Food and Drug Regulations (C.R.C., c. 870)

• C.08.003 (1) Despite section C.08.002, no person shall sell a new drug in respect of which a notice of compliance has been issued to the manufacturer of that new drug and has not been suspended under section C.08.006, if any of the matters specified in subsection (2) are significantly different from the information or material contained in the new drug submission, extraordinary use new drug submission, abbreviated new drug submission or abbreviated extraordinary use new drug submission, unless

  • (a) the manufacturer of the new drug has filed with the Minister a supplement to that submission;

  • (b) the Minister has issued a notice of compliance to the manufacturer of the new drug in respect of the supplement; and

  • (c) the notice of compliance in respect of the supplement has not been suspended under section C.08.006.

  • (d) [Repealed, SOR/2014-158, s. 13]

• (2) The matters specified for the purposes of subsection (1), in relation to the new drug, are the following:

  • (a) the description of the new drug;

  • (b) the brand name of the new drug or the identifying name or code proposed for the new drug;

  • (c) the specifications of the ingredients of the new drug;

  • (d) the plant and equipment used in manufacturing, preparation and packaging the new drug;

  • (e) the method of manufacture and the controls used in manufacturing, preparation and packaging the new drug;

  • (f) the tests applied to control the potency, purity, stability and safety of the new drug;

  • (g) the labels used in connection with the new drug;

  • (g.1) in the case of a new drug for human use, its packages;

  • (h) the representations made with regard to the new drug respecting

    • (i) the recommended route of administration of the new drug,

    • (ii) the dosage of the new drug,

    • (iii) the claims made for the new drug,

    • (iv) the contra-indications and side effects of the new drug, and

    • (v) the withdrawal period of the new drug; and

  • (i) the dosage form in which it is proposed that the new drug be sold.

• (3) A supplement to a submission referred to in subsection (1), with respect to the matters that are significantly different from those contained in the submission, shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug in relation to those matters.

• (3.1) A supplement to a submission referred to in subsection (1) shall contain, as the case may be,

  • (a) if, due to a matter specified in subsection (2) — other than the brand name of a new drug for human use — that the supplement concerns, it is necessary to modify a new drug’s labels:

    • (i) in the case of a new drug for veterinary use, a draft of every label to be used in connection with the new drug, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the new drug, or

    • (ii) in the case of a new drug for human use, mock-ups of every label to be used in connection with the new drug — including any package insert and any document that is provided on request and that sets out supplementary information on the use of the new drug — and mock-ups of the new drug’s packages; or

  • (b) if the supplement concerns the brand name of a new drug for human use:

    • (i) an assessment as to whether there is a likelihood that the new drug will be mistaken for another drug for which a drug identification number has been assigned due to a resemblance between the brand name that is proposed to be used in respect of the new drug and the brand name, common name or proper name of the other drug, and

    • (ii) mock-ups of every label to be used in connection with the new drug — including any package insert and any document that is provided on request and that sets out supplementary information on the use of the new drug — and mock-ups of the new drug’s packages.

• (4) If a supplement to an extraordinary use new drug submission or an abbreviated extraordinary use new drug submission concerns a matter specified in subparagraph (2)(h)(iii), the supplement shall contain the attestation and supporting information referred to in paragraph C.08.002.01(2)(a).

• C.08.003.01 (1) The following definitions apply in this section.

  submission

  submission means

  • (a) a new drug submission that is filed under section C.08.002;

  • (b) an extraordinary use new drug submission that is filed under section C.08.002.01;

  • (c) an abbreviated new drug submission that is filed under section C.08.002.1; or

  • (d) an abbreviated extraordinary use new drug submission that is filed under section C.08.002.1. (présentation)

  supplement

  supplement means a supplement to a submission that is filed under section C.08.003. (supplément)

• (2) Despite sections C.08.002, C.08.002.01, C.08.002.1 and C.08.003 and subject to subsection (3), the manufacturer of a new drug is not permitted to file a submission or supplement for the new drug on the basis of a direct or indirect comparison to any new drug in respect of which an authorization was issued under the ISAD Interim Order.

• (3) Subsection (2) does not prevent the manufacturer of a new drug from filing a submission or supplement for the new drug on the basis of a direct or indirect comparison to another new drug in respect of which an authorization was issued under the ISAD Interim Order if

  • (a) a notice of compliance is issued under section C.08.004 or C.08.004.01 in respect of a submission or supplement for that other new drug; and

  • (b) the comparison is in respect of the matters that were approved by the notice of compliance.

C.08.003.1 In examining a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission or a supplement to any of those submissions, the Minister may examine any information or material filed with the Minister by any person pursuant to Division 5 or section C.08.002, C.08.002.01, C.08.002.1, C.08.003, C.08.005 or C.08.005.1 to establish the safety and effectiveness of the new drug for which the submission or supplement has been filed.

• C.08.004 (1) Subject to section C.08.004.1, the Minister shall, after completing an examination of a new drug submission or abbreviated new drug submission or a supplement to either submission,

  • (a) if that submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or

  • (b) if that submission or supplement does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, issue a notice to the manufacturer to that effect.

