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Alarm bells ring over suppliers’ FMD readiness

Only one in five suppliers has started 'on-boarding'

August 22nd 2018

Tagged: DM Zone news FMD

By Ailsa Colquhoun

Pharmaceutical companies are being urged to start ‘on-boarding’ to the Falsified Medicines Directive; a letter suggests that only one in five companies has started addressing the technicalities involved.

The letter from the European Medicines Verification Organisation (EMVO) warns that time is running out for pharmaceutical suppliers to get involved. As of August 6, the date of the letter, companies were told that it can take up to six months to complete the onboarding process, but that only 131 working days remain until the FMD go-live date of Saturday 9 February, 2019.

“The very last opportunity to on-board timely [was] June 2018, companies were warned by EMVO. “Any on-boarding after that date may entail a risk to the company’s compliance with the FMD and consequently to the business too.”

In total, over 2000 pharmaceutical suppliers are expected to on-board to the FMD. This involves connecting to the EU Hub, where companies upload the unique identification data for each pack of medicine manufactured or repackaged. EMVO currently counts 841 companies that have signed the required participation agreement, of which 453 have reached the technical on-boarding stage. As of August 6, only 106 of these had completed their connection to the EU Hub.

EMVO describes technical on-boarding as “a challenging step in the whole on-boarding process”.

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