Actively reducing risk.

Global Risk Minimisation Measures - aRMMs

Signal and Risk Management

The need for Risk Minimisation Measures

Risk Minimisation Measures (RMMs) are a legal requirement of Competent Authorities (NCAs) which are put in place to protect patient safety, and failure to employ them may result in non-compliance with the possibilities of fines or other punitive actions.

Following the identification and assessment of a product’s risks, Risk Minimisation Measures (RMMs) form the range of activities that a Marketing Authorisation Holder (MAH) is obligated to put in place to mitigate those risks as part of their overall Risk Management System.

RMMs are split into two areas; routine RMMs (rRMMs) which are standard practices that apply to all medicinal products, and additional RMMs (aRMMs) which are considered when more specific actions are needed to improve the safe and effective use of the medicinal product.

Given the increased complexity of aRMM management, such activities need a detailed implementation plan, which ensures they are effectively applied and harmonised across all applicable markets. 

The Implementation plan will be based on the Risk Management Plan (RMP) obligations, the distribution strategy for aRMMs to healthcare professionals and patients, and proactive communication strategies to all other relevant parties (e.g. health authorities, PV partners, etc.).

A range of RMM activities.

The full scope of rRMM and aRMM Risk Minimisation Measures that can be used to mitigate product risk can be applied by iVigee’s fully experienced QPPV Office Services team, who can also provide all your Core RMM planning, implementation, and evaluation tools to provide a comprehensive Risk Management service.

Typical rRMM and aRMM activities iVigee uses include, but are not limited to:

Our holistic approach to risk and technology.

And as industry and regulators strive to digitalise RMMs to enhance medicinal product safety, iVigee is perfectly poised to capitalise on combining the extensive PV knowledge of our subject matter and IT experts with the innovative technologies, such as our world leading Regulatory Intelligence platform iViReg, for the latest legal requirements in over 90 countries.

iVigee is committed to safeguarding patient health and product safety through the effective implementation of RMMs as part of your strategic and tactical approach to product risk. 

Partnering with us guarantees delivery and insights, with complete oversight and compliance wherever your products are marketed.

Contact us about our Risk Management Minimisation services.

Whatever your RMM requirements, our experienced pharmacovigilance experts can provide the solution.

Email us at or fill in and submit the form below.

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