Falsified Medicines Directive

Falsified Medicines Directive (FMD) is a legislation implemented by the European Union (EU) to protect the public health by combating the increasing problem of falsified medicines. The directive was adopted in 2011 and came into effect on February 9, 2019.

Overview

The Falsified Medicines Directive (Directive 2011/62/EU) aims to prevent the entry of falsified medicines into the legal supply chain. It introduces harmonized safety and control measures to ensure the authenticity and quality of medicines distributed throughout the EU.

Key Provisions

The FMD introduces several key provisions to combat the problem of falsified medicines:

• Safety Features: All prescription medicines are required to have a unique identifier (a 2D barcode) and an anti-tampering device. The unique identifier is a serial number that is registered on a central database. This allows the medicine to be verified at any point in the supply chain.

• Supply Chain Verification: The FMD requires that the safety features are checked at various points in the supply chain, including by pharmacists before the medicine is dispensed to the patient.

• Internet Sales: The FMD introduces stricter rules for the online sale of medicines. Online pharmacies must display a common logo on every page of their website to show they are registered.

Impact

The FMD has had a significant impact on the pharmaceutical industry, requiring changes to manufacturing, packaging, and distribution processes. It has also increased the need for collaboration between stakeholders in the supply chain, including manufacturers, wholesalers, pharmacists, and regulators.

Criticisms

While the FMD has been praised for its efforts to protect public health, it has also faced criticism. Some argue that the directive does not go far enough in addressing the root causes of medicine falsification, such as weak regulatory systems and lack of access to affordable medicines.

See Also

• Pharmaceutical industry
• Public health
• European Union law