Food and Drug Regulations (C.R.C., c. 870)
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Regulations are current to 2024-10-14 and last amended on 2024-06-17. Previous Versions
RELATED PROVISIONS
— SOR/97-12, s. 66
66 Packages of drugs that are labelled in accordance with Part C of the Food and Drug Regulations, as those Regulations read on December 31, 1996, are not required to comply with the labelling requirements in these Regulations until January 1, 1999.
— SOR/98-423, s. 10
10 For the purposes of sections 11 to 13, Director has the same meaning as in section A.01.010 of the Food and Drugs Regulations.
— SOR/98-423, s. 11
11 Despite sections 1 and 7 to 9, if a numbered certificate of registration has been issued in respect of a drug but a drug identification number has not been assigned under section C.01.014.2 of the Food and Drug Regulations, as amended by section 4 of these Regulations, or under section 12 of these Regulations, then section C.01.001A, paragraphs C.01.015(2)(b) and C.01.062(5)(b) and Division 10 and the schedule and the table to Division 10 of Part C of the Food and Drug Regulations, as they read immediately before the coming into force of these Regulations, remain in force in respect of that drug until October 1, 1998, except to the extent that they require information that is not required by those provisions as amended by these Regulations.
— SOR/98-423, s. 12
12 (1) Despite these Regulations and subject to subsection (3), if the conditions set out in subsection (2) are satisfied, the Director shall, until October 1, 1998, provide to a manufacturer or importer referred to in paragraph (2)( c),
(a) if the information referred to in section C.01.014.3 of the Food and Drug Regulations as amended by section 5 of these Regulations has not been submitted in respect of the drug, the document referred to in subsection C.01.014.2(1) of the Food and Drug Regulations, as amended by section 4 of these Regulations; or
(b) in any other case,
(i) a drug identification number for the drug preceded by the letters “DIN”, or
(ii) where there are two or more brand names for the drug, the drug identification numbers assigned by the Director for the drug, each of which pertains to one of the brand names and is preceded by the letters “DIN”.
(2) The conditions referred to in subsection (1) are:
(a) a numbered certificate of registration has been issued for the drug under subsection C.10.004(1) of the Food and Drug Regulations as it read before the coming into force of these Regulations;
(b) the numbered certificate of registration has not been cancelled under section C.10.008 of the Food and Drug Regulations as it read immediately before the coming into force of these Regulations; and
(c) prior to September 1, 1998, the manufacturer or importer has submitted to the Director
(i) the name of the drug for which a drug identification number is to be issued, and
(ii) the information referred to in subsection C.01.014.1(2) of the Food and Drug Regulations.
(3) If more than one numbered certificate of registration has been issued for a drug on the sole basis of a difference in colour, flavour or fragrance, a single drug identification number shall be assigned in respect of the drug.
— SOR/98-423, s. 13
13 Despite section 4 of these Regulations and subject to section C.10.005 of the Food and Drug Regulations as that section read immediately before the coming into force of these Regulations, the Director may, until September 30, 1998, issue a numbered certificate of registration, if
(a) the manufacturer expressly requests that a numbered certificate of registration be issued for the drug; and
(b) its application was accepted by the Director for review before the coming into force of these Regulations.
— SOR/98-423, s. 14
14 Despite section 2, a manufacturer may, until September 30, 2000, label a drug with the label that was in use on September 30, 1998.
— SOR/2001-203, s. 11
11 An application concerning the sale of a drug for human use for the purposes of a clinical trial that is received under Division 8 of the Food and Drug Regulations before September 1, 2001 is subject to those Regulations and any procedures established under those Regulations as they read at the time the application was received.
— SOR/2003-11, s. 38
38 (1) The following definitions apply in this section.
- former Regulations
former Regulations means the Food and Drug Regulations as they read immediately before the day on which these Regulations come into force. (règlement antérieur)
- manufacturer
manufacturer has the same meaning as in section A.01.010 of the Food and Drug Regulations. (fabricant)
- prepackaged product
prepackaged product has the same meaning as in section B.01.001 of the Food and Drug Regulations. (produit préemballé)
(2) Despite sections 1 to 37 and subject to subsection (3), the former Regulations continue to apply to a prepackaged product that is labelled in accordance with the former Regulations until the day that is three years after the day on which these Regulations come into force, unless the label of the product, or any advertisement for the product that is made or placed by or on the direction of the manufacturer of the product, contains
(a) a statement or claim set out in column 4 of any of items 15, 16 and 22 to 26 of the table following section B.01.513 of the Food and Drug Regulations, as enacted by section 20 of these Regulations;
(b) a statement or claim set out in column 1 of the table following section B.01.603 of the Food and Drug Regulations, as enacted by section 20 of these Regulations; or
(c) the expression “nutrition facts”, “valeur nutritive” or “valeurs nutritives”.
(3) In applying subsection (2) to a prepackaged product that is sold by a manufacturer who had gross revenues from sales in Canada of food of less than $1,000,000 for the 12-month period immediately prior to the day on which these Regulations come into force, the reference to “three years” in that subsection shall be read as a reference to “five years”.
— SOR/2006-241, s. 2
2 Section C.08.004.1 of the Food and Drug Regulations, as it read immediately before the coming into force of these Regulations, applies to a drug in respect of which a notice of compliance was issued before June 17, 2006.
— SOR/2007-302, s. 12
12 Sections 1 to 6 and 11 of these Regulations do not apply to cheese that is made before these Regulations come into force.
— SOR/2013-74, s. 17
17 (1) Every person who, on the day on which these Regulations come into force, fabricates, packages/labels, tests or imports an active pharmaceutical ingredient may continue to do so without an establishment licence if they submit an application for a licence under section C.01A.005 of the Food and Drug Regulations within three months after that day.
(2) Subsection (1) applies until the determination of the licence application under section C.01A.008 or C.01A.010 of the Food and Drug Regulations.
