EMVO warns drugmakers risk missing FMD deadline

The group responsible for running the central hub for medicines verification in the EU has warned that around 1,500 companies have yet to start the process of linking to it.

The European Medicines Verification Organisation (EMVO) is worried that at current sign-up rates to its ‘on-boarding’ process, a lot of companies will not be ready to comply with the Falsified Medicines Directive (FMD) requirements when it comes into effect on February 9, 2019.  

As of August 6, 841 out of 2,291 companies have completed the first stage of the process and signed the participation agreement, but only 106 of those are fully connected to the hub, it says in a letter to drugmakers. 453 have reached the technical on-boarding stage – when their IT systems are linked to it – but the remainder have yet to do pass that “challenging” hurdle, says EMVO.

“In January 2018, EMVO announced that the very last opportunity to on-board timely is June 2018,” says the letter. “Any on-boarding after that date may entail a risk to the company’s compliance with the FMD and consequently to the business too.”

The on-boarding process takes up to six months to complete and, at the date of the letter, there were 131 working days remaining before the directive is implemented.

The EMVO also states that “in no case, shall it be responsible or liable for any late on-boarding or failure to on-board.”

The FMD requires a unique identifier in a 2D barcode on medicine packs that can be scanned at fixed points along the supply chain, as well as anti-tamper devices. The identifiers for saleable units must be uploaded to the EU hub to make it available for checking by pharmacies and wholesalers via the appropriate national medicine verification system, as shown below: