Mark Birse

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

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

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

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 …

PIC/S - Press release and news of MHRA hosted meetings and seminar, July 2016

Just 4 weeks ago the MHRA hosted the PIC/S Committee meeting, PIC/S Executive Bureau meeting, and PIC/S Annual Seminar at the Museum of Science and Industry (MOSI) in Manchester.

PIC/S 2016 - Manchester

The Medicines and Healthcare products Regulatory Agency (MHRA) UK is honoured to be the host of the 2016 PIC/S Seminar. This is an annual international event attended by both member and non-member authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). …