— SOR/2013-74, s. 18, as amended by SOR/2013-178, s. 125
18 The Food and Drug Regulations, as they read immediately before the coming into force of these Regulations, continue to apply in respect of whole blood and blood components until the day before the day on which subsection 3(2) of the Blood Regulations comes into force.
— SOR/2013-172, s. 12
12 If, on the day on which these Regulations come into force, the Director has not yet issued a letter of authorization under subsection C.08.010(1) of the Food and Drug Regulations in response to a request that was made by a practitioner before that day, subsection C.08.010(1.1) of those Regulations, as enacted by section 11, applies in respect of the request.
— SOR/2013-172, s. 13
13 For the purpose of paragraph 11(2)(a) of the Statutory Instruments Act, these Regulations apply before they are published in the Canada Gazette.
— SOR/2014-158, s. 14
14 The following definitions apply in sections 15 to 32:
- submission
submission means any of the following:
(a) a new drug submission that is filed under section C.08.002 of the Food and Drug Regulations;
(b) an extraordinary use new drug submission that is filed under section C.08.002.01 of those Regulations;
(c) an abbreviated new drug submission that is filed under section C.08.002.1 of those Regulations; or
(d) an abbreviated extraordinary use new drug submission that is filed under section C.08.002.1 of those Regulations. (présentation)
- supplement
supplement means a supplement to a submission that is filed under section C.08.003 of the Food and Drug Regulations. (supplément)
— SOR/2014-158, s. 15
15 Subsection C.01.014.1(2) of the Food and Drug Regulations, as it read immediately before the day on which section 1 comes into force, applies to an application for a drug identification number that is made under subsection C.01.014.1(1) of those Regulations before the day on which section 1 comes into force.
— SOR/2014-158, s. 16
16 Subsection C.08.002(2), subparagraph C.08.002.01(2)(b)(i) or paragraph C.08.002.1(2)(a) of the Food and Drug Regulations, as the case may be, as the applicable provision read immediately before the day on which section 1 comes into force, applies to a submission that is filed before the day on which section 1 comes into force.
— SOR/2014-158, s. 17
17 Section C.08.003 of the Food and Drug Regulations, as it read immediately before the day on which section 1 comes into force, applies to a supplement that is filed before the day on which section 1 comes into force.
— SOR/2014-158, s. 18
18 If a document referred to in subsection C.01.014.2(1) of the Food and Drug Regulations is issued for a drug in respect of an application referred to in section 15 or a submission referred to in section 16, section C.01.014.3 of those Regulations, as it read immediately before the day on which section 1 comes into force, applies in respect of the drug.
— SOR/2014-158, s. 19
19 If a notice of compliance is issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations for a drug in respect of a submission referred to in section 16, paragraph C.08.002(1)(d) of those Regulations, as it read immediately before the day on which section 1 comes into force, applies in respect of the drug.
— SOR/2014-158, s. 20
20 If a notice of compliance is issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations, for a drug in respect of a supplement referred to in section 17, paragraph C.08.003(1)(d) of those Regulations, as it read immediately before the day on which section 1 comes into force, applies in respect of the drug.
— SOR/2014-158, s. 21
21 In sections 22 to 32, drug means a drug for human use in dosage form other than a drug that belongs to one of the following classes:
(a) prescription drugs; or
(b) drugs that are permitted to be sold without a prescription but that are administered only under the supervision of a practitioner.
— SOR/2014-158, s. 22
22 Section A.01.016 of the Food and Drug Regulations, as it read immediately before the day on which section 1 comes into force, applies in respect of a drug during the period that begins on the day on which section 1 comes into force and that ends immediately before the day on which section 3 comes into force.
— SOR/2014-158, s. 23
23 Section A.01.017 of the Food and Drug Regulations, as enacted by section 2, and section C.01.004.01 of those Regulations, as enacted by subsection 4(1), do not apply in respect of a drug during the period that begins on the day on which section 1 comes into force and that ends immediately before the day on which section 3 comes into force.
— SOR/2014-158, s. 24
24 Paragraph C.01.014.1(2)(m) of the Food and Drug Regulations, as it read immediately before the day on which section 1 comes into force, applies to an application for a drug identification number in respect of a drug that is made under subsection C.01.014.1(1) of those Regulations during the period that begins on the day on which section 1 comes into force and that ends immediately before the day on which section 3 comes into force.
— SOR/2014-158, s. 25
25 Paragraph C.08.002(2)(j) of the Food and Drug Regulations, as it read immediately before the day on which section 1 comes into force, applies to a submission in respect of a drug that is filed during the period that begins on the day on which section 1 comes into force and that ends immediately before the day on which section 3 comes into force.
— SOR/2014-158, s. 26
26 If a document referred to in subsection C.01.014.2(1) of the Food and Drug Regulations is issued for a drug in respect of an application referred to in section 24 or a submission referred to in section 25, section C.01.014.3 of those Regulations, as it read immediately before the day on which section 1 comes into force, applies in respect of the drug.
— SOR/2014-158, s. 27
27 If a notice of compliance is issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations for a drug in respect of a submission referred to in section 25, paragraph C.08.002(1)(d) of those Regulations, as it read immediately before the day on which section 1 comes into force, applies in respect of the drug.
— SOR/2014-158, s. 28
28 If a notice of compliance is issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations for a drug in respect of a supplement that is filed during the period that begins on the day on which section 1 comes into force and that ends immediately before the day on which section 3 comes into force, paragraph C.08.003(1)(d) of those Regulations, as it read immediately before the day on which section 1 comes into force, applies in respect of the drug.
— SOR/2014-158, s. 29
29 Paragraphs C.01.014.1(2)(m.1) and (o) of the Food and Drug Regulations, as enacted by subsection 7(3), do not apply to an application referred to in section 24.
