Food and Drug Regulations (C.R.C., c. 870)
Full Document:
- HTMLFull Document: Food and Drug Regulations (Accessibility Buttons available) |
- XMLFull Document: Food and Drug Regulations [3810 KB] |
- PDFFull Document: Food and Drug Regulations [11713 KB]
Regulations are current to 2025-02-04 and last amended on 2024-12-18. Previous Versions
AMENDMENTS NOT IN FORCE
— SOR/2024-110, s. 76
76 The Food and Drug RegulationsFootnote 1 are amended by adding the following after section A.01.068:
Return to footnote 1C.R.C., c. 870
Non-application
A.01.069 These Regulations do not apply to a drug referred to in paragraph (b) or (c) of the definition biocide in subsection 1(1) of the Biocides Regulations.
— SOR/2024-110, s. 77
77 Subsection C.01.004.02(6) of the Regulations is amended by adding “and” at the end of paragraph (a), by striking out “and” at the end of paragraph (b) and by repealing paragraph (c).
— SOR/2024-110, s. 78
78 Paragraphs C.01.014.1(2)(c) and (d) of the Regulations are replaced by the following:
(c) the recommended route of administration;
— SOR/2024-110, s. 79
79 Subsection C.01.040.2(5) of the Regulations is repealed.
— SOR/2024-110, s. 80
80 The definition antimicrobial agent in subsection C.01A.001(1) of the Regulations is repealed.
— SOR/2024-110, s. 81
81 Subsection C.01A.002(1) of the Regulations is amended by adding “and” at the end of paragraph (c), by striking out “and” at the end of paragraph (d) and by repealing paragraph (e).
— SOR/2024-110, s. 82
82 Section C.02.002.1 of the Regulations is repealed.
— SOR/2024-238, s. 1
1 Subsection A.01.015(2) of the Food and Drug RegulationsFootnote 1 is replaced by the following:
Return to footnote 1C.R.C., c. 870
(2) The adequate directions for use required to be shown on the inner and outer labels of a drug under subparagraph C.01.004(1)(c)(iii) or paragraph C.04.009(2)(f) shall be in English and French if the drug is available for sale without prescription in an open self-selection area.
— SOR/2024-238, s. 2
2 Paragraph A.01.048(d) of the Regulations is replaced by the following:
(d) sections C.04.001 to C.04.006.
— SOR/2024-238, s. 3(2)
3 (2) Subsection C.01.004(5) of the Regulations is replaced by the following:
(5) Subsections (1) to (3) do not apply to a drug that is
(a) sold to a drug manufacturer;
(b) sold by a pharmacist under a prescription or by a practitioner, if its label shows suitable directions for use and meets the requirements set out in section C.01.005; or
(c) listed in Schedule D to the Act.
— SOR/2024-238, s. 5
5 Section C.01.014.1 of the Regulations is amended by adding the following after subsection (3):
(4) The Minister may request that a manufacturer of a drug for human use, other than a new drug, who has made an application under subsection (1) provide the Minister, within a period specified by the Minister that is reasonable in the circumstances, with a risk management plan for the drug that meets the requirements set out in section C.01.701, if the Minister has reasonable grounds to believe that
(a) there is a significant degree of uncertainty respecting the risks associated with the drug; or
(b) the drug presents a serious risk of injury to human health that warrants that measures, other than labelling, be taken to reduce the probability or severity of such an injury.
— SOR/2024-238, s. 6
6 Subsection C.01.014.2(2) of the Regulations is replaced by the following:
(2) The Minister may refuse to issue the document if
(a) the Minister has reasonable grounds to believe that the product to which the application for the drug identification number relates is not a drug;
(b) the Minister has reasonable grounds to believe that the sale of the drug would
(i) cause injury to the health of the purchaser or consumer, or
(ii) contravene a provision of the Act or these Regulations; or
(c) the Minister has requested a risk management plan for the drug under subsection C.01.014.1(4) and the manufacturer
(i) fails to provide the risk management plan within the specified period; or
(ii) provides the Minister with a risk management plan that does not meet the requirements set out in section C.01.701.
