Veterinary medicines reform in force today in Spain

Spain

Royal Decree 767/2025 streamlines registration and updates key controls and definitions

September 10, 2025

Micaela Izbicki

Life Sciences & Healthcare

On September 3, 2025, the Royal Decree 767/2025 was published, an update to two regulations that govern veterinary medicinal products: Royal Decree 1157/2021 (industrial manufacture) and Royal Decree 666/2023 (distribution, prescription, dispensing and use). This reform introduces the following relevant changes for manufacturers, distributors and veterinarians:

Faster market access for herbal and allergen-based products. One of the headline innovations is the creation of a simplified registration pathway—capped at ninety (90) days—for (i) traditional herbal veterinary medicines; and (ii) allergen-based products. Applicants must file electronically and present a reduced dossier, while the Spanish Agency of Medicines and Medical Devices ("AEMPS") retains power to refine data requirements.
No duplicate national applications. If a product is already authorized—or pending authorization—in another EU Member State, the AEMPS will refuse a Spanish dossier unless the sponsor opts for the mutual recognition proceeding. This codifies the "one product, one assessment" principle at EU level and avoids administrative duplication.
Streamlined advertising rules. When an advertisement targets only veterinarians, the mandatory safety legend ("Read the instructions… consult your veterinarian") is no longer required. Moreover, the mandatory data can be integrated via a QR code.
Updated definition of "dispensing". The "dispensing" definition is amended in accordance with the Judgment of the Supreme Court 1048/2024 (Contentious-Administrative Chamber), dated June 14, 2024. In particular, the specific reference to the requirement for these medications to always be subject to prescription has been removed.
Antimicrobial control obligations. Holders of veterinary establishments must document measures that reduce antibiotic use, in alignment with Spain’s sustainable antibiotic-use as set out in Royal Decree 992/2022 establishing the framework for action for the sustainable use of antibiotics in livestock species of interest.
Over-the-counter exceptions. Royal Decree 666/2023 generally bans the retail sale of "veterinarian-only" drugs. However, the reform carves out four exceptions (infusion fluids, mineral/vitamin infusions, immunologicals and hormones) listed in a brand-new Annex VI.
New legal definitions. Finally, the decree introduces specific definitions for "herbal substance", "herbal preparation" and "traditional herbal medicinal product".