Donation of Medicinal Products in Spain – AEMPS Regulatory Guidelines

Legal Framework

Donations of medicinal products in Spain are regulated under Directive 2001/83/EC (as amended), Royal Decree 782/2013 on wholesale distribution, and specific AEMPS guidance to ensure donated medicines meet the same quality, safety, and efficacy standards as those placed on the market. Donations are permitted only from authorised manufacturers, wholesalers, or pharmacies, and recipients must be qualified entities (e.g., healthcare facilities, NGOs with authorisation, or public health programmes). The framework aims to prevent falsified or substandard medicines while supporting humanitarian aid and access in resource-limited contexts. Donaciones de medicamentos - AEMPS

Eligible Donors and Recipients

• Donors: Must hold valid manufacturing or wholesale distribution authorisation from AEMPS or another competent authority (for EU/EEA donors).
• Recipients: Typically authorised healthcare institutions, non-profit organisations with health-related authorisation, or international humanitarian organisations. Private individuals cannot receive donations directly.
• Prohibited Donations: Controlled substances (narcotics, psychotropics), investigational medicinal products, expired medicines, or products without proper documentation.

Key Conditions for Donation

• Quality and Traceability: Donated medicines must be in original packaging, unopened (or properly resealed if samples), with at least 6 months remaining shelf life (exceptions possible with justification), and full batch traceability.
• Storage and Transport: Donors must ensure proper storage conditions (temperature, humidity) and use qualified transport meeting GDP standards.
• Documentation: Complete donation certificate including donor/recipient details, product list, batch numbers, expiry dates, quantity, and declaration of compliance with quality standards.
• No Financial Benefit: Donations must be free of charge; no commercial transaction or inducement allowed.
• Pharmacovigilance: Donors remain responsible for reporting any subsequent quality or safety issues related to donated products.

Special Cases

• Humanitarian Aid: Donations for international aid programmes may follow simplified procedures with prior AEMPS authorisation and coordination with the Spanish Agency for International Development Cooperation (AECID).
• Near-Expiry Donations: Possible under exceptional circumstances with risk assessment and recipient agreement.
• Veterinary Medicines: Separate rules apply, often aligned with similar principles.

Procedure and Authorisation

Donors must notify AEMPS in advance for large-scale or international donations and obtain specific authorisation when required (e.g., export of donated medicines). Recipients must confirm acceptance and proper use/intended purpose. AEMPS may inspect donation processes and require post-donation reports.

This regulated donation system balances the potential benefits of redistributing quality medicines with strict safeguards to protect public health. Detailed requirements, templates for donation certificates, application forms, and contact information are available on the AEMPS page dedicated to medicinal product donations. Donaciones de medicamentos - AEMPS