EMA: Consultation on revised policy on access to documents | EATG
lterrat's bookmarks 2017-02-22
Summary:
"The European Medicines Agency (EMA) launches today a public consultation on the proposed revision to its 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:
- The policy which has a new title to emphasise that it covers both scientific and corporate documents held by EMA;
- A new table with the access rules for corporate documents held by EMA: Output of the EMA policy on access to documents related to corporate documents;
- A revised table with the access rules for documents related to medicines for human and veterinary use held by EMA: Output of the EMA policy on access to documents related to medicinal products for human and veterinary use.
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."