Pharmacovigilance Good Practice Inspections in Spain – AEMPS System

Legal Basis and Purpose

Pharmacovigilance Good Practice (GVP) inspections in Spain are carried out under EU Regulation (EC) No 726/2004, Directive 2001/83/EC (as amended), and GVP modules issued by EMA, transposed nationally through Royal Decree 1344/2007 and related provisions. AEMPS, as the competent authority, performs these inspections to:

• Verify that marketing authorisation holders (MAHs) maintain effective pharmacovigilance systems.
• Ensure timely detection, assessment, and reporting of adverse reactions.
• Confirm appropriate risk management plans (RMPs) and implementation of risk minimisation measures.
• Assess compliance with signal detection, periodic safety update reports (PSURs), and post-authorisation safety studies.
• Protect public health by identifying non-compliance and requiring corrective actions.

Inspections may be routine, triggered (for-cause), or part of EU joint inspections coordinated by EMA. Inspección de Buena Práctica de Farmacovigilancia - AEMPS

Scope and Types of Inspections

AEMPS inspects:

• Spanish MAHs and their pharmacovigilance departments.
• Foreign MAHs with pharmacovigilance activities in Spain.
• Contracted pharmacovigilance service providers (e.g., QPPVs, literature monitoring vendors).
• Global pharmacovigilance systems when relevant to Spanish-marketed products.

Inspection types include:

• System inspections (full evaluation of the pharmacovigilance system).
• Product-specific inspections (focused on a particular medicine or safety issue).
• For-cause inspections (following serious non-compliance signals, complaints, or adverse findings).

Key Areas Assessed During Inspections

Inspections cover GVP Modules I–XVI, with particular focus on:

• Pharmacovigilance System Master File (PSMF) maintenance and accessibility.
• Qualified Person for Pharmacovigilance (QPPV) responsibilities and oversight.
• Adverse reaction collection, case processing, and expedited reporting.
• Signal management and validation processes.
• Risk management plans (RMP) implementation and effectiveness.
• Periodic safety update reports (PSURs) and development safety update reports (DSURs).
• Literature monitoring and global safety data integration.
• Quality management system, including SOPs, training, and deviation handling.
• Interaction with competent authorities and EMA.

Inspection Process and Outcomes

• Preparation: MAHs receive notification (usually 4–8 weeks) with scope, documents required, and interview list.
• Conduct: On-site (or remote) review of documentation, interviews with staff, and system demonstrations.
• Findings: Classified as critical, major, minor, or comments; critical/major findings require immediate action.
• Report and Follow-up: AEMPS issues a formal report; MAHs submit corrective/preventive action plans (CAPA) with timelines.
• Sanctions: Non-compliance may lead to enforcement measures, including variation, suspension, or revocation of marketing authorisation.

Practical Guidance for MAHs

MAHs should maintain an up-to-date PSMF, ensure QPPV availability, implement risk-based quality checks, and prepare for unannounced inspections. AEMPS provides guidance documents, checklists, and information on inspection procedures to support compliance.

This inspection programme strengthens pharmacovigilance oversight in Spain, contributing to continuous monitoring of medicine safety across the EU. Detailed inspection procedures, GVP module references, and contact information are available on the AEMPS pharmacovigilance inspection page. Inspección de Buena Práctica de Farmacovigilancia - AEMPS