On 14 November 2016 in Sofia was held a joint conference of GS1 Bulgaria and BgMVO on "Implementation of verification system of medicines in Bulgaria - basic requirements for pharmaceutical manufacturers and MAH".
The purpose of conducted joint conference of GS1 Bulgaria and BgMVO was to bring together representatives of companies - manufacturers of medicines, marketing authorization holders and representatives of regulatory bodies – Bulgarian Drug Agency, the National Health Insurance Fund and others, and to give an opportunity to discuss issues related to requirements of Directive 2011/62/EU on counterfeit medicines, building and implementing a system for checking medicines and marking the drugs with GS1 Data Matrix barcode.
The latest data provided by EUIPO (European Union Intellectual Property Office) shows 4.4% sales of counterfeit medicines in Europe and illegal trade of medicines on the internet 50%. Directive 2011/62/EU on falsified medicines, which is directed against the alarming increase of this phenomenon in the EU was adopted in 2011. As part of efforts to combat counterfeit medicines are taken steps to develop initiatives to promote pharmaceutical research in the EU to deal with counterfeiting and illegal distribution of medicines, to ensure access to quality information on prescription-only medicines and to improve the protection of patients by strengthening the pharmacovigilance.
To meet the requirements of Directive 2011/62/EU and the published delegated acts, up to February 9, 2019 each EU country must have a system for verification of medical products. Concerning that in April 2016 in Bulgaria is registered 'Bulgarian organization for verification of medicines "(BgMVO). Bulgaria is among the first countries in Europe established such an organization.
The use of 2D (two-dimensional) barcode is part of the technical requirements laid down in Directive 2011/62 / EC. Barcode GS1 Data Matrix will be used as an indicator for different levels of packaging of medicines, which is the link with international standards GS1.
GS1 standards enable unique identification and marking with barcode of goods and services, and serve the needs of different sectors of the industry to achieve greater efficiency, to reduce costs and to make management of processes better. The standards include RFID and sharing information in real-time by electronic exchange of documents - EDI (orders, advice, invoices), synchronization of master data and more. More than 2 million businesses worldwide performing various functions in the supply chain, have implemented standards in their business processes, allowing them to speak the same language.
Report of McKinsey & Company "Strength in unity: The promise of global standards in Healthcare" shows significant benefits for patient safety and reduce costs in the supply chain by using a single global standard in healthcare. According to the report, the introduction of global standards throughout the chain could save between 22 and 43 000 lives and lead to the prevention of complications in 0.7 to 1.4 million patients.