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Drugs

Health written question – answered on 11th June 2009.

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Photo of Jim Dobbin Jim Dobbin Labour, Heywood and Middleton

To ask the Secretary of State for Health what requirements there are upon pharmaceutical companies to report information on medicines for human use to his Department.

Photo of Gillian Merron Gillian Merron Minister of State (Public Health), Department of Health

All marketing authorisation holders of medicines for human use in the European Union are obliged by law to provide information on the safety of their products under Regulation 726/2004 and Directive 2001/83/EC (as amended). Detailed guidance is provided in Volume 9A of the Rules Governing Medicinal Products in the European Union and is available at the following link:

http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol9_en.htm

Obligations relating to reporting in clinical trials are given in Clinical Trials Directive 2001/20/EC, Articles 16 and 17. Some obligations are associated with specific deadlines for provision of information to competent authorities. Those related to safety of medicines include the submission of serious, suspected adverse drug reactions; the submission of Periodic Safety Update reports; and with respect to clinical trials, the reporting of suspected unexpected serious adverse reactions.

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