Risk management plan

The risk management plan is the document in which the applicant for, and subsequently the holder of, a marketing authorisation describes the safety profile of a medicinal product and the measures intended to prevent or minimise its risks. Introduced by the 2010 EU pharmacovigilance reform, it is required for every new marketing authorisation application and forms part of the risk management system provided for by Directive 2001/83/EC and Regulation (EC) No 726/2004. It is assessed together with the authorisation dossier and updated throughout the life of the product.

Content of the plan

The plan comprises a safety specification, which lists the important identified or potential risks and the missing information, a pharmacovigilance plan, which describes the monitoring activities and planned studies, and a risk minimisation plan. Minimisation measures are described as routine when they operate through the summary of product characteristics, the package leaflet and the packaging, and as additional when they require specific tools, such as educational material for prescribers, a patient card or a controlled distribution programme.

Conditions attached to the authorisation

Additional measures and post-authorisation safety or efficacy studies may be made conditions of the authorisation. Failure to comply exposes the holder to a variation, suspension or withdrawal of the authorisation, as well as to financial penalties. Any significant change to the plan is in principle implemented through a variation of the marketing authorisation, and the national implementation of additional measures, in particular the content of educational material, is approved by the competent authority of each Member State.

Generic risk management plans and competition issues

An applicant for a generic medicinal product authorisation submits a risk management plan that is in principle aligned with that of the reference medicinal product and implements equivalent minimisation measures. Access to controlled distribution programmes or to tools put in place by the originator may then become a lever for delaying the entry of competitors. The issue has mainly been debated in the United States, but the misuse of safety requirements to obstruct a generic could be examined in Europe as an abuse of regulatory procedure.

Key points

The risk management plan sets the safety commitments that the holder must honour after authorisation, and its additional measures may become conditions of that authorisation. It is read together with the summary of product characteristics, whose logic it shares. In any transaction involving a medicinal product, the list of additional measures and imposed studies, their progress and their cost should be checked, as they bear directly on the value of the product.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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