Welcome to the publications section.
We produce a range of publications, most of which are aimed at healthcare professionals or people working in the device or pharmaceutical industries. Some are available in full text as pdf documents.
19 Jun 2013 | Medical Device Alert: Implantable drug pumps and accessories manufactured by Medtronic (MDA/2013/042)
This Medical Device Alert has been issued as there is a risk of drug under- or overdose due to various issues when using implantable drug pumps and accessories manufactured by Medtronic.
19 Jun 2013 | Medical Device Alert: Laboratory test kit for vitamin B12 malabsorption manufactured by Orgentec Diagnostika GmbH, distributed in the UK by Launch Diagnostics (MDA/2013/041)
This Medical Device Alert has been issued as deterioration in the activity of affected lots may lead to false negative results outside of the manufacturer’s claims for performance which could result in a delay in diagnosis or treatment of vitamin B12 malabsorption.
19 Jun 2013 | Public consultation (MLX 379): Transposition of Directive 2011/62/EU (“the Falsified Medicines Directive”) into UK legislation
Between 18 October 2012 and 19 November 2012 the MHRA ran a public consultation on the transposition of the Falsified Medicines Directive 2011/62/EU into UK legislation. A summary of the responses is now available to read.
18 Jun 2013 | Class 1 Medicines recall (Action Now – including out of hours): AmBisome 50mg Powder for Solution for Infusion, Liposomal Amphotericin B - Gilead Sciences International Limited - EL (13)A/17
Gilead Sciences International Limited is recalling batches of AmBisome 50mg Powder for Solution for Infusion (Liposomal Amphotericin B) as a precautionary measure due to a potential lack of sterility assurance.
17 Jun 2013 | Medical Device Alert: Laboratory test kit manufactured by Orgentec Diagnostika GmbH, distributed in the UK by Launch Diagnostics (MDA/2013/040)
This Medical Device Alert has been issued as there is a possibility of false positive results in tests for the diagnosis of lupus when using laboratory test kits manufactured by Orgentec Diagnostika GmbH.
This section includes all our corporate publications, including our annual reports, corporate plans, business plans and our framework document.
This section includes the wide range of documents we produce which provide guidance on safety issues concerning medicines and medical devices.
This section includes the wide range of publications we produce to provide guidance to industry on the regulation of devices and medicines.
Public Assessment Reports (PARs)
Posters and leaflets