EU enlargement countries

The European Medicines Agency (EMA) takes part in projects to foster links with European Union (EU) enlargement countries, to lay the foundations of future co-operation in the Agency's networks.

The Agency's projects fall within the assistance programmes launched by the European Commission to support pre-accession activities.

Current beneficiaries include:

• Albania;
• Bosnia and Herzegovina;
• Kosovo (under United Nations Security Council Resolution 1244/99);
• the former Yugoslav Republic of Macedonia;
• Montenegro;
• Serbia;
• Turkey.

Instrument for Pre-accession Assistance

The European Commission's Instrument for Pre-accession Assistance (IPA) programme supports the participation of enlargement countries in the work of selected EU agencies.

EMA activities under the IPA programme aim to build working relationships with the beneficiary national competent authorities, to prepare for their future collaboration in the European medicines regulatory network.

To achieve this aim, the programme offers assistance to the beneficiaries' national competent authorities in aligning their standards and practices with those established in the EU and contributes to the creation of communication and information exchange systems that enable their effective participation in the networks of the EU regulatory system.

Programme activities include:

• inviting beneficiary countries to participate in Agency meetings and training courses as observers;
• organising ad hoc conferences and training sessions to exchange views, introduce the EU legal framework and identify areas for action.

Activities between 2007-2013

Between 2007-2013 EMA provided assistance to current beneficiaries and Croatia before it became a Member State on 1 July 2013.

For more details on the first phase of the IPA programme, see:

• Project description - Detailed information about the IPA programme

Between 2011-1013, EMA and the Croatian national competent authorities completed a pre-accession linguistic check for product information in the Croatian language. This supported the phasing in of Commission decisions on centrally authorised medicines in Croatian.

EMA and candidate countries held the following conferences and training events as part of the IPA programme:

• Reinforcing communication with patients and healthcare professionals (23/6/2014)
• EU 28: science, medicines, health - a regulatory system fit for the future (06-07/05/2013)
• Reinforcing patient safety in Europe (14-15/06/2011)
• Human and veterinary pharmaceuticals regulation: Towards EU accession: Serbia's regulatory challenges, expectations and opportunities (29-30/11/2010)
• Introductory meeting (01/02/2010)
• Good manufacturing practice training program for Turkish inspectors (20-21/10/2009)
• EU regulatory network - Challenges and opportunities for Croatia (13-14/11/2008)
• Seminar on recent developments in European pharmacovigilance and risk management (09-10/06/2008)

Agendas, meeting reports and presentations are provided on the meeting pages.

Multi-beneficiary project 2006-2007

A multi-beneficiary project supported the participation of Croatia and Turkey in certain EU Agencies, including EMA, between 2006-2007. For full details, see:

• Project description - Participation of Croatia and Turkey in EMA activities in 2006 and 2007