European Union enlargement
The European Commission has launched several assistance programmes to support preparatory measures for participation of European Union (EU) beneficiaries in pre-accession activities.
The Instrument for Pre-accession Assistance (IPA) programme was launched in late 2009 in order to support the participation of the Beneficiaries in the work of selected EU Agencies. The Beneficiaries included in the programme are:
- Bosnia and Herzegovina;
- Kosovo (under UNSC Resolution 1244/99);
- the former Yugoslav Republic of Macedonia;
The aim of the programme is to foster links between the European Medicines Agency and the Beneficiaries in order to ensure future co-operation in the Agency's networks.
The IPA programme supports the participation of nominated representatives of the countries concerned in selected meetings and training courses as observers. A document listing the meetings that these representatives can attend is available below.
The programme also supports the organisation of conferences to prepare the countries for integration into the European regulatory network for medicines.
For information on current and past assistance programmes, see:
- IPA Programme 2009-2011
Assistance for the involvement of Croatia, the former Yugoslav Republic of Macedonia, and Turkey, and also Albania, Bosnia and Herzegovina, Montenegro, Serbia and Kosovo (under UNSC Resolution 1244/99), in the activities of the European Medicines Agency.
- Transition IPA Programme 2008
Assistance for Croatia, Turkey and the former Yugoslav Republic of Macedonia.
- Multi-beneficiary programme 2006-2007
Assistance for Croatia and Turkey.
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 aims to facilitate the phasing-in of Commission Decisions on centrally authorised medicines once Croatia joins the EU on 1 July 2013.
For more information, including reference documents and product information templates translated into Croatian, see:
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.