Guidance on additions to the list of Nicotine Replacement Therapy dosage forms: Criteria
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Overview
Whether or not an NRT dosage form is on the List, Health Canada evaluates every NRT product for safety and efficacy before issuing a product licence. The exclusion of specific NRT dosage forms from the List was motivated by the necessity of protecting young persons from accessing NRTs for unintended uses, which could result in long-term harms to their health. Consequently, for Health Canada to consider adding an NRT dosage form to the List, there must be sufficient evidence demonstrating that these concerns may no longer be applicable to the dosage form in question.
Criteria
Health Canada will consider the criteria below to determine if a proposal to add a dosage form to the List should be drafted. Any requests for an NRT dosage form to be added to the List will be evaluated on a case-by-case basis, and additional evidence may be requested as needed.
The dosage form:
- has an established history of appropriate use; and
- is unlikely to be appealing to young people if made available for self-selection without pharmacist intervention; and
- is not associated with concerns of unintended uses if made available for self-selection without pharmacist intervention.
If, based on its assessment, Health Canada determines that the totality of evidence (including evidence beyond what you provide) is sufficient to conclude that the above criteria have been met, it will initiate the process of amending the List.