European Medicines Agency and HMA propose measures on dossier transparency
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 was yesterday released by the European Medicines Agency and the Heads of Medicines Agencies (HMA).
The draft document, which is open for comment until September 1, 2011, outlines the types of information included in marketing authorization applications that can be released following a request for access to documents, once a marketing authorization has been granted.
The consultation is being conducted to gather the views of stakeholders, including pharmaceutical companies, health care professionals and patient organizations.
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