After a synthetic outline of the EU pharmacovigilance system and its regulatory basis, the following article examines the new EU Regulation concerning the duty for drug companies to place the symbol of a black overturned triangle on the label and package of innovative drugs, referring the expression to drugs contained a new substance approved after January 2001; biologic and biosimilar drugs and drugs authorized under condition. The new regulation will be analyze at the light of the current European policy aim to foster a more active and responsible role of all the actors involved, with particular attention to the proactive measure drugs’ companies have to adopt.
Tutela del paziente e obbligo di black symbol per i farmaci innovativi. Gli effetti del Regolamento UE n. 198/2013
Guerra G
2013-01-01
Abstract
After a synthetic outline of the EU pharmacovigilance system and its regulatory basis, the following article examines the new EU Regulation concerning the duty for drug companies to place the symbol of a black overturned triangle on the label and package of innovative drugs, referring the expression to drugs contained a new substance approved after January 2001; biologic and biosimilar drugs and drugs authorized under condition. The new regulation will be analyze at the light of the current European policy aim to foster a more active and responsible role of all the actors involved, with particular attention to the proactive measure drugs’ companies have to adopt.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
