Public Consultation on EMA’s Policy on Access to Documents

The EMA is revising its general policy on access to documents (Policy/0043). The new draft document does not only include rules on how the Agency deals with requests for access to EMA’s own documents or data submitted by third parties in line with Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents (reactive publication of data) but also refers to the rules concerning proactive disclosure of clinical data according to EMA Policy/0070. The draft document is published for a 3-month public consultation. Those parts of the document that change the wording of the original document from 2010 are highlighted in yellow. The new wording in particular stresses that EMA aims to ensure the widest possible access to the documents that it produces or receives. In addition, the future Policy/0043

  • shall be extended to include corporate documents (e.g., procurement related documents, conflict of interests declarations). Further information can be taken from the Output of the European Medicines Agency policy on access to documents related to corporate documents;
  • classifies documents as either “releasable” or “non-releasable”;
  • clarifies when procedures are considered to be concluded and a section on transparency has been added to clarify the level of transparency on the requests, and on the beneficiaries of the requests;
  • contains in an Annex arrangements for the implementation of Regulation (EC) No 1049/2001. However, relevant information (i.e. on the scope, on the definitions) has been included in the body of the policy

If you wish to comment on the draft, please submit comments using the form provided on the Agency’s dedicated webpage to atdpolicy@ema.europa.eu until 16 May 2017.

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Published on 21. February 2017 in News EU