For MZ SR:
- Director-General of the Pharmacy and Drug Policy Section MUDr. Adam Dormouse
- Director of the Department of Classification, Pricing and Drug Policy PharmDr. Rastislav Pullmann
- PharmDr. Ľubomíra Tomčíková, CSc.
- Chief expert of MZ SR for clinical immunology and allergology prof. MUDr. Peter Pružinec, CSc.
For ALK Slovakia, s.r.o.:
- PharmDr. Ingrid Valkovová
- PharmDr. Vladimír Uraz, Director of ALK Slovakia, s.r.o.
The meeting took place on the basis of an application to include Acarizax in the list of categorised medicinal products and on the basis of the opinion received by the main expert of MZ SR Prof. MUDr. Peter Pružinec, CSc. to ensure sublingual allergenic immunotherapy for the treatment of mite allergy.
The meeting was opened by the Director General of the Department of Pharmacy and Drug Policy MUDr. Adam Hlôška.
ALK Slovakia, s.r.o.:
Representatives of ALK Slovakia, s.r.o. requested MZ SR to include Acarizax in the list of categorised medicinal products at the request of A1E via the electronic categorisation portal with effect from 1.4.2016.
For MZ SR:
MZ SR explained to the present that, following the application submitted by ALK Slovakia, s.r.o., Acarizax could not be included in the list of categorised medicinal products, because the application for inclusion of the medicinal product in the list of categorised medicinal products was not made in accordance with Act No. 363/2011 Coll. on the scope and conditions of reimbursement of medicinal products, medical devices and dietary foods on the basis of public health insurance and on the amendment of certain laws (hereinafter: Law No. 363/2011) The company ALK Slovakia, s.r.o. asked to submit a new application for the inclusion of Acarizax in the list of categorised medicinal products via the electronic portal categorisation in accordance with the current legislation and in accordance with compliance with the Act No. 363/2011 Coll. of the Slovak Republic stated that ALK Slovakia, s.r.o. can also submit an application for approval of the officially determined price of the medicinal product. It may also apply to health insurance companies for authorisation of reimbursement in accordance with Law No 363/2011 Z. z. z.
The sitting was closed by the Director General of the Department of Pharmacy and Drug Policy, Dr. Adam Hlôška.
She wrote: PharmDr. Lubomir Tomčíková, CSc.
Verified for ALK Slovakia, s.r.o.: PharmDr. Ingrid Valkovová
Approval: MUDr. Adam Hlôška