8 TECH OUTLOOKAug-Sept - 2018What is Serialization in the Pharma Industry?Pharmaceutical Serialization 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 serialization 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 serialization project easily takes around 6 to 9 months. Considering the duration of the project, the entire industry, including the pharmacies, should have been started now the serialization 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 Verification System (EMVS). The setup of this EVMS connection also takes time and should be properly planned for. Meanwhile the on-boarding fees are already increased and expected to increase further. So it is attractive to onboard early rather than late.Looking at the national Medicines Verification Organisations in each EU member state and some associated countries, the situation is not much better. The so-called national hubs will be the future platforms where the pharmacies need to be on-board. It is a million dollar question whether all national hubs & Pharmacies will be ready on time system wise. Recent Personal experience: I recently bought some medicines in 5 different pharmacies in my neighbourhood where I live in Barcelona. None of the pharmacies were aware of Serialization and had no clue that they will have to scan and verify every single pack in less than 10 months from now before it is dispensed to the patient. Ultimately this will control the dispension to the patient as a last step in the total chain and is the proof of the pudding of serialization.On the other hand, good things also happened in the Market, such as, the majority of the industry will be ready in time. Especially this part of the industry should already be compliant for non-EU markets where serialization became in force earlier than in the EU. The experience gained in these regions/industries can be of well use for EU FMD compliance.Serialization: In Full Compliance or a Race against the Clock?By Robert Jan van der Horst, CIO, DSM Sinochem PharmaceuticalsIN MY OPINION
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