The National Pharmacovigilance Network (RNF), that is the system by which reports of suspected adverse drug reactions (ADRs) are collected, managed and analysed in Italy, has been renewed. The new RNF features advanced functions for the management and analysis of ADRs reports in order to ensure an increasingly accurate assessment of the safety profile of medicinal products.
Among the news:
- a new international standardised format ISO Individual Case Safety Report (ICSR) ICH E2B(R3) for ADRs reporting has to be used in all EU countries to send and receive ADRs reports to and from the EudraVigilance System, with which the RNF is closely linked.
- for each pharmaceutical company, in addition to the appointment of the local contact person for pharmacovigilance on behalf of the pharmaceutical company, the deputy may also be appointed to support the local contact person in the management of reports of adverse reactions and/or take his/her place in the event of temporary absence.
- the appointment of a local contact person is required even if this role is assigned to the EU QPPV. Both the local contact person and the deputy will have to register themselves in the AIFA portal and to send a separate request to AIFA for their appointment, that should be then approved by the Company Users’ Administrator (CUA).
- any updates to the EU QPPV are directly accessible by AIFA through the art. 57 database, however any updates to the CUA or to the local contact person for pharmacovigilance or his/her deputy shall be updated in the AIFA portal, even if the role is assigned to the EU QPPV.
Moreover, there is a new online reporting method that complies with the new international standard format and has replaced the “Vigifarmaco” portal. So, healthcare professionals and patients/citizens can report a suspected adverse reaction through one of the following procedures:
- By filling in the reporting form and sending it via e-mail or fax to the Pharmacovigilance contact point of your facility, or to the Marketing Authorization Holder (MAH) of the drug suspected to have caused the adverse reaction
- Online on the AIFA website
RPN constantly monitors the AIFA website in order to stay up to date on this topic and is available to provide full support for the appointment of the local contact person for pharmacovigilance and his/her deputy and for the management of any local pharmacovigilance activity.