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Eurordis - Rare Disease Europe


Lesson 4: The Role of Patient Organisations in Pharmacovigilance

In addition to the EMA’s Pharmacovigilance Risk Assessment Committee, there are other ways that patients can take an active role in pharmacovigilance.

New EU legislation adopted in 2012 aims at reducing deaths resulting from negative side effects.

When new drugs arrive on the market, often little is known about their long-term effects on patients as they were tested in clinical settings that don’t necessarily mirror real life.

Risk Management Plans (RMPs)

Companies are required to submit a risk-management plan (RMP) to the European Medicines Agency (EMA) when applying for a marketing authorisation. To help applicants, EMA developed guidance on how to submit RMPs:

EMA’s Risk Management Plan

Example of a RMP

What does the black triangle mean?


Video presentation:

François Houÿez on the roles patients can take in ensuring their medicines are as safe as possible.

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