— SOR/2024-238, s. 7(4)
7 (4) Section C.01.014.21 of the Regulations is replaced by the following:
C.01.014.21 (1) The Minister may, at any time, impose terms and conditions on a drug identification number assigned for a drug or amend such terms and conditions after considering
(a) whether there are significant uncertainties relating to the benefits or risks associated with the drug;
(b) whether the requirements under the Act are sufficient for the following objectives to be met:
(i) optimizing the benefits and managing the risks associated with the drug,
(ii) managing the uncertainties relating to the benefits and risks, and
(iii) collecting information to enable the continuous assessment of the benefits and risks, the identification of any changes to them and the management of the uncertainties;
(c) whether the proposed terms and conditions may contribute to those objectives being met;
(d) whether compliance with the proposed terms and conditions is technically feasible; and
(e) whether there are less burdensome ways for those objectives to be met.
(2) The Minister shall notify, in writing, the manufacturer who was issued a document under subsection C.01.014.2(1) that sets out the drug identification number, of any terms and conditions imposed on the drug identification number and of any amendment to those terms and conditions.
— SOR/2024-238, s. 8
8 The Regulations are amended by adding the following after section C.01.625:
Risk Management Plans
C.01.700 For the purposes of sections C.01.703 and C.01.704, existing risk management plan means the most recent risk management plan for a drug that the drug’s manufacturer has provided to the Minister under these Regulations.
C.01.701 (1) A risk management plan for a drug that the drug’s manufacturer provides to the Minister under these Regulations must, taking into account the Canadian context, contain sufficient information to enable the Minister to identify and characterize the risks associated with the drug and to conclude that the plan, if implemented, would prevent or reduce those risks or address uncertainties associated with the drug and must include
(a) a description of the drug and the uses of the drug;
(b) a detailed description of the risks associated with the drug and the uncertainties relating to those risks;
(c) a detailed description of the measures that the manufacturer intends to take to address those uncertainties and monitor the situation with respect to them;
(d) a detailed description of the measures that the manufacturer intends to take to prevent or reduce those risks;
(e) a detailed description of how the manufacturer intends to evaluate the effectiveness of the measures referred to in paragraph (d); and
(f) a summary of the plan’s contents in English and French.
(2) Despite paragraph (1)(f), for the purposes of subsection C.01.014.1(4), paragraph C.08.002(2)(p), subparagraph C.08.002.01(2)(b)(xi), paragraph C.08.002.1(2)(a.1) and subsection C.08.003(3.2), the manufacturer may initially provide the summary of the risk management plan in either English or French if the manufacturer then provides a summary of the plan in the other language before the document that sets out the drug identification number assigned for the drug is issued under subsection C.01.014.2(1) or the notice of compliance is issued under section C.08.004 or C.08.004.01.
C.01.702 (1) The Minister may request that the manufacturer of a drug for human use for which a drug identification number has been assigned and not been cancelled provide the Minister, within a period specified by the Minister that is reasonable in the circumstances, with a risk management plan for the drug that meets the requirements set out in section C.01.701, if
(a) a risk management plan for the drug has not yet been provided to the Minister; and
(b) the Minister has reasonable grounds to believe that
(i) there is a significant degree of uncertainty respecting the risks associated with the drug, or
(ii) the drug presents a serious risk of injury to human health that warrants that measures, other than labelling, be taken to reduce the probability or severity of such an injury.
(2) The manufacturer must provide the risk management plan within the specified period.
C.01.703 In cases where there is already an existing risk management plan, the manufacturer of a drug for human use for which a drug identification number has been assigned and not been cancelled must, as soon as feasible, provide the Minister with an updated risk management plan for the drug that meets the requirements set out in section C.01.701 if
(a) the risks associated with the drug, or the uncertainties relating to those risks, are significantly different than those that are described in the existing risk management plan; or
(b) the measures that the manufacturer intends to take to prevent or reduce the risks associated with the drug, or to address the uncertainties relating to those risks and to monitor the situation with respect to those uncertainties, are significantly different than those that are described in the existing risk management plan.
