New website for medicines under additional monitoring launched
The European Medicines Agency (EMA) has introduced a new webpage related to medicines under additional monitoring. Patients and healthcare professionals can always check whether a certain medicine is subject to additional control on the Agency’s website which will be reviewed and updated every month.
Medicines under additional monitoring will have a black inverted triangle displayed in the package leaflet together with an informative text explaining what it means. The black triangle signifies that a medicine is being monitored even more closely than other medicines on the EU market. This intense process doesn’t mean that the medicine is dangerous, but it requires additional monitoring because it is new or there might not be enough information on its long-term use.
The triangle will be introduced in the medicines package leaflet on the 1 September 2013. The concept of additional monitoring was introduced by the new EU laws on the safety-monitoring of medicines, the pharmacovigilance legislation, which started to come into effect in July 2012. A black symbol will encourage patients and healthcare professionals to report suspected adverse events and the provisional list of medicines is already available here. This information is available in all EU languages.
For more information check the EMA webpage.
EMA glossary introduced
The European Medicines Agency (EMA) prepared a new website of a glossary. The glossary gives definition for the main regulatory terms used on this website and in the EMA documents.
The glossary is easy to navigate, simply by clicking on a letter the user is able to see a list of terms beginning with that letter. “The definitions in this glossary have been developed to help this website’s users understand regulatory terminology. Definitions may differ from those given in European Union legislation,” EMA states.
For more information check the EMA website.