We are delighted to continue our series: Pharma Industry’s Perspectives on Serialisation also in 2023 and it is with great pleasure that we welcome into our virtual space Mrs. Simona Cocoș, Zentiva Romania General Manager and APMGR (The Romanian Association of Generic Medicines Producers) President.
“We should first of all salute the role undertaken by the European Union (EU) institutions to protect the rights, health and safety of patients. In general, the EU represents an engine that accelerates and implements the necessary progress and changes, especially when member states fail to respond to existing needs and problems on their own.
The European Directive is the EU’s response to the alarming increase in the quantities of falsified medicines reaching patients illegally or legally. The European Medicines Verification System (EMVS), of which Romania is a part of through the National Medicines Verification System (NMVS), allows pharmacies, importers, wholesalers and other interested parties to verify in the secure database whether each medicine pack entered and available on the market and is authentic.
Zentiva Romania, as the other Romanian manufacturers, has undergone all the necessary steps to implement the serialisation system, from the equipment of the packaging lines, which correspond to the new requirements, to the updating of the product’s documentation, notifying authorities, production implementation and the registration of all MAH (Marketing Authorisation Holders) to OSMR (The Romanian Medicines Serialisation Organisation), as well as EMVO (The European Medicines Verification Organisation). Therefore, the two factories it owns in Romania fully obey the safety criteria, presenting the 2 standard safety systems: safety system 1: 2D code which contains a unique serial number in addition to the usual information (batch, product code, expiry date) and safety system 2: pack security element (sealing or gluing or special label), which indicates to the patient if the package has been previously opened.
Zentiva Romania has allocated important resources for the Directive’s implementation – investments in equipment and materials, technical, production and logistics solutions. Furthermore, significant human resources, multidisciplinary and inter-departmental, were involved in the complex serialisation process – for planning, coordination, synchronisation and execution. But all these costs have added to the claw-back tax and put additional pressure on the generics’ companies which offer modern, efficient treatments at affordable prices. We believe that any measure to protect patients is welcome, but the authorities must also take the necessary measures to ensure that the medicines which are vital for patients will no longer disappear from the market.
On a broader note, similar to the FMD Directive 2011/62/UE, we trust that the EU institutions will continue to act, including for the protection and promotion of European pharmaceutical companies as a way of protecting the interests and health of patients.
In Romania, Zentiva has the largest medicines’ production capacity with 2 factories in Bucharest: Zentiva factory, which has been operating without interruption for 60 years and Labormed factory. The Zentiva companies’ group is the leader of the local generic medicines market in both volume and value, as well as the volume leader of the overall market. 1 in 10 medicines sold in pharmacies are Zentiva products and 1 in 4 medicines administered in hospitals is a Zentiva product.” **IQVIA sell-out data (MAT Jan 2023)
