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Focus on Regulation

EMA public consultation on revised policy on access to documents

The EMA has launched a public consultation on its draft new Policy/0043 on access to documents. The document describes the EMA’s approach in balancing public and private interests involved in requests for access to documents received by the Agency.


Regulation (EC) No 1049/2001 sets out the principles, conditions and limits governing the right of access to the documents held by the EU Institutions and Agencies, including the EMA.

In December 2010, the EMA adopted its original Policy/0043 on access to documents. The Policy describes the principles followed by the EMA and the procedures governing requests for access to documents submitted to the Agency.

The revisions to the original Policy/0043, based on the EMA’s experience gained so far, are marked in yellow in the new draft Policy/0043.

The new draft Policy/0043

The principles governing disclosure established by the EMA in the original Policy/0043 have not undergone substantial changes. The EMA confirms, in particular, that the EMA “aims to ensure the widest possible access to the documents that it produces or receives and has in its possession” (page 2 of the new draft Policy/0043).

The new draft Policy/0043 includes, however, the following main new elements:

  • The scope of the new draft Policy/0043 has been extended to include corporate documents, such as procurement related documents, submission and opening of tenders and conflict of interest declarations. A new output table with the access rules for corporate documents held by EMA has been elaborated: “Output of the European Medicines Agency policy on access to documents related to corporate documents“;
  • The classification of the documents has been changed into “releasable” or “non-releasable”. Previously, documents were classified as “public” and “confidential”;
  • The section on protection of internal deliberations has been amended to clarify when access procedures are considered to be concluded;
  • A section on transparency of requests has been added. The new draft Policy/0043 includes the obligation for the beneficiaries of requested documents to state their affiliation at the time of making the request for access to documents. The affiliation of beneficiaries will be made public by the EMA, by publication of the number of requests by type of requester;
  • The new draft Policy/0043 contains in an Annex the procedural rules for the implementation of Regulation (EC) No 1049/2001.


The new draft Policy/0043 and the two output tables will be open for public consultation until 18 May 2017. This form should be used for comments and needs to be sent as a Word document to atdpolicy@ema.europa.eu

The comments will be reviewed and considered before a final version of the new draft Policy/0043 and the output tables are submitted to EMA’s Management Board for adoption.