GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Natural Health Products Regulations — 91.4
91.4 The added sulphites that are required to be shown on a label of a natural health product shall be shown as follows: (a) if the added sulphites are shown in the list of non-medicinal ingredients, (i) by the name “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents”, or (ii) individually by the applicable name set out in item 21, column 1, of table 2 of the Common Names for Ingredients and Components Document, except that the name “sodium dithionite”, “sulphur dioxide” or “sulphurous acid” must be followed, in parentheses, by the name “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents”; or (b) if the added sulphites are shown in a food allergen source, gluten source and added sulphites statement, by the name “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents”. SOR/2022-146, s. 20
Natural Health Products Regulations — 92
92 No reference, direct or indirect, to the Act, the Food and Drug Regulations or to these Regulations shall be made on any label of or in any advertisement for a natural health product unless the reference is specifically required by law.
Natural Health Products Regulations — 93
93 The following information in respect of a natural health product shall be shown on the principal display panel of the inner label and, if there is an outer label, on the principal display panel of the outer label: (a) its brand name; (b) its product number; (c) its dosage form; (d) if it is sterile, the words “sterile” and “ stérile ”; and (e) the net amount in the immediate container in terms of weight, volume or number. SOR/2018-69, s. 62 SOR/2021-46, s. 18(F) SOR/2022-146, s. 21
Natural Health Products Regulations — 93.1
 “Contains aspartame” and “ Contient de l’aspartame ” shall be shown in bold type under the heading “Warnings / Mises en garde ” or under the headings “Warnings” and “ Mises en garde ”. (13) Despite subsections (4), (5) and (6), if there is no risk information, including any cautions, warnings, contra-indications or known adverse reactions associated with the use of the natural health product, the heading “Warnings / Mises en garde ” or the headings “Warnings” and “ Mises en garde ” shall be omitted from the table. (14) The following information in respect of the natural health product shall be shown under the headings “Directions / Mode d’emploi ” or under the headings “Directions” and “ Mode d’emploi ”: (a) the recommended dose; and (b) the recommended duration of use, if any. (15) The recommended storage conditions of the natural health product shall be shown under the heading “Other information / Autres renseignements ” or under the headings “Other information” and “ Autres renseignements ”. (16) Despite subsections (4), (5), (6) and (15), the recommended storage conditions may be omitted from the table if they are shown elsewhere on the same label, and, if they are omitted and no information is to be included under the heading “Other information / Autres renseignements ” or the headings “Other information” and “ Autres renseignements ”, the heading or headings shall also be omitted. (17) The following information shall be shown under the heading “Non-medicinal ingredients / Ingrédients non médicinaux ” or under the headings “Non-medicinal ingredients” and “ Ingrédients non médicinaux ”: (a) a qualitative list, by common name, of the non-medicinal ingredients of the natural health product; and (b) if the natural health product contains mercury or any salts or derivatives of mercury as a non-medicinal ingredient, a statement that sets out the quantities of those ingredients. (18) The telephone number, email address or website address of a contact person who represents the product licence holder of the natural health product shall be shown under the heading “Questions?”. SOR/2022-146, s. 21
Natural Health Products Regulations — 93.2
93.2 The following requirements apply in respect of a table referred to in paragraph 93.1(1)(f): (a) the title shall be separated by a solid black line from the other information in the table; (b) each heading and the information that is shown under it shall be separated by a solid black line from any subsequent heading; (c) the type size of the characters of the title shall be larger than that of each heading; (d) the type size of the characters of each heading shall be larger than that of the information that is shown under each heading; (e) the title and the headings shall be in bold type; (f) the information that is shown under each heading shall be in regular type, except as otherwise provided; and (g) the title, the headings and the information that is shown under each heading shall all be shown in the same font type. SOR/2022-146, s. 21
Natural Health Products Regulations — 93.3
93.3 (1) If, despite the following measures, the available surface area for a label is insufficient to accommodate all of the information that is required to be shown in a table under section 93.1, the information required to be shown under subsection 93.1(17) shall be shown elsewhere on the same label: (a) the use of a bilingual table; (b) the use of condensed characters of a type size of at least 5 points to show information that is related to non-medicinal ingredients; and (c) the use of condensed characters of a type size of at least 5.5 points to show information that is not related to non-medicinal ingredients. (2) If, despite the application of subsection (1), the available surface area for the label is insufficient to accommodate all of the remaining information that is required to be shown in the table, the information required to be shown under subsection 93.1(17) shall be shown (a) in a leaflet that is affixed or attached to the outermost container of the natural health product; (b) in a package