For the Ministry of Health of the Slovak Republic ("the Ministry'):
- Director of the Division of Classification and Pricing, Mgr. Miriam Vulevová, MBA
- Official of the Department of Classification and Pricing, Jana Ivanova
For Takeda Pharmaceuticals Slovakia s.r.o. (hereinafter referred to as "Takeda"):
- Mgr. Bibiana Vallová, Market Access Manager
The meeting took place at the request of Takeda.
The meeting was opened by Mgr. Miriam Vuleva, MBA, Director of the Department of Classification and Pricing.
Takeda:
Pharmaceutical company Takeda presented planned requests for conditional inclusion in the list of categorised medicinal products for 2017. The subject of the possibility of changing the labelling restriction for medicinal products included in the classification list, whose Takeda holds the registration, was also discussed.
MZ SR:
The Ministry took note of the application plan for 2017. With regard to the extension of the indication restriction of medicinal products in the list of categorised medicinal products, the Ministry will proceed in accordance with the legislation in force on the basis of Act No. 363/2011 Coll. on the scope and conditions for reimbursement of medicinal products, medical devices and dietetic foods on the basis of public health insurance and on the amendment of certain laws as amended (hereinafter "the Act'). An amendment to the Act is currently being prepared, which will address, among other things, new models of how to pay the price of the medicine and possible participation of pharmaceutical companies in the continuation of treatment in patients outside the approved indication restriction.
She wrote: Ing. Jana Ivanova
Verified for Takeda: Mgr. Bibiana Vallová
Approval: Mgr. Miriam Vuleva, MBA
Date: 09.02.2017