Foreign Trade of Medicinal Products in Spain – AEMPS Regulatory Framework

Overview and Legal Basis

Foreign trade of medicinal products in Spain is regulated by EU harmonised legislation (Directive 2001/83/EC as amended, Regulation (EC) No 726/2004, Delegated Regulation (EU) 2016/161 on safety features) and national provisions including Royal Decree 1345/2007 and Royal Decree 782/2013. AEMPS, as the competent authority, authorises and supervises import, export, parallel distribution, and transit activities to ensure medicines maintain quality, safety, and efficacy during international movement, prevent entry of falsified products, and comply with customs and pharmacovigilance obligations. Comercio exterior - AEMPS

Import of Medicinal Products

• Authorised Imports: Medicines authorised in Spain/EU may be imported by authorised wholesalers or manufacturers; third-country imports require AEMPS import authorisation and verification of equivalent GMP standards.
• Parallel Imports: Products authorised in another EEA Member State can be parallel imported after AEMPS notification and repackaging/labeling approval.
• Safety Features: Mandatory verification and decommissioning of unique identifiers (DataMatrix) for products subject to the Falsified Medicines Directive.
• Customs Procedures: Imports under customs supervision must maintain storage conditions; AEMPS coordinates with customs authorities.

Export of Medicinal Products

• Exports to EEA: Authorised wholesalers may export medicines to other EEA countries without additional authorisation if compliant with GDP.
• Exports to Third Countries: Require AEMPS export certificate (Certificate of Pharmaceutical Product – CPP) confirming authorisation status, GMP compliance, and batch release.
• Parallel Distribution: EEA-authorised products may be exported via parallel channels after notification to AEMPS and the marketing authorisation holder.

Transit and Other Operations

• Transit: Medicines in transit through Spain must remain under customs supervision and not enter the Spanish market unless authorised.
• Re-export: Products imported under special regimes (e.g., temporary import) may be re-exported with AEMPS oversight.
• Donations and Humanitarian Supplies: Special procedures apply for non-commercial exports or donations, requiring AEMPS authorisation.

Key Compliance Requirements

• Authorisation Holders: Only entities with valid wholesale distribution or import authorisations can engage in foreign trade.
• Documentation: Full traceability, batch records, and verification of safety features throughout the process.
• Risk Management: Controls to prevent falsification, including supplier/customer legitimacy checks via AEMPS registers.
• Pharmacovigilance: Reporting obligations continue for exported products where Spain is the reference Member State.

Practical Guidance

AEMPS provides application forms, checklists, guidance documents, and contact points for import/export authorisations, parallel import notifications, CPP requests, and safety feature verification. The agency also publishes lists of authorised operators and relevant certificates.

This regulatory framework ensures Spain’s integration into the EU single market for medicines while safeguarding public health during international trade. Detailed procedures, forms, requirements, and updates are available on the AEMPS foreign trade section. Comercio exterior - AEMPS