Since February 9th, prescription medicines within the EU must comply with the new serialization guidelines. The establishment of new software and hardware was associated with high costs and validation efforts for many companies. Is this only the beginning? Other markets have already implemented stricter guidelines. Do we have to expect Track & Trace, aggregation and co. in the future?
Dr. Dmitrij Lisak, Senior Consultant at Thescon, has led many international projects in the area of FMD. How does he predict the future development?
Dr. Lisak, additional information have been integrated into the 2D Matrix Barcode in Russia. Which functions do these data fulfill and will we soon find the crypto key and crypto code here in the EU?
Dr. Lisak: “The crypto code is specific for the Russian Market. It represents a further legitimacy test that has to be met to fulfill the requirements of Russian authorities. The needs for the implementation are complex - from a technical point of view but also with regard to artwork and production line conditions.
Other markets did not publish any plans to introduce these complex approaches and it is, from my point of view, not very likely that they will introduce them in the future.”
Track & Trace (T&T) is a done deal in other countries such as China, USA and Russia. Do you expect the same development for Europe? Why hasn’t it been introduced in the EU already?
Dr. Lisak: “Track & Trace is related with significantly higher standards regarding IT systems and processes within the supply chain. In the USA, Track & Trace was not implemented over night but a phased introduction has been started that will be completed in 2023. Not only authorities of different countries request Track & Trace, but numerous companies have already implemented Track & Trace although there are no regulatory requirements. These companies intend to improve traceability and monitoring within their supply chain. From my point of view, it is only a matter of time for Track & Trace to be required by both, regulatory and market players in Europe.”
To date, serialization requirements in Europe mostly affect drugs that are available on prescription (Rx), only. In other countries, over the counter (OTC) products do also need to fulfill serialization requirements. Do you expect serialization to be obligatory for OTC products in Europe soon?
Dr. Lisak: “The differentiation between Rx and OTC products is, within the supply chain and from licence holder point of view, rather trivial. Falsification can target OTC products in the same way as Rx products as it has been shown for Omeprazol*. To consider Rx products exclusively makes sense when it comes to the implementation of completely new regulatory requirements, but to extend the FMD regulations to OTC products is the logical next step.”
Aggregation - in several countries such as China, Brazil, USA, Russia and Japan already required or planned. Is it only a matter of time for aggregation to be required in Europe?
Dr. Lisak: “Aggregation has already been implemented between several partners within the supply chain, although neither the EU-Hub nor the NMVS is currently prepared to transfer aggregation data. Especially logistics providers and dispensaries need products to be aggregated when it comes to Track & Trace, in order to ensure efficiency of their operating processes. Since I assume that Europe will implement Track & Trace in the medium term, the ability to aggregate and to work with aggregated products will be required consequently.”
Regulations in China require serialization for animal health products. Will there be similar regulations in the EU soon?
Dr. Lisak: “Track & Trace and FMD requirements shall reduce falsification events of pharmaceutical products and suppress the illegal market. Falsification targets expensive animal health products as often as human medicine products. Local authorities often react to local falsification events, which is why traceability of animal health products was implemented in China at an early stage. Similar regulations by other authorities can be expected in the future.”
Many thanks for your explanations, Dr. Lisak. I would like to end with a final question: Regulations are locally different and may change rapidly, as it was especially true for Russia during the last few years. Which recommendations do you give your customers to stay up-to-date when it comes to country specific requirements?
Dr. Lisak: “Websites of specialist consulting companies such as Thescon provide information on these topics in forms of interviews, whitepapers and web-seminars. Numerous customers (current as well as former ones) appreciate the personal exchange and contact us via telephone or meet us for a cup of coffee. Current developments on the international markets, experiences with suppliers and inspectors or just our perception of actual topics - we are happy to answer these questions and to share our knowledge.”
If you have any questions regarding global serialization requirements or other current regulations, please feel free to contact us without any obligation.
*In 2013 and 2014, falsifications of Omeprazol have been detected in Germany. About 600 000 packages of the counterfeit product have been found. Several manufacturers have been affected and had to recall their batches.