Everywhere I traveled this fall I had conversations with people from drug manufacturers who told me their top concern right now is that their contract manufacturers (CMOs) or contract packagers (CPOs) are not taking the actions necessary to be prepared to meet the approaching serialization mandates in the U.S., the E.U. and elsewhere on time. This threatens the manufacturer’s ability to be ready for those deadlines and they are grasping for something they can do now to fix the situation before it gets too late…if it isn’t too late already. Continue reading Lack Of Preparedness By CMO’s Imperils Pharma Manufacturers
The pharmaceutical supply chain in most markets is complex, but in my view, the one in the European Union easily takes the prize for being the most complex of any other. The addition of unit-level serialization and verification of authenticity to that supply chain over the next few years as required by the Falsified Medicines Directive (FMD) and the Delegated Act (EUDA) is going to be difficult (see “Breaking News: The EC Has Published The Delegated Act“). It represents a huge change to the way drugs are packaged and how they are handled by each entity in the supply chain. It is vital that the transition Continue reading Insufficient Transitional Measures Doom The FMD-EUDA
Last week SAP announced the availability of their brand new software module they are calling “SAP Advanced Track and Trace for Pharmaceuticals”, or ATTP. Pharmaceutical Commerce magazine published an article about it recently that provides the details of what is contained in this new module. The same issue contained a sponsored article from SAP about the module. As long-term readers of RxTrace know, I do not endorse specific products and I rarely even write about specific products. This essay is not an endorsement— Continue reading SAP Makes Bold Move Into Pharma Traceability
The European Commission published a discussion draft of the European Union Delegated Act (EUDA) about two weeks ago (See “Breaking News: The EC Has Published The Delegated Act“). The EUDA was called for in the Falsified Medicines Directive (FMD) back in 2011 and is primarily intended to define the “safety features” that must appear on most drugs three years after it is finalized. Assuming it gets finalized around the end of 2015, that means that manufacturers and repackagers targeting the European pharmaceutical market will need to begin placing the specified safety features on their drug packages near the end of 2018. EU Member States who already have an operational drug tracing law, like Italy and a few others, get an additional six years for companies to switch to the FMD and EUDA on drugs distributed there.
There are a lot of details Continue reading The ‘Unique Identifier’ in the EU Delegated Act
Phil Taylor of Securing Industry has scooped me on the publication of the Delegated Act on the safety feature that will eventually be required on all pharmaceutical packaging in the EU. Well done Phil! I’ve been traveling too much lately so I missed it until today! For the details, Continue reading Breaking News: The EC Has Published The Delegated Act