Regulation of animal vaccines - safety, efficacy, and availability in the focus
Experts from the Division Veterinary Medicine of the Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines met the Working Group "Combating Animal Diseases and Protective Immunisation" of the Federal Association for Animal Health (Bundesverband für Tiergesundheit e.V., BfT) for this year’s dialogue on various aspects of regulation and research of veterinary vaccines. Items on the agenda included the transfer of knowhow on the new EU Veterinary Medicines Regulation, official batch releases, and the Brexit.
"Immunological veterinary vaccines are no less important than human vaccines, since human health is closely related to animal health", said Professor Klaus Cichutek, president of the PEI.
"When exchanging ideas and experience with the BfT, we are rendering the regulatory requirements for marketing authorisations and batch release testing of veterinary vaccines transparent, and, that way, we undertake to become involved in their safety, efficacy, and availability. That way, we are making an additional contribution to the health of the population."
With the new EU Regulation for Veterinary Vaccines, the law makers provide the possibility to reduce the use of antibiotics, thus fighting antimicrobial resistances more effectively and improving the availability and safety of veterinary medicines. Participants discussed the effects of the regulation on research, development, marketing authorisations, and batch releases of veterinary vaccines. Another focus was the Brexit. As from April 2019, medicines agencies of the United Kingdom will no longer be available for procedures within the European Union (EU). The PEI informed the participants that it would be prepared to take on additional regulatory tasks.
Talks with the Working Group "Combating Animal Diseases and Protective Immunisation" have been taking place one a year for more than 20 years.
Effects of Brexit: The Paul-Ehrlich-Institut is making preparations
The EU Veterinary Medicines Regulation is planned to come into force in early 2019. After a transitional period of three years, it will be compulsory to apply the rules contained in this regulation.