The general consensus among close observers of the EU-Falsified Medicines Directive (EU-FMD) ‘Safety Features’ Delegated Act (DA), is that the final draft posted 13 August on the EU Commission website is very close to the definitive version that was due to be adopted by the end of the year. This means that by early 2019 (or possibly even late 2018), every pharma manufacturer that supplies Europe – whether originators, generics manufacturers, virtual pharma companies, parallel traders, re-packagers or contract manufacturers (CMOs) – must have adapted their packs, implemented their tamper evidence capability, and established the systems, processes and master data to be in full compliance with the EU-FMD. If they do not, they are no longer in a position to sell their products in the European Market.
As practitioners, 3C Integrity is working extensively with pharma companies to implement these capabilities, and is fully aware of the size of the task ahead. The deadline for implementation is approaching at rapid speed, the challenges are many and the capacity to provide equipment and solutions for the hundreds of pharma manufacturers and the thousands of manufacturing lines producing for the European market is being booked as we speak. So below is an outline of the 10 major considerations for pharma manufacturers:
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