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 Defective product report template

• 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) falisifed medicine by following the instructions on notifying falsified medicines:

• complete the  (Suspected) falsified medicinal product report template

• 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:

• National contact points for reporting emerging safety issues (ESIs)

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 template cover letter and the notification of withdrawn products report table.

For detailed guidance, see Withdrawn-product notification: questions and answers.

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 Withdrawn-product notification: questions and answers.

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 procedures for pharmacovigilance non-compliance .

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.

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 the work of the Agency. For further information, see Media centre.

For enquiries from the general public and other parties, send a question to the European Medicines Agency.

For medicinal products for human use:

Tel. +31(0)88 781 7599

For general pharmacovigilance queries 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 the Agency and regulatory authorities in Member States.

Julia Lidner
Tel. +31(0)88 781 7567
Email: certificate@ema.europa.eu

The Agency 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 78 8552
Email: silvia.domingo@ema.europa.eu

Vaccine antigen master file (VAMF) certificates:

Ragini Shivji
Tel. +31(0)88 78 8698

For all Vaccine antigen master file certificate questions, please send a question to the European Medicines Agency.

The Agency issues Plasma master files and Vaccine-antigen master files 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, please send a question to the European Medicines Agency.

Quality management practices are an integral part of the Agency's governance structure and its business processes. These practices help to ensure that the Agency 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 the Agency's meetings. It provides an interface between the Agency and delegates, assisting them with their travel and hotel bookings and any other query they may have.

Financial support services
Tel. +31(0)88 781 7105

Financial queries:
delegatereimbursements@ema.europa.eu

This service deals with reimbursement of all expenses related to travel and accommodation of experts attending scientific meetings, inside and outside the Agency's premises.

For support with this system, please 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, www.ema.europa.eu, or to make suggestions for future improvement, please 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 other enquiries, send a question to the European Medicines Agency.