Insights

The timely and transparent communication of safety information on medicinal products to healthcare professionals and the public is a core function of the Italian Medicines Agency (AIFA) and represents a fundamental element of the pharmacovigilance system in Italy.

Among the AIFA’s safety communication tools, Important Safety Information Notes (NIIS) - also known as Direct Healthcare Professional Communications, DHPCs- play a key role in ensuring that emerging safety data—such as new risks, changes in the benefit-risk balance, or updated conditions of use—are effectively translated into clinical practice.

NIIS are used to inform healthcare professionals about critical safety updates requiring immediate attention, such as new contraindications or risk minimization measures. These communications are typically disseminated by pharmaceutical companies following AIFA approval, ensuring consistency and regulatory oversight.

Experience, however, has shown that NIIS are not always immediately recognized as official safety communications, partly because they are distributed through marketing authorization holders. To address this challenge, AIFA has introduced a dedicated pictogram to enhance their visibility and impact.

The pictogram—featuring a magnifying glass and an exclamation mark in institutional blue and red—has been designed to convey vigilance and urgency at a glance. It will systematically appear on all NIIS materials, including envelopes, emails, and the documents themselves.

In this context, RPN supports companies in the preparation, review, and implementation of NIIS and other safety communications, providing tailored regulatory and scientific expertise to ensure compliance, clarity, and effective dissemination in line with national and EU requirements.