Food and Drug Regulations (C.R.C., c. 870)
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Regulations are current to 2026-06-14 and last amended on 2026-06-05. 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79 Subsection C.01.040.2(5) of the Regulations is repealed.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80 The definition antimicrobial agent in subsection C.01A.001(1) of the Regulations is repealed.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82 Section C.02.002.1 of the Regulations is repealed.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/2025-242, 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.
— SOR/2026-96, s. 1
1 (1) The definition discontinue in subsection C.01.001(1) of the Food and Drug RegulationsFootnote 1 is replaced by the following:
Return to footnote 1C.R.C., c. 870
- discontinue
discontinue means, in respect of the sale of a drug by the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug, to permanently cease the sale of the drug in Canada; (cesser)
(2) Subsection C.01.001(1) of the Regulations is amended by adding the following in alphabetical order:
- List of Drugs for the Purposes of Paragraphs (b) and (c) of the Definition drug in Subsection C.01.014.8(1)
List of Drugs for the Purposes of Paragraphs (b) and (c) of the Definition drug in Subsection C.01.014.8(1) means the List of Drugs for the Purposes of Paragraphs (b) and (c) of the Definition drug in Subsection C.01.014.8(1) of the Food and Drug Regulations that is published by the Government of Canada on its website, as amended from time to time; (Liste de drogues pour l’application des alinéas b) et c) de la définition de drogue au paragraphe C.01.014.8(1))
- shortage
shortage means, in respect of a drug, a situation in which the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug is unable to meet the demand for the drug in Canada; (pénurie)
— SOR/2026-96, s. 2
2 Section C.01.014.7 of the Regulations is renumbered as subsection C.01.014.7(1) and is amended by adding the following:
(2) For greater certainty, subsection (1) does not remove the requirement for the manufacturer to post information under subsection C.01.014.91(1).
— SOR/2026-96, s. 3
3 Section C.01.014.71 of the Regulations is replaced by the following:
C.01.014.71 If 12 months have elapsed since the day on which the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug — within the meaning of paragraph (a) of the definition drug in subsection C.01.014.8(1) — last sold the drug, the manufacturer shall so notify the Minister, in writing, within 30 days after the day on which that period ends.
— SOR/2026-96, s. 4
4 Section C.01.014.8 of the Regulations is replaced by the following:
C.01.014.73 (1) The Minister may add a drug to Part 1 of the List of Drugs for the Purposes of Paragraphs (b) and (c) of the Definition drug in Subsection C.01.014.8(1) only if the Minister has reasonable grounds to believe that a shortage or the discontinuation of sale of the drug, if it were to occur, could present a risk of injury to human health.
(2) The Minister may add a class of drugs to Part 2 of the List of Drugs for the Purposes of Paragraphs (b) and (c) of the Definition drug in Subsection C.01.014.8(1) only if the Minister has reasonable grounds to believe that a shortage or the discontinuation of sale of any drug that belongs to that class, if it were to occur, could present a risk of injury to human health.
C.01.014.8 (1) In sections C.01.014.9 to C.01.014.95, other than in section C.01.014.93, drug means any of the following drugs for which a drug identification number has been assigned and not been cancelled:
(a) the following drugs for human use:
(i) drugs included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act,
(ii) prescription drugs,
(iii) drugs that are listed in Schedule C or D to the Act, and
(iv) drugs that are permitted to be sold without a prescription but that are to be administered only under the supervision of a practitioner;
(b) drugs that are set out in Part 1 of the List of Drugs for the Purposes of Paragraphs (b) and (c) of the Definition drug in Subsection C.01.014.8(1); and
(c) drugs that belong to a class of drugs that is set out in Part 2 of that list.
(2) In sections C.01.014.9 and C.01.014.91, designated website means
(a) if a hyperlink is on the Government of Canada website in accordance with section C.01.014.92, the website that is maintained under contract with His Majesty in right of Canada; and
(b) if not, the part of the Government of Canada website that is represented as being for the purpose of posting information under sections C.01.014.9 and C.01.014.91.
