Good Distribution Practice for Medicinal Products in the EU – Spanish Implementation by AEMPS

Legal Basis and Scope

Good Distribution Practice (GDP) in Spain is governed by EU Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01), transposed through Royal Decree 782/2013 and aligned with Delegated Regulation (EU) 2016/161 on safety features. AEMPS is the competent authority responsible for authorising, inspecting, and supervising wholesale distribution activities to ensure medicines maintain their quality, safety, and efficacy from manufacturer to dispenser. The guidelines apply to all entities involved in wholesale distribution, storage, and transport of authorised human medicines, including brokers and parallel traders. Industria de distribución de medicamentos – BPD UE - AEMPS

Authorisation Requirements

• Wholesale Distribution Authorisation: Mandatory for any entity storing or distributing medicines at national or EU level; applications submitted to AEMPS include details on premises, quality system, responsible person, and procedures.
• Responsible Person: A qualified person must be designated to ensure GDP compliance and act as the contact point for AEMPS.
• Premises and Equipment: Suitable, secure, clean, and temperature-controlled facilities with validated monitoring systems (e.g., data loggers for cold chain).
• Transport: Qualified carriers and vehicles; risk-based approach for temperature-sensitive products.

Core GDP Principles

• Quality Management: Documented quality system with SOPs, risk assessments, deviation management, and self-inspections.
• Personnel: Trained staff with defined responsibilities; initial and continuous training programmes.
• Documentation: Complete records of receipt, storage, distribution, and returns; traceability of each batch.
• Storage Conditions: Appropriate environmental controls (temperature, humidity, light) with continuous monitoring and alarm systems.
• Complaints, Returns, and Recalls: Procedures for handling complaints, quarantining returns, and executing recalls in coordination with AEMPS.
• Falsified Medicines Prevention: Risk-based controls, verification of suppliers, and reporting of suspected falsified products.

Inspections and Certification

AEMPS conducts routine and for-cause GDP inspections. Satisfactory inspections result in a GDP certificate, valid for 5 years and recognised across the EU/EEA. Non-compliance may lead to improvement notices, suspension, or revocation of authorisation.

Practical Implications for Distributors

Distributors must integrate serialisation verification (scanning DataMatrix codes) and decommissioning via SEVeM, maintain an up-to-date quality system, and prepare for unannounced inspections. AEMPS provides guidance documents, checklists, training resources, and a public register of authorised distributors.

This implementation of EU GDP ensures high standards of medicine distribution in Spain, protecting patients from substandard or falsified products while facilitating legitimate parallel trade and supply chain efficiency. Detailed guidelines, application forms, inspection procedures, and authorised entity information are available on the AEMPS distribution industry page dedicated to EU GDP. Industria de distribución de medicamentos – BPD UE - AEMPS