Wednesday, June 1, 2011

Health News from Medical News Today: European Medicines Agency And Heads Of Medicines Agencies Propose Measures To Make Information In Application Dossiers More Transparent

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European Medicines Agency And Heads Of Medicines Agencies Propose Measures To Make Information In Application Dossiers More Transparent
1 Jun 2011, 4:00 pm

The European Medicines Agency and the Heads of Medicines Agencies (HMA) have released a guidance document on the identification of commercially confidential information and protection of personal data within the structure of the marketing-authorisation dossier for public consultation. The draft document, which is open for comment until 1 September 2011, outlines the types of information included in marketing-authorisation applications that can be released following a request for access to documents, once a marketing authorisation has been granted...


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