Paul-Ehrlich-Institut

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Im­prov­ing the Avail­abil­i­ty of Vet­eri­nary Medic­i­nal Prod­ucts and Pre­vent­ing An­tibi­ot­ic Re­sis­tance – New Le­gal Frame­work

The new EU Veterinary Medicinal Products Regulation and the national Veterinary Medicinal Products Act (Tierarzneimittelgesetz, TAMG) both came into force on 28 January 2022. The new legislation serves to protect animal welfare and to protect people from the transmission of diseases via animals or food of animal origin. The aim is to further increase the quality, safety, effectiveness, and availability of veterinary medicinal products in Germany and the European Union (EU) and to reduce the risk of antibiotic resistance. In addition, the new legal framework paves the way for further harmonisation of the EU internal market, reduced administrative burdens, and the creation of incentives for pharmaceutical innovations. The Paul-Ehrlich-Institut, responsible for immunological veterinary medicinal products, actively contributes to European harmonisation and national implementation processes with its regulatory expertise.

Dog is vaccinated (Source: Afrika Studio/Shutterstock.com)

The EU regulation sets new standards for veterinary medicinal product legislation in the European Union (EU). This will harmonise the framework for hitherto varying national legislation at the European level. Competent authorities and pharmaceutical companies as well as veterinarians and livestock owners will have to adapt to the changes.

Important Legislative Changes

  • The availability of immunological veterinary medicinal products is supported by a number of regulatory measures in the EU regulation. This includes the submission of a vaccine antigen master file, the use of vaccine platform technologies, and the application of the multi-strain dossier concept. This concept involves a single dossier containing the data for a unique and thorough scientific assessment of the different possible strains and their combinations, allowing for the approval of vaccines against antigenically variable inactivated viruses and bacteria. The authorisation of veterinary medicinal products for limited markets and in exceptional circumstances allows for a rapid response to each animal epidemiological situation.
  • A central pharmacovigilance database records reports of adverse events (AEs) from veterinary medicinal products. Statistical evaluations then justify decisions on measures needed to ensure the safety of medicinal products for animals.
  • Information on all authorised veterinary medicinal products and their availability in the European Union (EU) is recorded centrally in the Union Product Database (UPD).
  • The use of antibiotics in animals will be further restricted to limit the emergence and spread of antibiotic resistance. For example, antibiotics that are used in human medicine are prohibited for use in animals. Antibiotic consumption levels are recorded by animal species at the national level.

Veterinary Medicines within the Competence of the Paul-Ehrlich-Institut

The Paul-Ehrlich-Institut is responsible for immunological veterinary medicinal products such as vaccines and sera, monoclonal antibodies, and advanced therapy veterinary medicinal products for immunotherapy and animal allergens.

EU Regulation Background

The EU Veterinary Medicinal Products Regulation (EU) 2019/6 represents the first instance of directly applicable, harmonised regulations being issued in all member states. These regulations include areas such as 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 came into effect in the member states of the European Union on 28 January 2022. The regulation replaces the Veterinary Drugs Directive 2001/82/EC.

The new Veterinary Drugs Act (TAMG) also came into force on 28 January 2022. There are now separate regulations for human and veterinary medicinal products in Germany – the Medicinal Products Act (AMG) for human medicinal products and the Veterinary Medicinal Products Act (TAMG), the Animal Health Act (Tiergesundheitsgesetz, TierGesG), and the Animal Vaccine Ordinance (Tierimpfstoff-Verordnung, TierImpfVO) for veterinary medicinal products.

Updated: 03.02.2022