Of approximately 2,300 pharmaceutical companies who must be FMD-compliant by February 2019, fewer than 900 are on track to achieve this, the European Medicines Verification Organisation (EMVO) has warned.
The Belgian non-profit, which was set up to keep falsified medicines out of the European medicines supply chain, said in a letter to pharma companies that many were behind on the ‘on-boarding’ process needed to implement the Falsified Medicines Directive.
In the letter, which was dated Monday 6 August, EMVO said: “At the moment, only 131 working days remain before the Delegated Regulation comes into force.”
Of 2,291 companies who must complete the process, EMVO said it counts 841 who "have signed the required agreement, the Participation Agreement. 453 of them reached the Technical On-boarding and only 106 of them are connected to the Production environment of the EU Hub now.”
The process of becoming an ‘On-boarding Partner’ (OBP) of EMVO involves signing a Participation Agreement, completing Technical On-boarding and connecting to the Production environment of the EU Hub (a ‘central router’ through which product information will be transferred between manufacturers and parallel distributors on the one hand and national verification systems on the other). The whole on-boarding process can take up to six months, EMVO said.
June 2018 was the “very last opportunity” to begin this process in time to meet the 9 February 2019 deadline, the Organisation said.
Late on-boarding “may entail a risk to the company’s compliance with the FMD and consequently to the business,” EMVO warned, adding that while the organisation is there to help companies, “in no case shall it be responsible or liable for any late on-boarding or failure to on-board”.
Pharmaceutical companies have also been urged to make progress with their preparations for Brexit, as Pharmacy Magazine reported in July.
The European Medicines Agency said it “urges those companies who have not yet informed EMA of their Brexit preparedness plans to do so as soon as possible to mitigate any risks” to medicines supply within the EU.