EU-regulation 2019/6 will harmonise the rules for production and use of autogenous vaccines and sera. The related legislative process requests thedevelopment of a future new GMP standard especially for these products.The 2nd Workshop of EMAV, hold on 21st and 22nd of May in Amsterdam, focussed on the identification of common interests and positions of the EMAV members. EMAV members have decades of experience which should be used for the process of developing a future GMP-standard for these unique products.
Therefore the evaluation of the Guidelines on GMP for medicines, published by the European Commission (Regulation 1991/412/EEC VMP), and the Recommendations for the manufacture, control and use of inactivated autogenous veterinary vaccines within the EEA (EMA/CMDv/452656/2016) got the thematic priority in the Workshop discussion.
The General Assembly hold on 21st of May was used for the appointment of new EMAV members: Fatro S.p.A., represented by Francesco Molioto, Ozzano dell'Emilia/Italy, LABOCEA, represented by Nathalie Vassallo, Ploufragan/France, LABOKLIN GmbH & Co. KG, Bad Kissingen/Germany and Prophyl Ltd., represented by Pál Bajnóczi, Mohács/Hungary. Furthermore the General Manager of EMAV, Gerfried Zeller, reported about the registration of the association and the activities of the Board and the General Management of the association to the membership representing 9 EU countries by now.