Insights

The Italian Medicines Agency (AIFA) has published a document providing regulatory clarifications on managing reports of suspected adverse reactions associated with the use of radiopharmaceuticals, depending on their specific use and/or authorization status.

The following are key clarifications:

1. Radiopharmaceuticals with national marketing authorization: adverse reaction reports for radiopharmaceuticals authorized in Italy must be reported through National Pharmacovigilance Network (RNF) and/or Eudravigilance per Directive 2001/83/EC (as amended) and Regulation (EC) No. 726/2004, and national guidelines such as Ministerial Decree 30 April 2015.
2. Radiopharmaceuticals for special use: products authorized under special provisions (e.g., Law 648/1996, Law 94/1998) also require management of adverse reaction reports via RNF and/or Eudravigilance, highlighting their special-use status.

3. Radiopharmaceuticals imported, with foreign marketing authorization: these products lack national marketing authorization and are not included in the AIFA's authorized medicines database, so adverse reaction reports must be forwarded to AIFA and transmitted to the foreign Marketing Authorization Holder (MAH) that will report them in Eudravigilance.
4. Industry-prepared radiopharmaceuticals (Legislative Decree 219/2006, art. 5): adverse reaction reports for these patient-specific radiopharmaceuticals are not included in RNF but should be transmitted directly to AIFA.
5. Hospital-prepared galenic radiopharmaceuticals (Legislative Decree 219/2006, art. 3): Adverse reaction reports for these specific radiopharmaceuticals are not included in RNF but should be transmitted to the Italian Ministry of Health.

RPN will provide any further update and is available to provide full support for pharmacovigilance activities.