Consultation on revised policy on access to documents

News 17/02/2017

Comments from stakeholders invited until 18 May 2017

The European Medicines Agency (EMA) launches today a public consultation on the proposed revision to its PDF icon policy on access to documents . The policy describes the rules EMA applies to grant access to the documents that it holds, in accordance with Regulation (EC) No 1049/2001, which gives citizens a right to access EU documents.

The revision is based on EMA's experience with the original policy introduced in 2010. The new version extends the scope of the policy to include explicitly corporate documents and takes into account the Agency's proactive approach to transparency that has led to the publication of many more documents on the EMA website since 2010.

The three principal documents are:

Other changes include a new classification of the documents into 'releasable' or 'non-releasable' (previously, documents were classified as 'public' and 'confidential'); more clarity on when procedures are considered to be concluded and documents become releasable; and a new section that details the level of information to be made available in relation to requesters.

Providing access to documents is an important element of EMA's continued commitment to transparency. Since October 2016, the Agency has also given open access to clinical reports for new medicines for human use authorised in the EU. For every new medicine, citizens, including researchers and academics, can directly access thousands of pages from clinical reports submitted by pharmaceutical companies to EMA in the context of their marketing-authorisation applications. By providing open access to clinical data, EMA became one of the most transparent regulatory bodies worldwide.

The revisions to the access to documents policy are marked in yellow in the policy document. Stakeholders can submit their comments on the proposed revisions and the two output tables until 18 May 2017. This Microsoft Office document icon form should be used for comments and needs to be sent as a Word document to

All comments submitted will be reviewed and considered before a final version of the policy, the arrangements for implementation and both output tables are submitted to EMA's Management Board for adoption.

Regulation (EC) No 1049/2001 of the European Parliament and the Council of the EU aimed to enhance transparency by giving the European citizens and legal entities the right of access to documents of EU institutions, in line with principles, conditions and limits defined by legislation.

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