On January 22, 2018, a meeting of the Bulgarian Medicines Verification Organisation (BgMVO), SoftGroup and the Bulgarian manufacturers of medicinal products was held in Sofia, where the requirements for connection of the pharmaceutical companies with the European medicines verification hub (EU Hub) were discussed.
According to Directive 2011/62/EU against the counterfeit medicines, all manufacturers of medicines in the EU are required to connect with the EU 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 technical link to the Hub. At present, 4 Bulgarian pharmaceutical companies have successfully completed the administrative check, while in Europe, 396 companies have started the process. The total expected number of companies in Europe that need to connect to the Hub amounts to 2500.
During the meeting, Ms. Iliana Paunova, Executive Director of BgMVO, drew attention to the data requirements of the medicinal products (master data), the specifics related to the intended use of the medicines in the respective markets, as well as who has the right and responsibility to report data to the EU Hub. She explained the principles of the functioning of the entire European system and the place and role of BgMVO.
Mr. Venelin Dimitrov, CEO and Founder of SoftGroup, presented the hardware and software solutions of the company that ensure reliable serialization and optimization of the production processes in the pharmaceutical companies. SoftGroup is an innovative software company with over 12 years of experience in developing its own systems, with an emphasis on the field of pharmaceutical Serialization and Track & Trace solutions.
The meeting was attended by representatives of more than 10 Bulgarian pharmaceutical manufacturers, as well as experts from GS1 Bulgaria.