insert; or (c) on a website. (3) If, despite the application of subsection (2), the available surface area for the label is insufficient to accommodate all of the remaining information that is required to be shown in the table, the information required to be shown under paragraph 93.1(7)(b) shall be shown in the leaflet or package insert, or on the website, that contains the information required to be shown under subsection 93.1(17). (4) For the purposes of subsections (1), (2) and (3), the table shall include a statement under the title “Product Facts / Info-produit ” or “Product Facts” and “ Info-produit ” that indicates where the information required to be shown under subsection 93.1(17), and, if applicable, paragraph 93.1(7)(b), can be found. (5) The information that is required to be shown in a package insert or on a website shall appear in a table that complies with the requirements of sections 93.1 and 93.2. SOR/2022-146, s. 21
Natural Health Products Regulations — 93.4
93.4 If a natural health product has both an inner and outer label, the following information in respect of the product shall be shown on the inner label: (a) if the product is not imported, the name of the product licence holder and the telephone number, email address or website address of the contact person who represents the product licence holder; (b) if the product is imported, the name of the product licence holder or importer and the telephone number, email address or website address of the contact person who represents the product licence holder or importer; (c) a list of its medicinal ingredients that sets out (i) the proper name of each ingredient or, if the proper name is the chemical name, the common name, (ii) the quantity of each ingredient per dosage unit, and (iii) if applicable, the authorized potency of each ingredient; (d) at least one of its recommended uses or purposes; (e) its recommended route of administration; (f) its recommended dose; (g) its recommended duration of use, if any; (h) if it contains a food allergen, gluten or added sulphites, the statement “Allergens / Allergènes ” or the statements “Allergens” and “ Allergènes ” in bold type, followed by the food allergen source, gluten source and added sulphites statement, also in bold type; (i) if it contains aspartame, the statement “Contains aspartame / Contient de l’aspartame ” or the statements “Contains aspartame” and “ Contient de l’aspartame ” in bold type; (j) any other risk information, including any cautions, warnings, contra-indications or known adverse reactions associated with its use; (k) its recommended storage conditions, if any; (l) its lot number; and (m) its expiry date. SOR/2022-146, s. 21
Natural Health Products Regulations — 93.5
93.5 Sections 93.1 to 93.4 do not apply in respect of a natural health product if (a) the available surface area for the outer label — or, if there is no outer label, for the inner label — is 90 cm² or less; (b) the entire quantity of the product is to be used within one day or less in accordance with the directions on the label; (c) the immediate container contains no more than three recommended dosage units; or (d) the product has a localized effect and is (i) recommended to be used in the oral cavity or on the skin, (ii) recommended for aromatherapy, (iii) recommended for organotherapy, (iv) a throat lozenge, (v) a topical nasal decongestant or counterirritant, or (vi) a flower essence. SOR/2022-146, s. 21
Natural Health Products Regulations — 94
94 (1) If the immediate container of a natural health product is not large enough to accommodate an inner label that complies with the relevant requirements of sections 93 to 93.6, the product shall be labelled as follows: (a) the inner label shall show the following in respect of the natural health product, namely, (i) a brand name, (ii) a qualitative list of its medicinal ingredients, by proper name, or by common name if the proper name is the chemical name, in descending order of quantity per dosage unit, (iii) its recommended dose, (iv) its recommended duration of use, if any, (v) its lot number, (vi) its expiry date, (vii) its product number, (viii) if it is sterile, the words “sterile” and “ stérile ”, (ix) the net amount in the immediate container in terms of weight, measure or number, (x) its recommended use or purpose, and (xi) if it does not have an outer label, a statement that refers the purchaser or consumer to the leaflet that is required in accordance with subsection (2); and (b) the outer label, if any, shall comply with the relevant requirements of sections 93 to 93.6. (2) If the natural health product does not have an outer label, (a) the statements, information and declarations that would, but for subsection (1), be required to be shown on the inner label shall be shown in a leaflet that is affixed or attached to the immediate container; and (b) if section 93.1 applies to the product, the tables required under that section, including the information in them, shall be shown in the leaflet in the manner described in that section and in section 93.2. SOR/2018-69, s. 63 SOR/2022-146, s. 22
Natural Health Products Regulations — 95
95 (1) Subject to subsection (2), no person shall sell or import one or more of the following natural health products that is packaged unless it is contained in a security package: (a) a mouthwash; (b) a product to be inhaled, ingested or inserted into the body; or (c) a product for ophthalmic use. (2) Subsection (1) does not apply to lozenges. (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 (a) on the inner label; and (b) if the security feature is a part of the outer package, on the outer label. (4) Subsection (3) does not apply if the security feature of a security package is self-evident and is an integral part of the immediate container. SOR/2022-146, s. 23
