Instrument for Pre-accession Assistance project 2009-2011

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The Instrument for Pre-accession Assistance (IPA) project 2009-2011 involved meetings, training sessions and conferences designed to assist the beneficiary countries of Albania, Bosnia-Herzegovina, Croatia, the former Yugoslav Republic of Macedonia, Kosovo (under UNSC Resolution 1244/99), Montenegro, Serbia and Turkey with preparations for their future involvement in the European Medicines Agency's activities. It formed part of the IPA programme launched by the European Commission in 2009 in preparation for European Union (EU) enlargement.

Main objectives

The aim of this project was to build contacts and relationships between the Agency and the beneficiaries in preparation for these countries' future collaboration within the EU regulatory network.

This project aimed 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 was 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 communautaire into their national legislation;
  • prepare them for participation in the Agency's committees.

This project also ensured appropriate exposure and involvement in the EU Telematics programme, where applicable, to foster compliance with legislation (particularly Regulation (EC) No 726/2004 and Directive 2001/20/EC), and to enable the beneficiaries to become part of the electronic network upon accession.


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