— SOR/2026-96, s. 5
5 (1) The portion of subsection C.01.014.9(1) of the Regulations before paragraph (b) is replaced by the following:
C.01.014.9 (1) Subject to subsection (5), if a shortage of a drug exists or is likely to occur, the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug shall post the following information in English and French on the designated website:
(a) the manufacturer’s name and contact information;
(2) Paragraph C.01.014.9(2)(b) of the English version of the Regulations is replaced by the following:
(b) if they anticipate that a shortage will begin in six months or less, within five days after the day on which they make that determination; or
(3) Subsections C.01.014.9(3) and (4) of the Regulations are replaced by the following:
(3) If any of the information that was posted by the manufacturer changes, they shall update that information on the designated website within two days after the day on which they make or become aware of the change.
(4) Within two days after the day on which the manufacturer is able to meet the demand for the drug, they shall post information on the designated website to that effect.
— SOR/2026-96, s. 6
6 (1) The portion of subsection C.01.014.10(1) of the Regulations before paragraph (b) is replaced by the following:
C.01.014.91 (1) If the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug decides to discontinue the sale of the drug, they shall post the following information in English and French on the designated website:
(a) the manufacturer’s name and contact information;
(2) Paragraphs C.01.014.91(2)(a) and (b) of the Regulations are replaced by the following:
(a) if they decide to discontinue the sale of the drug in more than 12 months, at least 12 months before the day on which they will discontinue its sale; and
(b) if they decide to discontinue the sale of the drug in 12 months or less, within five days after the day on which they make that decision.
(3) Subsection C.01.014.91(3) of the Regulations is replaced by the following:
(3) If any of the information that was posted by the manufacturer changes, they shall update that information on the designated website within five days after the day on which they make or become aware of the change.
(4) For greater certainty, subsection (1) does not remove the requirement for the manufacturer to inform the Minister under section C.01.014.7.
— SOR/2026-96, s. 7
7 Section C.01.014.11 of the Regulations is replaced by the following:
C.01.014.92 If a person maintains a website under contract with His Majesty in right of Canada for the purpose of posting information under sections C.01.014.9 and C.01.014.91, the Minister shall ensure that a hyperlink to that website is on the Government of Canada website.
— SOR/2026-96, s. 8
8 (1) The portion of subsection C.01.014.12(1) of the Regulations before paragraph (a) is replaced by the following:
C.01.014.93 (1) The Minister may request that the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug — or any person who holds an establishment licence in respect of a drug for which a drug identification number has been assigned and not been cancelled — provide the Minister with information that is in their control if the Minister has reasonable grounds to believe that
(2) Subsection C.01.014.93(1) of the Regulations is amended by adding the following after paragraph (a):
(a.1) a shortage of the drug, if it were to occur, could present a risk of injury to human health;
(3) Paragraph C.01.014.93(1)(b) of the Regulations is amended by striking out “or” at the end of subparagraph (iii) and by replacing subparagraph (iv) with the following:
(iv) measures that could be taken to prevent or mitigate shortage risks associated with the drug, or
(v) measures that could be taken to mitigate the impacts of a shortage of the drug; and
(4) Subsection C.01.014.93(2) of the Regulations is replaced by the following:
(2) The manufacturer or licensee shall provide the requested information in the time, form and manner specified by the Minister.
— SOR/2026-96, s. 9
9 Section C.01.014.13 of the Regulations is renumbered as section C.01.014.94.
— SOR/2026-96, s. 10
10 Subsection C.01.014.14(1) of the Regulations is replaced by the following:
C.01.014.95 (1) If a person who holds an establishment licence distributes a drug for consumption or use outside Canada, the licensee shall immediately create a detailed record of the information that they relied on to determine that the distribution of the drug is not prohibited by section C.01.014.94.
