Regulatory oversight for the development and use of veterinary vaccines ensures their quality, safety and efficacy. As a part of the One Health approach, animal vaccines help to protect individuals from pathogens that can be transmitted from animals to humans, although these vaccines primarily make important contributions to livestock and pet health. At the December 2021 virtual exchange of expertise between the Paul-Ehrlich-Institut and the German Federal Association for Animal Health (Bundesverband für Tiergesundheit, BfT), the focus was on the European Veterinary Medicinal Products Regulation (EU) 2019/6, which becomes applicable nationally on 28 January 2022.
Animal vaccines are used for the prevention of epizootics and to combat common animal diseases in pets, livestock and wild animals. This means that they are of great importance for animal disease control, as well as for maintaining animal health and thus general animal welfare.
Furthermore, vaccination of farm animals in the supply chain is an increasingly important component of food safety in times when the use of antibiotics in livestock farming has come under scrutiny.
Experts from the BfT, several veterinary vaccine manufacturers, and the Paul-Ehrlich-Institut discussed in particular the conversion of temporarily granted authorisations to unlimited authorisations as well as current pharmacovigilance (drug safety) requirements for veterinary vaccines contained in Regulation (EU) 2019/6. In the future, signal management processes are to be used to detect frequently occurring side effects of veterinary vaccines in a timely manner. Subsequent measures will then be taken if needed. The regular safety reports, which until now have documented and evaluated notifications received by the companies, will no longer be required in the future.
Another point of discussion in the meeting was the centralised collection of medicinal product data in a European database (Union Product Database), to begin on 28 January 2022, which should lead to a harmonised collection of medicinal product data and support the digitalisation and standardisation of regulatory procedures.
The BfT expressly appreciated the steady, reliable commitment of the Paul-Ehrlich-Institut at the European level, both in the area of authorisation and in batch testing as an Official Medicinal Control Laboratory (OMCL). The introduction of shift work in the Paul- Ehrlich-Institut's testing laboratory for veterinary vaccines allowed time-sensitive batch testing to be continued without restriction, even during the Coronavirus pandemic. The Paul-Ehrlich-Institut is thus making a significant contribution to the reliable supply of safe and effective veterinary vaccines to the markets.
Other focus points at the meeting included the use of herd-specific vaccines and the activities of the following groups: the Standing Veterinary Vaccination Committee (Ständige Impfkomission Veterinärmedizin, StIKo Vet), the Coordination Group for the Mutual Recognition of Veterinary Medicinal Products and Decentralised Procedures, the Committee for Veterinary Medicinal Products at the European Medicines Agency (EMA), and the Expert Group 15V of the European Pharmacopoeia.
The EU Veterinary Medicinal Products Regulation (EU) 2019/6 is the first time that directly applicable, harmonised regulations were issued in all member states. These cover the areas of manufacturing, authorisation, pharmacovigilance, import, and export, as well as the dispensing and use of veterinary medicinal products. The new EU Regulation on veterinary medicinal products was published in the Official Journal of the European Union on 7 January 2019. It becomes applicable in the Member States of the Union on 28 January 2022. This regulation replaces the Veterinary Medicinal Products Directive 2001/82/EC.
Updated: 06.12.2021
