GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Natural Health Products Regulations — 9
9 (1) If the Minister refuses to issue or amend a product licence, the Minister shall send the applicant a notice that sets out the reason for the refusal. (2) The notice shall indicate that the applicant may, within 30 days after the date of the notice, request that the Minister reconsider the application. (3) If the applicant makes a request in accordance with subsection (2), the Minister shall (a) give the applicant an opportunity to be heard in respect of the application; and (b) reconsider the application after giving the applicant that opportunity. SOR/2022-146, s. 2
Natural Health Products Regulations — 10
10 (1) After reconsidering the application, the Minister shall issue or amend the product licence if the requirements of section 7 are met. (2) If the Minister again refuses to issue or amend the product licence, the Minister shall send the applicant a final notice that sets out the reason for the refusal.
Natural Health Products Regulations — 11
11 (1) If the licensee makes any of the following changes in respect of the natural health product, the licensee shall not sell any lot or batch of the natural health product affected by the change unless the product licence is amended accordingly: (a) a change to its recommended dose; (b) a change to its recommended duration of use; (c) the deletion or modification of risk information shown on any of its labels, including the deletion or modification of a caution, warning, contra-indication or known adverse reaction associated with its use; (d) a change of its recommended use or purpose; (e) a change of the source material of any of its medicinal ingredients; (f) changing any of its medicinal ingredients to or from being synthetically manufactured; (g) a change to the potency of any of its medicinal ingredients; (h) a change affecting its safety or efficacy that does not arise as a result of (i) a change to the quantity of a medicinal ingredient per dosage unit, (ii) the addition or substitution of a medicinal ingredient, (iii) a change to its dosage form, or (iv) a change to its recommended route of administration; or (i) one or more of the following changes to its specifications, namely, (i) the removal of a test method set out in the specifications, (ii) the modification of a test method set out in the specifications in a manner that widens the purity tolerances of the natural health product or the quantity, identity or potency tolerances of any of its medicinal ingredients, or (iii) the modification of a test method set out in the specifications in a manner that renders it less precise, accurate, specific or sensitive. (2) An application to amend a product licence shall be submitted to the Minister and shall contain the following information and documents: (a) the product number of the natural health product; (b) a statement identifying each change described in subsection (1) that has been made; (c) information demonstrating that the natural health product is safe and efficacious after the change; (d) the text of each label to be used in conjunction with the natural health product after the change, if the change is any of those described in paragraphs (1)(a) to (h); and (e) a copy of the revised specifications, if the change is any of those described in paragraph (1)(g) or (i).
Natural Health Products Regulations — 12
12 (1) If the licensee makes any of the changes described in subsection (2) in respect of the natural health product, the licensee shall, within 60 days after the day on which the change is made, (a) notify the Minister of the change; and (b) provide the Minister with the text of each label used in conjunction with the natural health product since the change, if the change is any of those described in paragraphs (2)(d) to (f). (2) For the purposes of subsection (1), changes in respect of a natural health product are (a) a change to any of the information submitted under paragraph 5(a) or (b); (b) a change to any of the information provided under section 22; (c) the addition or substitution of a non-medicinal ingredient, the addition or substitution of which does not affect its safety or efficacy; (d) its sale under a brand name other than one submitted under paragraph 5(e); (e) a change of the common or proper name of any of its medicinal ingredients; and (f) the addition of risk information to any of its labels, including the addition of a caution, warning, contra-indication or known adverse reaction associated with its use.
Natural Health Products Regulations — 13
13 For greater certainty, if the licensee makes any of the following fundamental changes in respect of the natural health product, the licensee shall not sell the natural health product affected by the change unless a product licence is issued in accordance with section 7 for the natural health product as changed: (a) a change to the quantity of a medicinal ingredient per dosage unit; (b) the addition or substitution of a medicinal ingredient; (c) a change to its dosage form; or (d) a change to its recommended route of administration. SOR/2022-146, s. 3(E)
Natural Health Products Regulations — 14
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 (i) its authorized quantity per dosage unit, (ii) its authorized potency, if any, and (iii) its authorized source material; (h) the recommended use or purpose that is authorized for the natural health product; and (i) the date on which the licence was issued. (2) Within 60 days after the day on which the product licence is issued, the licensee shall notify the Minister of any information set out on the licence that the licensee knows to be incorrect.