— SOR/2014-158, s. 30
30 Paragraphs C.08.002(2)(j.1) and (o) of the Food and Drug Regulations, as enacted by subsections 10(3) and (5) respectively, do not apply to a submission referred to in section 25.
— SOR/2014-158, s. 31
31 If a notice of compliance is issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations for a drug, paragraph C.08.003(2)(g.1) of those Regulations, as enacted by subsection 13(3), does not apply in respect of the drug during the period that begins on the day on which section 1 comes into force and that ends immediately before the day on which section 3 comes into force.
— SOR/2014-158, s. 32
32 Subsection C.08.003(3.1) of the Food and Drug Regulations, as enacted by subsection 13(4), does not apply to a supplement referred to in section 28.
— SOR/2016-74, s. 17
17 (1) In this section,
- former Regulations
former Regulations means the Food and Drug Regulations as they read immediately before the day on which these Regulations come into force. (règlement antérieur)
- saccharin sweetener
saccharin sweetener means a saccharin sweetener as defined in subsection E.01.001(1) of the former Regulations. (édulcorant à la saccharine)
(2) Despite sections 11 to 16, if, on the day immediately before the day on which these Regulations come into force, a saccharin sweetener was sold in accordance with Part E of the former Regulations, the sale of the sweetener may continue in accordance with Part E of the former Regulations for a period of one year beginning on the day on which these Regulations come into force.
— SOR/2016-305, s. 76
76 (1) The following definitions apply in this section.
- former Regulations
former Regulations means the provisions of the Food and Drug Regulations that are amended or repealed by these Regulations — other than those that are amended or repealed by any of sections 12 or 49 to 56 — as they read immediately before the day on which these Regulations come into force. (règlement antérieur)
- prepackaged product
prepackaged product has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations. (produit préemballé)
(2) Despite these Regulations, a prepackaged product may be labelled in accordance with the former Regulations or these Regulations until the day that is five years after the day on which these Regulations come into force.
— SOR/2017-76, s. 11
11 (1) In this section, fabricate, package/label, import and active pharmaceutical ingredient have the same meaning as in subsection C.01A.001(1) of the Food and Drug Regulations.
(2) Every person who, on or before the day on which section 7, subsections 8(1) and (3) and section 9 of these Regulations come into force, fabricates, packages/labels, tests or imports an active pharmaceutical ingredient for veterinary use may continue to do so without an establishment licence if they submit an application for a licence under section C.01A.005 of the Food and Drug Regulations within 14 months after that day.
(3) Subsection (2) applies until the determination of the licence application is made under section C.01A.008 or C.01A.010 of the Food and Drug Regulations.
— SOR/2017-259, s. 24
24 In sections 25 and 26, drug means a drug that is listed in Schedule C to the Food and Drugs Act, that is in dosage form and that was available for sale in Canada before the day on which these Regulations come into force.
— SOR/2017-259, s. 25
25 (1) Despite these Regulations, if the labels of a drug display information in accordance with one of the following provisions of the Food and Drug Regulations, as they read immediately before the day on which these Regulations come into force, that provision continues to apply in respect of the drug:
(a) subsection C.03.202(1);
(b) subsection C.03.203(1); or
(c) section C.03.208.
(2) Subsection (1) ceases to apply in respect of a drug
(a) if an application for a drug identification number for the drug is made under subsection C.01.014.1(1) of the Food and Drug Regulations within six months after the day on which these Regulations come into force,
(i) in the case of a kit as defined in section C.03.205 of the Food and Drug Regulations, 24 months after the day on which the final decision on the application is made, and
(ii) in the case of any other drug, 12 months after the day on which the final decision on the application is made; and
(b) if an application for a drug identification number for the drug is not made under subsection C.01.014.1(1) of the Food and Drug Regulations within six months after the day on which these Regulations come into force,
(i) in the case of a kit as defined in section C.03.205 of the Food and Drug Regulations, 30 months after the day on which these Regulations come into force, and
(ii) in the case of any other drug, 18 months after the day on which these Regulations come into force.
— SOR/2017-259, s. 26
26 (1) Despite these Regulations, subsection C.01.014(2) of the Food and Drug Regulations, as it read immediately before the day on which these Regulations come into force, continues to apply in respect of a drug.
(2) Subsection (1) ceases to apply in respect of a drug
(a) if an application for a drug identification number for the drug is made under subsection C.01.014.1(1) of the Food and Drug Regulations within six months after the day on which these Regulations come into force and a document referred to in subsection C.01.014.2(1) of the Food and Drug Regulations is issued in respect of the drug, on the day on which the document is issued;
(b) if an application for a drug identification number for the drug is made under subsection C.01.014.1(1) of the Food and Drug Regulations within six months after the day on which these Regulations come into force and the final decision on the application is a refusal to issue a document referred to in subsection C.01.014.2(1) of the Food and Drug Regulations in respect of the drug,
(i) in the case of a kit as defined in section C.03.205 of the Food and Drug Regulations, 24 months after the day on which the final decision is made, and
(ii) in the case of any other drug, 12 months after the day on which the final decision is made; and
(c) in the cases referred to in paragraph 25(2)(b), at the end of the period referred to in subparagraph 25(2)(b)(i) or (ii), as the case may be.
— SOR/2019-62, s. 4
4 In sections 5 and 6, information in respect of a clinical trial has the same meaning as in section C.08.009.1 of the Food and Drug Regulations.
— SOR/2019-62, s. 5
5 Despite subsection C.08.009.2(1) of the Food and Drug Regulations, information in respect of a clinical trial that is confidential business information and that is contained in a submission or supplement with respect to which one of the following circumstances occurred before the day on which these Regulations come into force ceases to be confidential business information on the day on which these Regulations come into force:
(a) the Minister issued a notice of compliance under section C.08.004 or C.08.004.01 of the Food and Drug Regulations;
(b) the Minister, after having notified the manufacturer under paragraph C.08.004(1)(b) or C.08.004.01(1)(b) of the Food and Drug Regulations that the submission or supplement did not comply with section C.08.002, C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1 of those Regulations, issued a notice to the manufacturer, in view of the omission by the manufacturer to amend the submission or supplement, that indicated that the submission or supplement was considered to have been withdrawn;
(c) the Minister notified the manufacturer under paragraph C.08.004(3)(b) or C.08.004.01(3)(b) of the Food and Drug Regulations that the submission or supplement did not comply with section C.08.002, C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1 of those Regulations.
