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 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;
• Section 6.1 of the Annex to EMA's Policy 43: European Medicines Agency policy on access to documents.

Policy on access to documents

EMA's policy on access to documents describes the rules the Agency applies to grant access to the documents it holds on human and veterinary medicines and documents not related to medicines.

EMA revised the policy in October 2018 based on its experience implementing the policy since it was introduced in 2010. The revisions update the provisions for medicines-related documents and also extend the policy's scope to documents that are not related to medicines:

• Policy 43: European Medicines Agency policy on access to documents

The policy is accompanied by two output tables outlining access rules for specific document types:

• Output of the European Medicines Agency policy on access to documents related to medicinal products for human and veterinary use
• Output of the European Medicines Agency policy on access to documents non-related to medicinal products for human and veterinary use

The revised policy takes into account stakeholder recommendations provided during a public consultation held in 2017:

• Overview of comments received on the draft policy/0043: European Medicines Agency policy on access to documents
• Overview of comments received on the output of the European Medicines Agency policy on access to documents related to medicinal products for human and veterinary use
• Overview of comments on the output of the European Medicines Agency policy on access to documents non-related to medicinal products for human and veterinary use

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 Guide 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 Rules for the implementation of Regulation (EC) No 1049/2001 on access to EMEA documents 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 EMEA 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 The European Medicines Agency code of good administrative behaviour.

Policies and guidance documents

Heads of Medicines Agencies / European Medicines Agency guidance document on the identification of commercially confidential information and personal data within the structure of the marketing-authorisation application: ...

Adopted

Guide on access to unpublished documents

Reference Number: EMA/304162/2014 Rev.6

Policy 43: European Medicines Agency policy on access to documents

AdoptedReference Number: EMA/729522/2016Legal effective date: 01/12/2010

Overview of comments received on the draft policy/0043: European Medicines Agency policy on access to documents

Reference Number: EMA/768660/2018

Output of the European Medicines Agency policy on access to documents related to medicinal products for human and veterinary use

Reference Number: EMA/127362/2006 Rev. 1Summary:

Output of the European Medicines Agency policy on access to documents related to medicinal products for human and veterinary use

Overview of comments received on the output of the European Medicines Agency policy on access to documents related to medicinal products for human and veterinary use

Reference Number: EMA/770027/2018

Output of the European Medicines Agency policy on access to documents non-related to medicinal products for human and veterinary use

Reference Number: EMA/183710/2016Summary:

Output of the European Medicines Agency policy on access to documents non-related to medicinal products for human and veterinary use

Overview of comments on the output of the European Medicines Agency policy on access to documents non-related to medicinal products for human and veterinary use

Reference Number: EMA/770394/2018

Draft EMEA policy on the practical operation of access to EMEA documents

Reference Number: EMEA/110196/2006/Final

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

Reference Number: EMEA/659316/2008/Final

Public consultation documents

Draft revised Heads of Medicines Agency / European Medicines Agency guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application dossier

Draft: consultation closedConsultation dates: 12/04/2024 to 28/06/2024Summary:

This guidance document is intended to be applicable to information/documents pertaining to the initial and variation of marketing authorisation application (MAA) dossiers of medicinal products for human use for which the regulatory procedure has been finalised, under the national, mutual recognition, decentralised and centralised procedures. “Finalised” shall mean that the marketing authorisation (MA) has been granted or refused or that the MAA has been withdrawn.

By extension, the principles laid down in this guidance can be considered for other types of finalised procedures such as orphan designations, Paediatric Investigation Plans (PIPs)/waivers or scientific advice. The application of the general principles laid down in this guidance is without prejudice to national rules on transparency. The guidance should be read in conjunction with the relevant applicable legislation and case law on transparency and data protection.

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

Draft policy/0043: European Medicines Agency policy on access to documents

Draft: consultation closedReference Number: EMA/729522/2016Summary:

European Medicines Agency policy on access to documents - Draft policy/0043

Data protection statement for the public consultation on European Medicines Agency policy on access to documents

Reference Number: EMA/108062/2017Summary:

The objective of this consultation is to receive the views of stakeholder and/or concerned individuals on the revised European Medicines Agency policy on access to documents, the output table on corporate documents and the output table for documents related to medicines for human and veterinary use.

Submission of comments form

Archive

Rules for the implementation of Regulation (EC) No 1049/2001 on access to EMEA documents

AdoptedReference Number: EMEA/MB/203359/2006 Rev 1 Adopted