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
- Officer of the Department of Classification, Pricing and Drug Policy of MVDr. Erika Hanzelyová
For SUKL:
- RNDr. Laura Michalová
For GSK:
- MUDr. Pavol Trnovec
- PharmDr. Katarína Velčicová
The meeting took place at the request of the Director-General of the Department of Pharmacy and Drug Policy MUDr. Adama Dormouse.
The meeting was opened by the Director General of the Department of Pharmacy and Drug Policy MUDr. Adam Hlôška and was interested in the availability of vaccines.
MZ SR
- What is the situation with monoampoule vaccines intended for compulsory vaccination? The Ministry is interested in whether GSK can bring monoampoule vaccines to Slovakia whether registered or not and in what time frame?
- Doesn't the company consider returning single-amples to the Slovak market within the categorisation?
- Is a vaccine correction plan possible?
GSK
To point 1: The company will find out what the situation is with registered and unregistered single-ampul vaccines and will inform the Ministry
To point 2: The company will also comment on this point
To point 3: They consider the correction plan (repacking 10 ampoules into 1 ampoule) to be risky.
The company drew attention to the fact that in the case of Priorix, the difference between imported and paid doses in the 1-3st quarter could be up to 30% and suggested that the MAH should carry out its own analysis and consider the next procedure.
SUKL:
To point 3: They do not recommend making a corrective plan (repacking 10 ampoules into 1 ampoule) for vaccines unless this is extreme.
The SUKL can only issue a re-export ban decision under the current legislation, monitoring and comparing the import and consumption of medicinal products.
MZ SR - tasks for GSK:
At the 4th meeting of representatives of members of the AIFM vaccine group with representatives of MZ SR, which will be held on 29.2.2016 inform about:
- Options for importing single-ampul vaccines and within what time horizon they can ensure this.
- Options for categorization of single-ampul vaccines.
The meeting was concluded by the Director General of the Department of Pharmacy and Drug Policy MUDr. Adam Dormouse
Signed by: MVDr. Erika Hanzely
Verified for GSK: MUDr. Pavol Trnovec
Verified for ŠUKL: RNDr. Laura Michalová
Approval: MUDr. Adam Hlôška