February 9th, 2019 marked the go-live of the European Medicines Verification System (EMVS), respectively the national implementation of the National Medicines Verification System (NMVS), verification platform through which the persons authorised to supply medical products to the population, can verify the authenticity of a product and ultimately, to decommission it.
The entire activity related to the medicines’ serialisation and the proper functioning of the verification system is supervised, according to the legal obligations, by ANMDMR (The Romanian National Agency for Medicines and Medical Devices) and recently a low decommissioning rate has been registered in the NMVS.
The decommissioning rate is the number of successful decommissioning for dispense transactions divided by the respective market size.
In Romania, from the data available in the NMVS, up to 40% of the serialized medicines packs are dispensed to patients without being decommissioned in the system.
This clearly shows a failure to fulfill the legal obligations of the authorised persons to supply medical products to the population according to the Delegated Regulation (EU) 2016/161, Art. 25, thus directly affecting the safety of patients by not verifying the authenticity of the released medicines.
Therefore, we underline the importance of this system for patients’ safety, and of course, the importance of following the legal obligations.
