Submitting risk management plans guidance document: RMP note to reviewer template
Include the note to reviewer in Module 1.3.8.2 with the submission of all RMPs and RMP-related materials.
RMP note to reviewer
| Document | Details of submission |
|---|---|
RMP |
Indicate reason for submission (examples provided)
|
Related materials |
Specify materials and indicate reason for submission (examples provided)
|
RMP submission details (PDF format should be followed.)
If applicable, indicate the RMP submitted within current transaction.
Indicate if the RMP is a
- Canadian RMP
- Reference RMP with Canadian-specific addendum
Include versions, final sign-off dates and data lock points
If applicable, indicate the most recently approved RMP by Health Canada.
Indicate if the RMP is a
- Canadian RMP
- Reference RMP with Canadian-specific addendum
Include Health Canada approval date, control and version numbers of document (if applicable).
If applicable, provide details on any related submissions currently undergoing Health Canada's review (including other versions of the RMP).
Include control and sequence numbers.
Indicate if the product monograph, product packaging or product labels are currently under review with Health Canada.
If applicable, provide details on whether any of the documents submitted are approved or undergoing review in other jurisdictions.
Specify whether the reference RMP or other RMP-related material has been submitted to another jurisdiction, identify the jurisdiction and clarify whether the submitted material is under review (with anticipated approval date) or has been approved (with date of approval).
Additional notes
Additional information for reviewers
Indicate any additional details that will guide the reviewer, for example:
- if there are planned actions in Canada, such as an intention to submit a safety update for the Canadian product monograph as a supplement to a submission
- high-level rationale for significant changes to an existing RMP
- rationale for differences between the reference RMP and the Canadian-specific addendum or to remove a safety concern, risk minimization measure or pharmacovigilance measure
- rationale if a generic or biosimilar RMP differs from the innovator RMP