Submitting risk management plans guidance document: RMP summary template

The RMP summary should include the following sections:

If 1 or more of the sections do not apply, you should still include them in the RMP summary with a notation that the section is not applicable.

It is not enough to submit an EU RMP summary as submitted for another jurisdiction. Your summary should contain Canadian-specific considerations.

Introduction

The introduction section should indicate that the document summarizes the content of the RMP.

Provide sufficient information to identify the product, including the:

The following text template may be used:

This is a summary of the risk management plan (RMP) for [product brand name] by [market authorization holder] under submission control number [submission control number]. The RMP describes important risks of [product name], [how these risks can be reduced or prevented] and how more information will be obtained about [product brand name]'s risks and uncertainties (missing information).

[Product brand name]'s product monograph and its patient medication information give essential information to health care professionals and patients on how [product brand name] should be used.

The drug and what it is used for

In this section, in a paragraph provide the:

Associated risks and minimization measures

Itemize routine risk minimization measures and state if the product has:

List of important risks and missing information

In this section, provide a list of the:

The list should contain all the important risks and missing information from the RMP, including Canadian-specific considerations.

The list should be presented in a table for easy reference.

Sample table for list of important risks and missing information

List of important risks and missing information
Classification Details

Important identified risks

-

-
-

Important potential risks

-

-
-

Missing information

-

-
-

Summary of important risks

Provide a separate table for each important identified risk and important potential risk. In each table, provide a summary of:

Provide a separate table for each missing information. In each table, provide a summary of:

The summary of each important risk should contain information from the RMP, including Canadian-specific considerations.

Sample table for important identified risks and important potential risks

Important identified risk or important potential risk
Insert risk as indicated in List of important risks and missing information
Presentation of the risk Details
Evidence for linking the risk to the drug -
Risk factors and risk groups -
Routine and additional risk minimization measures -
Additional pharmacovigilance measures -

Sample table for missing information

Missing information
Insert missing information as indicated in the List of important risks and missing information
Presentation of missing information Details
Risk minimization measures -
Additional pharmacovigilance measures -

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2025-02-24