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January 17, 2026
Approximately 5 minutes
Customs-Controlled and Supervised Medicinal Product Warehouses in Spain – AEMPS Guidelines
Customs-Controlled and Supervised Medicinal Product Warehouses in Spain – AEMPS Guidelines
Regulatory Framework
Warehouses under customs control or supervision for medicinal products in Spain are regulated under EU customs legislation (Union Customs Code – Regulation (EU) No 952/2013), national customs provisions, and pharmaceutical regulations including Royal Decree 782/2013 on wholesale distribution and EU Good Distribution Practice (GDP) guidelines (2013/C 343/01). AEMPS oversees the pharmaceutical aspects to ensure that medicines stored in such facilities (e.g., in free zones, customs warehouses, or temporary storage areas) maintain their quality, identity, and integrity pending customs clearance, import authorisation, or release for free circulation. These warehouses are typically used for imported medicines awaiting final release or for export consignments. Almacenes de medicamentos bajo control o vigilancia aduanera - AEMPS
Authorisation and Requirements
- Authorisation: Operators must hold a customs authorisation (e.g., customs warehouse type C or D, or temporary storage facility) from the Spanish Tax Agency (AEAT) and comply with AEMPS-specific pharmaceutical requirements.
- AEMPS Notification/Approval: Facilities storing medicinal products must be notified to or authorised by AEMPS as part of the wholesale distribution authorisation or as a specific customs-supervised storage site.
- Responsible Person: A qualified person must oversee pharmaceutical operations, ensuring GDP compliance within the customs-controlled environment.
- Premises and Security: Secure, segregated areas with restricted access; temperature mapping and monitoring for sensitive products (cold chain, ambient); protection against theft, tampering, or environmental degradation.
Key Compliance Obligations
- Storage Conditions: Medicines must be stored according to labelled conditions (temperature, humidity, light protection) with continuous monitoring and recording; validation of storage areas required.
- Traceability and Documentation: Full batch-level traceability; accurate records of receipt, storage duration, movements, and release; integration with customs documentation.
- Quality Assurance: Risk-based controls to prevent mix-ups, contamination, or falsification; quarantine procedures for non-released products; deviation and complaint management.
- Falsified Medicines Prevention: Verification of authenticity upon receipt where applicable; immediate reporting of suspected falsified products to AEMPS and customs authorities.
- Release Procedures: Medicines may only be released from customs supervision after AEMPS import authorisation (if required) and customs clearance; batch release certification by Qualified Person where applicable.
Inspections and Supervision
AEMPS conducts joint or coordinated inspections with customs authorities to verify compliance with both pharmaceutical and customs rules. Inspections cover storage conditions, documentation, security, and procedures. Non-compliance may result in suspension of storage activities, product detention, or regulatory sanctions.
Practical Considerations
Operators must maintain an up-to-date quality system adapted to the customs environment, train staff on dual customs-pharmaceutical obligations, and ensure rapid communication between customs and AEMPS. These facilities play a critical role in facilitating legitimate imports while safeguarding against substandard or falsified medicines entering the Spanish market.
This framework aligns customs procedures with pharmaceutical quality standards, supporting safe and efficient international trade of medicines. Detailed requirements, application procedures, guidance documents, and contact information are published on the AEMPS page dedicated to customs-controlled and supervised medicinal product warehouses. Almacenes de medicamentos bajo control o vigilancia aduanera - AEMPS
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