Medicines and Healthcare products Regulatory Agency

What's new

• 28 Jul 2010

  MHRA Business Plan 2010 and Corporate Plan 2010-15 published

  The MHRA has today published its Business Plan for 2010 and its Corporate Plan for 2010-2015.

• 27 Jul 2010

  Regulation of advanced therapy medicinal products in the UK

  The statutory instrument for implementing the UK's requirements under the hospital exemption scheme was laid in Parliament on 26 July 2010.

• 26 Jul 2010

  Current advice and information about the use of rosiglitazone (Avandia, Avandamet▼) in the treatment of diabetes

  New data have been published that raise concern about an increased risk of cardiovascular adverse effects of rosiglitazone. These data add substantially to existing evidence and point towards an increased cardiovascular risk with rosiglitazone compared with both placebo and with pioglitazone.

• 26 Jul 2010

  Shortages and supply chain obligations – Guidance for registered pharmacies that also hold wholesale dealer’s licences

  In November 2009, the MHRA together with the Department of Health and eight other bodies, published guidance on maintaining and protecting the supply chain. The MHRA has provided clarification on the guidance for registered pharmacies that also hold wholesale dealer’s licences.

• 23 Jul 2010

  Good Clinical Practice (GCP) Non-Commercial Symposium

  Now in its fifth year, this must-attend event, to be held in Manchester on 8 - 9 December, will focus on regulation, innovation and communication of non-commercial clinical trial systems.

• 21 Jul 2010

  Labelling of medicines: Reminder – update to labelling to comply with Article 54(a), 54(e) and 56(a)

  UK legislation was amended in 2004 to implement the new medicines labelling provisions in Title V of Council Directive 2001/83/EC [as amended]. The transitional period for the labelling of medicines which were the subject of a granted marketing authorisation at the time the regulations came into force ends on 30 October 2010.

• 20 Jul 2010

  Medical Device Alert: NicoletOne® System EEG recorder manufactured by CareFusion 209 Inc, formerly Viasys Healthcare Inc (MDA/2010/061)

  This Medical Device Alert has been issued due to reports of misinterpreted EEG results when using additional headbox configurations found within NicoletOne Systems with software versions 5.3, 5.4, and 5.7.

• 15 Jul 2010

  Heads of Medicines Agencies (HMA) draft strategy 2011-15 consultation

  The Heads of Medicines Agency (HMA) has launched a consultation on its draft strategy for the period 2011-2015.

• 14 Jul 2010

  Medical Device Alert: Sigmoidoscope and anoscope systems and accessories manufactured by Welch Allyn Limited (MDA/2010/060)

  This Medical Device Alert has been issued due to potential cross-contamination from inadequate decontamination of reusable insufflation bulb and light head accessories.

• 13 Jul 2010

  Class 2 Drug Alert (Action within 48 hours): LEO Laboratories Limited - Sodium Fusidate 500 mg for Intravenous Infusion - EL (10)A/18

  LEO Laboratories Limited is recalling all remaining stock of affected batches of Sodium Fusidate 500 mg for Intravenous Infusion, because glass particles have been identified in a very small number of vials of active material.