The EU Falsified Medicines Directive (FMD) has already been in force since 2011 but several key technical specifications were deferred. These final details have been published today.
As part of an EU-wide traceability system that involves pharmacies as well as manufacturers, drug makers (specifically, Market Authorisation Holders) will be required to implement the datamatrix coding process, known as serialisation, on all of their unit-of-sale packs. They will also need to make sure that their packs are tamper-evident, i.e. cannot be easily opened and reclosed without visible evidence. The deadlines for implementation of the safety feature requirements will be on 9 Feb. 2019 (with an extension for three countries which have existing medicine traceability systems).
These requirements pose hardware, software and process challenges for pharmaceutical companies, contract manufacturers (CMOs), distributors and pharmacies. Blue Sphere Health ("Bluesphere"), an international consultancy with offices in the UK and USA, advises companies who need help with these issues.
Bluesphere's Principal Consultant, Mark Davison, said: "We welcome this news, which removes any remaining ambiguity about what needs to be done and by when. The new regulations are challenging and business critical. Three years is a short time and the impact of further delay is real: non-compliance means no sale. Many smaller companies who waited for final publication will need to move fast. We bring peer best practice, vendor knowledge and implementation experience to help them catch up"
For further details on the FMD, how it affects your business, and how Bluesphere can help, contact us directly: [email protected]
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