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Mark Birse

Former Deputy Director of the Inspection, Enforcement and Standards Division and Head of the MHRA Inspectorate & Process Licencing which employs over 75 Inspectors covering GCP, GDP, GLP, GMP & GPvP and the Process Licencing team

Group Manager of MHRA Devices Safety and Surveillance Group & Devices Software and Apps Group.

Joined the MHRA in 2002 as a GMP Inspector having previously worked in the pharmaceutical industry for over 10 years.

https://www.linkedin.com/in/markbirse/

The pre-election period

Posted by: , Posted on: - Categories: Wider MHRA
Front of a polling station

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

Posted by: , Posted on: - Categories: Compliance matters, Good distribution practice, Good manufacturing practice
Various medicines in blister strips

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 …