We are now only two years away from the FMD (Falsified Medical Directive) coming into force in the UK. In the US, in accordance with the Drug Supply Chain Security Act (DSCSA) the deadline is November 2017. This means that all manufactures of drugs are required to mark packs with a product identifier, serial number, lot number and date of expiration.
The FMD is designed to improve the protection of public health with new uniformed, pan-European measures to ensure that all medicines are safe and that the trade of drugs is controlled. This directive will also see a new, EU-wide logo to identify legal online pharmacies, making it easier to distinguish between those online pharmacies that are operating legally and illegally throughout the EU.
Many of you reading this will immediately be wondering how Brexit will affect the UK’s involvement in the new FMD. The simple answer is that whatever the Brexit strategy the UK will not be able to ignore FMD, and with increased trade with the US likely, the more immediate DSCSA requirements are also vital to those companies trading globally. Experts also state that Brexit will not change the UK pharma industry’s aim to meet the 2019 deadline.
The implementation of serialisation.
The implementation of serialisation is much more complicated than it might initially appear, partly due to inconsistent and often incompatible guidelines across territories. There are still many un-answered questions within the FMD, such as if serialisation is required in all countries and if perhaps a global standard should be employed. The lack of a unified standard could lead to different governments having different guidelines, opening the industry up to potential loopholes and creating more opportunities for counterfeiters. This will undoubtedly cause headaches for the phrama industry and governments across the world.
How can Oakley ERP help?
Standardisation is going to be very complex to execute and a lack of forward planning could result in serious costs. We believe that for serialisation to be used most effectively, it should be part of a wider, multi-layered solution.
Sage 300 offers a complete solution for the FMD and enables pharmaceutical companies to track products throughout the entire supply chain. Implementation of the FMD, as previously stated, is unlikely to be a simple task, however using a software solution that is equipped to manage large volumes of data, across many departments, in multiple locations is undoubtedly the best place to start.
Oakley ERP not only offer pharmaceutical companies market leading Enterprise Resource Planning (ERP) Software but also employ an experienced team, with a combined experience of over 100 years in the industry and an unprecedented reputation, Oakley ERP are in a leading position help support the UK pharma industry through the FMD.
Contact our team here to find out more about how Oakley ERP can support your business with the new directive.