Document on the Identification of Commercially Confidential Information and Protection of personal Data within the structure of the marketing Authorisation (MA) dossier release of Information after granting of a marketing Authorisation
The Heads of Medicines Agencies (HMA) and European Medicines Agency (EMA) havebeen working together with a view towards achieving greater transparency of their operations and better addressing the increasing requests for information theyfrom members of the civil society.
This draft guidance document is presented as a consensus document agreed by theentire Network of Competent Authorities, laying down practical orientations for national and European authorities in regards to requests for access to information contained in MA dossiers.
For More Information Please Click: HMA & EMA: More Transparancy in Application Dossiers - DRAFT FOR PUBLIC CONSULTATION
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