EU Falsified Medicines Directive (2011/62/EU)

What it says

Directive 2011/62/EU amended Directive 2001/83/EC to prevent falsified medicines from entering the legal supply chain. It introduced safety features, a unique identifier and an anti-tampering device, for certain medicines, and tightened the rules on active substances, including GMP and written confirmations for those imported from outside the EU. It also set requirements for brokers and for the online sale of medicines to the public. The detailed safety feature rules are in Delegated Regulation (EU) 2016/161.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Safety features mean that packs are serialized at packaging and verified at the end of the supply chain, which places requirements on packaging lines, data systems and the connection to the national verification systems.
• Manufacturers of medicinal products are expected to use active substances made according to GMP and to confirm this through supplier qualification and audits, which brings the active substance supply chain into the quality system.
• Active substances imported into the EU generally need written confirmation from the exporting country regulator that GMP standards equivalent to the EU standards are met, unless a listed exception applies.

What inspectors look for

• Whether active substance suppliers have been qualified, audited and risk assessed, and whether the supporting confirmations and documents are on file.
• Whether serialization and verification systems on packaging lines are controlled and validated, and whether the associated data is accurate and protected.
• Whether the supply chain procedures address the risk of falsified or substandard materials entering the product.

Related regulations