Informative session on Regulation (EU) 2019/6 on Veterinary Medicinal Products

On 12 January 2023, DG SANTE organised a fourth information session for non-EU countries regarding the legislative measures being adopted to implement the EU Regulation on veterinary medicines to imports from third countries. DG SANTE involved the third countries partners from the early stages of the process and have very much appreciated hearing their views. Previous seminars were organised in March 2019, January 2020 and December 2020.

The seminar was attended by participants from more than 30 countries.

The One Health Director of DG SANTE stressed, at her introductory speech, the importance of fighting against antimicrobial resistance (AMR) that was declared in 2019 by the WHO as one of the top 10 global public health threats facing humanity. AMR is the silent pandemic or even the silent tsunami, a global threat to public health and animal health. Infections of bacterial origin are the second cause of death in the world.

The EU is acting against AMR. The Regulation on Veterinary Medicines (Regulation (EU) 2019/6), applicable since 28 January 2022, strengthens the EU action, fully in line with the "One Health" approach, internationally recognised as the only effective approach to tackle AMR and as such endorsed by WHO, the WOAH and the FAO among others. It lays down a wide range of concrete measures to fight AMR and to promote the prudent and responsible use of antimicrobials. It provides for the end to the use of antimicrobials for growth promotion and for preserving some of our most precious antimicrobials for humans.

However, AMR does not respect borders. Therefore Article 118 of this Regulation provides for the application of this ban also to animals and products of animal origin intended for human consumption to be exported to the EU. The Commission is doing the outmost to ensure a balanced approach which will deliver on the fight against antimicrobial resistance while minimising impacts on trade. It will also be proportional and respectful of the EU’s international obligations. The draft delegated act was notified to the WTO on 8 December 2022 with the deadline for comments by 6 February 2023.

The EU action alone will not suffice to fight against AMR, further steps need to be taken worldwide. DG SANTE invites non-EU countries to also engage on a decisive fight against AMR, especially in terms of antimicrobial consumption and use. We believe that collaboration at international level is of the utmost importance on this major public health issue. We remain committed to continue working on the fight against AMR and to engage with our trading partners and other WTO members, within multilateral international organisations and bilaterally, and to promote and support effective strategies to prevent and contain the global threat of AMR. We need to join forces in international fora, to identify common approaches to address AMR, to raise awareness of the public, healthcare and animal production professionals. A One Health approach is indispensable to have impact.