On 1 July 2013 Croatia joined the European Union. Croatia is now part of the European medicines network and its representatives will be fully involved in the activities of the seven Scientific Committees of the European Medicines Agency (EMA) as well as the Agency’s other activities.
Preparation for the participation of Croatia in the EMA’s activities began in 2007, when the European Commission’s Instrument for Pre-accession Assistance (IPA) programme for Croatia was put in place. Under the framework of the IPA, the Agency worked with the Croatian national competent authorities to prepare their participation in the EMA’s activities and contribute to the creation of information-exchange systems to support its integration into the European medicines network. As part of this programme, representatives nominated by Croatia participated as observers in selected meetings. This included EMA Scientific Committees meetings once Croatia became an acceding country. The EMA also organised conferences, training sessions and visits for Croatian experts on medicines regulation.
In January 2011, the EMA, together with the Croatian national competent authorities, started a pre-accession linguistic review of product information for centrally authorised medicines in the Croatian language. This procedure aimed to facilitate the phasing-in of European Commission decisions on centrally authorised medicines once Croatia joined the EU thereby avoiding delays in the supply of medicines in Croatia. The pre-accession check also aimed to avoid peaks of activity for regulators and industry around the time of accession.
Revised guidance which outlines practical considerations concerning the phasing-in of Commission decisions for centrally authorised products in Croatia is now in place. The guidance provides details on the inclusion of the Croatian language into the operational aspects of the centralised procedure.