'Rule Out No-Deal Brexit,' BIA Tells Government
The BioIndustry Association wants the government to rule out a “no-deal” Brexit, saying it would be bad for patients and the life sciences sector.
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A recent debate in the House of Lords saw some fiery words exchanged over the government’s plans for the life science sector in the event of a no-deal Brexit, with accusations that they would produce a “clunky” regulatory system and put industry’s future “at grave risk.”
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.
A parliamentary committee has called on the health department to provide more clarity as to how it plans to ensure continuity of medicine supplies in the event of a no-deal Brexit. At the same time, the government has produced a set of draft regulations allowing the UK MHRA to take over drug regulatory functions currently performed at EU level.