News and Educations

Notice to marketing authorisation holders on the update of Appendix IV and 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 IV and Appendix V on its website. Updated Appendix IV and Appendix V are available here.

Appendix IV defines the terms and abbreviations for "batch number” and "expiry date” to be used on the labelling of medicinal products. The update enabled that the batch number and the expiry date on small immediate packaging and blisters can be stated without any words or abbreviations.

Appendix V defines the contact information for reporting adverse reactions to HALMED which marketing authorisation holders are required to include in printed patient leaflets and summaries of product characteristics. With this update the possibility of reporting side effects using mobile application was introduced in the document.

Marketing authorisation holders should implement the change in Appendix V on the occasion of the first subsequent printing of the patient leaflet/summary of product characteristics. Patient leaflets and summaries of product characteristics which have already been printed do not need to be changed solely due to this change.