1. Public hearings

1.3. Purpose of a public hearing in the context of safety referral procedures

  • To seek public opinion, suggestions and recommendations on the acceptability of the risks associated with the medicine or class of medicines concerned. This would be particularly in relation to its therapeutic effects and therapeutic alternatives available, as well as on the feasibility and acceptability of risk management and minimisation activities.
  • To inform the debate of the PRAC, which continues to have the sole responsibility for giving its scientific recommendation on the safety of the medicine concerned.