PRAC recommendations on safety signals

PRAC recommendations for regulatory action (i.e. amendment of the product information) are submitted to:

the Committee for Medicinal Products for Human Use (CHMP), for endorsement, if the signal concerns a centrally authorised medicine. At the time of publication, the PRAC recommendations have been endorsed by the CHMP;
the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), for information, if the signal concerns a nationally authorised medicine. It is the responsibility of the medicines regulatory authorities in the Member States to oversee that these PRAC recommendations are adhered to.

Marketing-authorisation holders are expected to take action according to the recommendations. They should monitor the information on this page regularly to keep informed about the PRAC recommendations concerning their products.

The presence of a safety signal does not mean that a medicine has caused the reported adverse event. The adverse event could be a symptom of another illness or caused by another medicine taken by the patient.

The overview of PRAC recommendations is published after each month's CHMP and CMDh meeting. The first list was published in October 2013 and lists the recommendations from the September 2013 PRAC meeting. A cumulative list of all signals discussed at the PRAC since September 2012 is also available below.

Starting from the January 2015 PRAC meeting, the Agency now publishes recommendations for updates of product information translated into all official European Union (EU) languages.

The Agency publishes these translations in all official EU languages, as well as Norwegian and Icelandic, in the table below after review of their quality by the national regulatory authorities in EU Member States.

Marketing-authorisation holders can use these translations to update their product information.

The Agency expects this initiative to accelerate the implementation of changes to product information and to ensure consistency across EU countries, thus leading to better information for patients on their medicines.

For more information on how safety signals are assessed in the EU, see:

Signal management

Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1)

AdoptedLegal effective date: 22/11/2017Reference Number: EMA/827661/2011Summary:

Revision 1 is a major revision with modifications throughout and contains the following:

- Revised definition and process for emerging safety issues, previously addressed in GVP Module VI (IX.A.1.1. and IX.C.2.);

- Streamlined information on scientific aspects of signal management (IX.B.2. to IX.B.4.), statistical aspects now addressed in Addendum I;

English (EN) (283.21 KB - PDF)

First published: 25/06/2012Last updated: 12/10/2017

PRAC recommendations on safety signals

Expected publication dates of PRAC recommendations on safety signals

List of safety signals discussed since September 2012

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