The Italian Medicines Agency has published an online update on new methods to be implemented for the management of Italian reports of suspected adverse reactions in which no information is available on the structure of membership of the warning.Italy-Map-Colour
The new rules of pharmacovigilance provides that the holders of a marketing authorization ( MA ) to carry out regular screening of the internet or digital media (web site, web page, blog, vlog, social networks, internet forums, chat rooms, health portal ) to search for potential reports of suspected adverse reactions.While these activities the holder of the marketing authorization becomes aware of any suspected adverse reaction resulting from the use of a medicinal product, it is required to consider such information as spontaneous reports and manage the regulatory point of view those considered to be valid (according to the criteria laid down in EudraVigilance for your input) for reporting to regulatory authorities.
Same considerations should be observed for reports of suspected adverse reactions received by the holders of marketing authorizations by the device (health professional or patient) through any means (eg telephone communications, the results of market research or other) and for which no it is possible to trace the identity of the device. 
So, in all cases where it is not possible to determine the health facility membership of the warning  or the Head of Pharmacovigilance healthcare facility, holders of marketing authorizations are allowed to enter directly into EudraVigilance such cases, within 15 days from date of receipt, for serious adverse reactions, or 90 days for non-serious adverse reactions.
For the inclusion of these cases in EudraVigilance, with respect to information on the “primary source”, simply fill in at least the field “Country”.
For all other cases where it is known the health facility membership of the warning  remain in effect to the provisions previously issued, or that, until the EMA can ensure the functionality of Eudravigilance referred to in Article 24 of Regulation ( EC). 726/2004, amended by Regulation (EU) No. 1235/2010 of the European Parliament and of the Council, holders of marketing authorizations are required to forward to the Head of the PV of the health facility membership of the warning all reports of suspected serious or non-serious adverse reactions that have occurred in the country.
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