Natural Health Products Regulations — 15
15 If the information and documents submitted in respect of a product licence application under section 5 or an application for amendment under subsection 11(2) are insufficient to enable the Minister to determine whether the product licence should be issued or amended, as the case may be, the Minister may request that the applicant provide such additional information or samples of the natural health product as are necessary to make the determination.
Natural Health Products Regulations — 16
16 If the Minister has reasonable grounds to believe that a natural health product may no longer be safe when used under the recommended conditions of use, the Minister may request that the licensee provide the Minister, within 15 days after the day on which the request is received, with information and documents demonstrating that the natural health product is safe when used under the recommended conditions of use.
Natural Health Products Regulations — 17
17 (1) The Minister may direct the licensee, manufacturer, importer and distributor to stop their sale of a natural health product if (a) the licensee does not, within the required period, provide the Minister with the information and documents requested under section 16; (b) the information and documents provided by the licensee in accordance with section 16 do not demonstrate that the natural health product is safe when used under the recommended conditions of use; (c) in the case of a natural health product that is imported, the Minister has reasonable grounds to believe that the natural health product is not manufactured, packaged, labelled, imported, distributed or stored in accordance with the requirements set out in Part 3 or in accordance with requirements that are equivalent to those set out in Part 3; (d) in the case of a natural health product that is not imported, the Minister has reasonable grounds to believe that the natural health product is not manufactured, packaged, labelled, distributed or stored in accordance with the requirements set out in Part 3; or (e) the Minister has reasonable grounds to believe that the natural health product is not packaged or labelled in accordance with the requirements set out in Part 5. (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 (a) in the case of a direction to stop sale arising under either paragraph (1)(a) or (b), the natural health product is safe when used under the recommended conditions of use; (b) in the case of a direction to stop sale arising under paragraph (1)(c), the natural health product is manufactured, packaged, labelled, imported, distributed and stored in accordance with the requirements set out in Part 3 or in accordance with requirements that are equivalent to those set out in Part 3; (c) in the case of a direction to stop sale arising under paragraph (1)(d), the natural health product is manufactured, packaged, labelled, distributed and stored in accordance with the requirements set out in Part 3; (d) in the case of a direction to stop sale arising under paragraph (1)(e), the natural health product is packaged and labelled in accordance with the requirements of Part 5; or (e) the situation giving rise to the direction to stop the sale of the natural health product did not exist. SOR/2018-69, s. 45(F) SOR/2021-46, s. 17(F)
Natural Health Products Regulations — 18
18 (1) Subject to subsection (2), the Minister may suspend a product licence if the Minister has reasonable grounds to believe that (a) the licensee has contravened these Regulations or any provision of the Act relating to the natural health product; or (b) the licensee has made a false or misleading statement in the application submitted under section 5 or the application for amendment under subsection 11(2). (2) Subject to section 19, the Minister shall not suspend a product 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. 4
Natural Health Products Regulations — 19
19 The Minister shall suspend a product 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 — 20
20 If the Minister suspends a product licence under section 18 or 19, the Minister shall send the licensee a notice that sets out the reason for the 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 — 21
21 If the Minister cancels a licence under paragraph 20(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 — 22
22 (1) Subject to subsection (2), the licensee shall provide the Minister with the following information prior to commencing the sale of the natural health product: (a) in respect of each manufacturer, packager, labeller and importer of the natural health product (i) the person’s name, address and telephone number, and if applicable, the person’s facsimile number and electronic mail address, and (ii) if the person conducts the activity in Canada, the number assigned to the site licence issued in respect of that activity; (b) the name, address and telephone number, and if applicable, the facsimile number and electronic mail address of each distributor of the natural health product; (c) the address of each building in which the natural health product is manufactured, packaged or labelled; (d) the address of each building in which the natural health product is stored for the purposes of importation or distribution; and (e) if the natural health product is imported, evidence establishing that the natural health product will be manufactured, packaged, labelled, imported, distributed and stored in accordance with the requirements set out in Part 3 or in accordance with requirements that are equivalent to those set out in Part 3. (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. SOR/2018-69, s. 46(F) SOR/2021-46, s. 17(F) SOR/2021-46, s. 19(E)
Natural Health Products Regulations — 23
23 (1) Every licensee who sells a natural health product shall maintain the following records: (a) a list of all ingredients contained in each lot or batch of the natural health product that has been made available for sale; and (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. (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.
