Position Papers

Position Papers

EMAV Proposal:

EU-GMP-Annex for Autogenous vaccines

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Autogenous vaccines and sera are an important and well-established tool of veterinary medicine to fill the gaps left by licensed vaccines and sera in all categories of animals, contributing to the survival and well-being of livestock, pets, zoo- and exotoc animals by protecting against life-threatening infectious, especially rare infectious diseases.

Autogenous vaccines are also key to the reduction of use of antimicrobial substances and the need for pharmaceutical treatments in general, for the improvement of animal welfare by science-based prophylactic measures and to the protection of the environment at the same time.

REGULATION (EU) 2019/6 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC defines general conditions for the standardisation and harmo-nisation of the manufacturing and use of Autogenous vaccines in future.

It defines in Recital 70 “Although inactivated immunological veterinary medicinal products referred to in Article 2(3) should be manufactured in accordance with the principles of good manufacturing practice, detailed guidelines of good manufacturing practice should specifically be prepared for those products since they are manufactured in a way that is different from industrially prepared products. That would preserve their quality without hindering their manufacturing and availability.”

To support the development of a specific GMP guidance for Autogenous vaccines European manufacturers have compiled common positions for future standards for the manufacturing of autogenous vaccines. This position paper is an invitation of EMAV to competent authorities, users and other stakeholders to define a new standard for manufacturing and for a secured availability of Autogenous vaccines.

EMAV – European Manufacturers of Autogenous Vaccines and Sera - is representing actually 21 recognised manufacturers of Autogenous vaccines and antisera for animals from 12 EC member states and from the United Kingdom.

EMAV combines the interests of manufacturers of specific vaccines and sera for livestock, pets and exotic animals, to promote the European harmonization process.

For more information contact Dr. Klaus-Peter Behr (Chairman) or Dr. Gerfried Zeller (General Manager) at 8d8i0d15ncadf3eb8oae62@b71dee6dm4b9a86ve5.a3bcde5ed2e.