Some notes from our CMO Serialisation Seminar, Thursday 16th of June 2016.
Back in 2013, Codico ran a seminar, which was held in Carton House Co. Kildare, addressing the new challenges of serialisation for the pharmaceutical industry. At the time, the panel of experts could only speculate to what the future would look like for manufacturers striving to achieve compliance, based on what other jurisdictions had done in the past. Fast forward to 2016, and the EU Commission has ruled that by February 2019, all prescription drugs and some OTC drugs will carry one 2D Matrix Barcode, GTIN Number, Batch Number, Expiry Date and Serialised number (and national reimbursement number if required by that country), as well as other safety features, see here for Domino’s FMD Fast Facts).
Today, most large/global manufacturers have installed pilot lines and have some serialised product being packaged and coded shipping to countries that have implemented rulings (Turkey, Brazil etc) and now the count down is on until 2019 for FMD in the EU/Europe. For CMO’s, this has been a wait and see approach as understandable their business is customer requirement driven. One of the key outcomes from our CMO Seminar last week is that some global manufacturers have up to 400 CMO’s packing world wide and that number will reduce significantly in order to manage all the data that will be generated from the serialised information that derives from the packaging line. Therefore, it is safe to say that the early adopter mover CMOs will have the best chance of survival. Global manufacturers will need their CMO’s to store and transmit data at level 3 and 4 of the serialisation pyramid. See below diagram.
The outcome from the seminar spoke volumes in terms of what the CMO’s have to achieve to be ready for 2019, however serialisation solution providers such as Optel Vision, Crest Solutions (Antarres Vision) and others do have a scalable and flexible solution to get you up and running from the ground up. The coding and marking (printing) is a key element to getting the ball rolling and other suppliers can help in terms of barcode verification and data transfer (Microscan), project management and implementation project support (Sericode/Team Horizon), provision of information (GS1) and outsourcing capabilities (Almac Group).
The task of rolling out the FMD ruling is truly a landmark and gigantic task; The Falsified Medicines Directive will link 4,000 manufacturers, 150,000 pharmacies, 500 million people and 10 billion packs of prescription medicines across Europe.
Click here to view some photos from the event.
To discuss your coding and marking requirements for serialisation, please get in touch.