Croatia joined the European Union on July 1, 2013 and, therefore, became part of the European Medicines Network. The country will now be involved in European Medicines Agency (EMA) activities. Europe began preparing for Croatia’s participation in 2007 with the creation of the Instrument for Pre-accession Assistance (IPA) program and with ongoing work with Croatian authorities. Croatia participated in selected EMA meetings as part of the IPA program.
EMA and Croatia also started a pre-accession linguistic review of product information in January 2011 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.” EMA has issued revised guidance that outlines the phasing-in of authorized products in Croatia and operational aspects.
