Information system for proceedings connected to medicinal products: SamTrack
SamTrack is an information system that helps make drug-related procedures faster and more convenient.
What is it used for?
- Paperless and automated administration.
- Transfer of data and packaging codes of pending and valid marketing authorisations and medicinal product packaging in the information systems in the State Agency of Medicines (SamTrack, Register of Medicinal Products, Customer Portal, Register of Activity Licenses);
- Ensuring the up-to-datedness of the data on medicinal products in the Register of Medicinal Products, the Prescription Centre and the database of handlers of medicinal products;
- Enabling automated information exchange with the services of the European Medicines Agency.
Latest developments: IT solution related to the implementation of the European Union Clinical Trials Regulation
According to current regulations, it is difficult to conduct a clinical trial simultaneously in several European Union (EU) Member States. In December 2021, a new EU regulation was implemented, establishing a single clinical trials portal for the European Medicines Agency. This allows research sponsors to submit applications to all Member States at once. In the course of the project, the SamTrack II information system will be upgraded, in order to enable, among other things, automatic data exchange.
The development project facilitates communication with sponsors of clinical trials and supports the fulfilment of the tasks assigned to the State Agency of Medicines in the framework of clinical trials.
- SamTrack: 01.04.2020 - 31.03.2022
- IT solution for implementing the EU Clinical Trials Regulation: 15.12.2021 - 01.04.2023
The project is funded by the EU Regional Development Fund.