The Federation of Veterinarians of Europe (FVE) has adopted a statement calling for a pragmatic and risk-based approach to the prescription and use of veterinary medicinal products (VMPs) under Regulation (EU) 2019/6.
While veterinarians fully support regulatory compliance and responsible antimicrobial stewardship, strict enforcement of Article 106(1), requiring absolute adherence to the Summary of Product Characteristics (SPC) can in certain cases prevent clinicians from adapting dosage, duration, or route of administration even when clinically justified.
Evidence-based veterinary medicine sometimes necessitates carefully documented, risk-assessed adjustments to ensure effective treatment, avoid animal suffering, and protect public health.
- Veterinarians have all completed extensive education in pharmacology and have a legal duty to prevent animal suffering. When strict SPC adherence prevents effective or timely treatment adaptation, veterinarians conflict with professional obligations and formal compliance.
- Rigid SPC enforcement can paradoxically undermine optimal treatment. When dosing instructions are outdated or insufficiently aligned with current resistance patterns, veterinarians may be prevented from applying evidence-based adjustments that ensure therapeutic success.
- Current discrepancies between clinical necessity and legal wording create uncertainty for both veterinarians and inspectors. Some Member States already issued interpretative guidance, leading to fragmented application across the EU.
FVE therefore calls for:
- A common European approach that recognises veterinarians’ professional judgment and allows clinically justified flexibility; and
- Accelerated and future-proof harmonisation and updating of SPCs to reflect evolving scientific evidence.
