UK No-Deal Medicines Regulation Under Threat As Brexit Chaos Grows
Draft regulations on medicines and medical devices could get caught up in the chaos that seems about to engulf the UK parliament as opposition MPs attempt to avert a no-deal Brexit.
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Some changes have been made to UK legislation that will aim to ensure the effective operation of the regulatory system once the country leaves the EU. Areas affected include the QPPV, pediatric and orphan medicines, and the reference product for generic approvals.
Regulations that would allow the UK MHRA to work as a standalone regulator in the event of a no-deal Brexit have been laid before parliament. They cover a host of areas including new drug approval procedures, conversion of existing EU marketing authorizations into UK ones, pediatric and orphan exclusivities, imported medicines, and regulatory fees.
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