Autogenous vaccines: Quality of production and movement in a common market

Abstract

An international meeting, held in Munich, Germany, on 14–16 September 2021, explored the expectations and views of different stakeholders regarding the implementation of the new veterinary medicines Regulation (Regulation (EU) 2019/6) in respect to inactivated autogenous vaccines (AVs) in non-notifiable diseases. Guidance documents on specific Good Manufacturing Practice (GMP) for AVs are scheduled to be developed at EU and a wider international level in the future. Presentations and discussions by the experts from regulatory authorities, industry and users made it apparent that their views on the quality requirements for the starting materials as well as quality standards for premises, personnel and manufacturing were broadly aligned for most of the aspects considered. The conclusions and recommendations of this meeting are expected to facilitate the development of urgently needed guidance documents for a harmonised implementation of this element of the Regulation.