3. Public hearings

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.