The Instrument for Pre-accession Assistance (IPA) project 2011-2013 involves meetings, training sessions and conferences designed to assist the beneficiary countries of Albania, Bosnia-Herzegovina, Croatia, the former Yugoslav Republic of Macedonia, Kosovo (under United Nations Security Council Resolution 1244/99), Montenegro, Serbia and Turkey with preparations for their future involvement in the European Medicines Agency's activities. It forms part of the IPA programme launched by the European Commission in 2009 in preparation for European Union (EU) enlargement.
The project focused on Croatia to help foster its integration and provide further support for areas still needing development in view of its accession to the EU on 1 July 2013.
Main objectives
The aim of this project is to build contacts and relationships between the Agency and the beneficiaries in preparation for these countries' collaboration within the EU regulatory network.
This project aims to:
- prepare the national competent authorities of the candidate and potential candidate countries that are active in the field of medicinal products for their future participation in the Agency's networks;
- contribute to the creation of communication and information-exchange systems enabling the future participation of the beneficiaries in the Agency's networks.
The project is designed to establish an internationally open dialogue and working mechanisms with the beneficiaries to:
- help to facilitate the adoption of common technical requirements;
- identify areas where additional action might be needed to ensure the smooth transposition of the EU acquis (body of EU law) into their national legislation;
- prepare them for participation in the Agency's committees.
Pre-accession linguistic check for Croatian
In January 2011, the Agency, together with the Croatian national competent authorities, started a pre-accession linguistic checking process for product information in the Croatian language. This procedure aimed to facilitate the phasing-in of Commission decisions on centrally authorised medicines once Croatia joined the EU.
For more information, including reference documents and product information templates translated into Croatian, see:
- Croatian pre-accession linguistic check (human)
- Croatian pre-accession linguistic check (veterinary)
Information on the review of product information, including information on the practical considerations concerning the phasing-in of Commission decisions of centrally authorised products in Croatia, is available under Product information: Regulatory and procedural guidance.