Události
Pozastavení registrace,
stažení z trhu - Kexxtone
Stažení šarží M-1 AER
240 mg/ml
Stažení šarže VITAR Veterinae Artivit Sirup
Nesprávné označení u VLP
Fungiconazol 200 mg tablety pro psy
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Information on the project co-funded by EUROPEAN HEALTH AND DIGITAL EXECUTIVE AGENCY (HADEA)
Ústav pro státní kontrolu biopreparátů a léčiv participates in EU4Health Joint Action EU4H 11. EU4H 11 (Joint Action on quality of edicines and implementation of the pharmaceutical legislation/strategy) is part of the EU4Health programme funded by the uropean Commission. The total budget of this Joint Action amounts to more than 3 million EUR, 80% of the costs will be co-financed by the European Commission. The project aims at strengthening capacities of EU/EEA GMP/GDP inspectorates in the global vision of mutual reliance of inspection data to better ensure quality of medicinal products and protection of Public Health. 39 EU/EEA Medicines Inspectorates from a total of 29 EU/EEA countries are participating in EU4H11: they are supervising the regulatory compliance of pharmaceutical manufacturers of human and veterinary medicines throughout EU/EEA. The Joint Action is steered by Austria (AGES/BASG) as Coordinator, together with the National Competent Authorities of France (ANSM), Croatia (HALMED) and Hungary (NCPHP) work package leaders. The three main goals of EU4H 11 are: • Strengthening the Joint Audit Programme (JAP) for EU/EEA GMP Inspectorates. • Developing a proposal to include GDP to the existing Joint Audit Programme. • Establishing 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 member states’ participation in the JAP. The co-financing of costs related to training activities supports initial and continuous training of GMP inspectors, thus enhancing competences of GMP inspectors throughout EU/EEA. For further information, please contact: Ústav pro státní kontrolu biopreparátů a léčiv Hudcova 232/56A 621 00 Brno e-mail: Tato emailová adresa je chráněna před spamboty, abyste ji viděli, povolte JavaScript Koordinátor projektu: EU4H11 – Coordinator AGES/BASG: Tato emailová adresa je chráněna před spamboty, abyste ji viděli, povolte JavaScript Website: https://www.ages.at/en/research/project-highlights/eu4h11
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