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Submitting risk management plans guidance document: Preparing and submitting an RMP

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What to include in your risk management plan

All risk management plans (RMPs) submitted to Health Canada should meet a standard that is acceptable to the Minister.

To meet the standard, the RMP should consider the Canadian context and contain sufficient information to enable the Minister to:

The RMP should describe the:

It should also include a summary of the plan's contents, in English and French.

The information should be included within the standard sections of an RMP:

RMP note to reviewer

An RMP note to reviewer should accompany all RMPs, RMP updates and other RMP-related materials.

Submit the RMP note to reviewer under Module 1.3.8.2 along with the RMP.

The RMP note to reviewer is not meant to replace the general note to reviewer relevant to the entire submission (for example, guidance on the location of a particular document within the submission or reference of the product by a foreign trade name). Submit the general note to reviewer under Module 1.0.7.

For more information, consult:

The RMP note to reviewer should include:

Find more information on preparing an RMP note to reviewer.

Canadian-specific addendum

You do not need a Canadian-specific addendum if you have:

Include in the RMP or Canadian-specific addendum any Canadian-specific considerations, as well as a detailed description of how the information and measures apply to Canada.

Examples of special considerations for the Canadian context and related to medical practice or populations in Canada:

Also include in the Canadian-specific addendum:

Find more information on preparing a Canadian-specific addendum.

RMP summary

Include a summary as part of your RMP to meet the standard acceptable to the Minister. Health Canada will consider the RMP summary as part of the RMP review. You are expected to incorporate changes to the summary section of the RMP, as needed, as changes to the RMP occur during the review process.

The RMP summary should include an introduction as well as information on:

This summary should reflect the Canadian context and include Canadian-specific considerations.

Write the summary in clear and concise language that is accessible for many users, including:

To respect official language standards, you are encouraged to provide the summary in both English and French, along with an attestation that both language versions accurately reflect the content of the RMP. The summary in the second language, along with the attestation, can be provided during the review process. We will advise you in writing (for example, in a clarification request) once the review has reached a stage where the summary in the other language should be submitted.

You are responsible for verifying that the RMP summary does not contain confidential business information that you do not want made public.

To support transparency and increase access to information on drugs, Health Canada will make these summaries available upon request.

Some manufacturers voluntarily post Canadian drug product information on their websites, including the Canadian Product Monograph. To further support transparency and access to information on drugs, you are encouraged to post the RMP summary on your Canadian website, in both official languages.

Find more information on preparing an RMP summary.

Acceptable risk management plan document format

RMPs are acceptable in:

You should consult the European Medicines Agency’s Guidance on the format of the risk management plan (RMP) in the EU, in integrated format.

Note: If you use a reference RMP, you should include a Canadian-specific addendum containing information specific to the Canadian context. If you prepare the RMP specifically for Canada, you must consider the Canadian context throughout the RMP.

Procedures to file an RMP

There are currently 2 acceptable filing formats for RMPs or related documents:

For submissions in the eCTD format, consult:

For submissions in the non-eCTD electronic-only format, refer to the structure template recommended in:

For information on submission requirements and general procedures on how to file pre-market submissions, consult:

General considerations

An RMP reflects both clinical and non-clinical safety data. It should be updated throughout the drug's lifecycle as discussed and agreed upon with Health Canada.

When submitting RMPs, you should:

For RMP updates, submit clean and track change versions of the reference RMP, Canadian-specific addendum (if revised), and RMP summary, unless the changes involve a complete format change.

If there are simultaneous RMPs submitted for review, include final changes from the concurrent reviews when available.

If the RMP is part of a pre-market drug submission or application, the applicable timelines for those submissions apply. Regulatory correspondence for RMPs attached to a submission should include a reference to the control number.

Note: Elements of RMPs, such as controlled access or distribution programs, are not intended to restrict access to Canadian reference products (CRPs) for generic drug manufacturers for the purposes of conducting comparative testing. Any RMP elements should not be used as a reason to:

  • delay or hinder comparative testing by generic products or
  • hinder their ability to enter the market

You should have an adequate system in place to manage your commitments for RMPs. This system can be part of your global systems and processes. It should:

For more information on adequacy of a pharmacovigilance system, consult:

Contact information for submitting an RMP or other related documents

You should submit RMPs or other related documents to the Office of Submissions and Intellectual Property (OSIP) via the Common Electronic Submissions Gateway (CESG) using the regulatory enrolment process (REP).

