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

Purpose of RMP submission

Document	Details of submission
RMP	Indicate reason for submission (examples provided) RMP included with new drug submission that includes a new active substance RMP included with generic or biosimilar drug whose reference product has an RMP with additional risk minimization measures or additional pharmacovigilance measures RMP included with combinations or co-packages of products where at least 1 of the components is a drug that has its own DIN with an RMP that includes additional risk minimization measures or additional pharmacovigilance measures Updated RMP submitted with a supplement to a submission in support of a new indication Updated RMP submitted due to significant change in degree of uncertainty or serious risk of injury to human health RMP submitted following Health Canada's request under control number, letter dated (dd/mm/yyyy)
Related materials	Specify materials and indicate reason for submission (examples provided) Document (for example, risk minimization tool) in support of RMP submission or submitted as requested by Health Canada under control number, letter dated (dd/mm/yyyy) Document (for example, risk minimization tool or study protocol) submitted due to a new or heightened risk or uncertainty Document (for example, foreign review report) in support of aligning with RMP submitted to other foreign authorities

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