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January 7, 2026
Approximately 5 minutes
Verification of Legality of Suppliers and Customers in Pharmaceutical Distribution – AEMPS Guidance
Verification of Legality of Suppliers and Customers in Pharmaceutical Distribution – AEMPS Guidance
Legal Obligation
Wholesale distributors of human medicinal products in Spain must verify the legitimacy of their suppliers and customers as required by Article 111(1)(ca) of Directive 2001/83/EC (introduced by Directive 2011/62/EU on falsified medicines) and transposed into national law via Royal Decree 782/2013. This due diligence obligation aims to prevent falsified medicines from entering the legitimate supply chain. AEMPS provides practical guidance to help distributors fulfil this requirement effectively and consistently. Comprobación de la legalidad de proveedores y clientes - AEMPS
Verification of Suppliers
Before accepting medicines from a supplier, distributors must:
- Confirm the supplier holds a valid wholesale distribution authorisation or manufacturing authorisation (if applicable) by consulting the AEMPS public catalogue of authorised distribution entities.
- Check the supplier’s authorisation scope covers the medicines being supplied.
- Verify the supplier’s GDP certificate (for wholesalers) is current via the AEMPS register or EU GMP/GDP database.
- For EU suppliers: Cross-check against the EMA EudraGMDP database.
- For third-country suppliers: Ensure import authorisation and written confirmation of equivalent GMP standards (or rely on EU certification).
- Document the verification (date, method, outcome) and retain records.
Verification of Customers
Before supplying medicines to a customer, distributors must:
- Confirm the customer is a legitimate recipient (e.g., authorised pharmacy, hospital, another authorised wholesaler) by checking the AEMPS catalogue or relevant professional registers.
- Verify that the customer holds the necessary authorisation to receive and handle the medicines (e.g., pharmacy licence, hospital authorisation).
- For export customers outside Spain: Confirm the customer is authorised in their country and that export complies with Spanish and destination country rules.
- Document the verification process and retain evidence.
Practical Tools and Resources
- AEMPS Catalogue: Primary tool for checking Spanish wholesalers, importers, and intermediaries.
- EudraGMDP Database: For EU-wide GDP/GMP certificates and authorisations.
- National Registers: Pharmacy and healthcare facility registers from regional authorities.
- Risk-Based Approach: Enhanced checks for high-risk transactions (e.g., new suppliers, unusual volumes, third-country sources).
Documentation and Ongoing Monitoring
Distributors must maintain auditable records of all verifications for at least 5 years. Regular re-verification is recommended for ongoing relationships, especially upon changes in authorisation status. Immediate reporting to AEMPS is required if falsified or suspect medicines are identified.
This verification process is a key element of supply chain integrity in Spain, reducing the risk of falsified medicines reaching patients and supporting EU-wide efforts against pharmaceutical crime. Detailed checklists, flowcharts, and additional guidance are provided on the AEMPS page dedicated to legality verification of suppliers and customers. Comprobación de la legalidad de proveedores y clientes - AEMPS
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