Submitting risk management plans guidance document: RMP summary template
The RMP summary should include the following sections:
- an introduction
- the drug and what it is used for
- risks and uncertainties associated with the drug and measures to:
- prevent or reduce the risks
- address and monitor the uncertainties
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:
- brand name of the product
- name of the market authorization holder
- submission control number
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:
- name of the active substances
- approved indications of the drug in Canada
- route of administration of the product as reflected in the Canadian market authorization
Associated risks and minimization measures
Itemize routine risk minimization measures and state if the product has:
- routine or additional pharmacovigilance measures
- additional risk minimization measures
- missing information
List of important risks and missing information
In this section, provide a list of the:
- important identified risks
- important potential risks
- missing information
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
| 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:
- evidence for linking the risk to the drug
- risk factors and risk groups
- routine and additional risk minimization measures
- additional pharmacovigilance measures, if applicable
Provide a separate table for each missing information. In each table, provide a summary of:
- routine and additional risk minimization measures
- additional pharmacovigilance measures, if applicable
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
| 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
| Presentation of missing information | Details |
|---|---|
| Risk minimization measures | - |
| Additional pharmacovigilance measures | - |