Events
03/8 - Controllo dei corpi estranei o dei difetti nei prodotti medicinali riflessioni sulla evoluzione della procedura. Anna Farina, Raffaele Lecce, Gianluca Gostoli, Annalisa Montinaro 2003, 25 p.
Control of foreign bodies or defects in medicinal products: considerations on the procedure evolution.
Anna Farina, Raffaele Lecce, Gianluca Gostoli, Annalisa Montinaro
2003, 25 p. Rapporti ISTISAN 03/8 (in Italian)
A decree of the Italian Ministry of Health (February 27, 2001) gives new rules to be applied when a defect or a foreign body is found to be present in a released medicinal product. Such rules take care of some advices given by the Istituto Superiore di Sanità (Italian National Institute if Health) in the year 1999 with a critical assessment of all the activity derived from the previous Directive on the same issue: the prompt involvement of the inspective authority was suggested particularly when the defect or the foreign body found present in a medicinal product is easily identified. The implementation of these rules points out the need for a more careful approach, by health operators, in reading the Summary of the Products Characteristics of the medicinal products themselves.
Key words: Foreign bodies, defects, Pharmaco-surveillance, Medicinal products
Pubblicazioni
Publications Rapporti ISTISAN