EU to Introduce Stricter Prescription Drug Monitoring System

Oct 31 2014 - 12:46

Hungarian National Board Against Counterfeiting announced on its website that in the next few years, the European Union member states are expected to implement a stricter prescription drug monitoring system, aimed at preventing counterfeit medicines from entering the supply chain, based on the Falsified Medicines Directive, which will enter into force in 2018 in the EU.

According to the Directive, each drug package will need to be tamper-resistant and coated with a unique two-dimensional barcode, containing manufacturer’s code, serial number, national healthcare reimbursement number, batch number and expiration date. These measures will make unauthorized access to the protected package easily detected and allow genuine packs of drugs to be traced back to manufacturers and distributors.

Every prescription drug package will have to be registered in the common EU database from which it can only be removed if purchased by pharmacies or used in hospitals. To comply with the new system, the EU member states will need to introduce major IT-related changes, some of which may be complicated or time-consuming to implement. Some estimates say that this will affect 17 billion boxes of prescribed medicines per year, which come from 4,600 manufacturers and reach 177,000 distribution places.

Hungarian experts are somewhat concerned about these big changes, especially since in Hungary counterfeit pills have never gotten into the legal medicine chain, i.e. manufacturer – retailer – pharmacy/hospital/doctor.

“The best practice would be to gradually develop the IT system, starting with the most narrow medicine circle first, which means fewer packages with safety features and more drugs on the exception list”, stated Dr. Livia Ilku, head of the Hungarian Pharmaceutical Manufacturers Association.

Prepared by: Csilla Balogh

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Source: Hungarian National Board Against Counterfeiting

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