Since 2013, the Falsified Medicines Directive has coordinated supply chain safety measures across the European Union to prevent counterfeit and dangerous products from reaching patients. Its provisions include use of a unique identifier and anti-tampering devices on packaging, use of a medicine verification system, a common logo for legal online pharmacies, stronger rules on import of pharmaceutical ingredients, and record-keeping requirements for wholesale distributors.
The EU Falsified Medicines Directive (FMD) is a comprehensive regulatory framework implemented by the European Union to combat the growing threat of counterfeit medicines within the pharmaceutical supply chain. Enforced since February 9, 2019, the directive aims to enhance patient safety by ensuring the authenticity and traceability of medicinal products.
Key provisions of the EU FMD include the mandatory use of safety features on prescription medicine packaging, consisting of a unique identifier and an anti-tampering device. The unique identifier comprises a serialized 2D data matrix code that contains essential product information, such as batch number, expiration date, and a unique serial number. Pharmacists and other stakeholders in the supply chain must verify the authenticity of these identifiers before dispensing medicines to patients.
Additionally, the EU FMD establishes a European Medicines Verification System (EMVS), a secure database that facilitates real-time verification of medicinal products across the EU. Manufacturers, wholesalers, and other supply chain participants are required to connect to the EMVS to verify and authenticate medicines, thus preventing the distribution of counterfeit or substandard products.
By implementing these measures, the EU Falsified Medicines Directive aims to safeguard public health, maintain the integrity of the pharmaceutical supply chain, and bolster trust in the safety and efficacy of medicinal products circulating within the European Union. Compliance with these regulations is crucial for all stakeholders in the pharmaceutical industry to uphold the highest standards of quality and patient well-being.