Department of Health

Website of the Department of Health

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Medicines' supply

Guidance and statutory requirements for pharmaceutical companies.

Swine flu - a letter to pharmacy bodies

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.

Joint statement on key legal and ethical obligations for the medicines' supply chain

Published: 13 November 2009

The guidance sets out the key legal and ethical obligations that manufacturers, wholesalers, NHS Trusts, registered pharmacies and dispensing doctors have in the supply and trading of medicines. Recent increases in the export of medicines are a major contributor to supply problems and risk jeopardising patient care. It was developed jointly with ten organisations including the Department of Health representing the different parts of the supply chain

Discontinuing medicines

Guidance on discontinuing a medicine, including who should be consulted and who should be notified at each stage of the process.

Notification and management of medicines shortages

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.

MHRA guidelines

The MHRA medicines' supply guidelines complement the statutory requirements to inform the Licensing Authority and 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.

Counterfeit medicines

The MHRA conducted a public consultation on proposals to strengthen the UK supply chain against the increasing threat from counterfeit medicines. The consultation ran until 13 March 2009. The MHRA undertook 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 set out a range of proposals for change with various impacts on the current supply chain. The consultation also set out and sought views on anti-counterfeit proposals made by the European Commission.

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