European Pharmaceutical Manufacturer editor Reece Armstrong sits down with Neil Gleghorn, CEO of labelling provider Kallik, to discuss compliance challenges for manufacturers and the threat of counterfeit medicines.
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What are the current compliance hurdles facing pharmaceutical manufacturers and packagers?
The major challenge faced by most organisations is the proliferation of isolated stove-pipe systems that artificially limit levels of collaboration and insight that can potentially impact the accuracy of labelling and artwork content. Information sharing, transparency and traceability are often limited by obsolete systems and processes that can have a direct on levels of compliance. There is also a reluctance to change amongst some of the larger manufacturers due to the perceived risk of introducing new technologies, however, without taking this step organisations are at risk of becoming uncompetitive and unable to attract a modern workforce.
What are on the potential implications of Brexit on labelling in pharma?
It is currently acceptable for drugs and devices manufactured outside of the UK and sold into the UK to carry the EU address of the Marketing Authorisation Holder (MAH) to distribute products in the UK, but this may not be the case if a no-deal Brexit is reached. Simply, these products would need to carry a UK address, and post transition could even be required to carry UK and EU MAH addresses. Changes such as these can have a major downstream impact on supply chain operations. Getting all partners adequately prepared for an unknown set of labelling changes is creating major headaches for the healthcare industry right now. Furthermore, as we move beyond the transition period (assuming there is a deal) we’re likely to see more changes to labelling as the EU and UK could go their separate ways when it comes to future legislation.