After February 9, 2019 dispensing of prescription medicinal products to patients in the countries of the European Union and the European Economic Area will take place only after mandatory electronic verification. Each package will have a unique identification (two-dimensional matrix barcode) generated by the manufacturer or the importer and will have protection against falsification. The new system will be introduced under Directive 2011/62/EU on prevention of the entry into the legal supply chain of falsified medicinal products and ensuring supply of authentic medicinal products to patients, the Delegated Acts on the enforcement thereof and the relevant provisions in the Bulgarian legislation.
The system for electronic verification of medicines is pan-European and will be built by the pharmaceutical stakeholders themselves. On March 14, 2016 the Bulgarian Medicines Verification Organization (BgMVO) was established with the objective of promoting the enforcement of the Directive. The Association is a non-profit organization established by the stakeholders for the development, operation, and maintaining of an efficient medicines verification system in the Republic of Bulgaria.
Founding entities were the five organizations representing stakeholders in the sectors of manufacturing and distribution of medicines: the Association of the Research- based Pharmaceutical Manufacturers in Bulgaria, the Bulgarian Generic Medicines Association, the Bulgarian Association for Development of Parallel Trade, the Bulgarian Association of Pharmaceutical Wholesalers, and the Bulgarian Pharmaceutical Union. The founding organizations agreed that in their operations they will be abiding by the principles of consensus and equality among interested parties and cooperation with Bulgarian institutions and competent authorities, as well as with other national medicines verification systems in member-states of the European Union. The BgMVO members also unanimously supported the implementation of the European Standardized Verification System Model (”Blueprint Model”), which will lead to more efficient operation of the system and to cost optimization.
Further to the establishment of the BgMVO, we received congratulatory letters from the Bulgarian Drug Agency (BDA) and from the European Medicines Verification Organization (EMVO). The BgMVO is among the first organizations in Europe to be officially incorporated, which provides pharmaceutical manufacturers, wholesalers, and pharmacies with more time for analyses of registers, negotiations with European suppliers of the verification system, and coordination with regulators.
In 2016, the major objectives of the project were presented at a number of professional meetings, conferences, and congresses. An important task in the previous year was the selection of supplier of the verification system. In 2015, the EMVO approved three companies with information systems consistent with the requirements of the blueprint model. The Selection Committee, composed of experts and representatives of all stakeholders, conducted several meetings with each of these three companies. We expect to have the supplier appointment process finalized in April 2017. Achievements to date include considerable gains compared to initial bids. The pilot project will be launched in Quarter 4 of 2017. This will allow pressure-free development and deployment of the system, avoiding otherwise inevitable extra costs associated with short deadlines.
The operation of the organization is funded by membership fees from members of the entity, as well as by verification fees from marketing authorization holders (MAH). Under the Directive and the Delegated Acts, the costs of putting in place and operating the system shall be borne by the marketing authorization holders. In this connection, following a consultation with the Head Office of the National Revenue Agency, the BgMVO got VAT- registered. This would allow MAH to treat verification payments as business operation expenses. For pharmacies and wholesalers the costs of deploying the system would be minimal, primarily in connection with purchasing 2-D barcode readers.
In conclusion, due to the excellent cooperation, high-class professionalism, and commitment of all parties to the project, the past year witnessed major progress. Planning for the next year and a half, the objective would be to establish a working and efficient medicines verification system in Bulgaria, in strict compliance with the provisions of the Directive and the Single European Model.