For MZ SR:

For GlaxoSmithKline:

The meeting was held to ensure the continuity of measles vaccination, in combination with urinals, rubella.

Dr Adam Hlôška

  1. He welcomed the present representative of the Marketing Authorisation Holder PRIORIX and invited him to give an opinion to GlaxoSmithKline on the non-availability of the vaccine.
  2. He stressed that if the vaccine was not available for more than 60 days, the Ministry of Health of the Slovak Republic would have to proceed in accordance with the current legislation and initiate proceedings on the unavailability of a categorised medicinal product.
  3. He asked the holder's representative about possible ways of dealing with this situation.

MUDr. Pavol Trnovec

  1. He confirmed that there has been a report of an outage of the vaccine 28654 PRIORIX (inj. plv iol 10 x 0.5 ml+sol) from 15.9.2015 to 15.11.2015, while there are no stocks of this vaccine in the Slovak Republic.
  2. He said that the ministry would accept the procedure and that all legal sanctions would be imposed.
  3. He pointed out that M-M-RVAXPRO was included in the categorisation list, which could cover for a transitional period the demand for measles vaccine, in combination with varicella and rubella.
  4. He also pointed out the possibility that for a transitional period, in agreement with the main experts, the vaccination scheme for measles vaccination, in combination with urinals and rubella, would be modified.

Conclusion:
The Ministry of Health of the Slovak Republic based on the statements of the main experts in the field of paediatrics and epidemiology, as well as after discussions with representatives of the holder of the registration of M-M-RVAXPRO plu iul 10 x drug. +10 x solv. will inform the Public Health Office about the situation.

Mgr. Jana Kernats, PhD.
They verified: participants in the meeting

Approval: MUDr. Adam Hlôška, v.r.