Instructions for Reporting Suspected Illicit Traffic of Medicinal Products – AEMPS Guidance

Objective and Legal Context

AEMPS issues these instructions to assist wholesale distributors and other authorised entities in fulfilling their legal obligation to report any suspicion of illicit traffic, diversion, falsification, or other serious irregularities involving medicinal products. The guidance aligns with Royal Decree 782/2013, the Falsified Medicines Directive (2011/62/EU), and Delegated Regulation (EU) 2016/161, emphasising the critical role of the supply chain in detecting and preventing pharmaceutical crime. Timely reporting helps authorities investigate and disrupt illegal networks while protecting public health. Instrucciones para la comunicación de tráfico ilícito sospechoso de medicamentos - AEMPS

Indicators of Suspected Illicit Activity

Distributors should be alert to red flags such as:

• Requests for unusually large volumes or frequent small orders from new or unknown customers.
• Customers unwilling to provide authorisation details or insisting on cash payments / anonymous delivery.
• Prices significantly below market rates or pressure for rapid delivery without normal checks.
• Orders for medicines prone to abuse (e.g., benzodiazepines, opioids, anabolic steroids) without clear medical justification.
• Inconsistencies in documentation, forged certificates, or suspicious packaging/ labelling.
• Export requests to high-risk third countries without proper end-user declarations.

Reporting Procedure

When suspicion arises, distributors must:

• Immediately isolate the affected batches/products and cease further distribution.
• Document all relevant details: customer information, order history, communication records, product details (batch, expiry), delivery attempts, and observed irregularities.
• Notify AEMPS without delay via the dedicated email channel (tráfico.ilícito@aemps.es) or the online reporting form, including all supporting evidence (scans, photos, correspondence).
• Cooperate fully with any subsequent AEMPS or law enforcement investigation, providing access to records and premises as required.

Responsibilities and Protections

• Responsible Person: The Qualified Person or Responsible Person must oversee the assessment and reporting process.
• Confidentiality: Reports are treated confidentially; whistle-blower protections apply under Spanish law for good-faith reports.
• No Retaliation: Distributors acting in good faith are protected from liability when reporting suspicions.
• Record Keeping: Maintain records of all reports and related actions for audit purposes.

Additional Measures

Distributors are encouraged to implement internal alert systems, train staff on recognition of illicit patterns, and conduct periodic risk assessments of their customer base. Collaboration with AEMPS and other authorities is essential to strengthen supply chain integrity.

These instructions reinforce the proactive role of distributors in combating illicit pharmaceutical traffic, contributing to patient safety and the effectiveness of enforcement actions in Spain. The full document, including reporting templates, contact details, and further examples, is available on the AEMPS website. Instrucciones para la comunicación de tráfico ilícito sospechoso de medicamentos - AEMPS