The UK medicine regulator says some techniques set up to meet the requirements of the Falsified Medicines Directive (FMD) safety features are not functioning correctly.
A blog post on the Medicines and Healthcare Products Regulatory Agency (MHRA) website by expert Good Manufacturing and Distribution Practice (GMDP) Tracy Moore suggests the performance of FMS safety feature programs is very mixed.
Based on investigations in the first five months, since the safety features requirement came into force in February, the MHRA has seen “some excellent examples of strong systems” but also “some systems that required enhancement and samples of systems that failed to recognize falsified stock.”
From February 9, all formula medicines dispensed in Europe have to be verified at the point of dispensing by scanning a serialized, 2D Data Matrix unique identifier (UI) that gives each pack a unique identity, and a tamper-evident seal must protect the contents of packages.
Moore writes in the blog that systems must be able to identify decommissioned, stolen or recalled stock, and this should include not only the FMD 2D barcode unique identifier but also handle stock from the two countries (Greece and Italy) which have but to fulfill the FMD system because they are operating choices the EU legislation.
Moore writes that Where the 2D barcode UI is not yet in use, the MHRA is clear that you still must identify falsified, stolen or suspended stock received into your systems, including those that have already been decommissioned.
she mentioned, Inspectors will be studying for this step as part of your incoming goods checks.
Regulators in Europe have already recommended that enforcement of compliance failings will be soft in the starting period since the medicines verification system went live, as it is recognized that supply chain parties will need to develop better understanding and experience with the system. It’s not clear, however, how long that sophisticated passageway will last.
Meanwhile, the first documented case of a falsified medicine identified through FMD UI scanning was reported in the Netherlands last month.