1. Public hearings

1.6. Decision to hold a public hearing

The PRAC decides when to hold public hearings on a case-by-case basis, depending on the urgency of the matter and on other justified grounds, particularly with regard to the extent and seriousness of the safety issue.

Proposal for a public hearing

  • Referral procedures in accordance with Art. 20 of Regulation (EC) 726/2004, Art. 31 or Art. 107i of Directive 2001/83/EC
  • Proposal to hold a public hearing can be submitted by any PRAC member
  • Content of proposal
    • Purpose of the public hearing (what is intended to be achieved?)
    • Specific questions on which public opinion should be sought
    • Any additional information as appropriate

Evaluating the need

At the start of each referral the PRAC will consider the need to hold a meeting and the following points:

  • Feasibility to hold a public hearing in light of the urgency of the matter.
  • Nature and extent of the safety concern.
  • Therapeutic effect of the medicine/class of medicines and availability of therapeutic alternatives.
  • Potential impact of possible regulatory actions on therapeutic practice and availability of treatments.
  • Level of public interest.

Agreement to hold a public hearing will be reached by consensus or, if not, by majority vote.