Guidance on additions to the list of Nicotine Replacement Therapy dosage forms: How Health Canada will assess the evidence
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Overview
Before Health Canada begins its assessment, it will screen the submission to determine if the information and evidence provided is relevant and reliable. Health Canada may request additional information and evidence through an Information Request Notice (IRN) during the assessment of the evidence package.
Unsolicited information and evidence will not be accepted during the assessment of your submission. However, you may provide new evidence that was not available at the time of the submission in response to an IRN when applicable.
To determine if a proposal to add an NRT dosage form to the List should be drafted, Health Canada will assess whether 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.
Health Canada will consider the totality and quality of evidence, including gaps in information and other evidence available at the time. Health Canada retains its ability to request information or material, not specifically described in this document. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.
Decision process
Health Canada will determine whether a proposal to amend the List should be drafted after it has evaluated all available evidence.
Decision outcome
Positive decision
If Health Canada determines that the totality of evidence meets all criteria and warrants a proposal to add the NRT dosage form to the List, it will notify you in writing and will initiate the process to amend the List. See Additional Information on Amending the List section.
Negative decision
If Health Canada determines that the totality of evidence does not meet all criteria to warrant a proposal to add an NRT dosage form to the List, it will notify you in writing that a proposal to amend the List will not be drafted.
In the event of a negative decision, you may contact NNHPD Client Services Unit (nnhpd-dpsnso@hc-sc.gc.ca) within 30 days of the written notification for an opportunity to be heard. The rationale included in your request to be heard must be based on the original evidence package submitted. Information and material not submitted with the original evidence package will not be accepted.