Q&A on Human Pharmacovigilance Legislation in Spain – AEMPS Summary

Overview and Purpose

AEMPS maintains an official Q&A document addressing frequently asked questions on pharmacovigilance requirements for human medicines under Spanish law and EU regulations (primarily Regulation (EC) No 726/2004, Directive 2001/83/EC as amended, and GVP modules). The document helps marketing authorisation holders (MAHs), applicants, and other stakeholders understand obligations related to adverse reaction monitoring, risk management, and post-authorisation safety activities. It is regularly updated to reflect legislative changes and practical experience. Preguntas y respuestas sobre la legislación de farmacovigilancia - AEMPS

Key Topics Covered

Adverse Reaction Reporting

• Timelines: Serious adverse reactions must be reported within 15 days (expedited) or 90 days depending on type; non-serious reactions are submitted in periodic reports.
• Electronic Reporting: Use of EudraVigilance is mandatory; XML format and ICH E2B(R3) standards apply.
• Literature and Social Media: MAHs must monitor scientific literature and, where applicable, digital sources for potential safety signals.

Risk Management Plans (RMPs)

• Submission and Updates: RMP required at initial authorisation and must be updated when new safety information emerges or at specified intervals.
• Additional Risk Minimisation Measures: Conditions for implementation, effectiveness evaluation, and communication to healthcare professionals and patients.

Periodic Safety Update Reports (PSURs)

• Frequency: Determined by the authorisation procedure and product risk profile (e.g., every 6 months initially, then annually or longer).
• Content: Cumulative safety data, benefit-risk evaluation, signal assessment, and proposed actions.
• Single Assessment Procedure: EU coordinated PSUR assessment for harmonised conclusions.

Qualified Person for Pharmacovigilance (QPPV)

• Role and Responsibilities: Continuous availability, oversight of the pharmacovigilance system, and direct contact point for authorities.
• Back-up and Location: Requirements for deputy QPPV and residence in the EU/EEA.

Signal Management and Other Obligations

• Signal Detection: Continuous proactive monitoring using multiple sources.
• Post-Authorisation Safety Studies (PASS): When required, protocols and results submission.
• Pharmacovigilance System Master File (PSMF): Must be maintained and accessible for inspection.

Practical Implications

The Q&A clarifies common doubts on interpretation of requirements, responsibilities in multinational setups, language of submissions, and interaction with AEMPS and EMA. It emphasises the importance of maintaining robust pharmacovigilance systems to ensure timely risk identification and management, ultimately protecting patient safety.

This resource supports compliance and harmonisation across the EU while addressing Spain-specific aspects. The full Q&A document, including detailed answers and references to legal texts, is available on the AEMPS human pharmacovigilance industry section. Preguntas y respuestas sobre la legislación de farmacovigilancia - AEMPS