European Risk Management Plans (EU-RMP)

European Risk Management Plans (EU-RMPs) are required for all products submitted for registration in the European Union. EU-RMPs consist of the following sections:

1. Safety specification
2. Pharmacovigilance plan
3. Evaluation of the need for risk minimisation activities
4. Risk minimisation plan
5. Summary of the EU-RMP
6. Contact person details

Additionally, they may contain the following annexes:

1. Interface between EU-RMP and EudraVigilance (to be provided in electronic format)
2. Current (or proposed if initial EU-RMP) summary of product characteristics and package leaflet
3. Synopsis of ongoing and completed clinical trial programme
4. Synopsis of ongoing and completed pharmacoepidemiological study programme
5. Protocols for proposed and ongoing studies from the pharmacovigilance plan
6. Newly available study reports
7. Other supporting data
8. Details of proposed educational programme (if applicable)

We have applied our experience in developing and implementing risk management plans (RMPs) to helping our clients understand and meet requirements for EU-RMPs. We can help you develop all aspects of the plan so that it is ready for submission. Our services include:

• Evaluation of risks and safety concerns
• Determination of the appropriate level of detail for each section of the EU-RMP
• Development of specific measures and tools for the risk minimisation section.
• Evaluation of the EU-RMP
• Preparation of reports that can be provided to regulatory agencies.