The first was published on the European Medicines Agency website list of medicines subject to additional monitoring. This is an important step in applying the new pharmacovigilance legislation which provides for further surveillance activity for some types of medicinal products for which limited safety data are available, with a view to transparency and greater involvement of patients and healthcare professionals in reporting adverse reactions.
The provision, which provides for the inclusion of a black symbol - an inverted equilateral triangle - on package leaflets and Summaries of Product Characteristics starting next autumn, applies to the following types of medicines:
· products containing new active substances authorized in Europe after 1 January 2011;
· biological medicinal products (such as vaccines and plasma derivatives) and biosimilars for which post-marketing experience data are limited;
·
