European Medicines Agency - Document search - Access to documents 2013-05-10


"In accordance with European Union (EU) law, the Agency is committed to ensuring the widest-possible access to its documents following requests from the public. It is also committed to increasing its level of openness and transparency over its decision-making processes. At the same time, however, the Agency must guarantee that it continues to protect information held on individuals and the commercial interests of the organisations and individuals that it works with. The Agency's Management Board adopted the rules on access to documents in December 2006. These explain the legal basis of the right to access to documents and how requests for documents should be handled. They also describe the types of documents that can be made public, the documents that can only be released in part, and the documents that are confidential. Policy on access to documents ...   In November 2010, the Agency published a policy on how these rules should be implemented for documents relating to medicines for human and veterinary use. The policy gives wider access to documents held by the Agency than ever before, allowing access to all business-related documents unless there is a need to respect arrangements for regulators outside the EU or international organisations, or to protect the privacy and integrity of a natural or legal person.  As a general rule, the Agency releases documents once a procedure concerning a medicine has been finalised. This protects the decision-making process. The policy came into force at the time of publication. The policy is accompanied by a listing of the level of confidentiality that applies to the types of document produced by the Agency. The final policy was adopted following a public consultation starting in December 2008. It also took recommendations made by the European Ombudsman into account."


From feeds:

Open Access Tracking Project (OATP) »


oa.medicine oa.policies oa.comment oa.europe oa.biomedicine oa.privacy oa.clinical_trials oa.ema oa.medicine.veterinary oa.pharma

Date tagged:

05/10/2013, 12:28

Date published:

05/10/2013, 08:27