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

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

Submitting risk management plans guidance document

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RMP submission details

If applicable, indicate
the RMP submitted
within current
transaction

Canadian RMP or
reference RMP with
Canadian-specific
addendum

☐ 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

Canadian RMP or
reference RMP with
Canadian-specific
addendum

☐ 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)

If applicable, provide details on whether any of the
documents submitted are approved or undergoing
review in other jurisdictions

Include control and sequence numbers

Indicate if the product monograph, product packaging or
product labels are currently under review with Health
Canada

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

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Submitting risk management plans guidance document

