Ljubljana, 9.4.2018 – The European medicines verification organization has issued a positive assessment report for Medicine verification institute Slovenia, thus enabling the Slovenian medicine verification system (SiMVS) a connection to the production EU hub as the first entity in the EU.
Establishment and management of the national medicine verification system in Slovenia is led by Medicine Verification Institute Slovenia (MVIS – ZAPAZ), founded on October 6th 2016 by the following stakeholders: Forum of international research and development pharmaceutical companies, EIG, Slovene chamber of pharmacy, Slovenian chamber of commerce – medicine wholesaler section, Slovenian medicine manufactures association. After a year and a half of hard work of a small team of experts, MVIS has managed to successfully establish the national medicine verification system: we have taken initiative and responsibility to establish the necessary processes and standards of quality management and to take over coordination of testing the medicine verification system. For this reason, we have taken over leadership in working groups, consisting of other European countries, which will also use the same system as Slovenia. After assessing extensive project documentation, the European medicines verification organization sent us a positive assessment report on the 4th of April 2018 as the first European country, which is establishing a so-called “blueprint system”, thus enabling the National medicine verification system a connection to the production European hub. This means that the first manufacturers can already begin uploading data into the Slovenian system.
Participating countries using the same system will now be able to leverage extensive documentation prepared by ZAPAZ, and use it as a good practice example to implement their national systems faster.
In the pilot phase, a selection of Slovenian general and hospital pharmacies and wholesalers will be connected to the system. By 9th of February 2019, all other users must connect to the SiMVS, as required by the delegated regulation.
Implementation of legislative acts will be supervised by Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP), which has prepared the national regulation about implementation of the Delegated regulation together with the ministry of health.