In accordance with Directive 2011/62/EU of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products and Directive 2011/62/EU - also called the Falsified Medicines Directive (FMD) individual national states are requested to set up and manage repository system connected to European verification systems to enable to identify and verify the authenticity of an individual pack of a medicinal product.
Czech medicines verification system (CZMVS) is provided as a “blueprint solution” by Solidsoft Reply managed by Czech medicines verification organisation (CZMVO-NOOL)
Article 37 of Delegated regulation defines the obligations of legal entities setting up and managing repository system on national level as part of European repository systems. This Article, among other things, obliges CZMVO-NOOL to ensure that all potential cases of counterfeiting identified in the system are immediately investigated in accordance with Article 36 (a) and, where counterfeiting is confirmed, notify the competent national authorities, the European Medicines Agency and the Commission.
An ALERT MANAGEMENT SYSTEM was created by CZMVO-NOOL for the purpose of managing and evidence of investigation of individual alerts, as a support system for the National medicines verification system (CZMVS). The purpose fo this support system is to facilitate the administration associated with alerts investigations and to help automate the entire investigation process. Ultimately, the system helps to reduce the number of “false” suspicions of possible counterfeit.
Alert management can be done several ways:
- Integration of the user’s own alert management system with the alert management system operated by CZMVO-NOOL via API.
- For users not having their own alert management system or not allowed by their organization policy to integrate own system with other system, direct access to alert management system operated CZMVO-NOOL is available via the web interface.
- The existing system of e-mails with predefined links will be gradually replaced by the previous options (available for MAHs/OBPs only).