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January 10, 2026
Approximately 5 minutes
Register of Medicinal Product Intermediaries in Spain – AEMPS Public List
Register of Medicinal Product Intermediaries in Spain – AEMPS Public List
Regulatory Basis
The register of intermediaries for human medicinal products is established under Directive 2001/83/EC (as amended by Directive 2011/62/EU on falsified medicines), Delegated Regulation (EU) 2016/161 on safety features, and national implementation through Royal Decree 782/2013 on wholesale distribution. Intermediaries (brokers) are entities that negotiate independent of physical possession of medicines or arrange transactions without holding stock. AEMPS, as the competent authority, maintains this public list to promote transparency, allow verification of legitimacy, and support the fight against falsified medicines in the distribution chain. Registro de entidades de intermediación de medicamentos de uso humano - AEMPS
Authorisation Requirements
- Mandatory Registration: All intermediaries operating in Spain must be registered with AEMPS before commencing activities.
- Application Process: Submit application via AEMPS electronic portal with details on company identification, responsible person, procedures for transaction recording, risk management for falsified medicines, and declaration of no stock-holding.
- Responsible Person: Designation of a qualified individual responsible for compliance and liaison with authorities.
- No GDP Inspection Required: Unlike wholesalers, intermediaries are not subject to full GDP inspections but must demonstrate adequate controls.
Information in the Register
The public register includes for each authorised intermediary:
- Company name and tax identification number.
- Registration number and date.
- Address of registered office.
- Name of responsible person.
- Scope of activities (national/EU/third-country transactions).
- Status (active, suspended, revoked) and any conditions.
Entries are updated following authorisation, variations, or enforcement actions.
Access and Verification
- Online Availability: Freely accessible on the AEMPS website without login.
- Search Tools: Filter by name, registration number, province, or status.
- Verification Purpose: Marketing authorisation holders, wholesalers, pharmacies, and authorities can check legitimacy before engaging in transactions.
Compliance and Enforcement
Registered intermediaries must maintain records of all transactions, implement risk-based controls against falsified medicines, and report suspected falsifications immediately to AEMPS. Non-compliance or involvement in illicit activities may lead to removal from the register, prohibition of activities, or sanctions.
This public register strengthens oversight of intermediary activities in Spain, aligns with EU transparency obligations, and contributes to supply chain integrity and patient safety. The full register, search interface, guidance on registration, and related forms are available on the AEMPS dedicated page for the register of medicinal product intermediaries. Registro de entidades de intermediación de medicamentos de uso humano - AEMPS
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