Notification of Suspected Falsified Medicines in Spain – AEMPS Procedure

Legal Obligation and Purpose

Under Spanish and EU legislation (Directive 2011/62/EU transposed via Royal Decree 782/2013 and related provisions), any person or entity (manufacturers, distributors, pharmacies, healthcare professionals, or citizens) who suspects or detects a falsified medicinal product must notify AEMPS without delay. The primary objectives are:

• Rapid detection and interruption of falsified medicines in the legal supply chain.
• Protection of public health by preventing exposure to ineffective, substandard, or harmful products.
• Enabling traceability, investigation, and enforcement actions against falsification networks.

Failure to report known or strongly suspected falsifications may constitute a serious infringement. Notificación de sospechas de medicamentos falsificados - AEMPS

Scope of Reportable Suspicions

Reportable cases include:

• Medicines suspected of being falsified (counterfeit, tampered, falsely labelled, or diverted).
• Products with suspicious packaging, labelling, batch numbers, expiry dates, or appearance.
• Unexpected adverse reactions potentially linked to falsified products.
• Offers of unusually low-priced medicines outside normal distribution channels.
• Seizures or detections by customs, police, or other authorities.

The obligation applies to all authorised human medicines, including those for hospital and community use.

Notification Channels and Required Information

Notifications must be submitted promptly via:

• Online form on the AEMPS website (preferred for detailed submissions).
• Email to falsificados@aemps.es (for urgent initial alerts).
• Telephone during business hours (for immediate high-risk situations).

Essential information to provide:

• Description of the suspicion and circumstances of detection.
• Product details (name, active substance, strength, pharmaceutical form, batch number, expiry date, MA holder).
• Packaging and labelling abnormalities (photos recommended).
• Origin/source of the product and distribution chain information.
• Quantity involved and current location.
• Reporter’s contact details (confidentiality assured).

AEMPS acknowledges receipt and may request additional samples or documentation.

Actions Following Notification

Upon receipt, AEMPS:

• Assesses the risk level and urgency.
• Coordinates with the marketing authorisation holder, regional health authorities, and EU bodies (via EMVO and EudraVigilance).
• May initiate batch quarantine, recall, public alerts, or market withdrawal.
• Collaborates with law enforcement for criminal investigation when applicable.
• Updates the national falsified medicines register and informs stakeholders.

Reporters are informed of key outcomes when possible, respecting confidentiality and ongoing investigations.

Practical Guidance for Stakeholders

• Act immediately upon suspicion — early reporting can prevent harm.
• Preserve the product and packaging intact for potential analysis.
• Use secure channels to avoid further dissemination of falsified products.
• Healthcare professionals should verify authenticity via DataMatrix scanning (where implemented) or direct AEMPS consultation.

This notification system forms a critical component of Spain’s medicines safety net, complementing serialisation, verification features, and EU-wide falsified medicines controls. Detailed instructions, forms, and contact details are available on the AEMPS falsified medicines notification page. Notificación de sospechas de medicamentos falsificados - AEMPS