MHRA Reinforces Brexit Road-Map, Indian Firms Expect Tough Transition
The MHRA highlighted at a recent conference in India the key changes that await pharma in the event of a no-deal Brexit, and the agency’s general readiness in that scenario, including putting in place its own IT systems such as a UK national replacement for the EudraGMDP.
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March 1 saw the official departure of the European Medicines Agency for Amsterdam. The move from London, which is a result of the UK's decision to leave the EU, has caused huge upheaval for the agency, which has been in the UK capital since it was created in 1995.
In this second article on the regulations published by the government on how the UK would regulate medicines in a “no-deal” Brexit scenario, we look at what is being proposed for areas such as pediatric investigation plans, orphan medicines, pharmacovigilance, parallel trade, generics approvals, and good manufacturing and distribution practices.
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.