The Institute for State Control of Veterinary Biologicals and Medicines participates in the EU4Health Joint Action EU4H 11.
EU4H11 (Joint Action on quality of medicines and implementation of the pharmaceutical legislation/strategy) is part of the EU4Health programme funded by the European Commission. The total budget of this Joint Action is more than EUR 3 million, 80% of the costs will be co-financed by the European Commission. The project aims to strengthen the capacities of the EU/EEA GMP/GDP inspectorates in a global vision of mutual reliance on control data to better ensure the quality of medicines and protect public health. EU4H11 participates in 39 drug inspectorates from a total of 29 EU/EEA countries: oversee compliance by pharmaceutical manufacturers of human and veterinary medicines across the EU/EEA. The Joint Action is managed by Austria (AGES/BASG) as coordinator, together with the competent national authorities of France (ANSM), Croatia (HALMED) and Hungary (NCPHP) as heads of work packages.
The three main objectives of EU4H 11 are:
- Strengthening the joint JAP audit programme for GMP inspectorates in the EU/EEA.
- Drafting a proposal to include the GDP in the current joint JAP audit programme.
- Establishment of harmonised training and qualification processes for GMP inspectors in cooperation with the PIC/S Inspectorates’ Academy.
In addition, the co-financing of costs related to JAP activities supports the participation of Member States in the implementation of JAP audits. Co-financing of costs related to training activities supports the initial and continuous training of GMP inspectors, thus increasing the competence of GMP inspectors across the EU/EEA.
For further information, please contact:
Institute for State Control of Veterinary Biologicals and Medicines
Hudcova 232/56a
621 00 Brno
e-mail:
Project coordinator:
EU4H11 - Coordinator AGES/BASG:
Website: https://www.ages.at/en/research/project-highlights/eu4h11
Funded by the European Union. Views and opinions expressed are, however, those of the author(s) only and do not necessarily reflect those of the European Union or HaDEA. Neither the European Union nor the granting authority can be held responsible for them.