— SOR/2019-62, s. 6
6 (1) This section applies to information in respect of a clinical trial that is confidential business information and that is contained in a submission or supplement
(a) that was filed within 90 days before the day on which these Regulations come into force; and
(b) with respect to which the Minister notified the manufacturer under paragraph C.08.004(1)(b) or C.08.004.01(b) of the Food and Drug Regulations before the day on which these Regulations come into force that the submission or supplement did not comply with section C.08.002, C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1 of the Food and Drug Regulations.
(2) Despite subsection C.08.009.2(1) of the Food and Drug Regulations, information in respect of a clinical trial that is contained in a submission or supplement ceases to be confidential business information upon the expiry of whichever of the following periods applies if the manufacturer does not amend the submission or supplement within that period:
(a) 90 days after the day on which these Regulations come into force; or
(b) any longer period specified by the Minister.
— SOR/2019-62, s. 7
7 Sections 5 and 6 do not apply to information referred to in subsection C.08.009.2(2) of the Food and Drug Regulations.
— SOR/2019-98, s. 6
6 Despite these Regulations, beer may, until December 13, 2022, be sold in accordance with the Food and Drug Regulations, as they read immediately before the day on which these Regulations come into force.
— SOR/2019-217, s. 2
2 Despite these Regulations, vodka may, until December 13, 2022, be sold in accordance with the Food and Drug Regulations, as they read immediately before the day on which these Regulations come into force.
— SOR/2021-45, s. 18
18 (1) The following definitions apply in this section and in sections 19 to 30:
- authorization
authorization means an authorization that was issued under the ISAD Interim Order in respect of a new drug on the basis of
(a) an application submitted under section 3 of the ISAD Interim Order other than an application that was submitted on the basis of a direct or indirect comparison of the new drug to another drug; or
(b) an application submitted under section 4 of the ISAD Interim Order. (autorisation)
- supplement
supplement means a supplement to a new drug submission that is filed under section C.08.003 of the Food and Drug Regulations. (supplément)
(2) Unless the context otherwise requires, words and expressions used in this section and in sections 19 to 30 have the meanings assigned by the Food and Drug Regulations.
— SOR/2021-45, s. 19
19 (1) Despite subsection 2(1) of the ISAD Interim Order, the manufacturer of a new drug who is the holder of an authorization in respect of the new drug may file a new drug submission under section C.08.002 of the Food and Drug Regulations, or a supplement, for the new drug and subsection C.01.014.1(3) and Division 8 of Part C of those Regulations apply in respect of the submission or supplement.
(2) The authorization is revoked if the manufacturer does not file a new drug submission under section C.08.002 of the Food and Drug Regulations, or a supplement, for the new drug within one of the following periods, as applicable:
(a) in the case of an authorization that was issued before the day on which this section comes into force, 90 days after the day on which this section comes into force; or
(b) in the case of an authorization that is issued on or after the day on which this section comes into force, 90 days after the day on which the authorization is issued.
(3) If the manufacturer files a new drug submission under section C.08.002 of the Food and Drug Regulations, or a supplement, for the new drug within the applicable period set out in paragraph (2)(a) or (b), the authorization is revoked when one of the following circumstances occurs:
(a) the Minister issues a notice of compliance under section C.08.004 of those Regulations in respect of the submission or supplement;
(b) if the Minister issues a notice to the manufacturer under paragraph C.08.004(1)(b) of those Regulations in respect of the submission or supplement and the manufacturer does not amend the submission or supplement in accordance with subsection C.08.004(2) of those Regulations, the period referred to in subsection C.08.004(2) expires;
(c) the Minister issues a notice to the manufacturer under paragraph C.08.004(3)(b) of those Regulations in respect of the submission or supplement.
— SOR/2021-45, s. 20
20 The Food and Drug Regulations — other than the following provisions — do not apply to a new drug in respect of which an authorization was issued to the manufacturer of the new drug if, immediately before the day on which this section comes into force, the authorization was neither suspended nor revoked:
(a) sections A.01.014, A.01.015, A.01.022 to A.01.043, A.01.050, A.01.051 and A.01.060.1 to A.01.068;
(b) sections C.01.004 to C.01.011, C.01.014.9, C.01.014.10, C.01.017 and C.01.019, subsection C.01.020(1) and sections C.01.020.1, C.01.040.3 to C.01.053, C.01.064 to C.01.069 and C.01.401;
(c) the provisions of Divisions 1A and 2 of Part C;
(d) sections C.03.202, C.03.203 and C.03.206 to C.03.209; and
(e) sections C.04.013 to C.04.016, C.04.019 and C.04.020.
— SOR/2021-45, s. 21
21 (1) The drug identification number that was assigned under subsection 7(1) of the ISAD Interim Order in relation to a new drug that is referred to in section 20 continues to be assigned for the distinct combination of dosage form, strength and route of administration of the new drug.
(2) A reference in Divisions 1 and 1A of Part C of the Food and Drug Regulations — other than in sections C.01.050, C.01.052, C.01.053 and C.01A.003 — to a drug identification number is deemed to include a reference to the drug identification number that is referred to in subsection (1).
(3) A reference in section C.01A.003 of the Food and Drug Regulations to a distributor who holds a drug identification number is deemed to include a reference to the manufacturer who is referred to in section 20.
