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06/01/11

European medicines regulators agree a common, Europe-wide approach for the identification of commercially confidential information and personal data

 

Guideline provides for a harmonised approach across Europe when dealing with requests for access to marketing authorisation applications

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  • EMA/HMA Guidance document, adopted March 2012 for the human sector only
    Guidance on the identification of Commercially Confidential Information (CCI) and Personal Data (PPD) within the structure of the Marketing Authorisation (MA) application - Release of Information after the granting of a Marketing Authorisation
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  • EMA/HMA Principles to be applied to Guidance document, adopted March 2012
    Principles to be applied for the Implementation of the EMA/HMA Guidance on the identification of CCI and PPD in MA applications.
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  • NEW-> Overview of comments received on the Guidance on the identification of Commercially Confidential Information (CCI) and Personal Data (PPD) within the structure of the Marketing Authorisation (MA) application - Release of Information after the granting of a Marketing Authorisation (June 2012)
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Recommmendations on transparency

  • Release of information with regard to New Applications for medicinal products before and after opinion or decision on granting of a marketing authorisation (November 2010)
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  • Requests for access to PSURs (November 2009)
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  • Agenda/Minutes on product related issues (November 2008)
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