For questions about EMA and its work, use our online form:
You can send your question in any official EU language. We will reply in the same language within a reasonable timeframe and no later than two months from the date of receipt.
If you need immediate assistance with an EMA IT system, contact the appropriate EMA Service Desk.
EMA's switchboard number is +31 (0)88 781 6000.
The EMA switchboard is open Monday to Friday from 07:30 to 18:00 Amsterdam time, except for EMA holidays.
EMA's Service Desk provides technical support for issues related to information technology (IT) systems that EMA hosts.
This includes creating new accounts, accessing existing accounts, uploading data and using databases.
| EMA IT system | Contact details |
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Clinical Trials Information System (CTIS) Union Pharmacovigilance Database Union Product Database EudraCT EudraGMDP Eudralink EudraVigilance IRIS and SPOR services |
Use the EMA Service Desk (ServiceNow) |
You can log in using your existing EMA username and password.
If you do not have an account or do not know your username and password, see:
For urgent technical matters, contact +31 (0)88 781 8520.
Call the product emergency hotline number in the event of a potentially serious problem with a centrally authorised product outside of EMA business hours (i.e. Monday to Friday before 08:30 or after 18:00, at weekends or on EMA holidays):
This is an emergency number and should be used only in the event of a potentially serious problem with a centrally authorised product.
The details of your call may be documented, including personal data if you provide them (such as your name, contact details and nature of the issue raised), in accordance with our Privacy policy.
For more information, see:
Marketing and manufacturing authorisation holders are obliged to report product quality defects on centrally authorised medicines to EMA. This includes any quality defect, or suspected defect, which could result in a recall or abnormal restriction on supply.
For full reporting instructions, see:
For more information, see:
Marketing authorisation holders are also required to notify EMA of detection of a suspected falsified medicine.
For full reporting instructions, see:
For more information, see:
During office hours, marketing and manufacturing authorisation holders with further questions regarding quality defects, recalls or falsifications can contact EMA on:
Outside of EMA business hours, Marketing and manufacturing authorisation holders can call the emergency phone on:
Please note that this number is used by marketing and manufacturing authorisation holders for urgent information concerning defective products and cannot respond to other queries.
When a marketing authorisation holder becomes aware of an emerging safety issue, they should notify it in writing to:
To support reporting to Member States, EMA has published a list of national contact points:
For guidance on emerging safety issues, see:
Marketing authorisation holders of centrally authorised products (CAPs) should submit their marketing status notifications via the IRIS platform.
Marketing authorisation holders of nationally-authorised products (NAPs) should follow the recommendation under question 7 in the section 'Marketing status updates and withdrawals' on the Notifying a change of marketing status page.
Notify EMA by emailing withdrawnproducts@ema.europa.eu.
Marketing authorisation holders have to notify the competent authorities of any of the following actions they intend to take:
Medicinal products affected by any of these actions are considered 'withdrawn products'.
If marketing authorisation holders of medicinal products for human use, while managing and resolving deviations from their quality system, identify the need to inform EMA and national competent authorities (NCAs), the guidance outlined below should be followed.
The decision on notifying EMA and NCA should be based on whether the deviation constitutes significant non-compliance (including reporting obligations to EudraVigilance) which might impact the safety profile of an authorised medicinal product(s). There is no single threshold for reporting; it should be tailored to the specific pharmacovigilance system, product and issue. The submission of few individual late cases to the EudraVigilance database would not typically be regarded as significant deviation. EMA and NCAs will assess the notification in line with their procedures.
Guidance for reporting:
EMA and NCAs have been receiving these notifications via various channels.
This guidance has been developed to harmonise the notification process and streamline the receipt and assessment by NCAs and EMA.
Marketing authorisation holders should email phv-noncompliance@ema.europa.eu to request an exceptional extension to the submission timeframes for individual case safety reports (ICSRs).
This is only for extensions needed for reports from class action lawsuits, in line with section VI.C.2.2.10 of the Guideline on good pharmacovigilance practices (GVP) - Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev. 2)
In your request, please include the:
EMA is committed to ensuring the widest possible access to the documents that it produces, receives and has in its possession.
For access to documents that are not already published, use our online form:
The EMA building is located in the Zuidas district in Amsterdam.
For directions to the EMA building, see How to find us.
EMA press office
Tel. +31 (0)88 781 8427
Email: press@ema.europa.eu
The press office only deals with enquiries from media representatives on matters relating to EMA's work. For further information, see Media centre.
For enquiries from the general public and other parties, use our online form:
Marketing authorisation holders can use the the number listed below for urgent pharmacovigilance issues with medicines for human use:
For general pharmacovigilance queries, use our online form:
For medicinal products for veterinary use:
For general pharmacovigilance queries, use the online form:
For questions of a technical nature related to EVVet Web, EVVet Data Warehouse or IRIS Veterinary Signal Management Pharmacovigilance, use the EMA Service Desk platform:
The constant safety monitoring of medicines after authorisation ('pharmacovigilance') is an important part of the work of EMA and regulatory authorities in Member States.
Tel. +31 (0)88 781 6000
Email: certificate@ema.europa.eu
EMA issues certificates of medicinal products in conformity with the arrangements laid down by the World Health Organization. These certify the marketing authorisation and good manufacturing status of medicinal products in the European Union (EU) and are intended for use in support of marketing authorisation applications within and export to non-EU countries.
Plasma master file (PMF) certificates:
Silvia Domingo
Tel. +31 (0)88 781 8552
Email: silvia.domingo@ema.europa.eu
Vaccine antigen master file (VAMF) certificates:
Ragini Shivji
Tel. +31 (0)88 781 8698
For all Vaccine antigen master file certificate questions, use our online form:
EMA issues Plasma master files and Guideline on the scientific data requirements for a vaccine antigen master file (VAMF) certificates of medicinal products in conformity with the arrangements laid down by European Union (EU) legislation. The certification process is an assessment of the PMF or VAMF application dossier. The certificate of compliance is valid throughout the EU.
For all quality management system questions, use our online form:
Quality management practices are an integral part of EMA's governance structure and its business processes. These practices help to ensure that EMA operates to consistently high levels of quality, efficiency and cost-effectiveness.
Meeting and Conference Management
Tel. +31 (0)88 781 7700
Hotel and travel bookings:
bookings@ema.europa.eu
This service is responsible for ensuring support to EMA's meetings. It provides an interface between EMA and delegates, assisting them with their travel and hotel bookings and any other query they may have.
For support with submitting information on an authorised medicine, you can use the online EMA Service Desk portal or call +31 (0)88 781 8520 for urgent technical matters.
As per the EU pharmaceutical legislation Article 57(2) of Regulation 726/2004, marketing authorisation holders of medicinal products authorised in the European Union and European Economic Area are required to submit information on these medicines to the European Medicines Agency and must keep this information up to date.
To provide general feedback on EMA's corporate website, or to make suggestions for future improvement, you can write to website.feedback@ema.europa.eu. EMA will take all feedback and suggestions into account, but will not be able to reply to individual email messages.
For questions about EMA and its work, use our online form:
For guidance on how to submit a pre-submission request, see:
For guidance on how to contact EMA about post-authorisation matters, including using EMA's pre-submission queries service, see:
EMA has put in place a policy for handling of alleged breaches within its remit received from external persons, also known as whistleblowers.
For guidance on how to report a concern to EMA, see:
For questions about recruitment at EMA please see our career page:
You can also send questions to: