Guidelines on good pharmacovigilance practices (GVP) Introductory cover note, last updated with revision 3 of Module XVI on risk minimisation measures and its Addendum II on methods for their effectiveness evaluation for public consultation

 

 

A pubnlic consultation is launched for revision 3 of Module XVI on risk minimisation measures – selection of tools and effectiveness indicators and its new Addendum II on methods for effectiveness evaluation of risk minimisation measures. Together, these two GVP documents are meant to clarify and enhance tools for risk minimisation measures and strengthen methods for studying the effectiveness of the implementation of risk minimisation measures and the possible need for adjustments of risk minimisation measures in the interest of patient safety. Guidance on the important collaboration with patient and healthcare representatives in the related regulatory processes is included too.

For timelines when the remaining new Considerations will be published for public consultation, please  see the GVP webpage of the Agency’s website: https://www.ema.europa.eu/en/humanregulatory/post-authorisation/pharmacovigilance/good-pharmacovigilance-practices.