Some FMD safety feature systems not working, says MHRA

The UK drugs regulator says some systems set up to meet the requirements of the Falsified Medicines Directive (FMD) safety features are not functioning properly.

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 systems is very mixed.

Based on inspections in the first five months since the safety features requirement came into force in February, the MHRA has seen “some excellent examples of robust systems” but also “some systems that required improvement and examples of systems that failed to identify falsified stock.”

From February 9, all prescription medicines dispensed in Europe have to be verified at the point of dispensing by scanning a serialised, 2D datamatrix unique identifier (UI) that gives each pack a unique identity, and the contents of packs must be protected by a tamper-evident seal.

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) that have yet to implement the FMD system because they are operating alternatives the EU legislation.

“Where the 2D barcode UI is not yet in use, the MHRA are clear that it is still your responsibility to identify falsified, stolen or recalled stock received into your systems, including those that have already been decommissioned,” writes Moore.

“Inspectors will be looking for this step as part of your incoming goods checks,” she adds in what will be the first of a series of commentaries on the implementation.

Regulators in Europe have already suggested that enforcement of compliance failings will be soft in the initial period since the medicines verification system went live, as it is recognised that supply chain parties will need to develop better understanding and experience with the system. It's not clear however how long that tolerant approach will last.

Meanwhile, the first documented case of a falsified medicine identified though FMD UI scanning was reported in the Netherlands last month.