Guidance on additions to the list of Nicotine Replacement Therapy dosage forms: How to submit a request
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Overview
Before submitting an evidence package to add an NRT dosage form to the List, you must request a pre-submission meeting.
To request a pre-submission meeting, you must email the NNHPD Client Services Unit (nnhpd-dpsnso@hc-sc.gc.ca) at least 1 month before the proposed meeting date and include the following information in the pre-submission meeting package:
- The proposed NRT dosage form to be added to the List
- A brief description of the information and evidence to be submitted, including details of specific products, domestic studies, foreign studies, study methodologies, etc.
- A list of specific discussion questions
- 3 proposed meeting dates
The subject of the email requesting the pre-submission meeting must state "NRT List Amendment - pre-submission meeting request".
Submission content
To request that an NRT dosage form be added to the List, you must submit a single evidence package that includes:
- evidence of market experience and surveillance
- other supporting evidence outlined in this guidance
- minutes from the pre-submission meeting with Health Canada
- documentation of any other advice provided by Health Canada
The package should also clearly indicate what evidence is included and contain a cover letter summarizing the request.
During the pre-submission meeting, Health Canada may request that additional information or evidence be included in your evidence package.
Filing a submission
You should contact NNHPD Client Services Unit (nnhpd-dpsnso@hc-sc.gc.ca) to express your intent to submit an evidence package. The Client Services Unit will then reach out to advise where the package may be submitted.