and that is intended to discover or verify its clinical, pharmacological or pharmacodynamic effects, to identify any adverse events that are related to its use, to study its absorption, distribution, metabolism and excretion, or to ascertain its safety or efficacy. ( essai clinique )
Natural Health Products Regulations — Natural Health Products Regulations
good clinical practices means generally accepted clinical practices that are designed to ensure the protection of the rights, safety and well-being of clinical trial subjects and other persons, and the good clinical practices referred to in section 74. ( bonnes pratiques cliniques )
Natural Health Products Regulations — Natural Health Products Regulations
import means to import a natural health product into Canada for the purpose of sale in a clinical trial. ( importer )
Natural Health Products Regulations — Natural Health Products Regulations
investigator’s brochure means a document containing the preclinical and clinical information in respect of the natural health product that is described in paragraph 66(e). ( brochure du chercheur )
Natural Health Products Regulations — Natural Health Products Regulations
protocol means a document that describes the objectives, design, methodology, statistical considerations and organization of a clinical trial. ( protocole )
Natural Health Products Regulations — (a)
qualified investigator means the person responsible to the sponsor for the conduct of the clinical trial at a clinical trial site, who is entitled to provide health care under the laws of the province where the clinical trial site is located and who is (a) in the case of a clinical trial respecting a natural health product to be used for dental purposes only, a physician or dentist and a member in good standing of a professional medical or dental association; and (b) in any other case, a physician and a member in good standing of a professional medical association. ( chercheur qualifié )
Natural Health Products Regulations — (a)
research ethics board means a body that is not affiliated with the sponsor, and (a) the principal mandate of which is to approve the initiation of, and conduct periodic reviews of, biomedical research involving human subjects in order to ensure the protection of their rights, safety and well-being; and (b) that has at least five members, that has a majority of members who are Canadian citizens or permanent residents under the Immigration Act , that is composed of both men and women and that includes at least (i) two members whose primary experience and expertise are in a scientific discipline, who have broad experience in the methods and areas of research to be approved and one of whom is from a medical discipline or, if the clinical trial is in respect of a natural health product to be used for dental purposes only, is from a medical or dental discipline, (ii) one member knowledgeable in complementary or alternative health care, (iii) one member knowledgeable in ethics, (iv) one member knowledgeable in Canadian laws relevant to the research to be approved, (v) one member whose primary experience and expertise are in a non-scientific discipline, and (vi) one member who is from the community or is a representative of an organization interested in the areas of research to be approved and who is not affiliated with the sponsor or the site where the clinical trial is to be conducted. ( comité d’éthique de la recherche )
Natural Health Products Regulations — Natural Health Products Regulations
sponsor means an individual, corporate body, institution or organization that conducts a clinical trial. ( promoteur )
Natural Health Products Regulations — 64
64 (1) Subject to subsection (2), this Part applies to the sale or importation of natural health products to be used for the purposes of clinical trials involving human subjects. (2) Except for paragraph 65(1)(a), subsection 65(2), section 68, paragraphs 74(a) to (i), subsections 75(1) and 76(1) and (2), paragraphs 76(3)(a) to (d) and (f) to (h), subsection 76(4) and sections 77 and 80 to 83, this Part does not apply to the sale or importation of a natural health product for the purposes of a clinical trial authorized under section 68.
Natural Health Products Regulations — 65
65 (1) Despite section 4 and subject to subsection (2), no person shall sell or import a natural health product for the purposes of a clinical trial unless (a) the person is authorized under this Part; (b) the person complies with this Part and section C.01.064 of the Food and Drug Regulations ; and (c) if the natural health product is to be imported, the person has a representative in Canada who is responsible for the sale of the natural health product. (2) No person shall sell a natural health product for the purposes of a clinical trial (a) during the period of any suspension of the authorization under section 80 or 81; or (b) after cancellation of the authorization under paragraph 82(b).
Natural Health Products Regulations — 66
cinogenicity studies in any animal species tested in respect of the natural health product, if any, (vii) the results of clinical pharmacokinetic studies of the natural health product, if any, (viii) the information regarding natural health product safety, pharmacodynamics, efficacy and dose responses of the natural health product that were obtained from previous clinical trials in humans, if any, (ix) the known contra-indications for and the precautions to be taken in respect of the natural health product, and (x) the recommended treatment in the event of an overdose of the natural health product, if any; and (f) the proposed date for the commencement of the clinical trial at each clinical trial site. SOR/2018-69, s. 55(E)