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Practice run on public hearings

Practice run on public hearings

EMA conducted an internal practice exercise (dry run) in order to test the process and procedures for public hearings. Using a fictional scenario of a safety review, the PRAC experienced how such a hearing would take place. This has enabled EMA to ensure all practical arrangements needed for these hearings are in place and PRAC members to test this new form of interaction. Following this successful simulation, the PRAC is ready to incorporate public hearings as part of its core activities.

Public hearings are a new tool for EMA to engage European Union (EU) citizens in the regulation of medicines and to listen to their views and experiences. The pharmacovigilance legislation has given the PRAC the possibility to hold public hearings as part of certain safety reviews of medicines. Contributions made by the public during these hearings will be considered by the PRAC and inform the Committee’s decision-making.

Public hearings will be held on a case-by-case basis, where the Committee determines that collecting the views of the public would bring added value to its review. The first public hearing could take place as early as the fourth quarter of 2016, as soon as a relevant topic is identified.

More information is available on our 'public hearings' webpage as well as in the rules of procedure for these hearings.

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