The Italian regulatory authority AIFA has updated, in an information notice, “the procedures for managing Italian reports of suspected adverse reactions to medicinal products forreporter or the reporter’s affiliated organization is not known.”
New types of spontaneous reports
According to the new pharmacovigilance legislation, Marketing Authorization Holders (MAHs) are required to monitor not only the scientific literature for potential reports of suspected adverse reactions, but also communication channels used and populated by patients, such as websites, blogs, vlogs, social networks, internet forums, chats, and health portals.
Any adverse reaction identified through these activities, as explained in the AIFA notice, must be considered a spontaneous report, and the MAH is required to manage from a regulatory perspective those reports considered valid according to EudraVigilance criteria.
In the same way, reports received from healthcare professionals or patients through any channel, including telephone calls or market research activities, for which it is not possible to determine the identity of the reporter, must also be considered spontaneous reports.
How to obtain the necessary information about the reporter
In all cases where it is not possible to identify either the healthcare institution to which the reporter belongs or the pharmacovigilance responsible person of that institution, as stated in the AIFA communication, “Marketing Authorization Holders must enter the data directly into EudraVigilance within 15 days from the date of receipt of the information for serious adverse reactions, and within 90 days for non-serious adverse reactions.”
If, on the other hand, it is possible to identify the healthcare institution to which the reporter belongs, and until the EMA is able to ensure the full functionality of the EudraVigilance database (Article 24 of Regulation (EC) No 726/2004, as amended by Regulation (EC) 1235/2010 of the European Parliament and of the Council), MAHs are required to forward to the pharmacovigilance responsible thcare institution all reports of suspected serious and non-serious adverse reactions occurring within the national territory.