3. Public hearings
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