3. Public hearings


1. Public hearings

Public hearings are a tool allowing the EMA to engage with European Union (EU) citizens in the supervision of medicines and listen to their views and experiences.

The EU's pharmacovigilance legislation[1] enables the PRAC to hold public hearings during certain safety reviews of medicines. They support the committee's decision-making by providing perspectives, knowledge and insights into the way medicines are used.

[1] The legal basis for public hearings is Article 107j of Directive 2001/83/EC which gives the PRAC the possibility to hold public hearings for safety reviews conducted by the Committee under Article 20 of Regulation (EC) No 726/2004, and Articles 31 or 107i of Directive 2001/83/EC.