Other medicines regulatory guidance

 

Latest other medicines regulatory guidance

• 22 Oct 2008| Good Pharmacovigilance Practice Guide

  We are pleased to announce the imminent publication of the ‘Good Pharmacovigilance Practice Guide’ which is intended to complement currently available legislation and guidance, and to provide practical advice about achieving an appropriate system of pharmacovigilance.

• 19 Jun 2007| Rules and Guidance for Pharmaceutical Distributors 2007

  We are pleased announce the publication of 'Rules and Guidance for Pharmaceutical Distributors' which reproduces those elements of the 2007 edition of 'Rules and Guidance for Pharmaceutical Manufacturers and Distributors' (commonly known as the “Orange Guide”) specific to the wholesale supply and distribution of medicines for human use.

• 07 May 2007| Best Practice Guide for Processing National Applications

  We are pleased to announce the pilot of this best practice guidance for processing national marketing authorisation (MA) applications.

• 16 Nov 2005 |  Blue Guide: Advertising and Promotion of Medicines in the UK. (206Kb)

• 01 Jan 2004 |  A Guide to Defective Medicinal Products (200Kb)

• 01 Oct 2002| Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002

• 01 Jan 2001 |  Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products (171Kb)

• 01 Feb 2000 |  Guide to UK GLP Regulations 1999 (48Kb)

• 01 Jan 2000| The GLP Pocket-Book