At an EMAV General Assembly and Workshop EMAV members made use of the opportunity to discuss aspects of the implementation of the new EU Animal Health law in a guidance especially dedicated for the manufacturing and use of autogenous vaccines with acknowledged experts from European authorities.
Dries Minne, Policy officer veterinary medicinal products at Santé D4 of the European Commission, presented the status of the “Implementation of Regulation (EU) 2019/6 and the process and timelines for the development of the Implementing Act on GMP measures”. This really important status report and insight in the ambitious working process was a basis for a very fruitful discussion with the EMAV members.
With the “Overview about the process and timelines for the development of a GMP guideline for autogenous vaccines by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Working Group on Veterinary Medicine Products” Grégory Verdier, Chair of this Working Group, shared valuable information about the global harmonisation process for new European legal requirements for the manufacturing and use of autogenous vaccines in the EMAV session in April.
Gerfried Zeller, Managing Director of EMAV, directed the attention of the audience to the mandate of the European Commission with the subject „Implementing measures under Article 93(2) of Reg. (EU) 2019/6 as regards the good manufacturing practice for veterinary medicinal products and active substances used as starting materials“ where the Commission stated “that if the GMP requirements need to be adapted for the manufacturing of inactivated autogenous vaccines in order to ensure their manufacturing and availability since they are prepared in a way that is different from industrially prepared products, existing recommendations, e.g. … the European Manufacturers of Autogenous Vaccines and Sera (EMAV) EMAV Proposal: EU-GMP-Annex for Autogenous vaccines in 2021… has to be reviewed where possible.”
At the Paris meeting EMAV members adopted the EMAV ROADMAP 2022 – 2025 and an EMAV Manual about autogenous vaccines unanimously too. The next EMAV General Assembly was announced for April 2024 in Spain.