The regulatory framework for veterinary distribution in Spain
Spain's veterinary distribution market is governed by Royal Decree 666/2023, which implements EU Regulation 2019/6 on veterinary medicinal products into Spanish law. This regulation replaced the previous framework in 2023 and introduced significant changes for distributors, particularly around traceability, documentation and authorisation requirements.
For a European distributor looking to supply zoosanitary products to Spanish establishments (known as ECDs — Establecimientos Comerciales Detallistas), understanding this regulatory framework is not optional. It is the gatekeeper to market entry.
Key authorisations required
To distribute veterinary medicinal products in Spain, a company must hold a valid wholesale distribution authorisation (Autorización de Distribución Mayorista). This authorisation is issued by the Spanish Agency for Medicines and Medical Devices (AEMPS) and requires demonstration of appropriate storage facilities, quality management systems and qualified personnel.
For OTC (over-the-counter) veterinary products — antiparasites, biocides, medicated feeds and similar — the requirements are somewhat less stringent than for prescription medicinals, but the distribution authorisation is still required in most cases.
GDP certification: While not always legally mandatory, Good Distribution Practice (GDP) certification is strongly recommended and increasingly expected by Spanish ECDs as a trust signal. It demonstrates that your storage and distribution processes meet EU quality standards.
The PRESVET traceability system
PRESVET is Spain's national veterinary prescription and traceability system. It records all transactions of prescription veterinary medicines from manufacturer to end point of use. Distributors supplying prescription products to Spanish establishments must be able to interface with PRESVET or provide documentation compatible with it.
For OTC products, PRESVET is not directly applicable, but the underlying principle — full chain-of-custody documentation for every product movement — remains a regulatory expectation.
Product authorisation in Spain
A product authorised in one EU member state is not automatically authorised for sale in Spain. Under EU Regulation 2019/6, a centralised EU marketing authorisation is valid across all member states, but many veterinary products still operate under national authorisations. A product with a national authorisation in Poland, for example, would require a separate authorisation procedure for Spain unless it holds EU-wide approval.
This is one of the most common friction points for European distributors entering the Spanish market. Before agreeing to supply any product to a Spanish ECD, it is essential to verify its authorisation status for the Spanish market.
How Nexo handles this: As part of our distributor certification process, we verify that all products in a distributor's catalogue have valid authorisation for the Spanish market. We also provide the regulatory documentation for each order, ensuring the receiving ECD has everything they need for inspections and PRESVET compliance.
Practical implications for European distributors
The regulatory framework creates a real barrier to entry, but it also creates an opportunity. Most European distributors with competitive prices lack the local regulatory knowledge and relationships to navigate it efficiently. Nexo's model is designed precisely to address this: we provide the regulatory infrastructure, so distributors can focus on what they do best — supplying quality products at competitive prices.
Want to know if your products are eligible for the Spanish market?
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