C.01.704 (1) In cases where there is already an existing risk management plan, the Minister may request that the manufacturer of a drug for human use for which a drug identification number has been assigned and not been cancelled provide the Minister, within a period specified by the Minister that is reasonable in the circumstances, with an updated risk management plan for the drug that meets the requirements set out in section C.01.701, if the Minister, on the basis of information obtained after the existing risk management plan was provided, has reasonable grounds to believe that
(a) the risks associated with the drug, or the uncertainties relating to those risks, are significantly different than those that are described in the existing risk management plan; or
(b) the drug presents a serious risk of injury to human health that warrants that measures that are significantly different than those that are described in the existing risk management plan be taken to reduce the probability or severity of such an injury.
(2) The manufacturer must provide the updated risk management plan within the specified period.
— SOR/2024-238, s. 19
19 Subsection C.02.019(4.1) of the Regulations is replaced by the following:
(4.1) Subsections (1) and (2) do not apply to a distributor or importer of a COVID-19 drug if the lot of the drug is the subject of a request made under subsection C.04.007(2).
— SOR/2024-238, s. 22
22 Section C.03.206 of the Regulations is replaced by the following:
C.03.206 Sections C.01.005 and C.04.009 do not apply to a component or kit.
— SOR/2024-238, s. 23
23 Division 4 of Part C of the Regulations is replaced by the following:
DIVISION 4Schedule D Drugs
Definitions
C.04.001 The following definitions apply in this Division.
- biological source material
biological source material means
(a) biological material sourced or derived from humans;
(b) animals, including insects, or any biological material sourced or derived from them;
(c) plants or any biological material sourced or derived from them; or
(d) micro-organisms, including bacteria, viruses, fungi and bacteriophages, or any biological material sourced or derived from them. (matériel d’origine biologique)
- drug
drug means a drug that is listed in Schedule D to the Act that is in dosage form or an active ingredient that can be used in the preparation of a drug listed in that Schedule. (drogue)
- holder
holder, in respect of a drug identification number assigned for a drug, means the manufacturer to whom a document setting out the number was issued under subsection C.01.014.2(1). (titulaire)
Prohibitions on Sale
C.04.002 It is prohibited for a distributor or importer of a drug to sell the drug unless it has been fabricated, packaged/labelled and tested in accordance with this Division.
C.04.003 It is prohibited for a person to sell a drug that they have fabricated, packaged/labelled or tested unless they have fabricated, packaged/labelled or tested it, as the case may be, in accordance with this Division.
Biological Source Material
C.04.004 (1) It is prohibited for a person to use biological source material in the fabrication of a drug unless
(a) the biological source material is
(i) prepared and stored in a manner that ensures its suitability for use in the fabrication of the drug, and
(ii) collected, in the case of material of human or animal origin, under medical or veterinary supervision, as the case may be;
(b) the person collects the information that is necessary to allow the tracing of the biological source material; and
(c) any human from whom, or animal from which, the biological source material is collected — or any animal that is such material — is free from any disease that would make the material unsuitable for use in the fabrication of the drug.
(2) A person who uses biological source material in the fabrication of a drug must ensure that the material meets any specifications for the material that have been provided to the Minister in connection with the drug.
(3) A person who uses biological source material in the fabrication of a drug must retain any documents containing the information referred to in paragraph (1)(b) for a period that they determine after taking into account the following factors, but the period must end no earlier than five years after the day on which the biological source material was last used in the fabrication of the drug:
(a) the nature of the biological source material;
(b) the risks associated with the biological source material;
(c) the manner in which the biological source material is used in the fabrication of the drug; and
(d) if the fabricated drug is in dosage form, the intended use of the drug.
Prevention of Contamination
C.04.005 (1) Every person who fabricates a drug and every person who packages a drug in an immediate container must
(a) segregate all work involving infectious agents that require special handling, including spore-bearing pathogenic micro-organisms; and
(b) minimize the possibility of contamination of biological source material and drugs at the premises where the person fabricates or packages the drug, including by taking measures to protect against infection any individual who has access to the area where the person fabricates or packages the drug.
(2) It is prohibited for a person to conduct laboratory procedures of a diagnostic nature in their premises unless the conduct of those procedures is segregated from the fabrication, packaging/labelling and testing of drugs.
