The Federation of Veterinarians of Europe (FVE) has adopted a statement calling for a ‘pragmatic, risk-based approach’ to the prescription and use of veterinary medicines under the EU Regulation 2019/6. The strict interpretation of Article 106(1) requires absolute adherence to the product datasheet, the so-called Summary of Product Characteristics (SPC). This can prevent clinicians from adapting dosage, duration or route of administration – even if such adjustments are clinically justified.
When regulation and clinical reality diverge
In practice, cases sometimes require treatment adjustments to ensure therapeutic success and avoid unnecessary animal suffering. If SPCs are outdated or do not reflect current scientific knowledge, resistance patterns or clinical realities, strict enforcement can limit veterinarians’ ability to optimise treatment for the patient, FVE recalls.
Balancing veterinary care and legal compliance
‘This situation puts practitioners in a difficult position, balancing professional responsibility for animal health and welfare with formal regulatory compliance,’ explains Volker Moser, UEVP president. ‘It also creates uncertainty for veterinarians and inspectors alike, as interpretation of the rules differs between Member States.’ Some countries have already issued national guidance clarifying how clinicians may adapt treatments, leading to fragmented implementation across the EU.
Updating SPCs – necessary but slow
Several initiatives aim to address these challenges, such as the SPC harmonisation procedure, which seeks to align and standardise SPCs for nationally authorised products across EU Member States, and the ADRA project, which is reviewing dosage recommendations. However, these initiatives take time. Today, most medicines still rely on product information that does not fully reflect current evidence.
A call for pragmatic flexibility
FVE therefore calls for a common European approach that recognises veterinarians’ professional judgement and allows clinically justified ‘pragmatic flexibility’ in prescribing when supported by evidence and risk assessment. Furthermore, FVE urges policymakers to ‘accelerate the harmonisation and updating of SPCs,’ ensuring that product information keeps pace with scientific developments.Such a balanced approach would provide legal clarity for practitioners while enabling them to continue delivering effective treatment in the best interests of animal health, animal welfare and public health.
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