The General Council of Colleges of the Veterinary Profession of Spain has sent an independent legal report to the veterinary colleges. The analysis examines the consequences of a possible complete repeal of Royal Decree 666/2023, dated July 18, which establishes the rules for the distribution, prescription, dispensing, and use of veterinary medicines.
This study was prepared at a time when a modification of the same royal decree is being processed. The objective is to assess whether the complete repeal of the regulation could be a more favorable alternative for the interests of veterinary professionals.
One of the key conclusions of the report is that a full repeal of RD 666/2023 would not automatically reinstate the previous regulations. Royal Decrees 109/1995, 544/2016, and 191/2018, which were expressly repealed by the current decree, would not come back into force automatically.
Consequently, a repeal without a substitute regulation would leave essential aspects of the distribution, prescription, dispensing, and use of veterinary medicines without regulatory development. This would affect, among other issues, the veterinary first-aid kit, prescriptions and their issuance conditions, prior clinical examination, exceptional prescription, distance selling, communication of data on antimicrobials, and certain official controls. Furthermore, it could compromise Spain's compliance with its obligations under EU Regulation 2019/6, as this regulation refers to member states for development.
The study emphasizes the impact on the dispensing of medicines by veterinarians, a practice covered by RD 666/2023 to ensure treatment continuity. A full repeal would eliminate this express regulation, and Article 38 of the Law on Guarantees and Rational Use of Medicines, which reserves retail dispensing to pharmacies, could become more restrictive for veterinary professionals.
The report suggests that a complete repeal would not solve current difficulties and advocates for broader legislative reform, combined with professional participation in modifying RD 666/2023. It proposes recognizing veterinary centers as authorized establishments for the retail sale of veterinary medicines, facilitating medicine transfers, and simplifying obligations related to PRESVET.
The draft amendment to the decree already includes some advancements, such as the recognition of clinical judgment and the possibility of prescriptions covering up to six months for chronic treatments.
