What's new in December 2007

New for December

• 28 Dec 2007| Special Mail 5: Frequently Asked Questions (version 2)

  We have published an updated version of the Frequently Asked Questions to 'Special Mail 5: Guidance on the submission of applications to the MHRA'. This document should be read in conjunction with 'Special Mail 5', which defines a standard approach to sending submissions for medicines to the MHRA.

• 23 Dec 2007| E2B reporting with the MHRA

• 21 Dec 2007| Christmas and New Year opening times

  Our Christmas and New Year opening times.

• 21 Dec 2007| Complaints about the advertising of medicines

  The outcome of an investigation into a complaint about the advertising of medicines has been published.

• 21 Dec 2007| Advertising complaint - Metoject (methotrexate) - Journal advertisement - November 2007

  It came to our attention that an advertisement for Metoject produced by Medac UK claimed that Metoject was the ‘the only officially licensed MTX injection’. The case was upheld.

• 20 Dec 2007| MISG New Technologies Advisory Panel: Minutes

  Minutes of the Ministerial Industry Strategy Group (MISG) New Technologies Advisory Panel.

• 20 Dec 2007| One Liners issue 54 - December 2007

  This news sheet aimed at laboratory staff, details some of the device problems that have been reported to us which relate to the use IVDs or their results.

• 20 Dec 2007| MDA/2007/100 - Volumetric infusion pump. Smiths Medical (Graseby) 500 and 505 volumetric infusion pumps - all models

  We have been informed that there is the possibility of delivering an unintended 1.7 ml bolus if the pump door is opened and then immediately closed following a stoppage of the pump.

• 20 Dec 2007| Traditional Chinese Medicines found containing Aristolochic acids

  We have issued a press release warning of the dangers of four unlicensed Traditional Herbal products, Xiao Qin Long Wan, Chuan Xiong Cha Tiao Wan, Bai Tou Weng Wan and Xie Gan Wan, reported to contain aristolochic acids that have been found on the UK market.

• 18 Dec 2007| MAIL 164

  This, the final issue of our updating journal for medicines, includes articles on the Paediatric Regulation, Risk Management Plans, and guidance on the submission of Decentralised and Centralised Procedure applications.