What does the new European regulation on veterinary medicinal products change?

The new European regulation on veterinary pharmaceuticals came into force on 28 January 2022. The Director of the French Agency for Veterinary Medicinal Products (ANMV), Jean-Pierre Orand, assesses what will change.

What is this new regulation and what is its purpose?

Jean-Pierre Orand: Regulation (EU) 2019/6 represents a major step forward in the field of veterinary medicinal products. It aims to harmonise regulations and practices across Member States. Its main objectives include improving the safety and availability of veterinary medicinal products, strengthening action to address antimicrobial resistance, enhancing the EU internal market for veterinary medicinal products and reducing the administrative burden.

One development brought about by this reform is the establishment of new databases, reflecting a commitment to sharing information. In particular, a Union Product Database serves as a single source of information on all veterinary medicinal products authorised in the European Union. This database is accessible to the public.

In addition, adverse reactions to veterinary medicinal products are collected on an ongoing basis through a new European Pharmacovigilance Database (EudraVigilance Veterinary). This will allow for early identification of potential risks to animal or human health through active monitoring of emerging adverse events.

To help address antimicrobial resistance, the risk of emergence of resistant bacteria is now included in the benefit-risk balance of veterinary medicinal products. This could lead to a marketing authorisation being refused. Similarly, the use of antimicrobials for preventive treatment of individual animals or groups of animals is now prohibited, except in exceptional cases. Lastly, to ensure that they remain effective, the criteria for determining which antimicrobial substances should be dedicated to human medicine are now established at Union level. Veterinary medicinal products containing such substances, already banned in France, will be banned throughout the European Union.

How was the French Agency for Veterinary Medicinal Products involved in the development of the regulation?

As part of ANSES, the French Agency for Veterinary Medicinal Products (ANMV) represents France at the European Medicines Agency (EMA) on issues relating to veterinary medicinal products. The ANMV initiated legislative reform during the previous French Presidency of the European Union in 2008. It then participated in the work that led to the adoption of the new regulation in January 2019. Three years were then needed to prepare for its implementation. During this phase, the ANMV continued to drive reform by creating a task force, which it co-chairs with the EMA. To harmonise the implementation of the regulation and common procedures, this network of agency heads supported coordination among Member State competent authorities. The ANMV also participated in numerous working groups with both the EMA and the European Commission to develop the regulation’s implementing texts. The development of the databases common to all Member States posed a considerable challenge and was an essential step in which the ANMV was fully involved.The Agency has also been a driving force in identifying the necessary changes in national regulations. Regulations lay down common rules, but allow Member States to establish national rules for implementing EU provisions.

Does the regulation change the work of the ANMV?

Overall, the role of the ANMV remains the same. The ANMV is the competent authority for the assessment and management of risks associated with veterinary medicinal products in France. As a reminder, the ANMV’s responsibilities include issuing marketing authorisations for veterinary medicinal products, and monitoring their adverse effects and their quality. It is also responsible for authorising the import and temporary use of veterinary medicinal products, as well as for inspecting veterinary pharmaceutical establishments.

However, following the new regulation, the ANMV will no longer be in charge of the administrative management of establishments that manufacture or distribute medicated feedingstuffs, which are now governed by the provisions applicable to animal feed operators.

It will continue to be involved at Union level in the work to ensure that this regulation is implemented properly. At the international level, the ANMV has been active in providing training on the new European regulation to competent authorities in third countries. Their understanding of European legislation should then make it easier for French marketing authorisation holders to register their products in these countries.