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Bulgaria Health Commission approves new medicinal supply controls
The Bulgarian Health Commission has approved, at first reading, legislative changes to the Law on Medicinal Products in Human Medicine. The proposed measures aim to combat drug shortages through stricter oversight of medicine movement and improved supply chain transparency.
A central component of the reform is the use of the Specialized Electronic System for Tracking and Analysis of Medicinal Products (SESPA). This system will collect daily data regarding delivered quantities, orders, delivery refusals, and exports. Additionally, pharmacies will be granted the ability to monitor stock levels directly in wholesaler warehouses.
The legislation proposes a new method for identifying shortages. The current threshold of 65% of required quantities will be replaced by a criterion covering 100% of a single month's consumption, with calculations based on data from the previous 12 months rather than six.
To ensure domestic availability, the Minister of Health will have the authority to exceptionally prohibit the export of specific medicines if local needs are not met. The reforms also aim to expedite parallel imports from other EU member states; the Executive Agency for Medicines would be required to issue permits and price rulings within 14 days of receiving documentation. In regions lacking active pharmacies, doctors and dentists may be permitted to store and sell medicines.
Entities
Bulgaria · Bulgarian Health Commission · Executive Agency for Medicines · Ministry of Health · National Assembly
Claims
What the coverage asserts, and how many sources carry each claim.
- [○ 1 SOURCE] Doctors and dentists in areas without pharmacies may be permitted to store and sell medicines. ruse.news
- [● 3 SOURCES] Shortage calculations will be based on the last 12 months of data rather than six months. ruse.news · fakti.bg
- [● 3 SOURCES] The shortage threshold will change from 65% of required quantities to 100% of one month's consumption. ruse.news · fakti.bg
- [● 3 SOURCES] The Health Commission approved changes to the Law on Medicinal Products in Human Medicine at first reading. ruse.news · fakti.bg
- [● 3 SOURCES] The SESPA system will receive daily data on delivered quantities, requests, delivery refusals, and exports. ruse.news · fakti.bg
- [● 3 SOURCES] Pharmacies will gain the ability to check stock levels in wholesaler warehouses. ruse.news · fakti.bg
- [● 3 SOURCES] The Executive Agency for Medicines must issue parallel import permits within 14 days of receiving necessary documents. ruse.news · fakti.bg
- [● 3 SOURCES] The Minister of Health may exceptionally prohibit the export of specific medicines if domestic supplies are insufficient. ruse.news · fakti.bg