For the Ministry of Health of the Slovak Republic (hereinafter "the Ministry'):
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director of the Division of Classification and Pricing, Mgr. Miriam Vulevová, MBA
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director of Health Technology Assessment Department, MVDr. Mgr. Peter Mask, MPH
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official of the Department of Classification and Pricing, Jana Ivanova
For SANOFI PASTEUR (hereinafter "Sanofi'):
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Karel Torner, Sanofi Pasteur Head CZ & EN
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Ing. Štefan Chrenko, National Sales Manager
The meeting took place at the request of Sanofi.
The meeting was opened by the Director of the Department of Classification and Pricing, Mgr. Miriam Vuleva, MBA.
Sanofi:
The pharmaceutical company intends to re-submit the withdrawal application Imovax Rabies Vero (VERORAB) with SUKL code 93706 from the list categorised medicines. This is a rabies vaccine and since it is included in the categorisation list the same ATC group does not contain any other substitution of this vaccine, in Past Ministry to the marketing authorisation holder of the medicinal product refused. Sanofi in case of non-compliance with the withdrawal request, given its long-term low cost of production; consider any withdrawal of the marketing authorisation.
MZ SR:
The Ministry considers that the situation needs to be dealt with quickly and after the receipt of a withdrawal request will be in accordance with the current legislation. On this basis, she will ask the chief specialist of the Ministry for the epidemiology of the expert opinion on the application in question and will do so; the availability of the vaccine for Slovak patients.
CONCLUSION:
Sanofi will ensure the availability of VERORAB on the Slovak market even after removed from the categorisation list.
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She wrote: |
Ing. Jana Ivanova |