The quality of medicinal products available on the market is also ensured by a monitoring activity entailing the management of reports concerning the presence of defects in one or more batches of medicinal products or raw materials.
Reports of quality defects are sent to AIFA by private or public pharmacies, local (local health authorities) or hospital pharmacies, healthcare professionals, manufacturing companies or marketing authorization holders, the Istituto Superiore di Sanità (Italian National Institute of Health), AIFA offices as well as by the European Medicines Agency (EMA) and other EU national competent authorities or countries with which mutual recognition agreements are in place.
Private citizens can report defects only through pharmacies, physicians, local health authorities, or hospitals.
If the defect is verified and poses a health risk, restrictive measures are taken pursuant to article 142 of Leg. Decree 219/2006. Where appropriate, communication is also given through the AIFA website and the media.
If the reported product is manufactured in the national territory and is marketed in other EU Member States, an international Alert notice is disseminated through the Rapid Alert System (RAS), the network for the exchange of information between Member States.