Home Parliamentary News
HoL Answers - 23.02.10
Authenticity of Medicines
Lord Patel of Blackburn (Labour): To ask Her Majesty's Government how they ensure that medicine imported into the United Kingdom is genuine.
Baroness Thornton (Labour): In the United Kingdom, medicines for human use are regulated by the Medicines Act 1968 and supporting regulations and are subject to a licensing regime, to protect patient health.
The Medicines and Healthcare products Regulatory Agency (MHRA), which is responsible for the safety and licensing of medicines in the UK, regularly inspects authorised manufacturers, including importers, and distributors in the UK and conducts overseas inspections of manufacturers in third countries.
The MHRA has developed and implemented a comprehensive anti-counterfeiting strategy, which focuses on reducing the availability of counterfeit medical products in the UK and is available at: http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Adviceandinformationforconsumers/Counterfeitmedicinesanddevices/index.htm
In December 2008, the European Commission published proposals for changes to the EU legislation to strengthen it from the threat of counterfeit medicines entering the supply chain. Those proposals are still under discussion with member states and the European Parliament and are available at: http://ec.europa.eu/enterprise/sectors/pharmaceuticals/human-use/quality/fake-medicines/.
Posted 23 February 2010