— SOR/2026-96, s. 11
11 Paragraph C.01.020.1(2)(c) of the Regulations is replaced by the following:
(c) in the case of a drug imported under subsection C.10.001(2) or section C.10.006 or sold under subsection C.10.007.1(1), the identifying code or number of the drug, if any, assigned in the country in which the drug was authorized for sale;
— SOR/2026-96, s. 12
12 The Regulations are amended by adding the following before section C.10.001:
Drugs for an Urgent Public Health Need
— SOR/2026-96, s. 13
13 Paragraph C.10.001(2)(b) of the Regulations is replaced by the following:
(b) the drug is authorized by a foreign regulatory authority in the United States, the United Kingdom, Switzerland or the European Union to be sold for the same use or purpose as that described under subparagraph (a)(ii);
— SOR/2026-96, s. 14
14 The Regulations are amended by adding the following after section C.10.003:
Drugs for Exceptional Importation and Sale
— SOR/2026-96, s. 15
15 (1) The portion of subsection C.10.004(1) of the Regulations before the first definition is replaced by the following:
C.10.004 (1) The following definitions apply in this section and in sections C.10.005 to C.10.013.
(2) The definition drug in subsection C.10.004(1) of the Regulations is repealed.
(3) The definition designated drug in subsection C.10.004(1) of the Regulations is replaced by the following:
- designated drug
designated drug means
(a) a drug that is set out in Part 1 of the List of Drugs for Exceptional Importation and Sale; and
(b) a lot or batch of a drug that is set out in Part 2 of that list. (drogue désignée)
(4) Subsection C.10.004(1) of the Regulations is amended by adding the following in alphabetical order:
- business day
business day means a day other than
(a) a Saturday; or
(b) a Sunday or other holiday. (jour ouvrable)
(5) Subsection C.10.004(2) of the Regulations is replaced by the following:
(2) In sections C.10.005 to C.10.013, batch certificate, fabricate, import, MRA country, package/label, recognized building and wholesaler have the same meanings as in subsection C.01A.001(1).
(3) In this section and sections C.10.006 and C.10.009,
(a) specifications has the same meaning as in section C.02.002; and
(b) a reference to specifications is a reference to the specifications with which the designated drug is required to comply within the jurisdiction of the foreign regulatory authority referred to in paragraph C.10.006(1)(b).
(4) The definition expiration date in subsection C.01.001(1) does not apply in respect of a designated drug referred to in subsection C.10.007.4(1).
— SOR/2026-96, s. 16
16 Section C.10.005 of the Regulations is replaced by the following:
C.10.005 (1) Subject to subsection (3), the Minister may add a drug that is fabricated outside Canada to Subpart 1 or 2 of Part 1 of the List of Drugs for Exceptional Importation and Sale only if
(a) either of the following conditions is met in respect of another drug:
(i) the Minister has reasonable grounds to believe that there is a shortage or risk of shortage of the other drug for which a drug identification number has been assigned under subsection C.01.014.2(1) and not been cancelled, or
(ii) the sale of the other drug was discontinued;
(b) the Minister has reasonable grounds to believe that
(i) a shortage of the other drug if it were to occur, or the discontinuation of sale of it could present a risk of injury to human health,
(ii) the drug to be added to that list can be substituted for the other drug, and
(iii) the drug to be added to that list is authorized to be sold by a foreign regulatory authority within its jurisdiction; and
(c) in the case referred to in subparagraph (a)(ii), the drug to be added to that list is added on or before the day that is 36 months after the day on which the sale of the other drug was discontinued.
(2) Subject to subsection (3), the Minister may add a lot or batch of a drug that is fabricated in Canada to Subpart 1 or 2 of Part 2 of the List of Drugs for Exceptional Importation and Sale only if
(a) either of the following conditions is met in respect of another drug:
(i) the Minister has reasonable grounds to believe that there is a shortage or risk of shortage of the other drug for which a drug identification number has been assigned under subsection C.01.014.2(1) and not been cancelled, or
(ii) the sale of the other drug was discontinued; and
(b) the Minister has reasonable grounds to believe that
(i) a shortage of the other drug, if it were to occur, or the discontinuation of sale of it could present a risk of injury to human health, and
(ii) the lot or batch of the drug to be added to that list meets the following conditions:
(A) it can be substituted for the other drug,
(B) it is authorized to be sold by a foreign regulatory authority within its jurisdiction,
(C) it is fabricated for consumption or use outside Canada, and
(D) despite clause (C), it is no longer intended for export.
