The recent adoption of the EU FMD Delegated Act was a significant milestone for the pharmaceutical manufacturing industry – the official green light that signals a huge change for the industry, says Craig Stobie, Head of Global Life Sciences, Domino Printing Sciences.
The next few months are of vital importance for manufacturers and the success of their business from 2019 hinges on how prepared they are for item-level serialization.
While ‘serialization readiness’ is being widely talked about and manufacturers have fewer places to hide, a key concern is how different the progress stages are for so many EU manufacturers, highlighted through Domino’s serialization survey conducted this year.
‘The start’ of a serialization project means for some that initial research has taken place, while for others, this translates as a fully functioning pilot programme in operation.
The announcement signals the first phase of the process, which is a landmark for the European pharmaceutical packaging community, but the industry still has a long way to go as manufacturers in many cases are forced to reinvent their processes on the journey to compliance. Updating existing packaging lines to serialization-ready equipment is a truly mammoth task, from printing durable and lightfast codes at high speeds to the ability to handle the huge amounts of data item-level serialization will create.
Therefore, while the official adoption of the security feature Act enables manufacturers to move forward with their preparations, those that have left it until now to explore options are potentially putting their EU business at risk when the deadline arrives in 3 years’ time. Manufacturers must take the official publication of the safety features Act as the signal to move forward with no more hesitation and ensure they are not left behind in 2019: when the industry will be able to protect patients from the dangers of counterfeit medicines better than ever before.