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 Rules 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:
- Article 10 of Regulation (EC) No 1049/2001 of 30 May 2001 regarding public access to European Parliament, Council and Commission documents;
- Article 9 of the Rules for the implementation of Regulation (EC) No 1049/2001 of 19 December 2006 on access to European Medicines Agency documents.
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 (new)
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. Please submit comments using the form provided to email@example.com until 16 May 2017:
- EMA policy on access to documents
- Output of EMA policy on access the documents related to corporate documents
- Output of EMA policy on access the documents related to medicinal products for human and veterinary use (revision draft)
- Data protection statement for the public consultation on European Medicines Agency policy on access to documents
- Submission of comments form
How to submit a request
Identity and name of the organisation of the requester
The Agency does not release information on the identity of a person or the name of an organisation requesting access to EMA documents to third parties (e.g. the marketing-authorisation holder for a medicinal product) consulted as part of its assessment of the request. In particular with regards to the name of an organisation, this is in line with the Agency’s Code of Good Administrative Behaviour and specifically, the principle of proportionality set out in Section 4 of the Code.
When a document is requested using the online form, any data collected concerning the identity and/or the name of the organisation of the requester will be used for the sole purpose of processing the request and will not be disclosed to third parties. The Agency’s practice reflects the principle that the identity of a person and the name of the organisation requesting access to documents are irrelevant for the handling of the request.
Regulation (EC) No 1049/2001 does not require either the requester to reveal any information about their organisation, reasons or justifications for requesting access to documents, or require the Agency to disclose such information to a third party.
This is in line with Regulation (EC) No 45/2001, which sets out strict rules concerning the disclosure of personal data collected for the sole purpose of processing requests for access to 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 Rules 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 Rules 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.
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 European Medicines Agency Code of Good Administrative Behaviour.
Policies and guidance
|Document(s)||Language||Status||First published||Last updated||Effective Date|
|Guide on access to unpublished documents||(English only)||2014-11-24|
|Policy 43: European Medicines Agency policy on access to documents (related to medicinal products for human and veterinary use)||(English only)||adopted||2010-11-30||2010-12-01|
|Output of the European Medicines Agency policy on access to documents related to medicinal products for human and veterinary use||(English only)||2010-11-30|
|Draft EMEA policy on the practical operation of access to EMEA documents||(English only)||2008-12-17|
|Output of the draft EMEA policy on the practical operation of access to EMEA documents in the context of the authorisation and supervision of medicinal products for human and veterinary use||(English only)||2008-12-17|
|Rules for the implementation of Regulation (EC) No 1049/2001 on access to EMEA documents||(English only)||adopted||2007-01-10|