(3) The Minister may add a drug to Subpart 2 of Part 1 of the List of Drugs for Exceptional Importation and Sale — or a lot or batch of a drug to Subpart 2 of Part 2 of that list — only if
(a) the drug is for human use;
(b) the drug is not one of the following drugs:
(i) a drug included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act,
(ii) a prescription drug,
(iii) a drug listed in Schedule C or D to the Act, or
(iv) a drug that is permitted to be sold without a prescription but that is to be administered only under the supervision of a practitioner; and
(c) the Minister has reasonable grounds to believe that use of the drug can cause injury to human health or present a risk to public health and the injury or risk can be mitigated by the supervision of a practitioner or pharmacist.
C.10.005.1 For greater certainty, if a lot or batch of a drug is set out in Part 1 or 2 of the List of Drugs for Exceptional Importation and Sale, sections C.10.006 to C.10.013 apply only in respect of that lot or batch.
— SOR/2026-96, s. 17
17 (1) The portion of subsection C.10.006(1) of the Regulations before subparagraph (a)(i) is replaced by the following:
C.10.006 (1) Despite sections A.01.040 and C.01.004.1, a person who holds an establishment licence that authorizes the importation of a drug may import a designated drug set out in Part 1 of the List of Drugs for Exceptional Importation and Sale if the following conditions are met:
(a) the licensee provides the Minister, in the form and manner specified by the Minister and not later than three business days before the day on which the drug is imported, with a notification that contains the following information:
(2) Paragraph C.10.006(1)(b) of the Regulations is replaced by the following:
(b) the licensee provides the Minister with an attestation, signed and dated by an individual who has authority to bind the licensee, that confirms that the licensee possesses or has immediate access to the specifications for the drug;
(3) The portion of paragraph C.10.006(1)(d) of the Regulations before subparagraph (i) is replaced by the following:
(d) the following information in respect of the drug is set out in Part 1 of the List of Drugs for Exceptional Importation and Sale:
(4) Subparagraphs C.10.006(1)(d)(iii) and (iv) of the Regulations are replaced by the following:
(iii) the name of the foreign regulatory authority referred to in subparagraph C.10.005(1)(b)(iii),
(iv) the maximum limit for the total quantity of the drug that the licensee may import, if applicable,
(v) the date after which the drug may no longer be imported, if applicable, and
(vi) the lot or batch number of the drug, if applicable;
(5) Paragraphs C.10.006(1)(e) to (g) of the Regulations are replaced by the following:
(f) the total quantity of the drug that the licensee imports does not exceed the maximum limit referred to in subparagraph (d)(iv), if applicable;
(g) the drug is imported on or before the date referred to in subparagraph (d)(v), if applicable; and
(6) Subsection C.10.006(2) of the Regulations is repealed.
— SOR/2026-96, s. 18
18 Section C.10.007 of the Regulations is replaced by the following:
C.10.007 Section A.01.044 does not apply in respect of the importation of a designated drug under section C.10.006.
C.10.007.1 (1) Despite sections C.01.003, C.01.014 and C.08.002 and subject to subsections (3), (4) and (6), a person who holds an establishment licence may sell a designated drug that is set out in Part 2 of the List of Drugs for Exceptional Importation and Sale for consumption or use in Canada if the conditions set out in subsection (2) are met and, as the case may be,
(a) they are the distributor of the drug for consumption or use outside Canada; or
(b) they are a wholesaler of a drug.
