Contacts at the European Medicines Agency

Marketing authorisation holders should report product defects and recalls to EMA by following the instructions on notifying quality defects:

• complete defective_product_report_form.pdf;

• email this to EMA at qdefect@ema.europa.eu (or if necessary, fax the form to +44 (0)20 3660 5535).

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

If you do not, you can phone EMA on:

• Tel. +44 (0)20 3660 6000 (EMA switchboard)
• Tel. +44 (0)20 3660 7676 (for use only as stated in the instructions)

Urgent phone number for use outside of EMA business hours:

• Tel. +44 (0)7880 550697

For full reporting instructions, seeReporting a quality defect to EMA.

In order to protect public and animal health, marketing authorisation holders are required to notify EMA of any quality defect that could result in a recall or restriction on supply.

For more information, see Quality defects and recalls.

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Marketing authorisation holders should notify a withdrawn product to: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When notifying EMA, please use the template cover letter and the notification of withdrawn products report table.

For detailed guidance, see Withdrawn-product notification: questions and answers.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Medicinal products affected by any of these actions are considered 'withdrawn products'.

For more information, see Withdrawn-product notification: questions and answers.