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 [3683 KB] |
- PDFFull Document: Food and Drug Regulations [11494 KB]
Regulations are current to 2025-12-10 and last amended on 2025-07-01. Previous Versions
AMENDMENTS NOT IN FORCE
— 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79 Subsection C.01.040.2(5) of the Regulations is repealed.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80 The definition antimicrobial agent in subsection C.01A.001(1) of the Regulations is repealed.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82 Section C.02.002.1 of the Regulations is repealed.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. 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, 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. 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.
— SOR/2025-65, s. 2
2 Item 1 of Part III of the schedule to Part J of the Regulations is deleted.
— SOR/2025-242, s. 237
237 Parts G and J of the Food and Drug RegulationsFootnote 1 are repealed.
Return to footnote 1C.R.C., c. 870
— SOR/2025-246, s. 1
1 The definition Act in section A.01.010 of the Food and Drug RegulationsFootnote 1 is replaced by the following:
Return to footnote 1C.R.C., c. 870
- Act
Act means the Food and Drugs Act; (Loi)
— SOR/2025-246, s. 2
2 The definition nurse practitioner in subsection B.25.019(2) of the Regulations is replaced by the following:
- nurse practitioner
nurse practitioner has the same meaning as in subsection 1(1) of the Controlled Substances Regulations. (infirmier praticien)
— SOR/2025-246, s. 3
3 Subparagraphs C.01.004(1)(b)(i) to (iv) of the Regulations are replaced by the following:
(i) in the case of a prescription drug, the symbol “Pr”, which must not appear on the label of any other drug,
(ii) in the case of a controlled drug, as defined in subsection 1(1) of the Controlled Substances Regulations, other than one contained in a finished product referred to in section 3 of those Regulations, the following symbol in a clear manner and a conspicuous colour and size,
(iii) in the case of a narcotic, as defined in subsection 1(1) of the Controlled Substances Regulations, the symbol “N” in a colour contrasting with the rest of the label or in type not less than half the size of any other letter used on the label, and
(iv) in the case of a targeted substance, as defined in subsection 1(1) of the Controlled Substances Regulations, the following symbol in a colour contrasting with the rest of the label or in type not less than half the size of any other letter used on the principal display panel,
Image Description
Symbol consisting of a square outline divided diagonally in half from top left corner to bottom right corner. The top right half has an uppercase letter C inside. The lower left half has an uppercase letter T inside.
— SOR/2025-246, s. 4
4 Paragraph C.01.028(2)(c) of the Regulations is replaced by the following:
(c) a prescription drug or a controlled drug, narcotic or targeted substance, as those terms are defined in subsection 1(1) of the Controlled Substances Regulations, that is required by those Regulations to be sold under a prescription, as defined in that subsection.
— SOR/2025-246, s. 5
5 (1) The portion of subsection C.01.031.2(1) of the French version of the Regulations before paragraph (a) is replaced by the following:
C.01.031.2 (1) Les articles C.01.029 à C.01.031 ne s’appliquent pas aux drogues suivantes :
(2) Paragraph C.01.031.2(1)(a) of the Regulations is replaced by the following:
(a) a prescription drug or a controlled drug, narcotic or targeted substance, as those terms are defined in subsection 1(1) of the Controlled Substances Regulations, that is required by those Regulations to be sold under a prescription, as defined in that subsection;
— SOR/2025-246, s. 6
6 Paragraphs C.01.048(1)(a) to (d) of the Regulations are replaced by the following:
(a) a controlled drug or narcotic, as those terms are defined in subsection 1(1) of the Controlled Substances Regulations; or
(b) a prescription drug, as defined in subsection 1(2) of the Cannabis Regulations.
— SOR/2025-246, s. 7
7 Paragraph C.01.050(4)(b) of the Regulations is replaced by the following:
(b) controlled drugs, narcotics or targeted substances, as those terms are defined in subsection 1(1) of the Controlled Substances Regulations, that are required by those Regulations to be sold under a prescription, as defined in that subsection; and
— SOR/2025-246, s. 8
8 (1) Paragraph C.01.061(2)(b) of the English version of the Regulations is replaced by the following:
(b) no package contains less than the number of dosage units shown on the label except as provided in the table to this section; and
(2) Paragraph C.01.061(2)(c) of the Regulations is replaced by the following:
(c) in the case of a controlled drug or narcotic, as those terms are defined in subsection 1(1) of the Controlled Substances Regulations, no package contains more than the number of dosage units shown on the label except as provided in the table to this section.
— SOR/2025-246, s. 9
9 (1) Paragraph (a) of the definition wholesaler in subsection C.01A.001(1) of the Regulations is replaced by the following:
(a) a drug in dosage form that is listed in Schedule C or D to the Act or a prescription drug;
(2) Paragraph (c) of the definition wholesaler in subsection C.01A.001(1) of the Regulations is replaced by the following:
(c) a controlled drug or narcotic, as those terms are defined in subsection 1(1) of the Controlled Substances Regulations; or
— SOR/2025-246, s. 10
10 Paragraphs C.01A.004(3)(a) to (c) of the Regulations are replaced by the following:
(a) in the case of an activity with respect to a controlled drug or narcotic, as those terms are defined in subsection 1(1) of the Controlled Substances Regulations, a dealer’s licence issued under subsection 12(1) of those Regulations; or
(b) in the case of an activity with respect to a drug containing cannabis, as defined in subsection 2(1) of the Cannabis Act, a licence issued under that Act to conduct that activity in accordance with the Cannabis Regulations.
— SOR/2025-246, s. 11
11 Subparagraph C.01A.005(1)(j)(i) of the Regulations is replaced by the following:
(i) for each drug for which the licence is requested that is a controlled drug or narcotic, as those terms are defined in subsection 1(1) of the Controlled Substance Regulations, or a drug containing cannabis, as defined in subsection 2(1) of the Cannabis Act, and
— SOR/2025-246, s. 12
12 Item 6 of Table II to section C.01A.008 of the Regulations is replaced by the following:
Item Categories of drugs 6 Prescription drugs, drugs that are controlled drugs or narcotics, as those terms are defined in subsection 1(1) of the Controlled Substances Regulations, and drugs containing cannabis, as defined in subsection 2(1) of the Cannabis Act
— SOR/2025-246, s. 13
13 (1) The portion of section C.09.001 of the French version of the Regulations before paragraph (a) is replaced by the following:
C.09.001 Le présent titre ne s’applique pas aux drogues suivantes :
(2) Paragraphs C.09.001(a) and (b) of the Regulations are replaced by the following:
(a) a drug that is required by these Regulations to be sold under a prescription;
(b) a drug that is a narcotic, as defined in subsection 1(1) of the Controlled Substances Regulations, and that is required by those Regulations to be sold under a prescription, as defined in that subsection; or
(c) a drug that is intended for use exclusively in animals.
Page Details
- Date modified: