We produce a wide range of publications to provide guidance to the industry on the regulation of devices and medicines.
Latest Regulatory guidance
-
04 Apr 2013 | List of Terminated, Revoked and Cancelled Manufacturing and Wholesale Dealer Licences - 2010 - 2012
An updated version of the list of terminated and revoked manufacturing and wholesale dealer licences for May 2013.
(3845Kb)
-
04 Apr 2013 | Guidance Note 8: A guide to what is a medicinal product
A guide to what is a medicinal product
(164Kb)
-
14 Jan 2013 | Guidance on EU Commission Regulation 207/2012 on electronic labelling of medical devices
This news item relates to EU Commission Regulation 207/2012 on electronic labelling of devices.
-
06 Dec 2012 | How to change the legal classification of a medicine in the UK
Following the announcement in the Chancellor’s Autumn Statement, the MHRA has launched a new, streamlined procedure to speed the process of moving medicines from prescription-only to over-the-counter medicines.
-
02 Oct 2012 | Department of Health and MHRA Register of Licensed Wholesale Dealer Sites (Human Veterinary and Combined Sites) 2011
Following the announcement in the Chancellor’s Autumn Statement, the MHRA has launched a new, streamlined procedure to speed the process of moving medicines from prescription-only to over-the-counter medicines.
(7263Kb)
-
02 Oct 2012 | Department of Health and MHRA Register of Licensed Manufacturing Sites (Human Veterinary and Combined Sites) 2012
Following the announcement in the Chancellor’s Autumn Statement, the MHRA has launched a new, streamlined procedure to speed the process of moving medicines from prescription-only to over-the-counter medicines.
(1092Kb)
-
02 Oct 2012 | Register of Holders of Manufacturer's Authorisations for Investigational Medicinal Products (MIAIMP) - 2012
Following the announcement in the Chancellor’s Autumn Statement, the MHRA has launched a new, streamlined procedure to speed the process of moving medicines from prescription-only to over-the-counter medicines.
(797Kb)
-
16 Aug 2012 | Blue Guide: Advertising and Promotion of Medicines in the UK
The Blue Guide, Advertising and promotion of medicines in the UK, provides comprehensive guidance on the MHRA’s interpretation of the legal requirements for advertising medicines in the UK and how such advertising is regulated.
-
06 Jul 2012 | Guidance for notified bodies on the regulation of IVDs for self-testing
Home testing is a growing area of health care that places new opportunities and responsibilities on those requiring healthcare. Users of in vitro diagnostics (IVD) for self-testing (‘self-tests’) will not have the benefit of a healthcare professional on hand to advise them how to perform the test or to analyse and interpret the results. It is therefore vital that self-tests are suitable for lay use.
-
31 May 2012 | Best practice guidance on the labelling and packaging of medicines
Home testing is a growing area of health care that places new opportunities and responsibilities on those requiring healthcare. Users of in vitro diagnostics (IVD) for self-testing (‘self-tests’) will not have the benefit of a healthcare professional on hand to advise them how to perform the test or to analyse and interpret the results. It is therefore vital that self-tests are suitable for lay use.
(133Kb)
