Submitting risk management plans draft guidance document: Canadian-specific addendum template

On this page

• What to include in a Canadian-specific addendum
• Cover page
• RMP submission history in Canada
• Safety specification
• Pharmacovigilance measures in Canada
• Risk minimization measures in Canada and evaluation of their effectiveness
• Summary of the RMP in Canada
• References and appendices

What to include in a Canadian-specific addendum

A Canadian-specific addendum should address:

• risks or uncertainties that are unique to the Canadian context
• measures that the manufacturer intends to take that are unique to the Canadian context

Information may vary, however, a Canadian-specific addendum should contain the following sections:

• cover page
• RMP submission history in Canada
• safety specification
• pharmacovigilance measures in Canada
• risk minimization measures and evaluation of their effectiveness in Canada
• summary or conclusion of the RMP in Canada
• references
• appendices

In the event that 1 or more of the sections do not apply, such section(s) should still be included in the Canadian-specific addendum with a notation that the section is not applicable.

Cover page

The cover page of the Canadian-specific addendum should include:

• "risk management plan Canadian-specific addendum for [name of product or proposed brand name]"
• proper name or non-proprietary name in final dosage form
• the date of submission
• version, date of final sign-off and data lock point for the current Canadian-specific addendum
• version, date of final sign-off and data lock point for the core RMP

RMP submission history in Canada

In this section, provide the versions, in chronological order, of the RMPs submitted to Health Canada for evaluation, including a summary of changes made for each version. Include versions submitted by previous DIN holders, if applicable. This information can be in a table format for ease of reference, and should include:

• the core RMP version
• the Canadian-specific addendum version
• the date the RMP was submitted to Health Canada
• the application number (DSTS control number)
• a summary of changes from the previous version to the Canadian-specific addendum, or core RMP from the previous version submitted to Health Canada
• the rationale for change
• a scientific rationale should accompany significant changes to the RMP or Canadian-specific addendum

Safety specification

In this section, provide:

• the Canadian epidemiology
• a summary of Canadian-specific safety concerns
• a summary of any proposed changes

Epidemiology of the indications and target populations relevant to Canada

Indication

Provide the current or proposed indication according to the Canadian product monograph.

Epidemiology in Canada

Provide a brief summary of the Canadian epidemiology of the product's indication (incidence and prevalence in Canada). Specify any notable differences from the core RMP, including:

• the epidemiology of the medical condition
• risk factors for the authorized indication in Canada
• for example, in cases where it is different from the authorized indication in other major jurisdictions, such as Europe and the U.S.
• when the drug is meant to be used by a small group of patients in Canada

Details of target population

Provide any relevant information such as demographics of the target population and the setting for use of the product in Canada, including:

• the targeted population for use of the product, including specified groups such as:
• age or age categories such as pediatric or geriatric
• sex or gender
• racialized and/or ethnic minorities (when relevant for assessment of safety and risk management)
• underrepresented and/or underserved populations, such as:
• pregnant or lactating people
• patients with psychiatric disorders
• patients with relevant comorbidities
• populations with specific religious constraints
• the intended prescriber for the product and any considerations related to the medication use process, from prescribing to dispensing to administration and monitoring of the product
• the setting in which the product should be used, such as:
• hospitals
• outpatient clinics
• at home
• potential challenges to risk management
• for example, remote locations and rural communities may present challenges for monitoring or follow-ups
• particular risk management considerations for specified groups or populations, such as Indigenous populations
• potential for medication errors
• misuse or illegal use
• potential challenges related to availability of technologies, devices or supplies in Canada required for risk management or use of the product

Post-authorization experience

Include yearly and cumulative patient exposure in Canada since product launch.

Canadian-specific safety concerns

Indicate whether the safety concerns listed in the core RMP are applicable to Canada. If not, explain why.

If there are Canadian-specific safety concerns that are not listed in the core RMP, provide a detailed description of the safety concern.

Provide a clear justification, including scientific evidence, if there are safety concerns:

• that have been changed or amended
• that were included in the previous version and have now been removed
• included in the core RMP that are not considered relevant in Canada

It's not sufficient evidence to cite acceptance of such a change by another regulator without providing a rationale as justification.