Reference Preparations
C.04.006 Reference preparations that are used to test the purity or potency of a drug must allow for the control of the quality of the drug.
Lot Release
C.04.007 (1) In this section, suitable for sale, in respect of a lot of a drug, means that the lot has been fabricated, packaged/labelled and tested in accordance with these Regulations and in a manner that is consistent with information provided to the Minister regarding the quality and safety of the drug.
(2) The Minister may, for the purpose of assessing whether a lot of a drug in dosage form is suitable for sale, request that the following persons provide the Minister with any information, samples of the drug or its active ingredients, or material to be used to test the samples:
(a) a fabricator of the drug;
(b) a packager/labeller of the drug;
(c) an importer of the drug; or
(d) the holder of the drug identification number.
(3) It is prohibited for a person who is requested to provide information, samples or material under subsection (2), and any other person whom the Minister notifies of the request, to sell drugs from the lot to which the request relates unless the Minister notifies the person that the lot is suitable for sale.
Periodic Quality Reporting
C.04.008 The holder of the drug identification number for a drug in dosage form must, at the request of the Minister, provide the Minister, on an annual basis or at any longer interval specified by the Minister, with information regarding the quality of the drug and its active ingredients, including information regarding the consistency of the fabrication and packaging processes for the drug and the ingredients.
Labelling
C.04.009 (1) The principal display panel of both the inner and outer labels of a drug in dosage form must show
(a) the drug’s brand name, if any;
(b) the drug’s proper name, if any, which, if there is a brand name, must immediately precede or follow the brand name in type not less than one-half the size of that of the brand name;
(c) if there is no proper name, the drug’s common name, which, if there is a brand name, must immediately precede or follow the brand name in type not less than one-half the size of that of the brand name;
(d) the net quantity of the drug in the immediate container for the purpose of the inner label and the net quantity of the drug in the outer package for the purpose of the outer label;
(e) if the drug is sterile, an indication to that effect;
(f) if any of the drug’s medicinal ingredients are sourced or derived from human biological source material, an indication to that effect; and
(g) if any of the drug’s medicinal ingredients are sourced or derived from animal biological source material, the animal species from which each of those ingredients is sourced or derived.
(2) The inner and outer labels of a drug in dosage form must show on any panel
(a) the name of the holder of the drug identification number assigned for the drug;
(b) the potency of the drug, if applicable;
(c) the recommended dose of the drug;
(d) the lot number of the drug;
(e) the expiration date of the drug;
(f) adequate directions for use of the drug; and
(g) any other information that is necessary to prevent injury to human health.
(3) Paragraph (2)(f) does not apply if adequate directions for use of the drug must be displayed on the label in accordance with section C.01.004.02 or C.01.004.03.
(4) Despite paragraph (2)(g), if another provision of these Regulations requires that information referred to in that paragraph be shown on a particular panel of a label, the information must be shown on that panel.
(5) The outer label of a drug in dosage form must show on any panel
(a) the address of the holder of the drug identification number assigned for the drug;
(b) a quantitative list of any preservatives contained in the drug, by their proper names, or if a preservative has no proper name, by its common name;
(c) the approved storage conditions for the drug;
(d) any other information that is necessary for the proper storage and handling of the drug, accompanied, as the case may be, by any designated space for the addition of supplementary information in this regard by the person who stores or handles the drug; and
(e) in the case of a new drug for extraordinary use in respect of which a notice of compliance has been issued under section C.08.004.01, the following statement, displayed in capital letters and in a legible manner:
“HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS EXTRAORDINARY USE NEW DRUG FOR [naming purpose] BASED ON LIMITED CLINICAL TESTING IN HUMANS.
SANTÉ CANADA A AUTORISÉ LA VENTE DE CETTE DROGUE NOUVELLE POUR USAGE EXCEPTIONNEL AUX FINS DE [indication de la fin] EN SE FONDANT SUR DES ESSAIS CLINIQUES RESTREINTS CHEZ L’ÊTRE HUMAIN.”
