FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

UK Unveils Draft Legislation to Continue Drug Regulation in No-Deal Brexit

Feb. 1, 2019

The UK government released three pieces of draft legislation that cover the regulation of drugs, devices and clinical trials in a no-deal Brexit scenario.

The draft legislation amends the Human Medicines Regulations of 2012, which encompasses drug manufacturing, importation and distribution; authorization; labeling and advertising; and pharmacovigilance. The regulations were introduced in the UK’s parliament last week but are currently subject to approval.

The contingency legislation is needed in order for the Medicines and Healthcare products Regulatory Agency to “take on regulatory processes for human medicines and devices that are currently undertaken by the European Medicines Agency and other bodies,” the MHRA said.

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