— SOR/2021-45, s. 22
22 The manufacturer who is referred to in section 20 shall, within 15 days after the day on which the new drug is first sold in Canada, notify the Minister, in writing, of the date of that first sale, unless the manufacturer has already done so under section 8 of the ISAD Interim Order.
— SOR/2021-45, s. 23
23 The manufacturer who is referred to in section 20 shall, within 15 days after the day on which the manufacturer permanently discontinues the sale in Canada of the new drug, notify the Minister, in writing, of the date on which the sale was permanently discontinued, unless the manufacturer has already done so under section 9 of the ISAD Interim order.
— SOR/2021-45, s. 24
24 Despite the definition drug in section C.01.014.8 of the Food and Drug Regulations, sections C.01.014.9 and C.01.014.10 of those Regulations apply, with any necessary modifications, to the manufacturer who is referred to in section 20 in respect of the new drug.
— SOR/2021-45, s. 25
25 (1) Subject to subsection (2), sections 20 to 24 cease to apply to a new drug that is referred to in section 20 90 days after the day on which this section comes into force.
(2) If the manufacturer who is referred to in section 20 files, for the new drug, a new drug submission under section C.08.002 of the Food and Drug Regulations or a supplement, within the period referred to in subsection (1) or has filed such a submission or supplement before the day on which this section comes into force, sections 20 to 24 cease to apply to the new drug when one of the circumstances referred to in paragraphs 19(3)(a) to (c) occurs.
— SOR/2021-45, s. 26
26 (1) Despite subsection 1(3) of the ISAD Interim Order, for the purposes of the definition innovative drug in subsection C.08.004.1(1) of the Food and Drug Regulations, a medicinal ingredient is not considered to be approved in a drug by reason of the Minister having issued or amended an authorization under the ISAD Interim Order in respect of a COVID-19 drug that contains the medicinal ingredient.
(2) Subsection (1) ceases to apply on the day on which the ISAD Interim Order ceases to have effect.
— SOR/2021-45, s. 27
27 (1) Any terms and conditions of an establishment licence — other than those that are imposed by the Minister under the ISAD Interim Order — are deemed to be imposed by the Minister under subsection C.01A.008(4) of the Food and Drug Regulations.
(2) Any terms and conditions of an establishment licence that are imposed by the Minister under the ISAD Interim Order are deemed to be imposed by the Minister under section C.01A.012.1 of the Food and Drug Regulations.
— SOR/2021-45, s. 28
28 (1) Despite subsection 26(1) of the ISAD Interim Order, any establishment licence that is referred to in that subsection is not cancelled immediately before the ISAD Interim Order ceases to have effect if the holder of the establishment licence notifies the Minister in writing, before the day on which the ISAD Interim Order ceases to have effect, of their intention to continue to conduct activities in respect of the COVID-19 drug under the establishment licence.
(2) Despite subsection 26(2) of the ISAD Interim Order, any amendment that is referred to in that subsection to an establishment licence continues to have effect after the ISAD Interim Order ceases to have effect if the holder of the establishment licence notifies the Minister in writing, before the day on which the ISAD Interim Order ceases to have effect, of their intention to continue to conduct activities in respect of the COVID-19 drug under the amended establishment licence.
— SOR/2021-45, s. 29
29 Information and material in respect of a designated COVID-19 drug that were provided under paragraphs 28(1)(a) and (b) or 30(a) of the ISAD Interim Order are deemed to have been provided under, as the case may be, paragraphs C.08.009.03(1)(a) and (b) or C.08.009.05(a) of the Food and Drug Regulations.
— SOR/2021-45, s. 30
30 Section C.08.009.05 of the Food and Drug Regulations applies, with any necessary modifications, in respect of a designated COVID-19 drug that was imported under section 28 of the ISAD Interim Order.
— SOR/2021-57, s. 25
25 (1) In this section, new Regulations means the Food and Drug Regulations as they read on the day on which these Regulations come into force.
(2) A human milk fortifier, as defined in section B.25.001 of the new Regulations, that is set out in the List of Human Milk Fortifiers Sold in Canada as of March 25, 2021 that is published on a Government of Canada website does not need to be labelled in accordance with the new Regulations if it is labelled in the same way as it was labelled immediately before the day on which these Regulations come into force.
(3) Subsections (1) and (2) cease to have effect on the second anniversary of the day on which these Regulations come into force.
— SOR/2021-199, s. 9
9 A person who holds an establishment licence and who created a record in accordance with the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply), made by the Minister of Health on November 27, 2020 and published in Part I of the Canada Gazette on December 12, 2020, must retain the record in accordance with subsection C.01.014.14(2) of the Food and Drug Regulations.
— SOR/2021-199, s. 10
10 (1) In this section and in sections 11 to 15, Exceptional Importation and Shortages Interim Order No. 2 means the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19, made by the Minister of Health on March 1, 2021 and published in Part I of the Canada Gazette on March 20, 2021.
(2) In sections 11 to 15, designated biocide, designated drug, designated food for a special dietary purpose, designated hand sanitizer and designated medical device have the same meaning as in the Exceptional Importation and Shortages Interim Order No. 2.
— SOR/2021-199, s. 11
11 (1) Section C.10.008 of the Food and Drug Regulations applies in respect of a designated drug that was imported under the Exceptional Importation and Shortages Interim Order No. 2.
(2) Sections C.10.009 to C.10.011 of those Regulations apply to a person that holds an establishment licence in respect of a designated drug that they imported under that Interim Order.
— SOR/2021-199, s. 12
12 (1) Subject to subsection (2), subsections C.10.008(1) and (2) of the Food and Drug Regulations apply in respect of a designated biocide that was imported under the Exceptional Importation and Shortages Interim Order No. 2.
(2) For the purposes of subsection (1), that subsection C.10.008(1) is to be read without reference to
(a) sections A.01.015 and A.01.017 in paragraph C.10.008(1)(a);
(b) sections C.01.040.3 to C.01.049.1 in subparagraph C.10.008(1)(b)(i);
(c) subparagraph C.10.008(1)(b)(ii); and
(d) sections C.10.009 to C.10.011 in subparagraph C.10.008(1)(b)(iii).