(6) The inner label requirements of these Regulations do not apply in respect of a drug in dosage form whose immediate container is too small to accommodate an inner label that meets those requirements if
(a) the inner label shows
(i) the drug’s brand name, if any,
(ii) the drug’s proper name, if any,
(iii) the drug’s common name, if there is no proper name,
(iv) the drug identification number assigned for that drug, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”,
(v) the name of the holder of the drug identification number assigned for the drug,
(vi) the net quantity of the drug in the container,
(vii) the drug’s potency, if applicable, unless the drug contains more than one medicinal ingredient and the drug’s brand name is unique for a particular potency of the drug,
(viii) the drug’s lot number,
(ix) the drug’s expiration date,
(x) the drug’s route of administration, and
(xi) any other information that is necessary to prevent injury to human health; and
(b) the outer label meets the applicable requirements of these Regulations.
(7) The expiration date referred to in paragraph (2)(e) and subparagraph (6)(a)(ix) may be omitted from the label of a drug that is to be stockpiled by the following entities for use in emergency situations if the date is communicated by an alternative means to the individuals who administer the drug:
(a) the Government of Canada or the government of a province for the use of a department or agency of that government; or
(b) a municipal government or an institution of a municipal government.
Labelling — Prescription Drugs
C.04.010 (1) In the case of a drug in dosage form that is a prescription drug, the symbol “Pr” must be shown on
(a) the upper left quarter of the principal display panel of both the inner and the outer labels; or
(b) if the drug is packaged in a single-dose container, on the upper left quarter of the principal display panel of the outer label.
(2) Subsection (1) does not apply to a drug that is
(a) sold to a person who holds an establishment licence under Division 1A; or
(b) sold by a pharmacist under a prescription or by a practitioner, if its label shows suitable directions for use and meets the requirements set out in section C.01.005.
— SOR/2024-238, ss. 26(2), (4)
26 (2) Subsection C.08.002(2) of the Regulations is amended by striking out “and” at the end of paragraph (n), by adding “and” at the end of paragraph (o) and by adding the following after paragraph (o):
(p) in the case of a new drug for human use, a risk management plan for the new drug that meets the requirements set out in section C.01.701, if
(i) there is a significant degree of uncertainty respecting the risks associated with the new drug, or
(ii) the new drug presents a serious risk of injury to human health that warrants that measures, other than labelling, be taken to reduce the probability or severity of such an injury.
(4) Subsection C.08.002(2.3) of the Regulations is replaced by the following:
(2.3) If, at the time a new drug submission is filed for a public health emergency drug, the manufacturer is unable to provide the Minister with information or material that is referred to in any of paragraphs (2)(e) to (k), (m), (n) and (p) and (2.1)(b) and subsection (2.2) — and, as applicable, the corresponding material referred to in paragraphs C.08.005.1(1)(b) to (d) — or any of that information or material is incomplete, the manufacturer must provide the Minister, at that time, with a plan that specifies how and when they will provide the Minister with the missing information or material.
— SOR/2024-238, s. 27
27 Paragraph C.08.002.01(2)(b) of the Regulations is amended by striking out “and” at the end of subparagraph (ix), by adding “and” at the end of subparagraph (x) and by adding the following after subparagraph (x):
(xi) a risk management plan for the new drug that meets the requirements set out in section C.01.701.
— SOR/2024-238, s. 28
28 Subsection C.08.002.1(2) of the Regulations is amended by adding the following after paragraph (a):
(a.1) in the case of a new drug for human use, a risk management plan for the new drug that meets the requirements set out in section C.01.701, if one of the circumstances set out in subparagraphs C.08.002(2)(p)(i) and (ii) is met;
— SOR/2024-238, ss. 29(2), (4)
29 (2) Section C.08.003 of the Regulations is amended by adding the following after subsection (3.1):
(3.2) A supplement to a submission referred to in subsection (1) for a new drug for human use shall contain
(a) if a risk management plan for the new drug has not yet been provided to the Minister and one of the circumstances set out in subparagraphs C.08.002(2)(p)(i) or (ii) is met, a risk management plan for the new drug that meets the requirements set out in C.01.701; or
(b) if there is already an existing risk management plan as defined in section C.01.700 and one of the circumstances set out in paragraphs C.01.703(a), (b) or C.01.704(1)(b) is met, an updated risk management plan for the new drug that meets the requirements set out in section C.01.701.