Natural Health Products Regulations — 24
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 (b) a case report for each serious unexpected adverse reaction to the natural health product that occurs inside or outside Canada, within 15 days after the day on which the licensee becomes aware of the reaction. (2) A licensee who sells a natural health product shall annually prepare and maintain a summary report that contains a concise and critical analysis of (a) all adverse reactions to the natural health product that have occurred inside Canada; and (b) all reactions for which a case report is required to be provided under subsection (1), that have occurred (i) during the previous 12 months, and (ii) at a dose used or tested for the diagnosis, treatment or prevention of a disease or for modifying organic functions in humans. (3) If after reviewing a case report provided under subsection (1) or after reviewing any other safety data relating to the natural health product, the Minister has reasonable grounds to believe that the natural health product may no longer be safe when used under the recommended conditions of use, the Minister may request that, within 30 days after the day on which the request is received, the licensee (a) provide to the Minister a copy of any summary report prepared under subsection (2); or (b) prepare and provide to the Minister an interim summary report containing a concise and critical analysis of (i) all adverse reactions to the natural health product that have occurred inside Canada, and (ii) all reactions for which a case report is required to be provided under subsection (1), that have occurred (A) since the date of the most recent summary report prepared under subsection (2), and (B) at a dose used or tested for the diagnosis, treatment or prevention of a disease or for modifying organic functions in humans.
Natural Health Products Regulations — 25
25 Every licensee who commences a recall of a natural health product shall provide the Minister with the information referred to in section 62 within three days after the day on which the recall is commenced.
Natural Health Products Regulations — 26
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.
Natural Health Products Regulations — 27
27 (1) Subject to subsection (2), no person shall manufacture, package, label or import a natural health product for sale unless (a) the person holds a site licence issued in respect of the activity; and (b) the person conducts the activity in accordance with the requirements set out in Part 3. (2) No person who holds a site licence shall manufacture, package, label or import a natural health product for sale during the period of any suspension of the licence under section 39 or 40. SOR/2022-146, s. 5
Natural Health Products Regulations — 28
28 An application for a site licence shall be submitted to the Minister and shall contain the following information and documents: (a) the name, address and telephone number, and if applicable, the facsimile number and electronic mail address of the applicant; (b) a statement specifying which one or more of the activities of manufacturing, packaging, labelling or importing the applicant is proposing to conduct; (c) if the applicant is proposing to manufacture, package or label a natural health product, the address of each building in which each activity is proposed to be conducted; (d) if the applicant is proposing to import a natural health product, the address of each building in which that natural health product is proposed to be stored; (e) for each activity specified under paragraph (b), a statement indicating whether or not the applicant is proposing to conduct the activity in respect of a natural health product in sterile dosage form; and (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 establishing that they comply with the requirements set out in Part 3. SOR/2021-46, s. 17(F) SOR/2021-46, s. 19(E)
Natural Health Products Regulations — 29
29 (1) The Minister shall issue or amend a site licence if (a) the applicant submits an application to the Minister that is in accordance with section 28 or subsection 32(2), as the case may be; (b) the applicant provides the Minister with all additional information requested under section 37; and (c) the applicant does not make a false or misleading statement in the application. (2) If the Minister issues a site licence, the Minister shall assign that licence a site licence number.