(2) The conditions are the following:
(a) the licensee provides the Minister, in the form and manner specified by the Minister and not later than three business days before the day on which the licensee first sells the designated drug for consumption or use in Canada, with a notification that contains the following information:
(i) the licensee’s name and contact information,
(ii) the name and contact information of each fabricator, packager/labeller and tester of the drug and the address of each building in which it is fabricated, packaged/labelled or tested, and
(iii) in respect of the drug,
(A) its brand name,
(B) its medicinal ingredients,
(C) its dosage form,
(D) its strength,
(E) its route of administration,
(F) its identifying code or number, if any, assigned in the country in which it is authorized for sale, and
(G) a detailed description of its conditions of use;
(b) if the licensee meets the condition set out in paragraph (1)(b) and the designated drug is referred to in any of paragraphs (a), (c) or (d) of the definition wholesaler in subsection C.01A.001(1), the drug is in the same category as the category for which the establishment licence was issued;
(c) the following information in respect of the designated drug is set out in Part 2 of the List of Drugs for Exceptional Importation and Sale:
(i) the licensee’s name,
(ii) the information referred to in clauses (a)(iii)(A) to (F),
(iii) the name of the foreign regulatory authority referred to in clause C.10.005(2)(b)(ii)(B),
(iv) the maximum limit on the total quantity of the drug that the licensee may sell, if applicable,
(v) the date after which the licensee is no longer permitted to sell the drug, if applicable, and
(vi) the lot or batch number of the drug;
(d) the licensee ensures that the information referred to in clause (a)(iii)(G) is available in English and French and in a manner that permits the safe use of the designated drug; and
(e) the licensee has prepared a plan that specifies the measures to be taken in order for them to comply with paragraph (d).
(3) The licensee shall not sell, in total, the designated drug in a quantity that exceeds the maximum limit referred to in subparagraph (2)(c)(iv), if applicable.
(4) The licensee shall not sell the designated drug after the date referred to in subparagraph (2)(c)(v), if applicable.
(5) The licensee shall ensure that the information referred to in clause (2)(a)(iii)(G) is available in accordance with paragraph (2)(d) until at least the latest expiration date of the designated drug that they sold.
(6) This section does not apply — in respect of a designated drug sold by the licensee under subsection (1) — to another person who holds an establishment licence and sells the drug.
C.10.007.2 Despite sections C.01.003, C.01.014 and C.08.002, the fabricator of a designated drug who is neither the distributor of the drug for consumption or use outside Canada nor a wholesaler of the drug may sell the drug for consumption or use in Canada only to that distributor or such a wholesaler.
C.10.007.3 Paragraph C.02.018(3)(c) does not apply to a person who holds an establishment licence in respect of a designated drug that they sell under subsection C.10.007.1(1) or section C.10.007.2.
C.10.007.4 (1) Subject to subsection (2), sections C.10.008 to C.10.013 apply in respect of
(a) a designated drug that is imported under section C.10.006; and
(b) a designated drug that is sold under subsection C.10.007.1(1) or section C.10.007.2.
(2) Sections C.10.009 and C.10.010 do not apply in respect of a designated drug referred to in paragraph (1)(b).
— SOR/2026-96, s. 19
19 (1) The portion of subsection C.10.008(1) of the Regulations before paragraph (b) is replaced by the following:
C.10.008 (1) Subject to subsection (3) and sections C.10.007.3, C.10.009, C.10.010 and C.10.010.2, a sale of a designated drug is exempt from the following provisions:
(a) sections A.01.014 to A.01.017 and A.01.051; and
(2) Subparagraph C.10.008(1)(b)(i) of the Regulations is replaced by the following:
(i) sections C.01.016, C.01.017, C.01.019 to C.01.020.1 and C.01.040.3 to C.01.051.1,
(3) Subparagraph C.10.008(1)(b)(iii) of the Regulations is replaced by the following:
(iii) sections C.10.007.1 to C.10.013.
— SOR/2026-96, s. 20
20 (1) Subsection C.10.009(1) of the Regulations is replaced by the following:
C.10.009 (1) This section applies — but paragraph C.02.018(3)(c) and section C.02.019 do not apply — to a person who holds an establishment licence in respect of a designated drug that they import under section C.10.006.