(3) Subsection (1) ceases to apply on December 31, 2022 in respect of the sale of a designated biocide, other than at retail sale, that was imported under the Exceptional Importation and Shortages Interim Order No. 2.
(4) An importer must not sell a designated biocide that they imported under that Interim Order unless they ensure that the information referred to in paragraph 12(2)(d) of that Interim Order is available in English and French and in a manner that permits the safe use of the biocide.
(5) The importer must ensure that the information is available in accordance with subsection (4) until at least the expiration of the period that corresponds to the useful life of whichever of the designated biocides that they imported has the latest useful life.
— SOR/2021-199, s. 14
14 (1) Sections A.01.014 and A.01.016 of the Food and Drug Regulations, the provisions of Part B of those Regulations — other than sections B.24.100 and B.24.300 — and the provisions of Part D of those Regulations do not apply in respect of the sale of a designated food for a special dietary purpose that was imported under the Exceptional Importation and Shortages Interim Order No. 2.
(2) A sale of a designated food for a special dietary purpose that was imported under the Interim Order is exempt from paragraphs 4(1)(a) and (d) of the Food and Drugs Act in respect of the use or presence of any of the substances or materials referred to in paragraphs 24(2)(a) to (g) of that Interim Order.
(3) Subsections (1) and (2) cease to apply in respect of the sale of a designated food for a special dietary purpose on the food’s expiration date.
(4) An importer must not sell a designated food for a special dietary purpose that they imported under the Exceptional Importation and Shortages Interim Order No. 2 No. 2 unless they ensure that the information referred to in subparagraphs 25(2)(e)(ii) to (vii) of that Interim Order is available in English and French and in a manner that permits the safe preparation and use of the food.
(5) The importer shall ensure that the information is available in accordance with subsection (4) until at least the end of the day on the latest expiration date of the designated food for a special dietary purpose that they imported.
(6) In this section, expiration date has the same meaning as in section B.25.001 of the Food and Drug Regulations.
— SOR/2021-199, s. 15
15 A person who, immediately before the Exceptional Importation and Shortages Interim Order No. 2 ceased to have effect, was permitted, under subsection 30(2) of that Interim Order, to conduct an activity in respect of a designated hand sanitizer may continue to do so without holding an establishment licence that authorizes them to do so until the earliest of
(a) the occurrence of one of the circumstances referred to in paragraphs 30(2)(a) to (c) of that Interim Order, and
(b) September 1, 2023.
— SOR/2022-100, s. 10
10 (1) Unless the context requires otherwise, words and expressions used in this section have the same meaning as in subsection C.01A.001(1) of the Food and Drug Regulations.
(2) Subject to subsection (3), during the three-month period that begins on the day on which these Regulations come into force, a drug that has, until that day, been exempt, under subsection 37(1) of the Act, from the provisions prescribed in section A.01.048 of the Food and Drug Regulations and that continues to meet the conditions set out in subsection 37(1)
(a) may, despite section C.01A.004 of those Regulations, continue to be fabricated, packaged/labelled, tested, distributed or wholesaled by a person that conducted the activity before that day and that does not hold an establishment licence that authorizes the activity in respect of the drug; and
(b) is exempt from the provisions of Divisions 2 to 4 of Part C of those Regulations that are prescribed in section A.01.048.
(3) If, before the end of the three-month period, a person referred to in paragraph (2)(a) submits — in accordance with section C.01A.005 or C.01A.006 of the Food and Drug Regulations — an application for, or to amend, an establishment licence to authorize the activity that they have been conducting in respect of the drug, the person is, in respect of the activity, exempt from the requirement to hold an establishment licence and from the provisions referred to in paragraph (2)(b) until the Minister of Health
(a) issues the licence or amends it to authorize the activity; or
(b) notifies the person, after giving them the opportunity to be heard, that the licence will not be issued or amended.
(4) The exemptions referred to in subsection (3) cease to apply if the person withdraws the application.
— SOR/2022-168, s. 53
53 (1) The following definitions apply in this section.
- former Regulations
former Regulations means the Food and Drug Regulations as they read immediately before the day on which these Regulations come into force. (ancien règlement)
- prepackaged product
prepackaged product has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations. (produit préemballé)
(2) A prepackaged product is not required to be labelled in accordance with the following provisions of the Food and Drug Regulations if the product is labelled in accordance with the former Regulations and no change has been made to the label of the product to bring the product into compliance with any of the following provisions:
(a) sections B.01.350 to B.01.358;
(b) subsection B.01.503(1.1);
(c) subsection B.01.508(2);
(d) subsection B.01.509(2); and
(e) section D.01.001.2.
(3) A prepackaged product is not required to be labelled in accordance with the following provisions of the Food and Drug Regulations if it is labelled in accordance with the former Regulations and no change has been made to the label of the product to bring the product into compliance with any of the following provisions:
(a) subsections B.01.008.1(1), (3) and (4);
(b) paragraph B.01.008.2(2)(b);
(c) subsection B.01.010.3(1);
(d) section B.01.010.4;
(e) section B.01.014;
(f) section B.01.023;
(g) paragraph B.01.305(3)(g); and
(h) section B.01.467.
(4) A prepackaged product is not required to be labelled in accordance with the following provisions of the Food and Drug Regulations if it is labelled in accordance with the former Regulations and no change has been made to the label of the product to bring the product into compliance with any of the following provisions:
(a) subsection B.01.305(1) and paragraphs B.01.305(2)(a) and (3)(h);
(b) subparagraph B.01.401(3)(e)(ii) and items 2 to 5, 7, 8 and 16 of the table to section B.01.401;
(c) section B.01.500;
(d) sections B.01.502 to B.01.507;
(e) subsection B.01.508(1);
(f) subsection B.01.509(1);
(g) sections B.01.510 to B.01.512;
(h) subparagraph B.01.601(1)(c)(i);
(i) items 1 to 3 of the table following section B.01.603;
(j) paragraphs B.08.033(1.1)(a) and (1.2)(a);
(k) paragraphs B.08.034(1.1)(a) and (1.2)(a); and
(l) subsections B.24.003(1.1) and (4).
