Includes guidance and statutory requirements for pharmaceutical companies.
Chief Pharmaceutical Officer for England, Dr Keith Ridge has written to the key pharmacy trade bodies updating them on the latest arrangements for supply of medicines.
Guidance on discontinuing a medicine, including who should be consulted and who should be notified at each stage of the process.
Includes guidance for members of the Association of the British Pharmaceutical Industry (ABPI) and the British Generic Manufacturers Association (BGMA) to help minimise the impact of a shortage of a medicine, including proformas for companies to use to notify the Department of Health about an impending shortage.
These guidelines complement the statutory requirements to inform the Licensing Authority, the Medicines and Healthcare products Regulatory Agency (MHRA) of any disruptions to supply (the so-called 'sunset clause') under new European medicines legislation (Directive 2001/83/EC as amended). Information on complying with the relevant provisions can be found on the MHRA’s website at:
The MHRA is conducting a public consultation on proposals to strengthen the UK supply chain against the increasing threat from counterfeit medicines. The consultation will run until 13 March 2009. The MHRA has undertaken a comprehensive review of the current medicines supply chain and concluded that in respect of some economic operators the current regulatory regime no longer provides the level of confidence that the public expects. The consultation sets out a range of proposals for change that will impact on various aspects of the current supply chain. The consultation also sets out anti-counterfeit proposals made by the European Commission, and seeks views on those. The MHRA would welcome views on all these proposals and the consultation document can be found at the following web address