Check out Phil Taylor’s interview in Securingpharma with Ian and Christoph on recent updates to the timing of the EU-FMD’s Safety Features Delegated Act and the implications this has for industry.
The bottom line is that small players who leave it too late will not only miss out on the benefits of serialisation, but could also place their businesses in jeopardy.
Some smaller companies in the contract packaging and even the pharma manufacturing space who have not started the ball rolling yet may disappear, in some cases swallowed up by larger competitors who have grasped the opportunity.
The realisation that companies have a few more months to play with is unfortunately already having an impact on the willingness of some pharma companies to press ahead with plans to serialise their packaging lines, according to 3C Integrity’s Ian Haynes.
While big pharma is well on the way to serialising its packaging lines to come into compliance – and even though some early projects have had to be re-assessed as the nature of the requirements has evolved, such as the nature of the data repository – there is still a lack of engagement by smaller pharma companies and other organisations such as contract packagers.
“Since the delegated act schedule information has come out, we’ve seen a number of tier 2 and 3 companies sitting back again,” said Haynes. “I would be concerned that given the time it takes to implement serialisation they may be placing themselves at risk of missing the deadline.”