On March 27, 2023, Health Canada opened for consultation a proposed application of the definition of Canadian reference product under C.08.001.1(b) of the Food and Drug Regulations.
A generic drug manufacturer can file an abbreviated new drug submission (ANDS) based on a comparison to a 'Canadian reference product' (CRP) which is defined in s. C.08.001.1 of the Food and Drug Regulations as:
(a) a drug in respect of which a notice of compliance is issued under section C.08.004 or C.08.004.01 and which is marketed in Canada by the innovator of the drug,
(b) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, where a drug in respect of which a notice of compliance has been issued under section C.08.004 or C.08.004.01 cannot be used for that purpose because it is no longer marketed in Canada, or
(c) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, in comparison to a drug referred to in paragraph (a);
A manufacturer of certain human drug types, including prescription drugs, must submit a notification to Health Canada within 30 calendar days after a period of 12 consecutive months that a drug has not been sold on the Canadian market. After a complete notification is processed, Health Canada updates the status of the drug in the drug product database to 'Dormant'.
In its consultation document, Health Canada proposes:
- that this 'Dormant' status be evidence that the drug is "no longer marketed" for the purpose of s. C.08.001.1(b);
- "[i]n such situations, a manufacturer may file an ANDS or AEUNDS [abbreviated extraordinary use new drug submission] using an alternate CRP (e.g., a generic drug), provided the alternate CRP is otherwise acceptable to the Minister. Preferably, the alternate CRP would have been approved through the issuance of a Notice of Compliance under the ANDS or AEUNDS pathway by demonstrating bioequivalence on the basis of pharmaceutical and where applicable bioavailability characteristics with the 'Dormant' drug that would otherwise have been identified as the CRP in accordance with paragraph C.08.001.1(a)]"; and
- if the generic sponsor files using an alternate CRP and it is later determined that sales had restarted for the 'Dormant' drug by the date of the ANDS or AEUNDS filing, the submission would be requested to be withdrawn and/or may be subject to a negative decision.
The consultation is open until May 12, 2023.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.
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