Medicines regulatory news

This section provides the latest information about the regulation of medicines, including information that was previously published in 'MAIL', our updating journal for medicines which ceased publication at the end of 2007.

Free e-mail alerting service
If you would like to receive an e-mail notification when new content is added to this section, please subscribe to our free e-mail alerting service (see under 'Regulatory information - medicines' on the registration form):

   › MHRA e-mail alerting service

We hope you find this section useful. If you have any suggestions on how it could be improved, please e-mail webusability@mhra.gsi.gov.uk.

Latest medicines regulatory news

• 24 Jul 2008| Update on the "Sunset Clause": One-off exercise to establish the marketing status of all medicinal products on the UK market

  We have undertaken a one-off exercise to establish the marketing status of all medicinal products on the UK market, whether they have purely national authorisations, or were authorised under the decentralised or mutual recognition procedures.

• 23 Jul 2008| Consultation on advanced therapy medicinal products

  This consultation seeks your views on proposals for the UK’s exemption scheme for advanced therapy medicinal products (ATMPs) under Article 28 (2) of Regulation EC No 1394/2007 (“the ATMP Regulation”).

• 18 Jul 2008| Medicated and alcohol based wipes and swabs

  We have undertaken a comprehensive review of these types of products in the light of a number of queries regarding their regulatory status and differing views on the appropriate regulatory route within the EU.

• 17 Jul 2008| Revised European Pharmacopoeia monographs for heparin

  Following increased reports of adverse events associated with heparin preparations in America and some European countries, the European Pharmacopoeia monographs for Heparin Calcium and Heparin Sodium have undergone rapid revision and implementation in order to strengthen the level of testing required for quality control.

• 16 Jul 2008| Minutes from Ministerial Industry Strategy Group (MISG) New Technologies Advisory Panel - 29 April 2008

  The minutes of the fifth meeting of the MISG New Technologies Advisory Panel and invitation for proposals for topics to be discussed at the next meeting.

• 16 Jul 2008| Monthly performance on vetting of advertising

  Details of the monthly percentage of advertising pieces submitted for vetting where the MHRA provided a response to the company within the target response time of 5 working days. Updated for June 2008.

• 11 Jul 2008| New guidance on website advertising for medicines

  We have developed new guidance for companies offering website-based treatment services to ensure that prescription only medicines are not promoted to the public.

• 08 Jul 2008| Making payments to the MHRA

  We are reminding companies that when making electronic payments to the MHRA, an identifiable reference number must be quoted on the payment instruction.

• 08 Jul 2008| Reclassification of medicines

  Diclofenac potassium 12.5mg tablets may now be supplied without a prescription for the relief of mild to moderate pain and the symptoms of colds and flu.

• 07 Jul 2008| Periodic (annual) service fees for medicines licences for the period 1 April 2008 - 31 March 2009

  Companies are reminded that settlement of the 2008/09 invoices, which were issued on 30 May 2008, is now due.