Firstly, Kallik would like to wish all of its customers a very happy and prosperous New Year and would like to thank you for your continued business and support. We would also like to extend our greetings to our technology partners and those who are seeking to transform their labelling and artwork processes going forward but have yet to reach a decision on who to choose as their industry partner.
Looking ahead, 2018 is going to be an exciting and eventful year as we begin to see the effect of new legislation and regulation taking shape across several continents. Further extension of the UDI Final Rule will see this impacting hundreds of thousands of devices not previously affected. By the end of September this year, all packaging and labelling associated with Class I medical devices sold into the US must bear a UDI as the FDA moves closer towards completion of its UDI roll-out across the industry.
Continuing with the UDI theme, 2018 will see Europe moving closer to the date when the new Medical Device Regulations (MDR) will replace the existing Medical Device Directive (MDD). This now being just over two years out. With much of the impacted industry focusing on capturing and compiling the content required for submission to the EU equivalent of the GUDID (EUDAMED), the additional requirement for publishing all labelling content electronically (including eIFU’s and labelling content being published on manufacturer’s websites) has not been given the attention we believe it requires. This is one area where you can expect to see new thought leadership from ourselves as we move further into the year. Please feel free to visit our blog pages where we’ll be posting our first post on this topic later this month with subsequent articles and papers to follow.
Turning from Medical Device to Pharmaceuticals and serialisation, the previously announced delayed enforcement of the US Drug Supply Chain Security Act (DSCSA) by one year to November 2018 acknowledged that some pharmaceutical manufacturers along with their contract manufacturers were not in a state of readiness to comply. It is less likely that the deadline will be extended further, so the pressure is increasing to ensure all impacted medicines will carry a product identifier on their labelling and packaging. Focusing back on the EU, the deadline for complying with the Falsified Medicines Directive (FMD) is approaching fast with this currently set for February 2019. Many of the challenges faced by European based manufacturers are expected to be similar to those encountered by their US counterparts, including the need for a unique serial number to be made present on all packaging and labelling.
As both the chemicals and cosmetics industries continue to seek further growth through gaining entry into new emerging markets, compliance with local labelling legislation is a must in order to prevent delays in satisfying import controls that could otherwise see stock being impounded for months. Here again, clear corporate oversight with an ability to capture and tailor product labelling content to satisfy local markets is paramount.
So, what can you expect from Kallik this year? Well, this year will see us further strengthen our enterprise-wide labelling solution for heavily regulated industries. Some of these enhancements will make it easier for our customers to encapsulate all their labelling and artwork processes in one single solution across all types of print and packaging. This will give greater visibility, control and corporate oversight both in-house and out across extended supply chains. Other enhancements will simplify the roles of all those involved in capturing and collating content, further de-risking potential non-compliance whilst at the same time, increasing productivity. We’re looking forward to sharing some of these enhancements with you very soon, so please check back with us here on a regular basis for further updates.
Finally, once again, all of us here would like to wish you all continued success both throughout 2018 and beyond and we look forward to continuing to develop both existing and new relationships across the industry.
The Kallik Team