Q: Asger Christensen (Renew, DK) - Antibiotics for animals (2022-02-08)
Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products aims to reduce the use of antibiotics in the EU. However, the implementation of the regulation is having a number of unfortunate consequences in some Member States.
1.Does the Commission acknowledge that the implementation of the regulation could lead to an increase in the consumption of antibiotics in the Nordic Member States in particular?
2.In its interpretation of the regulation, has the Commission taken into account those Member States that have already significantly reduced their antibiotic consumption?
3.Will the Commission allow some flexibility in the implementation of the regulation in those Member States where the implementation of the regulation actually leads to an increase in the consumption of antibiotics?
A: Ms Kyriakides on behalf of the European Commission
Regulation (EU) 2019/6[1] sets out measures to reduce the use of antimicrobials in animals. According to Article 106(1), veterinary medicines shall be used in accordance with the terms of their marketing authorisation. The specific cases allowing for a derogation from this obligation are described in the regulation.
The Commission was made aware by two Member States that the application of Article 106(1) could lead to an increased use of antimicrobials on their territory, as until now, some antimicrobials had been prescribed by veterinarians at a lower dosage or for a shorter period of time than indicated on their summary of product characteristics.
However, an increasing body of evidence shows that the use of antimicrobials at low dosages (including sub-therapeutic dosages) can favour antimicrobial resistance.
Nevertheless, if based on experience gained, summaries of product characteristics appear out-of-date or inappropriate, mechanisms to ask for their review and update are available to national competent authorities under the regulation, as they were under the previous legislation.
The Commission has invited national competent authorities to use these mechanisms as a priority to ask for a revision of the summary of product characteristics of those antimicrobials.
Also marketing authorisation holders have the obligation to ensure that summaries of product characteristics are kept up to date with current scientific knowledge, in line with Article 58(4) of the regulation
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