PART 3Good Manufacturing Practices (continued)
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 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.
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.
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.
Sterile Natural Health Products
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.
Lot or Batch Samples
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.
62 Every manufacturer, importer or distributor who commences a recall of a natural health product shall provide the Minister with the following information in respect of that natural health product within three days after the day on which the recall is commenced:
(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 each manufacturer, importer and distributor of the natural health product;
(f) the reasons for commencing the recall;
(g) the quantity manufactured or imported into Canada;
(h) the quantity that was distributed in Canada;
(i) the quantity remaining in the possession of each manufacturer, importer and distributor of the natural health product; and
(j) a description of any other action that the manufacturer, importer or distributor, as the case may be, is taking in respect of the recall.
PART 4Clinical Trials Involving Human Subjects
63 The following definitions apply in this Part.
- adverse event
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)
- clinical trial
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)
- good clinical practices
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)
import means to import a natural health product into Canada for the purpose of sale in a clinical trial. (importer)
- investigator’s brochure
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)
protocol means a document that describes the objectives, design, methodology, statistical considerations and organization of a clinical trial. (protocole)
- qualified investigator
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)
- research ethics board
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)
sponsor means an individual, corporate body, institution or organization that conducts a clinical trial. (promoteur)
- SOR/2018-69, s. 54(F)
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