(2) Subparagraph C.10.009(2)(b)(i) of the Regulations is replaced by the following:
(i) the licensee has evidence that the Minister considers satisfactory, in the interests of the health of the consumer or purchaser, to demonstrate that lots or batches of the designated drug sold to them by the vendor of the lot or batch are consistently manufactured in accordance with and consistently comply with the specifications for that drug,
(i.1) the licensee undertakes periodic complete confirmatory testing, with a frequency that the Minister considers satisfactory, in the interests of the health of the consumer or purchaser, and
(3) Subsection C.10.009(3) of the Regulations is replaced by the following:
(3) The licensee shall possess or have immediate access to the specifications for the designated drug until at least the latest expiration date of the designated drug.
(4) Subsection C.10.009(6) of the Regulations is repealed.
— SOR/2026-96, s. 21
21 Subsection C.10.010(3) of the Regulations is replaced by the following:
(3) The licensee shall provide the requested records in the time, form and manner specified by the Minister.
— SOR/2026-96, s. 22
22 The Regulations are amended by adding the following after section C.10.010:
C.10.010.1 A person who holds an establishment licence and imports a designated drug under section C.10.006 — or a person who holds an establishment licence and sells a designated drug under subsection C.10.007.1(1) and is not the manufacturer of the drug — shall submit to the Minister, in the form and manner specified by the Minister, a report of all information relating to the following serious adverse drug reactions within 15 days after the day on which they receive or become aware of the information, whichever occurs first:
(a) any serious adverse drug reaction that has occurred in Canada with respect to the drug; and
(b) any serious unexpected adverse drug reaction that has occurred outside Canada with respect to the drug.
C.10.010.2 (1) Despite subsection C.01.050(4), section C.01.050 applies — in respect of a designated drug — to a person who holds an establishment licence and imports the drug under section C.10.006 or a person who holds an establishment licence and sells the drug under subsection C.10.007.1(1), with any necessary modifications.
(2) A reference to a foreign regulatory authority in the applicable paragraph of subsection C.01.050(2) includes a reference to the foreign regulatory authority referred to in subparagraph C.10.006(1)(d)(iii) or C.10.007.1(2)(c)(iii), as the case may be, if that foreign regulatory authority is not set out in any of Parts A to C of the List of Foreign Regulatory Authorities for the Purposes of Section C.01.050 of the Food and Drug Regulations, published by the Government of Canada on its website, as amended from time to time.
C.10.010.3 A drug that is removed from the List of Drugs for Exceptional Importation and Sale before the date referred to in subsection C.10.011(2) continues to be considered a designated drug for the purposes of sections C.10.010.1, C.10.010.2 and C.10.011 until that date.
C.10.010.4 (1) No person shall sell on a retail basis a designated drug that is set out in Subpart 1 of Part 1 or 2 of the List of Drugs for Exceptional Importation and Sale unless the information referred to in clause C.10.006(1)(a)(iii)(G) is available in English and French to the purchaser or consumer in any of the following manners:
(a) the information accompanies the drug;
(b) the information is provided in writing to the purchaser or consumer at the time of sale;
(c) in the case where the drug is accessible to the public for self-selection, copies of the information are placed adjacent to the drug in a manner that permits the purchaser or consumer to take one.
(2) For the purposes of subsection (1), the English and French versions of the information referred to in clause C.10.006(1)(a)(iii)(G) need not be available in the same manner.
(3) Subsection (1) does not apply to the sale of a designated drug that is set out in Subpart 1 of Part 1 or 2 of the List of Drugs for Exceptional Importation and Sale by a pharmacist under a prescription, or by a practitioner.
— SOR/2026-96, s. 23
23 Subsection C.10.011(2) of the Regulations is replaced by the following:
(2) The licensee shall ensure that the information is available in accordance with subsection (1) until at least the latest expiration date of the designated drug that they imported.
