Newsletters

Latest newsletters

• 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.

• 18 Oct 2007| MAIL 163

  This issue of our updating journal for medicines includes: compliance with new legal requirements for patient information leaflets; an update on Periodic Safety Update Reports (PSUR) applications; the Pharmacovigilance Service Desk providing a service to marketing authorisation (MA) holders; and the Regulatory Information Service.

• 24 Jul 2007| MAIL 162

  This issue of our updating journal for medicines includes: best practice guidance on the processing of national marketing authorisations; compliance with the new legal requirements for patient information leaflets; and a request for notification of inspections performed in the UK by overseas Inspectorates.

• 30 May 2007| MAIL 161

  This issue of our updating journal for medicines includes clarification of the fee applicable for product licence applications and variations which are electronic Common Technical Document (eCTD) compliant.

• 20 Apr 2007| MAIL 160

  This issue of our updating journal for medicines includes articles on: the proposals for MHRA fees (implemented on 1 April 2007); when risk management plans are required; and guidance for notification of serious breaches of Good Clinical Practice (GCP) or the trial protocol.

• 06 Feb 2007| MAIL 159

  This issue of our updating journal for medicines includes an article on disruptions to the supply of medicines and interpretation of the 'Sunset Clause', and information on requesting the MHRA to act as Reference Member State (RMS) in decentralised procedures.

• 24 Nov 2006| MAIL 158

  This issue of our updating journal for medicines includes a reminder about our Regulatory Information Service and an article on the provision of scientific advice for risk management planning.

• 23 Nov 2006| Special Mail 5: Guidelines on submission of applications to the MHRA

  Special issue of MAIL with FAQs, defining a standard approach to sending submissions to the MHRA.

• 13 Oct 2006| Special Mail 6: Drugs, Devices and Regulations (DDR '07) Conference and Exhibition

  Special Mail 6 highlights our 'Drugs, Devices and Regulations' conference and exhibition to be held in London on 5-6 February 2007.

• 28 Sep 2006| MAIL 157

  This issue of our updating journal for medicines includes articles on updated product information for neuroleptics and new requirements for patient information leaflets.