Naudingos nuorodos
Available Slots for RMS procedures in 2023

For the last few years, the Agency has been actively involved in the registration procedures of medicinal products as a reference state (RMS), responsible for preparing a medicinal product evaluation protocol that is recognized/not recognized by other parties participating in the procedure.

In 2023, it is already planned to accept 18 RMS procedures, but in the III-IV quarter of that year, the Agency is ready additionally to accept 5 more procedures. Since a very small number of procedures will be additionally accepted in 2023, priority will be given to applications for registration of medicinal products intended for children, as well as antibiotics, as there is a lack of medicinal products of the aforementioned groups in the Lithuanian market.

We would like to point out that the participation of the Office in medicines registration procedures as a reference state is very important for the whole country, as it primarily ensures the conditions for new medicines to enter the Lithuanian market. At the same time, competition between marketing authorization holders is encouraged, which means that conditions are created for drug prices to decrease and the availability of drugs to patients is increased. Meanwhile, Lithuanian manufacturers have more favorable conditions to present their developed and produced medicines to the markets of other EEA countries.