— SOR/2026-96, s. 24
24 The Regulations are amended by adding the following after section C.10.011:
C.10.012 A person who holds an establishment licence in respect of a drug shall not sell a designated drug set out in Subpart 2 of Part 1 or 2 of the List of Drugs for Exceptional Importation and Sale except to a practitioner, a pharmacist, a hospital as defined in subsection C.01.020.1(4) or another person who holds an establishment licence in respect of a drug.
C.10.013 A pharmacist or a person working under a pharmacist’s supervision shall not sell a designated drug set out in Subpart 2 of Part 1 or 2 of the List of Drugs for Exceptional Importation and Sale on a retail basis unless the drug is not accessible to the public for self-selection.
Extended Expiration Dates
C.10.014 The following definitions apply in this section and in sections C.10.015 to C.10.021.
- extended expiration date
extended expiration date means, in respect of a specified lot or batch, the date set out in column 2 of the List of Drugs with Extended Expiration Dates. (date limite d’utilisation reportée)
- List of Drugs with Extended Expiration Dates
List of Drugs with Extended Expiration Dates means the List of Drugs with Extended Expiration Dates that is published by the Government of Canada on its website, as amended from time to time. (Liste des drogues dont la date limite d’utilisation est reportée)
- specified lot or batch
specified lot or batch means a lot or batch of a drug set out in column 1 of the List of Drugs with Extended Expiration Dates. (lot ou lot de fabrication inscrit)
C.10.015 (1) The Minister may add a lot or batch of a drug to column 1 of the List of Drugs with Extended Expiration Dates and a date to column 2 of that list in relation to the lot or batch only if
(a) a drug identification number has been assigned to the drug under subsection C.01.014.2(1) and not been cancelled; and
(b) the Minister has reasonable grounds to believe that
(i) there is a shortage or risk of shortage of the drug,
(ii) a shortage of the drug, if it were to occur, could present a risk of injury to human health, and
(iii) the lot or batch will comply with the specifications for that drug until at least the date to be added to column 2.
(2) In subsection (1), specifications has the same meaning as in section C.02.002.
C.10.016 Sections C.10.017 to C.10.021 apply in respect of a specified lot or batch and its extended expiration date if the following information is also set out in the List of Drugs with Extended Expiration Dates:
(a) the drug’s brand name;
(b) the drug identification number assigned to the drug;
(c) the name of the manufacturer of the drug;
(d) the expiration date of the lot or batch; and
(e) the date on which the Minister added the lot or batch to that list.
C.10.017 Despite the definition expiration date in subsection C.01.001(1), a reference to an expiration date in the provisions of this Part — other than paragraph C.10.016(d) — is, in respect of a specified lot or batch, a reference to its extended expiration date.
C.10.018 Subparagraphs C.01.004(1)(c)(v) and (3)(b)(vii), paragraph C.04.009(2)(e) and subparagraph C.04.009(6)(a)(ix) do not apply in respect of a specified lot or batch.
C.10.019 Sections C.01.014 and C.08.003 do not apply in respect of a specified lot or batch if its extended expiration date is the only change in respect of the lot or batch that relates to the information previously provided to the Minister in connection with the drug.
C.10.020 (1) Within five days after the day on which a specified lot or batch is added to the List of Drugs with Extended Expiration Dates, the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug shall notify any person who holds an establishment licence and to whom they sold the lot or batch of its extended expiration date.
(2) Any person who holds an establishment licence, who has sold a specified lot or batch and who is notified of its extended expiration date shall, within five days after the day on which they are notified, notify any other person to whom they sold the lot or batch of that date.
C.10.021 No person shall sell a specified lot or batch after its extended expiration date.
— SOR/2026-96, s. 25
25 The Regulations are amended by replacing “designated drug” with “drug” in the following provisions:
(a) subparagraph C.10.006(1)(a)(ii);
(b) the portion of subparagraph C.10.006(1)(a)(iii) before clause (A);
(c) subparagraphs C.10.006(1)(a)(v) and (vi); and
(d) paragraph C.10.006(1)(c).
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