13. February 2019 | Economy

Falsification Directive takes effect

Falsification Directive takes effect
The two new safety features are to prevent falsifications
Source: securPharm e.V.

Since 9 February, the new safety regulations of the EU Directive for increasing protection from falsification of medicines have been in effect. This has started the "securPharm" system of an eponymous organization initiated by the industry, wholesalers, and pharmacists.

Two safety features mandatory

The packaging of prescription medicines must now generally have two safety features: a tamper-evidence seal, and a unique serial number, which will be checked for genuineness and validity immediately before the medicine is dispensed to the patient. During a transition period, packaged medicines already on the market may continue to be sold and used until they expire.

Launched in 29 countries

The securPharm system is embedded into a Europe-wide protective system of the legitimate supply chain against falsified medicines. Initially the safety systems will take effect in 26 EU Member States, as well as in Norway, Iceland, and Liechtenstein. By 2025, Italy's and Greece's systems will also be added. Roughly 22,000 manufacturers, pharmacies, wholesalers, and hospitals have been integrated into the securPharm system.

edited by Christiane Lingrön

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