We have all walked past a building site, looked at the billboard with the picture of the striking new structure that is supposedly going to stand here one day, then surveyed the gaping hole in the ground, the piles of material stacked up, the builders and equipment busily moving about week after week without any visible results and wondered: will this ever happen?
Many observers who have been watching the building site that is the EMVS, the European Medicines Verification System, must have been asking themselves the same question. They must be wondering if the Europe-wide system and processes mandated by Directive 2011/62/EU would be ready in time, or possibly ever…
There have been plenty of reports of activity over the last few years, of course: EMVO has been issuing progress on OBPs onboarding activity, though showing a slow pace; countries have been reporting that their national organisations have been set up; stakeholder organisations have been busy engaging their members and there has been a steady stream of conference, webinars, articles and also controversy.
But so far, by Easter 2018, there were only two components of the Europe-wide repository systems infrastructure in production: The European Hub and the sole national system, Germany‘s SecurPharm.
However, after a long time of seemingly little progress, suddenly the structure of the building site begins to rise before us: Cranes lift element after element, the pace of activity increases further and where there appeared to be no change for ages, the building suddenly grows before our eyes – what has been only an architect’s vision for a long time is rapidly becoming reality.
The same could be said of the EMVS: This past week has seen additional 4 National Systems being connected to the European hub: Slovenia, Denmark, Sweden and Ireland, and the schedule published by EMVO lists 11 systems as expected to be going live through Q2 and early Q3. These are big steps bringing Europe rapidly closer to the reality of a operational EMVS and the routine end-point medicines verification process that is envisioned by the EU-FMD.
No doubt there is still much work to be done, by all stakeholders whose participation is mandated by the legislator but by mid year, the reality of 16 markets – over half the countries in the EU-FMD 2019 scope – will be a reality: 16 countries will have operational medicines verification systems connected to the European Hub and with an increasing flow of unique identifiers being uploaded, in readiness for the go-live date of 9th February 2019, it will be impossible to deny that this ambitious edifice, designed to protect patients across Europe, is going to opened its doors for business in 300 days from now.
So, to mix metaphors: It is time to make your way to the gate, the last call is not far off and boarding will close soon; in this case – and as a timely reminder – the on-boarding to the European Hub that all manufacturers selling in Europe need to progress by the end of June or miss their guaranteed access to the system that is necessary for their continued access to the European market.
Email firstname.lastname@example.org for help to successfully on-board in time and with added value to your organisation or register to attend our free webinar on the 18 April: https://register.gotowebinar.com/register/7719472516839486210