What's new in November 2007

New for November

• 30 Nov 2007| Public consultation (MLX 346): Proposals for amendments to the range of medicines which can be sold, supplied or administered by registered midwives

  MLX 346 seeks your views on proposals for amendments to the range of medicines which can be sold, supplied or administered by registered midwives.

• 29 Nov 2007| Joint prosthesis: Knee implants - Urgent Medical Device recall of femoral and tibial components of TC PLUS, VKS and RT PLUS manufactured by Plus Orthopaedic AG / Smith & Nephew

  We are aware of this urgent recall and the manufacturer's recall letters with a full list of affected part numbers have been published.

• 29 Nov 2007| Aprotinin (Trasylol): Suspension of UK marketing authorisations (licences)

  The Commission on Human Medicines (CHM) has advised that the UK marketing authorisations (licences) for aprotinin (Trasylol) should be suspended pending the outcome of a full Europe-wide review of the balance of risks and benefits. This review is expected to take at least three months and the licences will be suspended from 7 December until further notice.

• 29 Nov 2007| Press release: Warning: Dangerous acids found in Chinese medicines

  We have found four unlicensed Traditional Chinese medicines (TCM) herbal products reported to contain aristolochic acids on the UK market.

• 27 Nov 2007| MDA/2007/088 - Injectable polymeric cements used in percutaneous vertebroplasty, balloon kyphoplasty and pedicle screw augmentation

  The MHRA have issued updated advice on bone cements used in vertebroplasty and kyphoplasty procedures.

• 26 Nov 2007| Making medical device vigilance more effective - Important forthcoming changes in EU medical device vigilance guidance

  We have published a short article which includes the development of the guidance, key areas that have changed and best practice vigilance guidance for manufacturers selling onto the UK market.

• 23 Nov 2007| First MHRA Anti-Counterfeiting Strategy and new counterfeit reporting hotline launched

  The first MHRA Anti-Counterfeiting Strategy has been published, setting out the MHRA's approach to combating the availability of counterfeit medicines and devices in the UK for the next three years. We have also launched a new dedicated 24-hour hotline for reporting suspected counterfeit medicines and devices.

• 21 Nov 2007| Class 2 Drug Alerts (action within 48 hours) issued for FDC International Ltd products

  We have issued three Drug Alerts directing FDC International Ltd to recall any remaining stock of: Chloramphenicol eye drops 0.5% in FDC, Almus and Ivax liveries; Hypromellose eye drops BP 0.3%; and Timolol eye drops 0.25 and 0.5% in FDC, APS, Almus and Ivax liveries.

• 21 Nov 2007| Class 2 Drug Alert (action within 48 hours): FDC International Ltd, Chloramphenicol eye drops 0.5% in FDC, Almus and Ivax liveries - EL(07)A/26

  The MHRA are directing FDC International Ltd to recall any remaining stock of the above products due to rough surfaces on the bottle delivery tip. The product has been distributed in the three liveries listed above.

• 21 Nov 2007| Class 2 Drug Alert (action within 48 hours): FDC International Ltd - Hypromellose eye drops BP 0.3% - EL(07)A/25

  We are directing FDC International Ltd to recall any remaining stock of these products due to rough surfaces on the bottle delivery tip.