Serialisation in Drug Production

As a marketing authorisation holder, you must continuously be aware of and implement global regulatory developments with regard to serialisation, aggregation and tracking requirements. In particular, sometimes very extensive reporting requirements must be taken into account when implementing the respective solutions, this applies both to local production in an affected market, but also to exports to affected markets. The Arvato CSDB solution modules ensure stable mapping of the necessary processes and smooth integration with the regulatory systems.

Regardless of whether you produce yourself and/or have your products manufactured by CMOs, due to the necessary exchange of serialisation data, your challenges include in particular the integration and interaction with your CMOs and/or production or packaging lines. The request-based provision of serial numbers to and subsequent reporting from your CMOs is carried out quickly and reliably via our network. Proven connectors for the well-known hardware manufacturers are also available for the connection of the lines.

For you as a contract manufacturer, efficient and lean serialisation processes are of particular importance. Due to the necessary exchange of serialisation data, your challenges include in particular the integration and interaction with your (numerous) customers on the one hand and with production and packaging lines on the other. The request for serial numbers from and the subsequent reporting to your customers is carried out quickly and reliably via our network. Proven connectors for the well-known hardware manufacturers are also available for the connection of the lines.

According to the EU Falsified Medicines Directive (FMD), pharmaceutical wholesalers are also required to physically verify existing products and to decommission them if necessary.

Our experience in the digitalisation of business processes in the logistics sector helps licensed pharmaceutical wholesalers to implement the necessary process changes quickly and precisely. At the heart of the solution is the Arvato Smart Logistics Platform - Healthcare Suite - part of our proven platform platbricks, which ensures smooth operations in over 40 companies every day.

Our Serialisation & Anti-Counterfeiting team is an official service provider of the European Medicines Verification Organisation (EMVO).

We supply National Verification Systems for 17 countries in Europe - including securPharm in Germany, France MVO, SecurMed UK or SEVEM - and successfully connect them to the EU Hub. As an EMVO-certified supplier of national blueprint systems, we are always up to date with international regulations.

Similarly to the countries of the European Union and the United States, for example, Russia has also developed a system for serializing medications. With regard to the timeframe, the transition period for the mandatory marking and reporting of pharmaceuticals to the state information system was extended from January 1, 2020 to July 1, 2020. 

We provide you with a detailed white paper on "Serialization of Medications in Russia", in which we explain how companies in the pharmaceutical industry can use our know-how to meet the ambitious requirements in order to continue to operate in Russia.