Submitting risk management plans draft guidance document: RMP summary template

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• Summary specifications
• Introductory paragraph
• The drug and what it is used for
• Associated risks and minimization measures

Summary specifications

The RMP summary should include specific sections, which mirror the EU RMP Summary format sections. These are:

• an introductory paragraph
• 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

In the event that 1 or more of the sections do not apply, they should still be included in the RMP summary with a notation that the section is not applicable.

It is insufficient to submit an EU RMP summary as submitted for another jurisdiction. This is because the summary must contain Canadian-specific considerations and must be provided in both English and French.

For a template of the EU RMP summary, refer to:

• Guidance on the format of the risk management plan (RMP) in the EU – in integrated format

Introductory paragraph

The introductory paragraph should indicate the purpose of the document and the name of the product.

It is suggested that the following text template be used, which is the text template used in the EU RMP template, modified for Canada:

"This is a summary of the risk management plan (RMP) for [product name]. The RMP details important risks of [product name], [how these risks can be reduced or prevented] and how more information will be obtained about [product name]'s risks and uncertainties (missing information).

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

The drug and what it is used for

In this section, provide in paragraph form the:

• name of the active substances
• approved indication(s) 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 format for ease of reference.

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
• risk minimization measures
• additional pharmacovigilance measures, if applicable

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

• risk minimization measures
• additional pharmacovigilance measures, if applicable

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