(5) A food to which any of the following provisions of the Food and Drug Regulations applies is not required to contain an amount of vitamin D that complies with the requirement set out in the provision if the food contains an amount of vitamin D that complies with the requirement set out in the provision of the former Regulations:
(a) paragraph B.08.003(b);
(b) paragraph B.08.004(c);
(c) paragraph B.08.005(c);
(d) paragraph B.08.007(d);
(e) paragraph B.08.010(d);
(f) paragraph B.08.011(e);
(g) paragraph B.08.012(f);
(h) paragraph B.08.013(c);
(i) paragraph B.08.014(d);
(j) paragraph B.08.016(c);
(k) paragraph B.08.017(d);
(l) paragraph B.08.018(d);
(m) paragraph B.08.019(e);
(n) paragraph B.08.020(d);
(o) paragraph B.08.023(e);
(p) paragraph B.08.026(e); and
(q) subparagraph B.09.016(b)(iii), including as it applies to calorie-reduced margarine.
(6) For the purposes of the prohibitions set out in section B.08.029 of the Food and Drug Regulations, a food is not required to contain the amount of vitamin D set out in the applicable subsection of that section if the food contains an amount of vitamin D that falls within the range set out in the subsection of the former Regulations.
(7) This section ceases to have effect on December 31, 2025.
— SOR/2022-169, s. 31
31 (1) The following definitions apply in this section and sections 32 to 36.
- Threshold Levels for Cautionary Statements and Other Conditions of Use
Threshold Levels for Cautionary Statements and Other Conditions of Use means the document entitled Threshold Levels for Cautionary Statements and Other Conditions of Use, published by the Government of Canada on its website, as it reads on the day on which these Regulations come into force. (Seuils maximaux relatifs aux mises en garde et autres conditions d’utilisation)
- TMAL Lists
TMAL Lists means one or more of the following lists, published by the Government of Canada on its website, as they read on the day on which these Regulations come into force:
(a) the List of beverages, beverage mixes and concentrates;
(b) the List of caffeinated energy drinks; and
(c) the List of conventional foods. (Listes LAMT)
(2) Unless the context requires otherwise, words and expressions used in this section and sections 32 to 36 have the same meaning as in the Food and Drugs Act and the Food and Drug Regulations.
— SOR/2022-169, s. 32
32 (1) Subject to section 35, the manufacturer of a food for which a Temporary Marketing Authorization Letter was issued under subsection B.01.054(1) of the Food and Drug Regulations and for which a Temporary Marketing Authorization number is set out in the TMAL Lists is exempt from the application of the Food and Drug Regulations in respect of the food if the following conditions are met:
(a) when the Letter expired, the food was not the subject of an outstanding request that it be withdrawn from the market; and
(b) since the expiration of the Letter,
(i) subject to subsection (2), the manufacturer has complied with the Food and Drug Regulations, as they read immediately before the day on which these Regulations come into force, except any provision set out in Appendix 1 to the Letter with which the food does not need to comply,
(ii) the manufacturer has complied with the following conditions set out in Appendix 1 to the Letter, as applicable:
(A) there are no marks, statements, labels or advertisements, including product sampling, that promote the food for consumption by children or by pregnant or breastfeeding women,
(B) the food contains the substances referred to in Appendix 2 to the Letter in the amounts set out in that Appendix,
(C) the statements set out in Appendix 1 to the Letter, or statements with equivalent meaning, are shown on the label of the food,
(D) no claims are made on the label of the food relating to physical performance or health benefits of the food, and
(E) the conditions set out in Appendix 3 to the Letter are complied with, and
(iii) no substance set out in column 1 of the List of Permitted Supplemental Ingredients has been added to the food, with the exception of a substance
(A) set out in Appendix 2 to the Letter, or
(B) used as a food additive to which a marketing authorization applies.
(2) The manufacturer may, in respect of the food referred to in subsection (1), comply with the provisions of the Food and Drug Regulations that were amended by sections 1 to 11, 13 to 48, and 57 to 75 of the Regulations Amending the Food and Drug Regulations (Nutrition Labelling, Other Labelling Provisions and Food Colours), as they read on December 13, 2016.
