The pharmaceutical industry recently welcomed a draft of the Delegated Regulation linked to the EU FMD (Directive 2011/62/EU). Craig Stobie, Head, Global Life Sciences team, Domino Printing Sciences, shares his views.
Up until this point, manufacturers can’t be blamed for their frustration as they are faced with expensive decisions as to how they upgrade their lines in preparation for the 2018 compliance deadline, without formal confirmation of the Directive’s individual requirements. In fact, while many manufacturers have pilot projects under way, Domino’s latest ACHEMA serialization survey revealed that 20% of manufacturers asked are still either in the early planning stages or are currently looking for solutions providers.
The confirmation of a 2D Datamatrix machine readable code, unique identifier, human readable elements and repository management system, provides important clarification for national stakeholders and enables them to move forward in their decision-making activities – something many manufacturers with smaller budgets have not comfortably been able to do before now.
Some questions around the Directive still remain, such as how the industry will adapt to the stipulation that the 2D matrix takes place of all other visible barcodes, or the suggestion that parallel importers can continue to use original identifiers as long as the system supports the verification of a pack for a different market — but for most manufacturers the release of this draft is the serialization green light.
What is under scrutiny now though is the current deadline of 2018 as we wait for the European Parliament and Council to review the text before it can be published in the Official Journal of the EU in the first quarter of 2016. As the EU must allow three years between official publication and the enforcement of the legislation, we could be looking at a potential new deadline of 2019. While this could a small victory for some, confirmation of the entirety of the FMD’s Delegated Acts is what the industry needs to ensure no one is left at the starting block.