Viola Macolić Šarinić, MD, PhD, Viola Macolić Šarinić, MD, PhD, Head of the Agency for Medicinal Products and Medical Devices of the Republic of Croatia

The presentation will focus on the activities of the Croatian Agency for Medicinal Products and Medical Devices (HALMED) following the Croatia’s accession to the European Union, as well as the impact that the recent legislation changes have had upon the regulation of medicinal products in Croatia.
The presentation will give an overview of the HALMED’s first experiences with the new marketing authorisation procedures for medicinal products that were introduced in Croatia; mutual recognition procedure (MRP) and decentralised procedure (DCP) used for authorisation of medicinal products in more than one EU member state, and centralised procedure (CP) used for the authorisation of medicinal products in all member states.
By accessing the EU, Croatia gained immediate access to all medicinal products authorised through centralised procedure. At the same time, it was required to revoke the national marketing authorisations for centrally authorised medicinal products that were issued before the accession and for which the data exclusivity of the reference medicinal product authorised in the EU via CP procedure has not elapsed. By becoming a part of the European Medicines Network, the EU 8+2(+1) formula for data and marketing exclusivity started to apply to Croatia, as well.
The presentation will also deal with HALMED’s endeavours in obtaining an active role in decentralised procedures (DCP) and mutual recognition procedures (MRP) as referent member state’s (RMS) competent authority.
Along with the new authorisation procedures, the new Croatian Medicinal Products Act, which entered into force on 1 July 2013, distinguishes between two means of entering the medicinal products in the Republic of Croatia; entry and import, which will be discussed in this presentation, as well.
Special emphasis in this presentation will be placed on the new pharmacovigilance legislation, which came into effect in the EU in 2012. As the new European pharmacovigilance directive has been fully adopted in Croatia prior to its accession to the EU, the challenges HALMED is now facing in this field include further engaging in the EU processes, primarily with respect to active participation in the work of the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), taking over referrals and the role of rapporteur, and signal management for each active substance put under HALMED’s responsibility for the territory of EU.
HALMED’s early preparation for the accession to the EU has paid off from the scientific, regulatory and technical point of view. Croatian representatives are now fully involved in the activities of the EMA’s seven scientific Committees, as well as in its other activities. HALMED’s next goal is to become a contributing Agency in the European regulatory framework and to provide education to the applicants to make them fully prepared for the challenges they will be facing.