What's new in September 2011

New for September

• 30 Sep 2011 | Requests for the UK to act as Reference Member State
  

  

  This page provides information on applications for a marketing authorisation through the Decentralised Procedure (DCP) with the UK as Reference Member State (RMS).

• 30 Sep 2011 | Decentralised Procedure (DCP)
  

  

  The DCP is for applicants who wish to market a medicinal product in EU countries.

• 29 Sep 2011 | Press release: UK medicines watchdog plays vital role in £5 million international fake drugs bust
  

  More than £5 million worth of counterfeit and illegal medicines has been seized across the globe as part of a week-long international crackdown on the illicit internet trade in pharmaceuticals.

• 28 Sep 2011 | Non-steroidal anti-inflammatory drugs (NSAIDs) and risk of heart problems
  

  MHRA advice on the use of non-steroidal anti-inflammatory drugs (NSAIDs) remains the same despite a review by Hull York Medical School linking these drugs with an increased risk of heart attack or stroke.

• 28 Sep 2011 | Medical Device Alert: Implantable pacemakers manufactured by Medtronic (MDA/2011/097)
  

  This Medical Device Alert has been issued  because following a software update the new battery impedance elective replacement indicator (ERI) threshold may trigger an unexpected ERI in some EnRhythm® and EnRhythm MRI™ devices.

• 28 Sep 2011 | Advertising complaints: Clinics advertising botulinum toxin products – August 2011
  

  The companies in this article have amended their advertising following MHRA action on complaints to ensure that Prescription Only Medicines are not promoted to the public.
  

• 28 Sep 2011 | Advertising complaints: Aimspro information on Proventus website - July 2011
  

  The MHRA asked Proventus to review the information on their website following concerns that claims made about Aimspro, an unlicensed medicine, could be misleading.

• 28 Sep 2011 | Advertising complaints: Westerwood Clinics and Believe Lashes Clinic, consumer website advertising - June 2011
  

  Complaints to the MHRA about the promotion of Latisse (bimatoprost) on the websites of Westerwood Clinics and Believe Lashes Clinic. The MHRA upheld the complaints.

• 27 Sep 2011 | Medical Device Alert: Reusable laryngoscope handles - all models and manufacturers (MDA/2011/096)
  

  This Medical Device Alert has been issued because the MHRA received a coroner’s report of an inquest which found that a patient death was caused by a failure to decontaminate a laryngoscope handle appropriately between each patient use.

• 22 Sep 2011 | Company-led drug recall: Physeptone 1mg/ml Oral Solution Sugar Free, 500ml - Martindale Pharma - CLDA(11)A/16
  

  A small portion of this batch has been found to be yellow in appearance rather than green. Analysis indicates that the bottles affected do not meet specification.