Continuous work on system improvements and strengthening of quality is carried out in the European Medicines Verification System. Starting from October, a Quality Council was established in the Arvato group that includes 16 countries and a representative of the Latvian Medicines Verification Organization (LZVO) was elected in the Council. The Quality Council plays a very important role in representing quality issues between the various groups involved, such as the EMVO, Solidsoft, Arvato, as well as within the group, which is comprised of both technical representatives and heads of national organizations.
The Latvian Medicines Verification System and the national verification systems of 15 other Member States were developed and are maintained by Arvato Systems GmbH, while the European Medicines Verification System or European HUB, as well as the national systems of other Member States, have been developed by SolidSoft.
As the number of the issues addressed in the Quality Council has increased, the countries have decided to expand the composition of the council, and Andra Poļakova, Quality Manager of the Latvian Medicines Verification Organization, Rita Freitag from Austria and Nuno Lages from Portugal have been elected to the Council.
“Further work of the Council will be related to the overall improvement and/or integration of the quality system in each organization, i.e. all according to the same principle, because the verification system is based on the Blueprint model. Our task will also be to provide as much support as possible to the various groups involved, as well as to maintain the existing quality level,” says Andra Poļakova, LZVO Quality Manager.
The basis for the establishment of the verification system is the EU Falsified Medicines Directive (2011/62/EU) and delegated regulation laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (EU 2016/161). The system covers prescription medicines and one over-the-counter medicinal product – omeprazole.