Updated on 19 December 2012
The falsified medicines legislation will enter into force in January 2013. The Agency and the NCAs will work on topics such as the development of the Union database which will contain certificates of good manufacturing practice and good distribution practice from all Member States.
The European Commission plans to submit a legal proposal in the first half of 2013 that will represent a major revision of the legal framework for the authorisation of veterinary medicines. The Agency will work closely with the European Commission to provide technical support as it prepares its proposals.
Greater communication and transparency
The Agency will continue to foster its approach to communication and transparency in order to strengthen public confidence in the Agency and the EU system of evaluation and supervision of medicines. The publication of the agendas and minutes of all scientific committees' meetings is planned. Following the successful workshop in November 2012 on access to clinical-trial data and transparency, the Agency will start a consultation with stakeholders at the beginning of 2013 in order to publish a policy on the release of data from clinical trials in early 2014.
Increasing efficiency of activities
These activities will be implemented in a difficult economic environment. The pressures on resources of the Agency and the network will be further augmented by the need to implement new legislative tasks and the continuous increase in activities for which there is no fee revenue, and which will be partly funded through cross-subsidisation from fee-related activities. A programme aimed at increasing efficiency of operations will continue, and will include implementation of a new information and communication technology (ICT) strategy to support the optimised processes of the Agency.