For MZ SR:
- director-General Department of Pharmacy and Drug Policy MUDr. Adam Hlôška
- director of the Department of Classification, Pricing and Drug Policy PharmDr. Rastislav Pullmann
For Izomedact, s.r.o.:
- PharmDr. Pavel Vizner
- PharmDr. Faith Vizner
The meeting took place at the request of the company representative Izomedact, s.r.o., who asked for a meeting regarding the increase of the official the determined prices of 99mTc/99Mo generators.
The meeting was opened by the Director General of the Pharmacy Section and MUDr. Adam Hlôška.
Isomedact, s.r.o.:
Izomedact, s.r.o. is a supplier of radiopharmaceuticals Mallinckrodt Medical BV Mallinckrodt Medical B.V. is holder of registration of radiopharmaceutical Ultra-TechneKow FM (99mTC-generator). From 1.1.2016 Mallinckrodt Medical B.V. will increase prices 99mTc/99Mo generators about 35%, which is contrary to Slovak legislation allowing for a maximum increase of 5% in the price per product in the calendar year. Mallinckrodt Medical BV makes an effort to maintain prices a radiopharmaceutical on the same level. There has been no increase in their prices in recent years. The cost of producing Mo-99 will increase significantly and therefore it will be necessary to increase also the price of the above-mentioned radiopharmaceutical for the final customer (nuclear workstations medicine).
The main reason for the increase is the global shift in production from Highly enriched uranium (HEU) for enriched uranium (LEU). Additional costs linked to production and also lower yield forces production companies to increase price 99mTc/99Mo generators.
MZ SR:
He informed Izomedact s.r.o. about the legislative options for dealing with an application for an increase in an officially determined price.
The registration holder must proceed with the price change in accordance with existing legislation. The proposal for an official price of the medicinal product cannot exceed the European the reference price of the medicinal product. According to § 2 letter. f) Act 363/2011 Z.z. o scope and conditions for reimbursement of medicinal products, medical devices and dietetic foods for on the basis of public health insurance and amending certain laws as amended, the European reference price for the medicinal product shall be understood as average of the three lowest prices among the official drug prices in the other Member States; if the medicinal product has an officially fixed price in only one of the other Member States the official price of the medicinal product in that State; if the medicinal product is officially priced at two of the other Member States, average prices in those Member States.
The holder of the registration has the possibility to cancel the officially fixed price a medicinal product not included in the list of categorised medicinal products and withdrawn a list of officially determined prices.
The sitting was concluded by the Director General of the Pharmacy Section; and MUDr. Adam Hlôška.
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She wrote: |
Mgr. Judita Janek PharmDr. Faith Vizner MUDr. Adam Hlôška, Director General of the Department of Pharmacy and Drug Administration policies |