The directive, which gained European parliament approval in February, establishes a legal framework defining falsified medical products and differentiates them from other illegal or substandard drugs.
The new rules require that prescription drugs have safety features that enable both the verification of individual drug packs throughout the supply chain and the identification of any that have been tampered with.
It also requires that all importers, manufacturers and distributors of active pharmaceutical ingredient (APIs) be registered as ‘brokers of medicinal products.’
Pharmaceutical firms must also verify that their API suppliers comply with good manufacturing and distribution practices (GMP/GDP) and that excipients used in drug products are suitable.
The directive also requires that member states impose penalties for firms the make manufacture of such products. Member countries must also have recall mechanisms in place to enable the speedy withdrawal of any fake drugs that are detected.
The document also tries to clamp down on internet pharmacies, which are a suspected entry point for large number of falsified medicines into the supply chain.
“Websites offering medicines must be linked to the website of the respective competent authority on which a list of all persons or bodies in that member state that are authorised to offer medicinal products for sale via internet must be available.
“Furthermore, such web-pages must, in order to facilitate identification, display a common logo. These new provisions are without prejudice to member states' right to regulate retail sales of medicinal products.”
The directive was adopted without debate at a session of Council of the EU’s Transport, Telecommunications and Energy Council in Brussels on Sunday with one minor revision.
Authorities in Belgium, Greece and Italy, which all have systems in place that allow the identification of drug packs at the point where they are dispensed, asked for more time to transition to new safety feature system described in the directive.