Farmacovigilanza

Il giorno 10.03.2011 l'AIFA ha spedito a tutte le aziende il seguente comunicato per informare a chi e come spedire gli PSURs. In particolare: 

 A) for centralised application PSURs, for which Italy acts as Rapp/Co-Rapp, 2 copies should be sent:

1 copy should be addressed to:

European Assessment Unit

Italian Medicines Agency (AIFA)

Via del Tritone, 181

00187 Rome Italy

and the 2nd copy should be addressed to the official Rapp/co-Rapp address as reported in the EMA web page.

B) for centralised application PSURs for which Italy does not act as Rapp/Co-Rapp 1 copy should be addressed to:

 Pharmacovigilance Unit

Italian Medicines Agency (AIFA)

Via del Tritone, 181

00187 Rome Italy

C) For MR/DC and National applications 2 copies of the PSUR should be addressed both to:

Pharmacovigilance Unit

Italian Medicines Agency (AIFA)

Via del Tritone, 181

00187 Rome Italy