NEWS AND VIEWS FROM THE PHARMACEUTICAL FINE CHEMICAL AND CUSTOM MANUFACTURING SECTOR

Thursday 20 December 2012

MHRA to seek API details

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) will soon contact UK-based marketing authorisation holders to request data on APIs imported into the UK to ensure they are manufactured in accordance with the EU GMP or, if imported into the EU, with equivalent rules. The MHRA recently said that almost 1200 API plants may require inspection to meet the EU rules.
MHRA

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