Contacts at the European Medicines Agency

Outside of EMA business hours (i.e. Monday to Friday before 08:30 or after 18:00, at weekends or on Agency holidays) you may call the product emergency hotline: +31 (0)88 781 7600.

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.

Marketing and/or manufacturing authorisation holders are obliged to report to EMA any product quality defect, including a suspected defect, of a centrally authorised medicine which could result in a recall or abnormal restriction on supply, following the instructions on notifying quality defects:

• complete the below form: 

Note: This form needs to be opened with a PDF reader. EMA advises to save the document first, and then open with a PDF reader, such as Acrobat Reader.

• email this to EMA at qdefect@ema.europa.eu

You should receive an acknowledgement in four hours during EMA business hours.

If you do not, you can phone EMA on:

• Tel. +31 (0)88 781 6000 (EMA switchboard)
• Tel. +31 (0)88 781 7676 (for use only as stated in the instructions)

Urgent phone number for use outside of EMA business hours:

• Tel. +31 (0)65 008 9457

For full reporting instructions, see Reporting a quality defect to EMA.

For more information, see Quality defects and recalls.

Marketing authorisation holders are required to notify EMA of detection of a (suspected) falsified medicine by following the instructions on notifying falsified medicines:

• complete the (Suspected) falsified medicinal product report
  Note: This form needs to be opened with a PDF reader. EMA advises to save the document first, and then open with a PDF reader, such as Acrobat Reader.

• email this to EMA at qdefect@ema.europa.eu

You should receive an acknowledgement in four hours during EMA business hours.

If you do not, you can phone EMA on:

• Tel. +31 (0)88 781 6000 (EMA switchboard)
• Tel. +31 (0)88 781 7676 (for use only as stated in the instructions)

Urgent phone number for use outside of EMA business hours:

• Tel. +31 (0)65 008 9457

For full reporting instructions, see Reporting a falsified product to EMA.

For more information, see:

• Falsified medicines: reporting obligations
• Falsified medicines: overview

When a marketing authorisation holder becomes aware of an emerging safety issue, they should notify it in writing to:

• EMA by emailing p-pv-emerging-safety-issue@ema.europa.eu;
• the relevant competent authority or authorities in the Member State(s) concerned.

To support reporting to Member States, EMA has published a list of national contact points:

• Emerging safety issues (ESI) contact points at the national competent authority (NCA) level

For guidance on emerging safety issues, see:

• Good pharmacovigilance practices (GVP) Module IX on signal management

Marketing authorisation holders should notify a withdrawn product to:

• the Member State(s) concerned;
• EMA by emailing withdrawnproducts@ema.europa.eu.

When notifying EMA, please use the Cover letter template for notification of "withdrawn products" by marketing authorisation holders and the Template to be used to notify the European Medicines Agency and concerned Member States of 'withdrawn products' report table.

For detailed guidance, see Notifying a change of marketing status.

Marketing authorisation holders have to notify the competent authorities of any of the following actions they intend to take:

• temporary or permanent cessation of marketing of a medicinal product;
• suspension of marketing of a medicinal product;
• withdrawal of a medicinal product from the market;
• request for the withdrawal of a marketing authorisation;
• non-application for the renewal of a marketing authorisation.

Medicinal products affected by any of these actions are considered 'withdrawn products'.

For more information, see Notifying a change of marketing status.

Marketing authorisation holders should email phv-noncompliance@ema.europa.eu to notify the European medicines regulatory network about any issues complying with pharmacovigilance obligations.

In your notification, please state the actions you are taking to correct the issue and to prevent it happening again, along with timelines.

EMA will deal with the notification in line with its Standard operating procedure for notifications from marketing authorisation holders on pharmacovigilance non-compliance issues.

Marketing authorisation holders should email phv-noncompliance@ema.europa.eu to request an exceptional extension to the submission timeframesfor 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:

• reason for requesting the extension;
• planned duration of the extension;
• medicinal products concerned.

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:

• Send a question to the European Medicines Agency

For medicinal products for human use:

Tel. +31 (0)88 781 7599

For general pharmacovigilance queries, use our online form:

• Send a question to the European Medicines Agency

For medicinal products for veterinary use:

Jos Olaerts
Tel. +31 (0)88 781 8624
Email: vet-phv@ema.europa.eu

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:

• Send a question to the European Medicines Agency

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:

• Send a question to the European Medicines Agency

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 newwebsite@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:

• Send a question to the European Medicines Agency

For guidance on how to submit a pre-submission request, see:

• Pre-authorisation guidance

For guidance on how to contact EMA about post-authorisation matters, including using EMA's pre-submission queries service, see:

• Contacting EMA: post-authorisation