Natural Health Products Regulations — 96
96 Sections A.01.061 to A.01.063 of the Food and Drug Regulations apply in respect of natural health products.
Natural Health Products Regulations — 97
97 Subsections C.01.001(2) to (4) and C.01.028(1), paragraphs C.01.028(2)(b) and (c), section C.01.029, subsection C.01.031(1), paragraphs C.01.031.2(1)(a) and (c) to (g), subsection C.01.031.2(2), and paragraphs C.01.031.2(3)(a) and (c) of the Food and Drug Regulations apply in respect of natural health products.
Natural Health Products Regulations — 98
98 Section C.01.012 of the Food and Drug Regulations applies in respect of natural health products.
Natural Health Products Regulations — 99
99 Sections A.01.022 to A.01.026 of the Food and Drug Regulations apply in respect of natural health products.
Natural Health Products Regulations — 100
100 Sections A.01.040 to A.01.044 of the Food and Drug Regulations apply in respect of natural health products. SOR/2018-69, s. 64
Natural Health Products Regulations — 101
101 Section A.01.045 of the Food and Drug Regulations and Appendix III to those Regulations apply in respect of natural health products.
Natural Health Products Regulations — 102
102 Sections A.01.050 and A.01.051 of the Food and Drug Regulations apply in respect of natural health products.
Natural Health Products Regulations — 103
103 Subsection C.01.015(1) and paragraphs C.01.015(2)(d) to (f) of the Food and Drug Regulations apply in respect of natural health products.
Natural Health Products Regulations — 103.1
103.1 Section C.08.010 and subsections C.08.011(1) and (3) of the Food and Drug Regulations apply in respect of natural health products with the following modifications: (a) a reference to “new drug” is to be read as a reference to “natural health product”; (b) the sale of a natural health product can only be authorized for human use; (c) in subparagraph C.08.010(1)(b)(i), the reference to “adverse drug reactions” is to be read as a reference to “adverse reactions”; (d) paragraph C.08.010(2)(c) is to be read as follows: (c) the Minister has not, in respect of a natural health product, suspended the product licence under subsection 18(1) or section 19 of the Natural Health Products Regulations or cancelled the product licence under paragraph 20(b) of those Regulations; (e) in subsection C.08.011(1), the reference to “section C.08.002” is to be read as a reference to “subsection 4(1) of the Natural Health Products Regulations ”; and (f) in subsection C.08.011(3), the reference to “these Regulations” is to be read as a reference to the Natural Health Products Regulations . SOR/2004-119, s. 1 SOR/2020-212, s. 3 SOR/2023-247, s. 10
Natural Health Products Regulations — 103.15
103.15 (1) Sections C.11.002 and C.11.003 of the Food and Drug Regulations apply in respect of natural health products for which a product licence has not been issued. (2) If the Minister issues an authorization to sell a specified quantity of a natural health product under subsection C.11.003(1) of the Food and Drug Regulations , any quantities of the drug that are sold in accordance with the authorization cease to be considered to be natural health products as of the time of sale. SOR/2023-18, s. 5
Natural Health Products Regulations — 103.2
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.1 to the Act. SOR/2007-288, s. 2 SOR/2021-46, s. 16
Natural Health Products Regulations — 103.3
103.3 A natural health product is exempt from subsection 3(2) of the Act with respect to its sale by a person where the natural health product is represented by label or is advertised by that person 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.1 to the Act. SOR/2007-288, s. 2 SOR/2021-46, s. 16
Natural Health Products Regulations — 103.4
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) An order referred to in subsection (1) may provide that the order be repeated at specified intervals during any period that does not exceed six months. (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 (ii) in a month that follows the month in which it is distributed, if the expiry date consists only of a month and year; (c) the natural health product meets the requirements of these Regulations. (4) For the purposes of this section, practitioner and pharmacist have the same meaning as in subsection C.01.001(1) of the Food and Drug Regulations . SOR/2020-75, s. 2
Natural Health Products Regulations — 103.5
103.5 A person who, under subsection 103.4(1), receives an order for and distributes or causes to be distributed a natural health product as a sample shall (a) maintain records showing (i) the name, address and description of each person to whom the natural health product was distributed, (ii) the brand name, quantity and dosage form of the natural health product distributed, and (iii) the date on which the natural health product was distributed; and (b) keep those records and all orders received for natural health products under subsection 103.4(1) for a period of not less than two years from the date on which the distribution referred to in the records was made. SOR/2020-75, s. 2
Natural Health Products Regulations — 103.6
103.6 A person may distribute or cause to be distributed a natural health product, in dosage form, as a sample to any consumer that is 18 years of age or older 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, (ii) in a month that follows the month in which it is distributed, if the expiry date consists only of a month and year; (c) the natural health product meets the requirements of these Regulations. SOR/2020-75, s. 2
Natural Health Products Regulations — 108
108 (1) Subject to section 110, a person may, without complying with these Regulations, sell a drug to which these Regulations apply that is assigned a drug identification number in accordance with section C.01.014.2(1) of the Food and Drug Regulations , until the earlier of (a) the day on which an application for a product licence in respect of the drug is disposed of or withdrawn, and (b) December 31, 2009. (2) A person who sells a drug under subsection (1) shall conduct that sale in accordance with the requirements of the Food and Drug Regulations .
