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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:
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.