The European Union (EU) has established a robust legal framework for the licensing, manufacturing, and distribution of medicines. In July 2011, the EU adopted the Falsified Medicines Directive (FMD) to enhance protection against falsified medicines.
The FMD aims to prevent falsified medicines from entering the legal supply chain and reaching patients, introducing harmonized safety and control measures across Europe. These measures are grouped into four main pillars:
Safety Features of Medicines:
From 9 February 2019, most prescription medicines and some over-the-counter medicines in the EU must have a unique identifier (2D barcode) and a Tamper-Evident Device TED). Manufacturers upload this information to a central EU repository. Wholesalers, pharmacies, and hospitals scan medicines at various points to verify authenticity, ensuring secure dispensing to patients.
- Supply Chain and Good Distribution Practice:
The Directive introduces new responsibilities for wholesalers and brokers, defining brokering activities and incorporating them into good distribution practice (GDP) guidelines. The EudraGMDP database now includes GDP information, enhancing oversight of medicine distribution.
- Active Substances and Excipients:
Since July 2013, all active substances manufactured outside the EU and imported into the EU must be accompanied by a written confirmation from the regulatory authority of the exporting country, ensuring compliance with EU-equivalent good manufacturing practices (GMP). Some countries with equivalent regulatory frameworks are exempt from this requirement.
- Internet Sales:
The Directive mandates an obligatory logo for websites of legally operating online pharmacies and approved retailers in the EU. This logo links to national regulatory authority websites, helping consumers identify authorized online pharmacies and retailers, ensuring the authenticity of purchased medicines. Member States have implemented awareness campaigns to inform the public about the logo and the risks of falsified medicines.
The FMD strengthens the security of the medicine supply chain, ensuring medicine authenticity and enhancing public health protection.