If additional safety concerns need to be considered or a risk is reclassified or removed, provide a description and the scientific rationale for the changes. For the Canadian context, examples include:

• genetic, external or other factors that are unique to the population, such as:
• sex
• gender
• race
• ethnicity
• the proposed or approved indications
• the expected use of the product, including the:
• potential for off-label use
• potential for medication errors
• potential harm from an overdose
• potential for transmission of infectious agents
• risks in pregnant and lactating people or in children
• risks associated with other members of the pharmacological class

If applicable, include information on:

• clinical trial exposure in Canada
• post-authorization experience worldwide and in Canada, including regulatory actions since product approval (Canadian and worldwide)
• include reference to the section in the core RMP

Sample summary table of safety concerns in Canada

Pharmacovigilance measures in Canada

In this section, provide:

• the routine pharmacovigilance measures in Canada
• the additional pharmacovigilance measures in Canada
• a summary table of pharmacovigilance measures in Canada

Also, in this section, confirm that all pharmacovigilance measures, including routine measures and additional measures, listed in the core RMP apply to Canada. If the pharmacovigilance measures are not relevant to the Canadian context, provide an explanation.

Routine pharmacovigilance measures in Canada

Provide information on the routine pharmacovigilance measures in the Canadian context, including:

• details of pharmacovigilance practices and history since product launch
• Canada-specific monitoring of adverse events, including search strategy, and reconciliation with the Canada Vigilance Database

If these routine pharmacovigilance measures in Canada differ from the core RMP, provide an explanation.

If there are Canada-specific safety concerns identified in the previous section, describe the routine pharmacovigilance measures that have been, or will be, implemented to address these safety concerns.

Refer to the sections in the core RMP, if applicable.

Additional pharmacovigilance measures in Canada

Provide information on the additional pharmacovigilance measures in the Canadian context, such as copies of the study protocols or synopsis.

For each additional pharmacovigilance measure listed in the core RMP, state how it is relevant to the Canadian context at the time of submission. Include how:

• findings from the activity will inform the risk characterization and RMP updates in Canada
• milestones and timelines for reporting, including any deliverables, will be provided to Health Canada
• the pharmacovigilance measure is conducted in Canada, for example:
• study has Canadian sites
• registry can enroll Canadian patients

Where additional pharmacovigilance measures only apply to Canada or if international pharmacovigilance measures differ from those proposed for Canada, provide a description and a detailed reason for these differences.

Refer to the sections in the core RMP, if applicable.

If there are Canadian-specific additional pharmacovigilance measures that are not listed in the core RMP, provide a detailed description of the additional pharmacovigilance measures using the same format as in the core RMP.

Sample summary table of pharmacovigilance measures in Canada

Risk minimization measures in Canada and evaluation of their effectiveness

In this section, provide details of:

• the routine risk minimization measures in Canada
• the additional risk minimization measures in Canada, including the plans to evaluate the effectiveness of risk minimization measures in Canada
• a summary table of risk minimization measures in Canada

Also, in this section, confirm that all risk minimization measures, including routine measures and additional measures listed in the core RMP apply to Canada. If the risk minimization measures do not apply to Canada, provide an explanation.

Routine risk minimization measures in Canada

Provide detailed information on the routine risk minimization measures in Canada for the safety concerns that apply to Canada at the time of submission. If these routine risk minimization measures in Canada differ from the core RMP, provide an explanation.

When discussing routine risk minimization measures in Canada, refer to the most recent version of the Canadian product monograph, product packaging and product labels.

Additional risk minimization measures in Canada

Provide information on the additional risk minimization measures in the Canadian context, including a history of additional risk minimization measures that may have been discontinued.

For these measures:

• include the objective and rationale
• include a description of their implementation including the target audience, how and when the tools or material will be disseminated
• if applicable, compare additional risk minimization measures proposed in Canada with those in other jurisdictions and provide a reason for using a different approach
• describe plans to evaluate their effectiveness and include timelines for reporting
• if applicable, compare the manner used to evaluate the effectiveness of the risk minimization measures in Canada with the manner used in other jurisdictions and, if they are different, explain the reason for these differences

Include in the appendix copies of any tools or materials used in risk minimization measures.

Sample summary table of additional risk minimization measures in Canada

Summary of the RMP in Canada

In this section, provide a summary of the:

• safety issues specific to Canada
• routine and additional pharmacovigilance measures
• risk minimization measures

Sample summary table of risk management information

References and appendices

References

In this section, provide any references used in the Canadian-specific addendum.

Appendices

Include as an appendix any materials referred to within the Canadian-specific addendum. Examples include:

• study protocols for planned Canadian pharmacovigilance studies
• pharmacovigilance materials such as adverse event and medication error follow-up questionnaires implemented in Canada
• additional risk minimization materials used in Canada, such as:
• consent forms
• patient/caregiver guide
• patient cards, wallet/alert cards
• health care professional checklist
• health care professional education program/materials