Autogenous vaccines: Quality of production and movement in a common market. (April 2022) - Grein, Kornelia
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. Highlights: Autogenous Vaccines: Quality of production and movement in a common market – Meeting 14–16 September 2021, Munich. Inactivated autogenous vaccines (AVs) in non-notifiable animal diseases. AVs are only allowed in emergency situations when licensed vaccines are not available. AVs are manufactured from pathogens from the concerned epidemiological unit or unit having an epidemiological link. Good Manufacturing Practice guidelines to harmonise the quality of manufacture and final product will be developed.