The pre-election period

In the coming weeks, you will notice that it’s much quieter than usual on the MHRA Inspectorate blog.  It’s because between midnight on Friday, 21 April and the general election on 8 June is the pre-election period.

Imported Unlicensed Medicines and Centrally Authorised Medicines intended for other EU Member States

Previously, we have reminded importers of unlicensed medicines that Centrally Authorised medicines are the subject of Marketing Authorisations from the EMA, valid in all Member States and therefore cannot be notified for import into the UK as unlicensed medicines, unless …

Too much pressure: a behavioural approach to Data Integrity (Part 2)

The first post in this series described the importance of organisational behaviour on the success of data integrity control measures.  Behavioural issues are often unsuitable for technical guidance, but the Inspectorate blog provides an opportunity to address this complex issue.