FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

MHRA Prepares for No-Deal Brexit With Six Guidances

March 18, 2019
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The UK’s Medicines and Healthcare products Regulatory Agency issued six new guidances in preparation for a possible no-deal exit by the United Kingdom from the EU on March 29.

Five guidances focus on importing and exporting medicines, providing recommendations on air freighting medicines, importing investigational drugs, the written confirmation process for exporting active substances, and importing medicines from a European Economic Area state that is approved for import.

A separate guidance lists approved countries for importing and batch testing medicines and manufacturing active substances.

The agency also issued a guidance offering its latest thinking on submitting, processing and assessing completed pediatric studies in a no-deal Brexit situation.

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