— SOR/2022-169, s. 33
33 (1) Subject to section 35, if a manufacturer of a food has submitted a request for a Temporary Marketing Authorization Letter for the food before the day on which these Regulations come into force and a Temporary Marketing Authorization Letter has not been issued under subsection B.01.054(1) of the Food and Drug Regulations before that day, the manufacturer is exempt from the application of the Food and Drug Regulations in respect of the food if the following conditions are met:
(a) the Minister notifies the manufacturer, in accordance with subsection (2), that the sale of the food is authorized;
(b) subject to subsections (3) and (4), the manufacturer complies with the Food and Drug Regulations as they read immediately before the day on which these Regulations come into force;
(c) no substance set out in column 1 of the List of Permitted Supplemental Ingredients has been added to the food, with the exception of a substance
(i) contained in the food in the amount specified in the request in response to which the Minister has issued a notice referred to in paragraph (a), or
(ii) used as a food additive to which a marketing authorization applies;
(d) with respect to a food, other than a food referred to in paragraphs (f) and (g), if a substance set out in column 1 of the table to Part I of the Threshold Levels for Cautionary Statements and Other Conditions of Use has been added to the food — other than as a food additive to which a marketing authorization applies — and the total amount of that substance contained in the food is equal to or above the thresholds set out in columns 2 to 6 of the table for that substance, the label of the food carries the applicable cautionary statements set out in the headings to columns 2 to 6 of that table or statements with equivalent meaning;
(e) if the cautionary statement “Not intended for children”, “For adults only” or “If you are pregnant or breastfeeding consult a Health Care Practitioner prior to use”, or a statement with equivalent meaning, appears on the label of the food, there are no marks, statements, labels or advertisements, including product sampling, that promote the food for consumption by children or by pregnant or breastfeeding women, as the case may be;
(f) with respect to a food that is a beverage that contains added caffeine and has a total amount of caffeine of more than 200 parts per million, the label of the food carries the following cautionary statements or statements with equivalent meaning:
(i) if a substance set out in column 1 of the table to Part I of the Threshold Levels for Cautionary Statements and Other Conditions of Use has been added to the food — other than as a food additive to which a marketing authorization applies — and the total amount of that substance contained in the food is equal to or above the threshold level set out in column 8 for that substance, the applicable cautionary statement set out in the heading to column 8 of that table or a statement with equivalent meaning, and
(ii) the cautionary statements set out in the headings to columns 2 to 4 of the table to Part II of the Threshold Levels for Cautionary Statements and Other Conditions of Use or statements with equivalent meaning;
(g) with respect to a food that contains added caffeine, other than a food referred to in paragraph (f), the label of that food carries the following cautionary statements or statements with equivalent meaning:
(i) if a substance set out in column 1 of the table to Part I of the Threshold Levels for Cautionary Statements and Other Conditions of Use has been added to the food — other than as a food additive to which a marketing authorization applies — and the total amount of that substance contained in the food is equal to or above the thresholds set out in columns 2 to 6 for that substance, the applicable cautionary statements set out in the headings to columns 2 to 6 of that table or statements with equivalent meaning, and
(ii) if the total amount of caffeine contained in the food is equal to or above the thresholds set out in columns 2 to 4 of the table to Part II of the Threshold Levels for Cautionary Statements and Other Conditions of Use for the food category set out in column 1 to which the food belongs, the applicable cautionary statements set out in the headings to columns 2 to 4 of the table to Part II or statements with equivalent meaning;
(h) with respect to a food referred to in paragraph (f) or (g), the manufacturer complies with the conditions of use set out in column 6 of the table to Part II of the Threshold Levels for Cautionary Statements and Other Conditions of Use for the food category set out in column 1 to which the food belongs; and
(i) if the cautionary statement “Not recommended for children, pregnant or breastfeeding women and individuals sensitive to caffeine”, or a statement with equivalent meaning, appears on the label of the food, there are no marks, statements, labels or advertisements, including product sampling, that promote the food for consumption by children or by pregnant or breastfeeding women.
(2) The Minister must provide written notification to the manufacturer that the sale of the food is authorized if
(a) the manufacturer submits to the Minister
(i) the information referred to in subparagraphs B.01.054(1)(a)(i) to (vii) of the Food and Drug Regulations as they read immediately before the day on which these Regulations come into force, and
(ii) any other information requested by the Minister to assess the information referred to in subparagraph (i); and
(b) the food belongs to a food category set out in column 1 of the List of Permitted Supplemented Food Categories;
(c) in the case where a substance set out in column 1 of the table to Part I to the Threshold Levels for Cautionary Statements and Other Conditions of Use has been added to the food, the total amount of that substance contained in the food does not exceed the maximum daily level set out in column 7 or 9 of Part I of the table for that substance; and
(d) in the case where caffeine has been added to the food, the total amount of caffeine contained in the food does not exceed the maximum level per serving set out in column 5 of the table to Part II to the Threshold Levels for Cautionary Statements and Other Conditions of Use for the food category to which the food belongs.
(3) The manufacturer need not, in respect of the food referred to in subsection (1), comply with the following provisions of the Food and Drug Regulations as they read immediately before the day on which these Regulations come into force:
(a) section B.01.043,
(i) in respect of caffeine that has been added to the food for a use other than a use set out in columns 2 to 4 of item C.1 of the List of Permitted Food Additives with Other Accepted Uses, published by the Government of Canada on its website, as amended from time to time, or
(ii) in respect of an extraction solvent that has been used in the manufacturing of an extract that has been added to the food other than as a flavouring;
(b) section B.01.045, in respect of caffeine that has been added to the food and that does not meet the specifications set out in the Food Chemicals Codex, tenth edition, 2016, published by the United States Pharmacopeial Convention, Rockville, MD, United States of America, as that or any subsequent edition, including their supplements, may be amended from time to time;
(c) section D.01.009;
(d) section D.01.011;
(e) section D.02.009; or
(f) section D.03.002.
(4) The manufacturer may, in respect of the food referred to in subsection (1), comply with the provisions of the Food and Drug Regulations that were amended by sections 1 to 11, 13 to 48 and 57 to 75 of the Regulations Amending the Food and Drug Regulations (Nutrition Labelling, Other Labelling Provisions and Food Colours), as they read on December 13, 2016.
(5) For greater certainty, the notification referred to in paragraph (1)(a) cannot be a Temporary Marketing Authorization Letter issued under subsection B.01.054(1) of the Food and Drug Regulations.
— SOR/2022-169, s. 34
34 A manufacturer that is exempted under section 32(1) or subsection 33(1) is also exempt from the application of paragraphs 4(1)(a) and (d) of the Food and Drugs Act in respect only of a substance set out in column 1 of the List of Permitted Supplemental Ingredients that has been added to the food.
— SOR/2022-169, s. 35
35 A manufacturer is not exempted under subsection 32(1) or subsection 33(1) in respect of the food referred to in subsection 32(1) or subsection 33(1), as the case may be, if the Minister notifies the manufacturer, in writing, that the Minister has reasonable grounds to believe that the use of the food is detrimental to the health of the consumer.
— SOR/2022-169, s. 36
36 Sections 32 to 35 cease to have effect on December 31, 2025.
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