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?

Please check our content on COVID-19 before sending a question about EMA’s work in response to the pandemic:

EMA is not involved in advising on travel requirements in the European Union (EU), such as vaccination, quarantine or testing for travellers. 

Decisions about which COVID-19 vaccines are included, for example, in the EU Digital COVID Certificate, are taken by the EU Member States. EMA is in charge of the scientific evaluation of vaccines for EU marketing authorisation. The acceptability criteria for travel purposes are broader and can include, for example, World Health Organization (WHO) listed vaccines that have not necessarily undergone the EMA process of authorisation.

Official information on this topic is available in all EU languages at: 

Before requesting a document from EMA:

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Guide on access to unpublished documents

 

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

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