Medicines Regulatory Guidance

Latest medicines regulatory guidance

• 03 Feb 2012 | List of Terminated, Revoked and Cancelled Manufacturing and Wholesale Dealer Licences - 2010 - 2011  (1803Kb)
  

• 03 Feb 2012 | List of New Manufacturing and Wholesale Dealer Licences - 2010 - 2011  (1357Kb)
  

• 18 Nov 2011 | Department of Health and MHRA Register of Licensed Wholesale Dealer Sites (Human Veterinary and Combined Sites) 2011  (6331Kb)
  

• 17 Nov 2011 | Department of Health and MHRA Register of Licensed Manufacturing Sites (Human Veterinary and Combined Sites) 2011  (1008Kb)
  

• 17 Feb 2011 | Best Practice in Reporting of Individual Case Safety Reports (ICSRs)
  

  We have today published guidance for industry that sets the MHRA's position on how to code adverse drug reactions (ADRs) to a high-quality standard for entry into our Sentinel database.  This ‘Best Practice’ guide has been developed combining ideas from both industry trade associations and the MHRA.

• 03 Feb 2011 | Best practice for ensuring the efficient supply and distribution of medicines to patients
  

  This guidance has been developed and is supported by eleven organisations, including the MHRA, following detailed consideration of the current problems with the supply chain, especially those caused by increased exports of medicines from the UK.

• 16 Jul 2010 | Reminder – update to labelling to comply with Article 54(a), 54(e) and 56(a)  (81Kb)
  

• 11 Dec 2009 | Register of Holders of Manufacturer's Authorisations for Investigational Medicinal Products (MIAIMP) - 2011  (714Kb)
  

• 01 Dec 2009 | Department of Health and MHRA Register of Licensed Manufacturing Sites (Human Veterinary and Combined Sites) 2009  (3890Kb)
  

• 24 Aug 2009 | Guidance on completion of GMP QC Lab change form - April 2009  (81Kb)