International Trade Regulations for Medicinal Products in Spain – AEMPS Framework

Legal and Regulatory Basis

International trade of human medicinal products in Spain is governed by EU harmonised rules, primarily Directive 2001/83/EC (as amended by the Falsified Medicines Directive 2011/62/EU), Regulation (EC) No 726/2004, Delegated Regulation (EU) 2016/161 on safety features, and GMP/GDP guidelines (EudraLex Volumes 4 and 5). National implementation occurs through Royal Decree 782/2013 on wholesale distribution, Royal Decree 1345/2007 on authorisation, and specific AEMPS procedures. The framework ensures quality, safety, efficacy, and traceability during cross-border movements while preventing entry of falsified or non-compliant products. Comercio exterior - AEMPS

Import Operations

• Intra-EEA Imports: Authorised wholesalers may import medicines from other EEA countries if compliant with GDP and safety feature verification (decommissioning of unique identifiers where required).
• Third-Country Imports: Require AEMPS import authorisation; APIs and finished products from non-EEA countries need written confirmation of equivalent GMP standards or EU GMP certification.
• Parallel Imports: Permitted after AEMPS notification, repackaging approval, and verification that the product is identical to the Spanish-authorised version.
• Customs Coordination: Imports under customs supervision must maintain storage conditions; AEMPS collaborates with customs authorities for risk-based controls.

Export Operations

• Intra-EEA Exports: Authorised wholesalers may export to other EEA countries without additional authorisation if GDP-compliant.
• Third-Country Exports: Require AEMPS export certificate (Certificate of Pharmaceutical Product – CPP or Certificate of GMP); batch release documentation and end-user declarations may be needed.
• Parallel Distribution: EEA-authorised products can be exported via parallel channels after notification to AEMPS and the marketing authorisation holder.

Transit and Special Regimes

• Transit: Medicines transiting Spain must remain under customs supervision and not enter the Spanish market unless separately authorised.
• Re-export and Temporary Import: Special authorisation required for temporary imports (e.g., clinical trials) or re-export of non-marketed products.
• Humanitarian Donations and Emergency Supplies: Simplified procedures with prior AEMPS approval, often coordinated with the Spanish Agency for International Development Cooperation (AECID).

Compliance and Documentation Requirements

• Authorisation Holders: Only entities with valid wholesale distribution, import, or export authorisations may engage in international trade.
• Safety Features: Mandatory verification and decommissioning for products subject to the Falsified Medicines Directive.
• Traceability and Records: Full batch traceability; records retained for at least 5 years.
• Risk Management: Enhanced controls for high-risk transactions (third-country sources, controlled substances).

AEMPS provides application forms, checklists, guidance on certificates, and contact points for import/export authorisations, parallel import notifications, and special regimes. The agency also publishes lists of authorised operators and relevant certificates.

This regulatory structure integrates Spain into the EU single market for medicines while maintaining robust controls over international movements to protect public health. Detailed procedures, forms, requirements, and updates are available on the AEMPS foreign trade section. Comercio exterior - AEMPS