1. Public hearings

1.2. Definition of public hearing

A public hearing is:

  • A forum to which the public is invited to express its views and concerns on a pre-defined set of questions on issues related to the safety of a particular medicinal product, a medicinal substance or a therapeutic class, whilst also considering the therapeutic effects of these products.
  • A channel for the PRAC to take the public’s views and concerns into account, particularly where options for regulatory actions and risk management activities will need to be considered in a wider public health context. 

This input is of particular value once the PRAC has assessed all available data and is considering regulatory options to manage or minimize risks with a medicine in a wider public health context.