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Ukraine's State Medications Service has announced that the automated system for tracking of medications in circulation is ready for industrial testing, the Information-analytical Bulletin of the Cabinet of Ministers of Ukraine informs.
The system in November 2013 will be loaded with individual numbers of medication packages furnished by manufacturers and distributors (importers) who might voluntarily want to participate in the project.
This type of coding (GS1 ECC200 - data-matrix) has been successfully tested in the European Union and is compliant with general European practice, as confirmed by representatives of the European Directorate for Quality of Medications and Health (EDQM), who visited Ukraine this summer.
State Medications Service head Olexiy Soloviev said introduction of an all-European system for tracking of medications in Ukraine will help solve a problem of keeping electronic registers, which can keep track of the entire supply chain and change of drug ownership at any stage of treatment to the end user, while preventing sub-standard drugs from getting to consumers and helping fight fraud in healthcare.
The essence of identification of original drugs is that data on the drug are received by automated system at all stages: from production to sale in pharmacies. From the very beginning (during production of a drug batch), a certified drug maker sends a message to the system about production of the batch, with tracking of shipment to distributor and further distribution to pharmacies.
Government analysts cite the June 8, 2011 European Union Directive 2011/62/EU designed to prevent counterfeit medications from reaching legitimate retail networks. The directive came into force on Jan. 1, 2013. EU member states have to bring their legislation and trade practices in line with requirements of this Directive by 2017. Among other things, it states that a unique identifier shall be marked by manufacturer at each prescription drug registered in the country, as well as some OTC drugs.
Ukraine is planning the stepwise implementation of automated tracking system for circulation of drugs by 2017.
Experts say that the State Medication Service joined the Pharmaceutical Inspection Cooperation (PIC/S), which brings together the regulatory bodies of countries with strict regulatory system (other than Ukraine, it includes the EU and some other developed countries. Ukraine is the only CIS country accepted in this organization).
Ukraine from 2010 to 2013 implemented the European legislation, whose purpose is to bring the quality control of medications in line with quality standards adopted by the EU. Ukraine in 2011 first introduced - and later toughened - criminal penalties for counterfeit medications.
Improved quality control of drugs by the government and the State Medication Service helped boost export of domestic medications by 25%. Domestically producted medications today exported to all continents, except Australia.