Registration from the working meeting of representatives of GSK, Merck Sharp & Dohme s.r.o. and Sanofi-aventis Pharma Slovakia s.r.o. with representatives of MZ SR, on 2.02.2017 at 11.00 p.m. at MZ SR

For the Ministry of Health of the Slovak Republic (hereinafter "the Ministry'):

• director General of the Department of Pharmacy and Drug Policy, PharmDr. PhDr. Matej Petrovich

• director of the Division of Classification and Pricing, Mgr. Miriam Vulevová, MBA

• official of the Department of Classification and Pricing, Jana Ivanova

For GSK (hereinafter referred to as "GSK'):

• Dr. Andrea Kočišová, General Manager

• Sonya Strašková, TAM Vaccines

For Sanofi-aventis Pharma Slovakia s.r.o. (hereinafter referred to as "SANOFI'):

• Ing. Štefan Chrenko, National Sales Manager

• Karin Takáčová, Head of Market Access & Public Affairs

For Merck Sharp & Dohme s.r.o. (hereinafter referred to as "MSD"):

• Ing. Miroslav Dedík

The meeting was held at the request of the Director-General of the Section pharmacy and drug policy.

The meeting was opened by the Director of the Department of Classification and Pricing, Mgr. Miriam Vuleva, MBA.

GSK, SANOFI and MSD:

The reason for requesting a meeting is to alert GSK, SANOFI and MSD to the fact that there may be insufficient amounts of vaccines against viral hepatitis for adults on the Slovak market. Pharmaceutical companies have presented a model for the planning of the supply of hepatitis vaccines for adults (hereinafter "the vaccine'). The production of vaccines is planned in advance by Predicted consumption based on previous demand and production lasts approximately 2 years. Produced vaccines are gradually imported into their storage and from there they are further distributed to distribution companies. Due to The epidemiological situation in the last period can be assumed to have failed All 3 vaccines: HAVRIX, VAQTA, AVAXIM. In recent years, consumption These vaccines are growing significantly. All relevant firms submitted in December 2016 Applications for the withdrawal of vaccines from the categorisation list of medicinal products (hereinafter referred to as "the list of medicinal products') In the event of a crisis, there will be vaccines for patients not available. By submitting A3 to the company, they wanted to minimise the risk of getting the fines they face in the event of non-availability of medicinal products on the market. All companies declare an effort to import vaccines as soon as possible. Availability of vaccines on the market plan to ensure that vaccines of different types of packaging are imported in exceptional circumstances, such as categorized, with prior agreement of health insurance companies their reimbursement, which shall be the same as those in their categorisation list.

MZ SR:

The Ministry became aware of the current state of vaccine stocks in individual holders and stressed the need to take all further steps to ensuring the availability of vaccines by the tissue vaccination for insured persons health insurance companies under current legislation. It also pointed out the fact that even if the MR SR has a maximum time limit of 90 days, however, may decide at any time within this interval. Ministry requested information on the possibility of planned deliveries of other forms of packaging, which companies will send by 10.2.2017. The Ministry will also deal with a proposal to organise regular meetings of company farm representatives; experts, distributors and insurance companies and the creation of the working group of MZ SR, responsible for the availability of vaccines on the market.