Natural Health Products Regulations — 30
30 (1) If the Minister refuses to issue or amend a site licence, the Minister shall send the applicant a notice that sets out the reason for the refusal. (2) The notice shall indicate that the applicant may, within 30 days after the date of the notice, request that the Minister reconsider the application. (3) If the applicant makes a request in accordance with subsection (2), the Minister shall (a) give the applicant an opportunity to be heard in respect of the application; and (b) reconsider the application after giving the applicant that opportunity. SOR/2022-146, s. 6
Natural Health Products Regulations — 31
31 (1) After reconsidering the application, the Minister shall issue or amend the site licence if the requirements of subsection 29(1) are met. (2) If the Minister again refuses to issue or amend the site licence, the Minister shall send the applicant a final notice that sets out the reason for the refusal.
Natural Health Products Regulations — 32
32 (1) A licensee shall not conduct any of the following activities unless the site licence is amended accordingly: (a) conduct any activity for a which a site licence is required that the licensee is not already authorized to conduct; (b) if the licensee is authorized to manufacture, package or label a natural health product, conduct that activity in a building in which they are not authorized to do so; (c) if the licensee is authorized to import a natural health product, store a natural health product in a building in which they are not authorized to do so; or (d) if the licensee is authorized to conduct an activity, but not already authorized to conduct it in respect of a natural health product in sterile dosage form, conduct the activity in respect of a natural health product in that form. (2) An application to amend a site licence shall be submitted to the Minister and shall contain the following information and documents: (a) the licence number; (b) a statement that specifies each activity referred to in subsection (1) that the licensee is proposing to conduct; and (c) a report from a quality assurance person establishing that 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. SOR/2018-69, s. 47(E) SOR/2021-46, s. 18(F) SOR/2021-46, s. 19(E)
Natural Health Products Regulations — 33
33 If the licensee makes any of the following changes, the licensee shall notify the Minister of the change within 60 days after the day on which the change is made: (a) a change to the information submitted under paragraph 28(a); and (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).
Natural Health Products Regulations — 34
34 A site licence shall set out the following information: (a) the name and address of the licensee; (b) the site licence number; (c) each activity that the licensee is authorized to conduct and a statement indicating whether the activity is authorized to be conducted in respect of a natural health product in sterile dosage form; (d) if the licensee is authorized to manufacture, package or label a natural health product, the address of each building in which the licensee is authorized to conduct that activity; and (e) if the licensee is authorized to import a natural health product, the address of each building in which the licensee is authorized to store that natural health product. SOR/2021-46, s. 13(F)
Natural Health Products Regulations — 35
35 (1) A site licence expires on the first anniversary of the day on which it was issued unless it is renewed in accordance with section 36. (2) A site licence that is renewed in accordance with section 36 expires on the day on which the renewal period ends unless the licence is further renewed in accordance with section 36.
Natural Health Products Regulations — 36
36 (1) The Minister shall renew a site licence if (a) the licensee submits a request to renew the licence to the Minister no later than 30 days before the day on which the licence expires; (b) the licensee provides the Minister with all additional information requested under section 37; and (c) the renewal of the licence is not likely to result in injury to the health of a purchaser or consumer. (2) If the Minister renews a site licence, the Minister shall renew it for a period of (a) one year, if on the next anniversary of the day on which the licence was issued, the licensee will have held the licence for a period of less than three years; (b) two years, if on the next anniversary of the day on which the licence was issued, the licensee will have held the licence for a period of at least three years but less than nine years; or (c) three years, if on the next anniversary of the day on which the licence was issued, the licensee will have held the licence for a period of nine years or more. (3) A site licence renewal becomes effective on the day after the anniversary of the day on which the licence was issued.