Verification after 1.1.2021 and Alert Management System

CZMVO informs about a change in the dispensing of prescription medicines that are subject to “FMD legislation" (Falsified Medicine Directive). The obligation to verify their authenticity is in place, imposed by this European and Czech legislation, namely the Commission Delegated Regulation (EU) 2016/161 and the amendment to Act No. 378/2007 Coll. of January 2019, valid from February 9, 2019.

In the past, however, the Ministry of Health of the Czech Republic met the requirements of pharmacists in the form of a "transitional period" allowing the dispensing of medicinal products despite an error message, the so-called alert, which shows that the authenticity of the medicinal product was not successfully verified in CZMVS. Starting in January 2021, this has been stopped and it is therefore necessary for each alert to be checked and closed, more precisely it must be confirmed by the MAH or end user (or NOOL for system alerts) that the pack is not a counterfeit. Only then can the pharmacy dispense the medicine to the patient. Rapid and accurate investigation of the resulting alerts is therefore in the interest of all parties - marketing authorization holders, distributors, pharmacies and especially patients.

CZMVO offers a connection to the Alert Management System (AMS), where you can quickly and conveniently resolve alerts via an API or web interface. More information about AMS functionalities can be found in the appendix and on our website in the section „Alert Management“.

• AMS_general.jpg (1 MB)
• AMS_changes.jpg (1 MB)