EMA Policy 0043

The European Medicines Agency Policy 0043 governs the agency’s approach to the retrospective release of certain documents when in the agency’s possession. This includes Clinical Study Reports (and other parts of the Common Technical Document including Modules 2.5 and 2.7), Investigator’s Brochures, and Periodic Safety Update Reports.  In colloquial terms, it is the agency’s freedom of information. The policy is dated 30 November 2010, effective from 1 December 2010 and its official title is “European Medicines Agency policy on access to documents (related to medicinal products for human and veterinary use).”

Online here: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2010/11/WC500099473.pdf