Warning for Marketing Authorization Holders, Distributors and Pharmacies on Inaction in Investigation Alerts in AMS (Alert Management System)
The State Institute for Drug Control warns that in accordance with Article 37 letter d) Commission Delegated Regulation (EU) 161/2016 (hereinafter referred to as the “Regulation”) entered into force, supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features (SF) appearing on the packaging of medicinal products for human use, a notice is issued regarding the inaction of marketing authorization holders, distributors and pharmacies in investigation with alerts.
It is necessary that reports on potential cases of falsification of medicinal products are resolved in the shortest possible time, thereby eliminating the suspicion of falsification and, subsequently, in certain cases, it is possible to release the packaging of the medicinal product from the so-called quarantine and issue it to the patient. This is the only way to ensure safe medicinal products for patients.
In accordance with the intention of European Medicines Verification Organisation (EMVO), the Národní organizace pro ověřování pravosti léčiv (NOOL) has created a national Alert Management System (AMS – Alert Management System), with the help of which, through an application programming interface (API) or a web interface, it can quickly and easily resolve all alerts. The national Alert management system is further developed according to the requirements of the pan-European Alert Management System (EAMS).
AMS is a support system of the Národní systém pro ověřování pravosti léčiv (NSOL). The purpose of this support system is to facilitate the administration associated with alert investigation, to help automate the entire alert investigation process, and to share information about the outcome of the investigation. Ultimately, the system helps reduce the number of “false” suspicions of possible forgery.
Therefore, the State Institute for Drug Control considers the use of AMS necessary to ensure the control of medicinal products through safety features and warns marketing authorization holders, distributors and pharmacies to use it and not to leave unresolved alerts in AMS. The obligation to resolve all alerts results from Article 37 letter d) Regulation 2016/161, whereby NOOL cannot fulfill this obligation other than in cooperation with marketing authorization holders, distributors and pharmacies.
Department of quality defects
20/02/2023