On January 22, 2018 a meeting of the Bulgarian Medicines Verification Organisation, Softgroup and Bulgarian manufacturers of medicinal products was held in Sofia, when the requirements for connecting the manufacturers of medicinal products with the European Medicines Verification Hub were discussed.
According to Directive 2011/62/EU on falsified medicinal products, all manufacturers of medicinal products in the EU are obliged to connect with the European Medicines Verification Hub. The process involves two stages - the administrative stage of the legitimacy check, as well as the conclusion of an agreement with the European Medicines Verification Organisation (EMVO) and the stage of technical connection to the Hub. At present, 4 Bulgarian companies producing medicinal products have successfully completed the administrative connection, and in Europe a total of 396 companies have started the process. The total expected number of companies in Europe to connect to the hub is 2,500.
At the meeting Mrs. Illiana Paunova, Executive Director of BgMVO, drew attention to the data requirements (master data) of the medicinal products, the specifics related to the intended use of the medicines in the respective markets, as well as those who have the right and the responsibility for introducing the data into the European hub. She explained the principles of the functioning of the overall European system and the respective place and role of BgMVO.
Mr. Venelin Dimitrov, Executive Director of Softgroup, presented the hardware and software solutions of the company to ensure reliable serialisation and optimisation of production processes in the pharmaceutical companies. Softgroup is an innovative Bulgarian software company specialising in the development of products designed to counter falsification of medicines.
The meeting was attended by representatives of more than 10 Bulgarian companies, producers of medicinal products, as well as experts from GS1 Bulgaria.