Do, tell and undo? Type 1A variations in the UK

“The Gold Sheet” September 2010, Vol. 44, No. 009
Word Count: 227 / Article # 08440091008_b

Executive Summary

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) announced that, for various reasons, it had to reject one third of the Type 1A variations applications it has received. Companies can implement these minor so-called "do and tell" changes in the European Union before notifying regulatory authorities. The only catch is if authorities like MHRA reject the submissions, the changes must be immediately undone

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