§ 86.3 Recordkeeping requirements. (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. 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) If the sponsor discontinues a clinical trial in its entirety or at a clinical trial site, the sponsor may resume selling or importing the natural health product for the purposes of the clinical trial in its entirety or at the clinical trial site if, in respect of each clinical trial site where the sale or importation is to be resumed, the sponsor submits to the Minister the information referred to in subparagraphs 66(c)(ix) to (xi) and paragraphs 66(d) and (f). 81 The Minister shall suspend the authorization to sell or import a natural health product for the purposes of a clinical trial, in its entirety or at a clinical trial site, before giving the sponsor 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 clinical trial subject or other person. (c) the applicant does not make a false or misleading statement in the application. 14 (1) A product licence shall set out the following information: (a) the name and address of the licensee; (b) the product number of the natural health product; (c) the dosage form that is authorized for the natural health product; (d) the recommended route of administration that is authorized for the natural health product; (e) the recommended dose that is authorized for the natural health product; (f) the recommended duration of use, if any, that is authorized for the natural health product; (g) in respect of each medicinal ingredient of the natural health product. (2) If the natural health product is one in respect of which a drug identification number is assigned in accordance with subsection C.01.014.2(1) of the Food and Drug Regulations and at the time the product licence is issued in respect of the natural health product it is already being sold, the licensee shall provide the information referred to in subsection (1) within 30 days after the day on which the product licence is issued. (d) the issuance or amendment of the licence, as the case may be, is not likely to result in injury to the health of a purchaser or consumer. (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. As the Canadian natural health industry grapples with a product-licensing deadline of January 1, 2010, the process seems mired in misinformation and industry confusion. (ii) at a dose used or tested for the diagnosis, treatment or prevention of a disease or for modifying organic functions in humans. (ii) the qualified investigator will immediately, on discontinuance of the clinical trial by the sponsor, in its entirety or at a clinical trial site, notify both the clinical trial subjects and the research ethics board of the discontinuance, provide them with the reasons for the discontinuance and advise them in writing of any potential risks to the health of clinical trial subjects or other persons; (g) for each clinical trial site, a copy of the protocol, informed consent form and any amendment to the protocol or informed consent form that have been approved by the research ethics board for that clinical trial site; and. 111 Until December 31, 2009, a person may sell a lot or batch of a drug referred to in section 108 that is not labelled or packaged in accordance with the requirements of Part 5 if the lot or batch is packaged in accordance with the requirements of the Food and Drug Regulations. Records. (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. (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. 103.4 (1) If a practitioner or pharmacist has signed an order specifying the proper name or common name, the brand name and the quantity of a natural health product, the person who receives the order may distribute or cause to be distributed the natural health product, in dosage form, as a sample to that practitioner or pharmacist if the natural health product meets the requirements of these Regulations. 2 See Table 2 of this section.. 3 Use Asbestos Limit §1926.1101.. 4 [Reserved]. Regulations are current to 2021-02-24 and last amended on 2020-09-28. 95 (1) Subject to subsection (2), no person shall sell or import a natural health product that is packaged unless the natural health product is contained in a security package. 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. (x) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the research ethics board that approved the protocol referred to in paragraph (a) and approved an informed consent form containing the statement referred to in paragraph (b), (xi) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of any research ethics board that has previously refused to approve the protocol referred to in paragraph (a), its reasons for doing so and the date on which the refusal was given, and, (A) that the clinical trial will be conducted in accordance with good clinical practices and these Regulations, and. 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. Natural Toxins: Advisory Levels for Deoxynivalenol (DON) in Finished Wheat Products for Human Consumption and Grains and Grain By-Products used for Animal … 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; •The current requirements for product & site licences continue to apply. 103.2 A natural health product is exempt from subsection 3(1) of the Act with respect to its advertisement to the general public as a preventative, but not as a treatment or cure, for any of the diseases, disorders or abnormal physical states referred to in Schedule A to the Act. 93 (1) Subject to section 94, the inner and outer labels shall show the following information in respect of a natural health product: (iv) if it is sterile, the words “sterile” and “stérile”, and, (v) the net amount in the immediate container in terms of weight, measure or number; and. (e) the situation giving rise to the direction to stop the sale of the natural health product did not exist. § 86.5 Documentation requirements for interstate movement of covered livestock. 4 (1) Subject to subsections (2) and (3), no person shall sell a natural health product unless a product licence is issued in respect of the natural health product. (f) in respect of the buildings, equipment, practices and procedures used to conduct each activity specified under paragraph (b), a report from a quality assurance person demonstrating that they comply with the requirements set out in Part 3. 26 This Part does not apply to any activity that is conducted in respect of a natural health product solely for the purposes of a clinical trial as defined in section 63. (a) a reference in those sections to “new drug” shall be read as a reference to “natural health product”; (b) the reference in subsection C.08.011(1) of the Food and Drug Regulations to “section C.08.002” shall be read as a reference to “subsection 4(1) of the Natural Health Products Regulations”; (c) subsection C.08.010(1) of the Food and Drug Regulations is to be read without reference to the words “or veterinary”; and. (i) the date on which the licence was issued. (b) a change that substantially alters any building, equipment, practice or procedure in respect of which a report from a quality assurance person was submitted under paragraph 28(f). Search for Words; Search within Specific Title(s) Search for a Specific Regulatory Section; Find a Specific Regulatory Agency (3) Despite subsection (1), a person may distribute or cause to be distributed a natural health product, in dosage form, as a sample to a practitioner or pharmacist without a signed order if that natural health product has a localized effect and is for administration either in the oral cavity or on the skin, or is a throat lozenge, and if all of the following conditions are met: (a) the natural health product is part of a class of natural health products that is set out in column 1 of List A and contains, as its only medicinal ingredients, one or more of those set out in column 2, each of which corresponds to that class, in the corresponding quantity set out in column 3, and the natural health product is consistent with the descriptive information set out in columns 4 to 6; (b) the expiry date of the natural health product falls on a day that is, (i) at least 30 days after the day on which it is distributed, if the expiry date consists of a day, month and year, or. 1. The Natural Health Products Bill is intended to come into force by July 2016. 3 Except where otherwise indicated in these Regulations, the provisions of the Food and Drug Regulations do not apply to natural health products. (3) Subject to subsection (4), a statement or illustration that draws attention to the security feature of the security package referred to in subsection (1) shall be shown. (2) The Minister shall lift a direction to stop the sale of a natural health product if the licensee provides the Minister with information and documents demonstrating that. (iii) the common name of each medicinal ingredient that it contains. The legislation establishes a new regulatory scheme, separate from food and medicines regulation, to control low-risk natural health products (NHPs) such as garlic capsules. (i) its authorized quantity per dosage unit, (ii) its authorized potency, if any, and, (h) the recommended use or purpose that is authorized for the natural health product; and. (2) The records shall be maintained by the licensee for a period of one year following the expiry date of the natural health product to which that record relates. (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. 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. (ii) one member knowledgeable in complementary or alternative health care. 29 (1) The Minister shall issue or amend a site licence if. 24 (1) A licensee shall provide the Minister with, (a) a case report for each serious adverse reaction to the natural health product that occurs inside Canada, within 15 days after the day on which the licensee becomes aware of the reaction; and. (2) The common name or proper name of a medicinal ingredient or non-medicinal ingredient shall be shown in any other language if the name does not have an English or French equivalent.