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January 3, 2026
Approximately 5 minutes
Pharmaceutical Distribution and Laboratory Authorisations in Spain – AEMPS Requirements
Pharmaceutical Distribution and Laboratory Authorisations in Spain – AEMPS Requirements
Regulatory Framework
Pharmaceutical distribution and related laboratory activities in Spain are governed by EU Directive 2001/83/EC (as amended), Delegated Regulation (EU) 2016/161 on safety features, and national legislation including Royal Decree 782/2013 on wholesale distribution and Royal Decree 1345/2007 on medicinal products. AEMPS is the competent authority responsible for authorising, inspecting, and supervising entities involved in manufacturing, import, wholesale distribution, and quality control of human and veterinary medicines. The system ensures product integrity, prevents falsification, and maintains supply chain security. Laboratorios farmacéuticos y entidades de distribución - AEMPS
Authorisation Types
- Manufacturing Laboratories: Full manufacturing authorisation required for production, packaging, labelling, or import of medicinal products; includes sterile, biological, and radiopharmaceutical facilities with additional specific requirements.
- Wholesale Distribution Entities: Authorisation for storage, dispatch, and distribution of medicines; must comply with Good Distribution Practice (GDP) guidelines.
- Control Laboratories: Authorisation for quality control testing (chemical, biological, microbiological); often linked to manufacturing or import authorisations.
- Import/Export Entities: Specific import authorisation for medicines from third countries, including verification of GMP equivalence.
Applications are submitted via AEMPS electronic portal with detailed dossiers covering premises, equipment, personnel, quality systems, and procedures.
Key Compliance Obligations
- Good Distribution Practice (GDP): Temperature-controlled storage, qualified transport, documentation of distribution chain, and falsified medicines risk management.
- Good Manufacturing Practice (GMP): For laboratories involved in production or testing; includes validation, calibration, and batch release by Qualified Person.
- Traceability and Serialisation: Mandatory use of unique identifiers (DataMatrix) and verification/decommissioning via SEVeM (national medicines verification system).
- Pharmacovigilance and Quality Defects: Immediate reporting of quality defects or recalls; coordination with AEMPS for market actions.
Inspections and Certification
AEMPS conducts routine and for-cause inspections to verify compliance. Successful inspections result in:
- GDP certificates for distributors.
- GMP certificates for manufacturers and control labs.
- Certificates recognised across the EU/EEA under mutual recognition.
Non-compliance may lead to suspension, withdrawal of authorisation, or sanctions.
Practical Considerations
Entities must notify AEMPS of significant changes (e.g., site relocation, new activities) via variation procedures. AEMPS maintains public registers of authorised entities. Guidance documents, application forms, inspection checklists, and contact points are provided to facilitate compliance.
This authorisation and supervision framework ensures safe, effective, and traceable medicines throughout the Spanish distribution chain, supporting public health and EU market harmonisation. Complete requirements, forms, guidance, and authorised entity lists are available on the AEMPS pharmaceutical distribution and laboratories section. Laboratorios farmacéuticos y entidades de distribución - AEMPS
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