FMD & Serialisation after the end of the transitional period

by | Apr 17, 2020 | Blog

Many of us wondering what will happen after the end of the transition period as we become a third country to the EU. What will happen to FMD requirements, can we still use the EU hub, would we have access, will be removed from the country list?

MHRA answer on this topic is the following:

EU regulations on medicines continue to apply to the UK throughout the transition period, during which the UK will negotiate a new trade agreement with the EU. Until then market access will not change, there will be continued mutual recognition of manufacturing and distribution licenses, as well as associated inspections. We are still unsure if there will be a UK hub or we can still use the European Hub as part of the FMD.

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