Notice to marketing authorisation holders on the update of Appendix V


Agency for Medicinal Products and Medical Devices of Croatia (HALMED) informs marketing authorisation holders that the European Medicines Agency (EMA) published the updated Appendix V on its website on 5 May 2017.

This document is an appendix to product-information templates, which defines the contact information for reporting adverse reactions to HALMED, which markething authorisation holders need to specify in printed package leaflet. This document has become effective on the date of its publishing, and marketing authorisation holders should implement the change on the occasion of the first subsequent printing of the package leaflet. Package leaflets that have already been printed do not need to be destroyed solely due to this change.

The updated Appendix V is available on EMA's website, or here.