Guidance on additions to the list of Nicotine Replacement Therapy dosage forms: Additional information on amending the List
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Overview
Upon the review of a request to add a dosage form to the List, Health Canada may draft a proposed amendment to the List as appropriate. This would also apply if Health Canada determines that a dosage form should be removed from the List. If a proposed amendment is drafted, Health Canada will publish a Notice of Proposal to notify the Canadian public of its intent to amend the List. Health Canada will also send a notification to the World Trade Organization (WTO) regarding the proposal, as appropriate.
The Notice of Proposal will provide a summary and rationale for the proposed amendment and will be published online for public consideration. The notice will generally specify a 90-day open comment period during which interested parties may provide input on the proposal.
Once consultations are concluded and it has been determined that Health Canada will proceed with an amendment to the List, Health Canada will notify stakeholders of the amendment and update the List in both official languages. Health Canada will also send the notification to the WTO. Please note that provinces and territories have the authority to further restrict the conditions of sale of natural health products.
If it has been determined that Health Canada will not proceed with an amendment to the List, it will communicate this decision on its website and withdraw the proposal.
Information on how documents incorporated by reference are amended is available in Health Canada's Incorporation by Reference Policy, which builds on the foundation provided by the Cabinet Directive on Regulation and the Treasury Board of Canada Secretariat's Policy on Regulatory Development.
Note: Any amendment to the List will impact all NRT products in that dosage form. Health Canada will notify all impacted product licence holders of such amendments at the time of publication.