Access to documents

In accordance with European Union (EU) law, the European Medicines Agency (EMA) 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, 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 PDF iconRules for the implementation of Regulation (EC) No 1049/2001 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 document that can be made public, the documents that can only be released in part (i.e. after redaction), and the documents that are confidential.

The Agency reserves the right to charge applicants for the cost of producing and sending copies of documents. This is in accordance with:

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 came into force at the time of publication. It 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. The policy was adopted following a public consultation and took recommendations made by the European Ombudsman into account.

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 is accompanied by a listing of the level of confidentiality that applies to the types of document produced by the Agency.

Revised policy on access to documents

EMA is revising its policy on access to documents. The revised policy extends the policy's scope to corporate documents and includes information on access rules to these documents. It also updates information on the table on access rules to documents on human and veterinary medicines.

EMA published the revised draft policy on 15 February 2017 for a 3-month public consultation:

Who can request access to documents

Citizens of the EU and natural or legal persons residing or having their registered office in an EU Member State have the right of access to EMA documents under Article 2(1) of Regulation (EC) No 1049/2001. This right to access concerns documents held by EMA (that is to say, documents drawn up or received by EMA and in its possession).

The Agency is no longer in a position to process access to documents requests issued from outside the EU. This is due to a high volume of requests resulting in an excessive workload and in order to avoid EMA's core business tasks and performance being jeopardised by the administrative workload related to activities under Regulation (EC) 1049/2001 regarding public access to documents.

How to submit a request

Access-to-documents requests should be submitted by completing the online form. For further information, see the PDF iconguide on access to unpublished documents .

Definitions used in access to documents

  • 'Document' means any content regardless of its medium (a written document stored electronically or on paper, or an audio, video or audio-visual recording) concerning a matter relating to the policies, activities and decisions falling within the Agency's area of responsibility.
  • Documents are classified as:
    • 'Restricted': information whose unauthorised disclosure at the time of an access-to-documents request could be disadvantageous to the interests of the EU Institutions, the Member States and/or the Agency, but which may be made available to the public in the future. Documents are classified 'restricted' if they fall into any of the categories listed Article 3 of the PDF iconRules for the implementation of Regulation (EC) No 1049/2001 and their premature disclosure might be prejudicial to the interests of the Agency;
    • 'Confidential': information whose unauthorised disclosure could harm the essential interests of the EU Institutions, the Member States and/or the Agency. Documents are classified 'confidential' if they fall under any of the exceptions laid down in Article 3 of the PDF iconRules for the implementation of Regulation (EC) No 1049/2001 on Access to documents ;
    • 'Public': information that is not classified as either restricted or confidential.
  • 'Commercially Confidential Information' (CCI) refers to the safeguarding of the privacy of sensitive information.
  • 'Protected Personal Data' (PPD) refers to protected data related to a living individual who can be identified from that data.
  • 'Redacted documents' are documents that, in their original form, contain sensitive information (such as CCI or PPD) and which information must be blacked out before access to these documents may be granted.
  • 'Third party' refers to any natural or legal person, or any entity outside the Agency, including the Member States, other Community or non-Community institutions and bodies and third countries.

Public documents

All our public documents are made available on the EMA website. If you cannot find a particular public document on our website, you can ask the EMA to provide it to you by sending a question to the European Medicines Agency.

Your request will not be processed as a request for access to documents, but as a request for information in accordance with the PDF iconEuropean Medicines Agency Code of Good Administrative Behaviour .

Policies and guidance

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