1. Public hearings

1.8. Impact of a public hearing on PRAC opinion


  • The information gathered in the public hearing informs the debate within the PRAC
  • The contributions made by the public during a public hearing will be considered by the PRAC
  • The assessment report will reference how the outcome of the public hearing will be addressed in the decision-making at the level of the PRAC

For more information please refer to the following texts:

Rules of procedure on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC)
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/rules-procedure-organisation-conduct-public-hearings-pharmacovigilance-risk-assessment-committee_en.pdf

Public hearings Guidance for participants
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/public-hearing-guidance-participants_en.pdf