The needs of the population for access to medicinal products provided in pharmacies are determined on a territorial basis through a National Pharmacy Map, the Parliament finally decided with the adopted provisions of the Medicinal Products in Human Medicine Act.
The National Pharmacy Map helps to determine the regions, municipalities and cities/villages with a shortage of open pharmacies by carrying out an analysis of the population's access to pharmacies. The National Pharmacy Map is based on regional pharmacy maps, the adopted texts provide.
The proposals of the left-wing to include representatives of the Bulgarian Medical Association in the preparation of the regional pharmacy map were not accepted. MPs decided that, when drafting the regional pharmacy map, the Minister of Health would appoint a committee for each region that would include the Regional Governor, two representatives of the Regional Health Inspectorate, two representatives of the Regional Health Insurance Fund, two representatives of the regional college of the Bulgarian Pharmaceutical Union, one representative of the regional college of the Bulgarian Association of Assistant Pharmacists, one representative of the representative organisations for the protection of patients' rights recognised under the Health Act, and one representative of each municipality in the region concerned. The Regional Governor will be appointed as Chairman of the Committee, MPs decided.
The regional pharmacy map will contain data on the demographic structure and consumption of medicinal products for home treatment by the population on the territory of the region, the number, types of activities and distribution of open pharmacies on the territory of the region, as well as the number of working master pharmacists and assistant pharmacists.
The National Pharmacy Map will be prepared by a National Committee appointed by order of the Minister of Health, who is Chairman of the Committee.
The National Pharmacy Map will contain the regional pharmacy maps as well as the specific minimum needs of the population for access to medicinal products, distribution of open pharmacies by population number by regions, municipalities and cities/villages, graphical indication of open pharmacies on the map of the country according to the type of activities they perform, analysis of the access of the population to medicinal products provided in pharmacies by type of activities by regions, municipalities and cities/villages;
The National Pharmacy Map will be approved by a decision of the Council of Ministers on a proposal from the Minister of Health and will be updated, if necessary.
During the debate, left-wing MP Georgi Mihaylov said that there are no pharmacies at all in over 70 municipalities, while there is a surplus in the big cities. He recalled the basic principles governing the structure of the pharmacy network, namely the distance from pharmacy to pharmacy and population.
The Bulgarian Drug Agency (BDA) will coordinate the activities regarding the control of medicinal products in conjunction with the Regional Health Inspectorates (RHI). This was voted by Parliament, which is discussing changes to the Medicinal Products in Human Medicine Act at a second reading.
The proposal of BSP’s Valentina Naydenov for the Agency to issue and suspend licenses for both import and export of medicines was not accepted.
The Bulgarian Drug Agency will generate a unique national identification number for each medicinal product and record it in the registry, the NA recorded.
The medicinal product identification number will ensure the unambiguous identification of each medicinal product and the interoperability of healthcare information systems. It will be used by all persons, in all registers and other databases, as well as in the medical documentation relating to medicinal products.
The Marketing Authorisation Holder will ensure that the individual identification mark on each package is entered in the registry system in accordance with the EU Delegated Regulation.
The Marketing Authorisation Holder of a medicinal product derived from human blood or human plasma will, prior to the release on the market of each batch of the product, submit to the BDA samples of the finished product and/or bulk/undiluted product and/or intermediate and starting product samples in quantities specified in the Manual for batch release of the medicinal product by an official control body issued by the European Directorate for the Quality of Medicines and Healthcare.