Eurordis - Rare Disease Europe

Where and how to report an adverse drug effect?

You may opt to report an adverse event yourself. There are different tools for you to report: online forms, printed materials (provided by your doctor, pharmacist or your patients’ organisations), or by telephone.

In the map below, you can find out more about where and how to report an adverse drug effect in most European countries.

Links to help lines: I find it complex to report an adverse drug effect. Can anyone help?

To start with, you can ask your pharmacist or a nurse. Some patient organisations working with pharmacovigilance authorities can also explain how to best complete the report.

The European Network of Rare Diseases Help Lines is also trained to respond to any question you may have in this respect. They can even fill in the form for you, by asking you the relevant questions when you call them. This will ensure highest reporting quality by making sure all questions are answered.

Not all Member States have a national help line for rare diseases; however, for the following Member States you can contact*:

Belgium

RadioOrg: info@radiorg.be

Bulgaria

  Information Centre for Rare Diseases and Orphan Drugs: 00 359 32 57 57 97

Croatia

Hrvatska Linija Pomoci za Rijetke Bolesti: 08009966

France

Maladies Rares Info Services: 01 56 53 81 36 – www.maladiesraresinfo.org AFM-Téléthon: 0810 811 088

Italy

Telefono Verde Malattie Rare: 800 89 69 49 / Coordinating Centre Rare Diseases Veneto Region: 00 39 049 82 15 700

Portugal

Linha Rara: 707 100 200

Romania

NORO Help Line: 40 360 103200  Myasthenia Gravis Romania: 0744704399

Spain

SIO-Feder: 918 22 17 25

*Please note that the list above may not be completely updated. EURORDIS keeps an updated list of European helplines here.

EudraVigilance

Since April 2012, the European Medicines Agency has opened one of its treasure chests to the public: all reports made by patients, consumers, healthcare professionals, and industry are collected and stored in a database called EudraVigilance. This database contains millions of suspected adverse drug reactions and other information, which before April 2012, only pharmacovigilance experts and the pharmaceutical industry could access.

If you connect on the Internet to www.adrreports.eu, you can access information extracted from the EudraVigilance database. You can search for a specific medicine and access the information that can be publicly released on any suspected reactions reported for that medicine.