Key data
| Regulation | Corrigendum to Commission Delegated Regulation (EU) 2023/361 — CELEX:32023R0361R(01) |
|---|---|
| Base regulation | Commission Delegated Regulation (EU) 2023/361, published in the OJ L 52 of 20 February 2023 |
| Reference legislation | Regulation (EU) 2016/429 of the European Parliament and of the Council (animal health legislation) |
| Publication of the corrigendum | 25 March 2026 |
| Entry into force | 20 February 2023 (date of the original corrected regulation) |
| Affected parties | Farmers, veterinarians, the veterinary pharmaceutical industry and animal health authorities |
| Territorial scope | All EU Member States, including Spain |
| Category | European Legislation |
Farmers and livestock sector operators in Spain have an immediate obligation: to review their health protocols and confirm that they comply with the corrected version of Commission Delegated Regulation (EU) 2023/361. This regulation, which supplements Regulation (EU) 2016/429 on animal health, sets out the conditions under which specific veterinary medicines may be used to prevent and control animal diseases included in the EU's official list.
The corrigendum published on 25 March 2026 rectifies material errors in technical provisions. Although it may appear to be a bureaucratic formality, these errors directly affect how veterinary treatments must be applied on livestock holdings. A protocol based on the erroneous version may constitute a non-compliance detectable during an official animal health inspection.
What does this regulation establish?
Commission Delegated Regulation (EU) 2023/361 develops the specific rules for the use of certain veterinary medicines as a tool for preventing and controlling animal diseases. These diseases are included in the official list established by Regulation (EU) 2016/429, the EU's framework animal health legislation.
The corrigendum now published rectifies material errors in the technical provisions of that regulation. Although the text of the corrigendum does not publicly detail each specific error beyond its technical nature, the practical effect is clear: the corrected version is the only legally valid version, and any health protocol based on the original version containing errors must be updated.
| Element | Detail |
|---|---|
| Type of correction | Rectification of material errors in technical provisions |
| Corrected regulation | Commission Delegated Regulation (EU) 2023/361 (OJ L 52, 20.2.2023) |
| Enabling legislation | Regulation (EU) 2016/429 — EU animal health framework legislation |
| Subject matter | Conditions for the use of veterinary medicines for the prevention and control of listed animal diseases |
| Territorial application | Mandatory in all EU Member States, including Spain |
| Direct recipients | Veterinarians, competent authorities and livestock sector operators |
Economic and operational impact
The main impact of this corrigendum is not economic in terms of new fees or direct costs, but rather operational and compliance-related. Livestock holdings and the veterinarians working with them must bear the cost of reviewing and, where necessary, updating their health protocols.
The specific risks of failing to act include:
- Non-compliances detected during official animal health inspections, which may lead to sanctioning proceedings.
- Use of veterinary medicines under conditions that are no longer legally valid, with potential consequences for the traceability and certification of livestock products.
- Issues in quality audits or export certifications that require demonstrating compliance with European health legislation.
For the veterinary pharmaceutical industry, the corrigendum may entail reviewing the technical and commercial documentation associated with the affected medicines, as well as the instructions for use provided to veterinarians and farmers.
Who is affected?
- Farmers and livestock sector operators: They must verify that their protocols for the use of veterinary medicines to prevent listed diseases comply with the corrected version of the regulation.
- Veterinarians: As prescribers and administrators of treatments, they are responsible for ensuring that the conditions of use comply with the corrected technical provisions.
- Veterinary pharmaceutical industry: Companies marketing the affected medicines must review their technical documentation and instructions for use.
- Animal health authorities: The competent bodies in Spain and in the other Member States apply the corrected version in their official controls.
Practical example
A pig farm in Castilla y León has an established health protocol for the prevention of a disease included in the EU's official list. That protocol was designed by the farm's veterinarian using the Commission Delegated Regulation (EU) 2023/361 in its original version published in February 2023 as a reference.
Following the publication of this corrigendum on 25 March 2026, the veterinarian must compare the technical provisions of the corrected version with those that served as the basis for the current protocol. If any of the conditions for the use of veterinary medicines have changed as a result of the rectification of material errors, the protocol must be updated before the next official animal health inspection.
Failing to do so exposes the holding to a regulatory non-compliance detectable during inspection, even if the treatments applied are clinically correct, because what is assessed in the official control is compliance with the applicable regulation in its valid version.
What should businesses do now?
- Locate the corrected version of Commission Delegated Regulation (EU) 2023/361 in the Official Journal of the EU and compare it with the original version (OJ L 52, 20.2.2023) to identify which technical provisions have been corrected.
- Review the current health protocols on the holding or within the company to verify whether any of the conditions for the use of veterinary medicines are based on the provisions that have been rectified.
- Coordinate with the reference veterinarian to update the affected protocols, documenting the change and the date of update in order to demonstrate compliance in the event of an official inspection.
- Inform the team responsible for quality and traceability about the existence of this corrigendum, especially if the holding operates under export certifications or third-party audits that require demonstrating compliance with European legislation.
- If you are part of the veterinary pharmaceutical industry, review the technical documentation and instructions for use of the affected medicines and update the materials provided to veterinarians and farmers.
Frequently asked questions
What exactly does the corrigendum to EU Regulation 2023/361 correct and why does it matter?
The corrigendum rectifies material errors in Commission Delegated Regulation (EU) 2023/361, which sets out the conditions for using specific veterinary medicines in the prevention and control of animal diseases included in the EU's official list. The errors affect technical provisions applied by veterinarians, competent authorities and livestock operators. Compliance is mandatory in all Member States, including Spain.
When did the corrigendum to the European veterinary regulation enter into force?
The date of entry into force is 20 February 2023, which corresponds to the date of publication of the original Commission Delegated Regulation (EU) 2023/361 in the Official Journal of the EU (L 52). The corrigendum published on 25 March 2026 has retroactive effect from that date, meaning that protocols must comply with the corrected version as of that moment.
What must farmers do to comply with the corrected version of the regulation?
Farmers and livestock sector companies must verify that their health protocols comply with the corrected version of Regulation 2023/361. This involves reviewing the procedures for the use of veterinary medicines for the prevention and control of EU-listed diseases, and coordinating with their reference veterinarian to confirm that the treatments applied meet the corrected technical provisions.
Who is affected by this corrigendum to the European veterinary regulation?
It directly affects four groups: farmers and livestock sector operators, veterinarians who prescribe and administer treatments, the veterinary pharmaceutical industry that markets the affected medicines, and animal health authorities that carry out official controls. Compliance is mandatory in all EU Member States, including Spain.
What is the risk of not adapting protocols to the corrected version?
Farmers and livestock sector companies that do not align their health protocols with the corrected version of Regulation 2023/361 may incur non-compliances detectable during official animal health inspections. The regulation is mandatory in Spain and in all EU Member States.
Official source
View the full regulation at the official sourceDisclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, please consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=CELEX:32023R0361R(01)