Press Release: European Medicines Agency and Heads of Medicines Agencies propose measures to make information in application dossiers more transparent

Author (Corporate)
Series Title
Series Details EMA/435707/2011 (1.6.11)
Publication Date 01/06/2011
Content Type

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), on 1 June 2011, 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.

Source Link http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/06/news_detail_001267.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1
Related Links
EMA: Press Release: EMA/435707/2011 (1.6.11) http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2011/06/WC500107026.pdf

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