• (2) If a new drug submission or an abbreviated new drug submission or a supplement to either submission does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, the manufacturer who filed the submission or supplement may amend the submission or supplement by filing additional information or material within 90 days after the day on which the Minister issues a notice to the manufacturer under paragraph C.08.004(1)(b) or within any longer period specified by the Minister.

• (3) Subject to section C.08.004.1, the Minister shall, after completing an examination of any additional information or material filed in respect of a new drug submission or an abbreviated new drug submission or a supplement to either submission,

  • (a) if that submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or

  • (b) if that submission or supplement does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, issue a notice to the manufacturer to that effect.

• (4) A notice of compliance issued in respect of a new drug on the basis of information and material contained in a submission filed pursuant to section C.08.002.1 shall state the name of the Canadian reference product referred to in the submission and shall constitute a declaration of equivalence for that new drug.

• C.08.004.01 (1) Subject to section C.08.004.1, the Minister shall, after completing an examination of an extraordinary use new drug submission or an abbreviated extraordinary use new drug submission or a supplement to either submission,

  • (a) if that submission or supplement complies with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or

  • (b) if that submission or supplement does not comply with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, issue a notice to the manufacturer to that effect.

• (2) If an extraordinary use new drug submission or an abbreviated extraordinary use new drug submission or a supplement to either submission does not comply with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, the manufacturer who filed the submission or supplement may amend the submission or supplement by filing additional information or material within 90 days after the day on which the Minister issues a notice to the manufacturer under paragraph C.08.004.01(1)(b) or within any longer period specified by the Minister.

• (3) Subject to section C.08.004.1, the Minister shall, after completing an examination of any additional information or material filed in respect of an extraordinary use new drug submission or an abbreviated extraordinary use new drug submission or a supplement to either submission,

  • (a) if that submission or supplement complies with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or

  • (b) if that submission or supplement does not comply with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, issue a notice to the manufacturer to that effect.

• (4) A notice of compliance issued in respect of a new drug for extraordinary use on the basis of information and material contained in a submission filed pursuant to section C.08.002.1 shall state the name of the Canadian reference product referred to in the submission and shall constitute a declaration of equivalence for that new drug.

• C.08.004.1 (1) The following definitions apply in this section.

  abbreviated new drug submission

  abbreviated new drug submission includes an abbreviated extraordinary use new drug submission. (présentation abrégée de drogue nouvelle)

  innovative drug

  innovative drug means a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph. (drogue innovante)

  new drug submission

  new drug submission includes an extraordinary use new drug submission. (présentation de drogue nouvelle)

  pediatric populations

  pediatric populations means the following groups: premature babies born before the 37th week of gestation; full-term babies from 0 to 27 days of age; and all children from 28 days to 2 years of age, 2 years plus 1 day to 11 years of age and 11 years plus 1 day to 18 years of age. (population pédiatrique)

• (1.1) For the purposes of the definition innovative drug in subsection (1), a medicinal ingredient is not considered to be approved in a drug by reason of the Minister having issued or amended an authorization under the ISAD Interim Order in respect of a COVID-19 drug that contains the medicinal ingredient.

• (2) The purpose of this section is to implement Articles 20.48 and 20.49 of the Agreement between Canada, the United States of America and the United Mexican States, as defined in the definition Agreement in section 2 of the Canada–United States–Mexico Agreement Implementation Act, and paragraph 3 of Article 39 of the Agreement on Trade-related Aspects of Intellectual Property Rights set out in Annex 1C to the Agreement Establishing the World Trade Organization, as defined in the definition Agreement in subsection 2(1) of the World Trade Organization Agreement Implementation Act.

• (3) If a manufacturer seeks a notice of compliance for a new drug on the basis of a direct or indirect comparison between the new drug and an innovative drug,

  • (a) the manufacturer may not file a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission in respect of the new drug before the end of a period of six years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug; and

  • (b) the Minister shall not approve that submission or supplement and shall not issue a notice of compliance in respect of the new drug before the end of a period of eight years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug.

• (4) The period specified in paragraph (3)(b) is lengthened to eight years and six months if

  • (a) the innovator provides the Minister with the description and results of clinical trials relating to the use of the innovative drug in relevant pediatric populations in its first new drug submission for the innovative drug or in any supplement to that submission that is filed within five years after the issuance of the first notice of compliance for that innovative drug; and

  • (b) before the end of a period of six years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug, the Minister determines that the clinical trials were designed and conducted for the purpose of increasing knowledge of the use of the innovative drug in those pediatric populations and this knowledge would there-by provide a health benefit to members of those populations.

• (5) Subsection (3) does not apply if the innovative drug is not being marketed in Canada.

• (6) Paragraph (3)(a) does not apply to a manufacturer if the innovator consents to the filing of a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission by the manufacturer before the end of the period of six years specified in that paragraph.

• (7) Paragraph (3)(a) does not apply to a manufacturer if the manufacturer files an application for authorization to sell its new drug under section C.07.003.

• (8) Paragraph (3)(b) does not apply to a manufacturer if the innovator consents to the issuance of a notice of compliance to the manufacturer before the end of the period of eight years specified in that paragraph or of eight years and six months specified in subsection (4).

• (9) The Minister shall maintain a register of innovative drugs that includes information relating to the matters specified in subsections (3) and (4).