(4) Subsection C.08.003(7) of the Regulations is replaced by the following:
(7) If, at the time the manufacturer files, for a public health emergency drug, a supplement to the new drug submission referred to in subsection (1), the manufacturer is unable to provide the Minister with information or material that relates to any of the matters referred to in paragraphs (2)(d) to (h), subsection (3.2), paragraph (5)(b) and subsection (6) — and, as applicable, the corresponding material referred to in paragraphs C.08.005.1(1)(b) to (d) — or if any of that information or material is incomplete, the manufacturer shall provide the Minister, at that time, with a plan that specifies how and when they will provide the Minister with the missing information or material.
— SOR/2024-238, s. 31
31 The Regulations are amended by adding the following after section C.08.003.1:
C.08.003.2 In cases where there are significant uncertainties respecting the evidence of the effectiveness of a new drug that was provided in a new drug submission or supplement to a new drug submission, the Minister may, in examining the submission or supplement, take into account whether terms and conditions that may be imposed or amended under section C.01.014.21 would enable the Minister to obtain additional information respecting the uncertainties if
(a) the new drug is intended to diagnose, treat, mitigate or prevent a disease, disorder or abnormal physical state, or symptom of a disease, disorder or abnormal physical state, that poses or may pose a serious risk of injury to human or animal health; and
(b) either
(i) the recommended purpose and conditions of use of the new drug do not fall within the recommended purposes and conditions of use of any other drug for which a drug identification number has been assigned and not been cancelled, or
(ii) the recommended purpose and conditions of use of the new drug do fall within the recommended purposes and conditions of use of any other drug for which a drug identification number has been assigned and has not been cancelled, but the Minister has reasonable grounds to believe that the new drug is significantly more effective or poses a significantly lower risk than the other drug.
— SOR/2024-238, s. 32
32 The Regulations are amended by adding the following after C.08.003.2:
C.08.003.3 For greater certainty, the obligation of the manufacturer to provide a risk management plan referred to in paragraph C.08.002(2)(p), subparagraph C.08.002.01(2)(b)(xi) or paragraph C.08.002.1(2)(a.1) or C.08.003(3.2)(a) or an updated risk management plan referred to in paragraph C.08.003(3.2)(b) may arise at any time before the Minister issues a notice of compliance under section C.08.004 or C.08.004.01 or a notice under paragraph C.08.004(3)(b) or C.08.004.01(3)(b).
— SOR/2024-238, s. 38(2)
38 (2) Subsection C.08.011.2(2) of the Regulations is amended by adding “and” after paragraph (i), by striking out “and” after paragraph (j), and by repealing paragraph (k).
— SOR/2024-238, s. 39(2)
39 (2) Subsection C.10.001(5) of the Regulations is amended by adding “and” after paragraph (i), by striking out “and” after paragraph (j), and by repealing paragraph (k).
— SOR/2024-238, s. 45(4)
45 (4) Terms and conditions that have been imposed on a drug identification number and that are in effect immediately before the day on which subsection 7(4) of these Regulations comes into force remain in effect.
— SOR/2024-238, s. 46
46 (1) For the purposes of paragraphs C.01.702(1)(a) and C.08.003(3.2)(a) of the Food and Drug Regulations, a risk management plan for the drug is considered to have not yet been provided in the following cases:
(a) where no risk management plan for the drug has been provided before the day on which the obligation to provide such a plan under those Regulations comes into force; and
(b) where the most recent risk management plan for the drug was provided before the day set out in paragraph (a) but the Minister does not provide, either by that day or after it, an indication to the manufacturer of the drug that the plan was acceptable.
(2) The most recent version of the risk management plan for a drug that has been provided to the Minister before the day on which section 8 of these Regulations comes into force and in respect of which the Minister provided, either by that day or after it, an indication that the plan was acceptable is considered to be the existing risk management plan as defined in section C.01.700 of the Food and Drug Regulations.
- Date modified: