TECH OUTLOOKSeptember - 201919What is Serialisation in Pharma Industry?By Robert Jan van der Horst, CIO, DSM Sinochem PharmaceuticalsSerialisation: In full compliance or a race against the clock?What is Serialisation in the Pharma Industry?Pharmaceutical Serialisation is the tracking and tracing of the passage of prescription drugs through the supply chain from manufacturing to dispensing to the patient. A unique serial number to each medicinal pack is assigned, which is linked to information about the product's origin, batch number and expiration date. With less than 10 months to go to the moment that the EU Falsified Medicines Directive (FMD) comes into force (09-02-2019), the serialisation journey shows all signs of a race against the clock. A significant number of businesses (estimated 25 percent) have not yet started the journey and/or are not yet on full swing. A typical serialisation project easily takes around six to nine months. Considering the duration of the project, the entire industry, including the pharmacies, should have been started now the serialisation project. Complicating factors as of today is that lack of expert resources in the industry as well as with service providers, the lack of available equipment in the market and time consuming validation activities of systems can easily double the project throughput time.A large part of the industry (mainly the market authorisation holders and logistic service providers) also needs to connect to the European Medicines Robert Jan van der HorstCIO INSIGHTS
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