Reporting side effects of medicines
EMA launches survey to assess whether patients and doctors are aware of the arrangements for reporting of side effects
The European Medicines Agency (EMA) has launched a survey to better understand patients’ and healthcare professionals’ awareness of reporting adverse drug reactions, including for medicines under ‘additional monitoring’.
Medicines under additional monitoring are monitored particularly closely by regulatory authorities. They are easily identified by a black inverted triangle displayed in their package leaflet and in the information for healthcare professionals, called the ‘summary of product characteristics’ (SmPC). Healthcare professionals and patients are encouraged to report any suspected adverse reactions.
Regulatory authorities continuously look at reports of side effects alongside all the information they already have to make sure that the benefits of medicines remain greater than their risks and to take any necessary action.
The survey’s main aim is to evaluate the awareness, attitudes and reporting behaviours of patients and healthcare professionals to report side effects. The questionnaire is translated into all official European Union languages and takes no more than 10 minutes to complete. It will be open for responses until 9 October 2017. The results of the survey will be analysed by EMA and the European Commission and the conclusions will be published in 2018.
- Medicines under additional monitoring
- Partners and networks: healthcare professionals
- Partners and networks: patients and consumers
- Healthcare professionals: information for you
- Patients and carers: information for you
Latest News from
ESMA publishes final report on Money Market Funds rules20/11/2017 14:25:00
ESMA has published a final report on the Money Market Funds Regulation (MMFR), which contains final versions of the technical advice, draft implementing technical standards (ITS), and guidelines on stress test scenarios carried out by MMF managers under the MMFR.
ESMA clarifies endorsement regime for third-country credit ratings20/11/2017 13:25:00
ESMA has published its Final Report updating its Guidelines on the application of the endorsement regime under the CRA (Credit Rating Agencies) Regulation.
Non-state and subnational climate actors should not operate in a policy vacuum20/11/2017 12:30:00
Civil society, cities and regions call for targeted support for their vital contribution to implementation of the Paris Agreement
2018 EU budget: jobs, investments, migration challenge and security20/11/2017 11:30:00
The EU institutions have reached an agreement on the 2018 EU budget– a reflection of the political priorities of the Juncker Commission.