For MZ SR:
- Director General of the Department of Pharmacy and Drug Policy MUDr. Adam Table
- Director of the Division of Classification, Pricing and Drug Policy PharmDr. Rastislav Pullmann
For the Slovak Society of Nuclear Medicine and Radiation Hygiene SLS:
- Chief expert of the MZ SR on nuclear medicine doc. Dr Ivan Conc., CSc., m. prof.
The meeting took place at the request of MZ SR, which started MUDr. Adam The Director General of the Department of Pharmacy and Drug Policy asked representative of the Slovak Society of Nuclear Medicine and Radiation Hygiene SLS to present its requirements.
doc. Dr. Ivan Režňák, CSc., m. prof.:
He asked for support and assistance in dealing with the imminent supply crisis 99mTc/99Mo generators. Global problems with the production of 99Mo and related production 99mTc/99Mo generators (change of technology forced restrictions in the fight against terrorism and cessation of operations Some nuclear reactors) are due to start in the third quarter 2015 increase their prices for final customers, i.e. health equipment, about 50%. It realises that in this context, necessary to adjust the price for 99mTc/99Mo generators o amount which is in breach of the legislation allowing a maximum of 5% increase in the price of the product in the calendar year.
It calls for these forced price adjustments for technetium generators did not lead to a stop in the supply of technetium generators to Slovakia. It would have a devastating impact on all medical nuclear facilities. medicine in Slovakia and the provision of diagnostic and medical-prevention care in the field.
MUDr. Adam Dormouse:
Informed the Slovak Society of Nuclear Medicine and Radiation SLS hygiene on legislative options to address the request for increase the officially determined price.
The holder of the registration must proceed with the price change in accordance with the applicable 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. on the scope and conditions for reimbursement of medicinal products, medical devices and dietary food based on public health insurance and amending European reference the price of the medicinal product is the average of the three lowest prices from the official determined prices of the medicinal product in other Member States; if the medicinal product is officially designated price only in one of the other Member States, the official price of the product in that State; if the medicinal product is officially priced in two of the other Member States States, average prices in these Member States.
The marketing authorisation holder shall be able to cancel the officially determined price of the medicinal product which not included in the list of categorised medicinal products and discard a list of officially determined prices.
He stated that MZ SR will contact registration holders 99mTc/99Mo generators and solve this problem.
The meeting was concluded by the Director General of the Department of Pharmacy and Drug Administration Policy Dr. Adam Hlôška.
Signed up by Mgr. Judita Janek
MUDr. Ivan Režňák, CSc., m. prof.
Approval: MUDr. Adam Hlôška, Director General of the Department of Pharmacy, and
drug policy