Send a question to the European Medicines Agency

Use this form to send a request for information from the European Medicines Agency (EMA) or to make a formal request for access to EMA documents that are not already published on this website.

For technical support with EMA's IT systems (e.g. Eudravigilance, IRIS, EudraCT), please see Ask for assistance with an EMA IT system.

Read our Frequently asked questions before sending EMA a question. These provide answers to questions sent regularly to the Agency by its stakeholders, such as:

• What is the Agency responsible for?
• Are all medicines in the European Union approved via the Agency?
• How are herbal medicines evaluated?
• What are the responsibilities of the Agency in the assessment of certain categories of medical devices?
• Can the Agency help to fund my work?
• My medicine has been evaluated by the Agency but is not available in my country. Why not?

COVID-19

Please check our content on COVID-19 before sending a question about COVID-19 vaccines:

• Coronavirus disease (COVID-19)
• COVID-19 medicines
• COVID-19 vaccines: key facts
• Safety of COVID-19 vaccines

EMA cannot currently process all access-to-documents requests immediately

Before requesting a document from EMA:

• check first if the document is available on our website;
• see the Agency's policy on Access to documents, which includes information on how to submit a request.

EMA cannot currently process all access-to-documents requests at the same time.

This is because their number increased while EMA was operating under a business continuity plan during the COVID-19 pandemic.

EMA is making every effort to process all requests as soon as possible. It is dealing with requests in a chronological order, based on time of receipt. An access-to-documents coordinator will inform you when your procedure starts.

In order to ensure a manageable flow of requests in a fair, timely and consistent way, the following approach applies:

• Each access-to-documents request cannot exceed two documents
• A requester/affiliation can have a maximum of five access to documents requests in queue

For more information, please refer to Q17 and Q18 of the

Guide on access to unpublished documents

Reference Number: EMA/304162/2014 Rev.8

 

The current arrangements are in line with EMA's policy on access to documents. This states that the Agency will apply the principle of proportionality in order not to jeopardise core business tasks and its performance due to workload related to activities within Regulation (EC) No 1049/2001.

EMA collects information you provide concerning your location for the sole and exclusive purpose of processing requests for access to documents and the application of Article 2(1) of Regulation (EC) No 1049/2001. For more information, see Access to documents. 

For information on how EMA uses your details, see the:

European Medicines Agency’s privacy statement concerning requests for information or access to documents via 'Send a question' form or phone call

Reference Number: EMA/415481/2019 Rev. 2 Summary:

European Medicines Agency’s Privacy Statement concerning requests for information or access to documents

Send your question

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Who are you? Please select...Academia/research instituteConsultantDelegate to EMAEU National Competent AuthorityEU institution (EC etc.)Healthcare professionalJournalistLaw firmNot-for-profit organisationPatient or consumerPharmaceutical industryRegulator outside the EUSeeking job at the EMA

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Please select your type of enquiry

I want you to answer a question

I want an unpublished document (maximum 2 documents per request)

I want help identifying which unpublished document I need

For more information on these enquiry types and how we handle them, see:

• The European Medicines Agency code of good administrative behaviour
• Access to documents (opens in a new window)
• Guide on access to unpublished documents

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