For transactions in e-CTD format, consult:

For transactions in non-eCTD format, consult:

Do not file the RMP using a supplement to a submission when requested post-authorization or for RMP updates, unless it is needed to assess the drug’s safety and effectiveness in relation to the supplement to a submission being filed.

Review of risk management plans

Review bureaus at the Marketed Health Products Directorate (MHPD) conduct the review of RMPs, updates and other related materials.

RMPs included with a drug submission or application

Health Canada will screen the submission. If you do not provide an RMP or if you provide a rationale in the absence of an RMP, but we determine an RMP should be submitted, we will request one.

If we identify issues or have questions during our review, we will send a communication (such as a clarification request) to you, including the timelines for response.

Once we have completed our review, we will notify the appropriate pre-market directorate of the result.

We will provide you with written notice to confirm if the RMP included in the submission is acceptable.

For information on the timelines to respond and RMPs included with a drug submission or application, including the screening process, consult:

Post-market RMP submissions

Health Canada may send a letter to you at any time to request an RMP or an update to an existing RMP. You should submit the requested RMP or RMP update within the timelines specified in our request.

You should also submit an update to an RMP as soon as feasible if the risks or uncertainties, or the measures you intend to take, are significantly different from those described in the existing plan.

If we identify issues or have questions during our review, we will send a communication (such as a clarification request) to you, including the timelines for response. The timeline to respond is usually between 15 and 30 calendar days. These are guidelines only and can be adjusted based on the nature of the request. Any responses to these clarification requests should be sent to the MHPD.

When we have completed our review, we will inform you of the outcome.

Status requests

The MHPD will review the RMP and inform you of the outcome.

For information on the timelines of a drug submission, consult:

Contact the regulatory project manager in MHPD if you have questions about the RMP part of your submission.

To support transparency, information on the status of a review that is not part of a drug submission or application will continue to be included in the industry access to the submission tracking system.

We will share the final RMP review report with you upon request.

Acceptability and implementation

To be deemed acceptable for the Canadian context, the RMP should contain sufficient information to enable the Minister to:

As part of the review, we will determine acceptability based on the following:

The RMP should include sufficient detail on the timing of implementation of measures, evaluation of measures and reporting.

In our review, we will also consider whether the plan, including the proposed measures, is feasible and reasonable.

The proposed measures should be implementable in Canada and consider the Canadian context:

The measures in an RMP should not unduly limit access or distribution of products to patients and health care providers.

To ensure the proposed measures are feasible, reasonable and implementable in Canada, you may wish to consult interested and affected parties, such as Canadian health care providers (for example, physicians, nurses, pharmacists).

Following acceptance, we expect you to implement and perform the pharmacovigilance and risk minimization measures in accordance with the descriptions and timelines outlined in the RMP. You are also expected to implement and perform any measures outlined in subsequent RMP updates found to be acceptable.

Health Canada will confirm follow-up actions outlined in the RMP, as needed.

The Minister may use authorities under the FDA or FDR to respond to risks and uncertainties that are not sufficiently addressed by an RMP.

These authorities include:

Record-keeping

You should keep a copy of the RMP, as well as records of the decisions you made when creating and updating the plan. You should also keep the information you relied on when making those decisions, and have them readily available when we request them.

Document all decisions related to creating or updating the RMP, including those that concern:

Examples of information that you may rely on when making these decisions could include:

The RMP outlines the measures that you intend to take, as well as the manner in which you intend to evaluate the effectiveness of those measures. For this reason, you should also keep:

We recommend that you keep the RMP and records for at least 5 years after the drug has been discontinued in Canada, unless other regulatory requirements for documentation apply.

You are also responsible for preserving data integrity. Based on how documents are preserved, you should consider having processes to:

For more information on record-keeping best practices, review:

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2025-02-24