We produce a wide range of publications to provide guidance to the industry on the regulation of devices and medicines.
Latest Regulatory guidance
-
03 Feb 2012 | List of Terminated, Revoked and Cancelled Manufacturing and Wholesale Dealer Licences - 2010 - 2011
(1803Kb)
-
03 Feb 2012 | List of New Manufacturing and Wholesale Dealer Licences - 2010 - 2011
(1357Kb)
-
18 Nov 2011 | Department of Health and MHRA Register of Licensed Wholesale Dealer Sites (Human Veterinary and Combined Sites) 2011
(6331Kb)
-
17 Nov 2011 | Department of Health and MHRA Register of Licensed Manufacturing Sites (Human Veterinary and Combined Sites) 2011
(1008Kb)
-
09 Jun 2011 | Directives Bulletin 10 - The Classification Rules
(70Kb)
-
17 Feb 2011 | Best Practice in Reporting of Individual Case Safety Reports (ICSRs)
We have today published guidance for industry that sets the MHRA's position on how to code adverse drug reactions (ADRs) to a high-quality standard for entry into our Sentinel database. This ‘Best Practice’ guide has been developed combining ideas from both industry trade associations and the MHRA.
-
03 Feb 2011 | Best practice for ensuring the efficient supply and distribution of medicines to patients
This guidance has been developed and is supported by eleven organisations, including the MHRA, following detailed consideration of the current problems with the supply chain, especially those caused by increased exports of medicines from the UK.
-
04 Aug 2010 | Guidance Note 1 - Guidance Notes for Manufacturers on Clinical Investigations to be carried out in the UK
(741Kb)
-
16 Jul 2010 | Reminder – update to labelling to comply with Article 54(a), 54(e) and 56(a)
(81Kb)
-
05 Jul 2010 | Cardiac ablation catheters - guidance on the vigilance system (VG09)
This document gives advice to manufacturers on the notification of adverse incidents involving cardiac ablation catheters under the medical devices vigilance system.