Natural Health Products Regulations — 109
109 An application for a product licence that is made in respect of a drug referred to in subsection 108(1) on or before December 31, 2009 is not required to contain the information referred to in paragraph 5(g).
Natural Health Products Regulations — 110
110 A sale or importation of a drug to which these Regulations apply that, before January 1, 2004, is authorized for the purposes of a clinical trial under Division 5 of Part C of the Food and Drug Regulations shall continue to be regulated under that Division.
Natural Health Products Regulations — 111
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 .
Natural Health Products Regulations — 112
112 If during the period beginning on January 1, 2004 and ending on December 31, 2005, the information referred to in section 22 is not available to the licensee prior to commencing the sale of the natural health product or within 30 days after the day on which the license is issued in respect of the natural health product, as the case may be, the licensee shall provide the information to the Minister immediately after it is available to the licensee.
Natural Health Products Regulations — 113
113 (1) A person who, before January 1, 2004, manufactures, packages, labels or imports for sale a drug to which these Regulations apply may continue to conduct the activity in respect of that drug without complying with the requirements of Parts 2 and 3, until the earlier of (a) the day on which that person’s application for a site licence to conduct that activity in respect of the drug is disposed of or withdrawn, and (b) December 31, 2005. (2) A person who conducts an activity under subsection (1) shall conduct that activity in accordance with the requirements of the Food and Drug Regulations .
Natural Health Products Regulations — 114
114 (1) A person who, before January 1, 2004, distributes a drug to which these Regulations apply may continue to conduct the activity in respect of that drug without complying with the requirements of Part 3 until December 31, 2005. (2) A person who conducts an activity under subsection (1) shall conduct that activity in accordance with the requirements of Division 2 of Part C of the Food and Drug Regulations .
Natural Health Products Regulations — 115
115 A person may sell a lot or batch of a drug referred to in section 108 that is not manufactured, packaged, labelled, imported, distributed or stored, as the case may be, in accordance with the requirements of Part 3 if (a) the lot or batch is manufactured, packaged and labelled before January 1, 2006; and (b) any manufacturing, packaging, labelling, importation, distribution or storage of the lot or batch that is not conducted in accordance with the requirements of Part 3 is conducted in accordance with the requirements of Division 2 of Part C of the Food and Drug Regulations . SOR/2021-46, s. 17(F) SOR/2021-46, s. 18(F)
Natural Health Products Regulations — 116
116 (1) Except for section 6, these Regulations come into force on January 1, 2004. (2) Section 6 comes into force on July 1, 2004.
Natural Health Products Regulations — Natural Health Products Regulations
Any of the following vitamins: biotin folate niacin pantothenic acid riboflavin thiamine vitamin A vitamin B 6 vitamin B 12 vitamin C vitamin D vitamin E vitamin K 1 vitamin K 2
Natural Health Products Regulations — (a)
A substance set out in Schedule D to the Act, except for the following: (a) a drug that is prepared from any of the following micro-organisms, namely, an alga, a bacterium or a fungus; and (b) any substance set out on Schedule D when it is prepared in accordance with the practices of homeopathic pharmacy
Natural Health Products Regulations — (a)
(a) a drug that is prepared from any of the following micro-organisms, namely, an alga, a bacterium or a fungus; and