New AIFA pictogram for DHPCs in Italy: what changes in safety communications

AIFA, the Italian Medicines Agency, has introduced an official pictogram to make Direct Healthcare Professional Communications immediately recognisable in Italy. In the Italian regulatory context, these communications are known as Note Informative Importanti di Sicurezza, or NIIS. Following the announcement published by the Agency on 27 May 2026, the new symbol was presented during the pharmacovigilance session of the 65th AFI Symposium, an Italian scientific event dedicated to the pharmaceutical industry and healthcare sector, which we attended on 10 June. Based on the presentation delivered by Dr Laura Sottosanti, we analyse the composition of the pictogram, how it is intended to be used, and the role of visual identity in risk communication

During the pharmacovigilance session of the 65th AFI Symposium, Dr Laura Sottosanti from AIFA dedicated part of her presentation to the evolution of Important Safety Communications and to the new pictogram for DHPCs in Italy.

The initiative, officially announced by AIFA on 27 May 2026, aims to strengthen the recognisability and impact of communications addressed to healthcare professionals, making them easier to identify among the many informational materials they receive on a daily basis.

The pictogram introduces a uniform visual identity for DHPCs distributed in Italy. It does not change their scientific or regulatory content, but adds a recognisable element that signals their institutional nature and their relevance for medicinal product safety.

Direct Healthcare Professional Communications, or DHPCs, are communications addressed directly to healthcare professionals to inform them of new evidence or relevant measures concerning the safety of a medicinal product.

In Italy, these communications are referred to as Note Informative Importanti di Sicurezza, or NIIS. They may be prepared by the Marketing Authorisation Holder in agreement with the competent authority, or issued directly by the regulatory authority.

They may concern, for example, the identification of a new risk, the introduction of restrictions of use, changes to contraindications, or new recommendations for patient monitoring.

Their function is operational: healthcare professionals must be able to quickly understand which medicinal products are involved, what safety information has emerged, and what actions should be taken in clinical practice.

Healthcare professionals receive updates, scientific materials, administrative communications, and promotional content every day. In this context, even a scientifically correct and complete message may lose effectiveness if its nature is not immediately recognised.

A consistent visual identity helps distinguish DHPCs from other types of communication and draws attention to their content.

The new pictogram therefore, addresses three complementary needs:

• making DHPCs in Italy immediately recognisable;
• strengthening the institutional identification of the communication;
• encouraging careful reading of the safety information and recommendations.

The graphic component therefore, supports the textual content and contributes to the ability of the communication to reach its intended recipient clearly.

The new pictogram combines three graphic elements:

• a document bearing the AIFA logo, identifying the official and institutional nature of the communication;
• a magnifying glass, linked to the observation and assessment of safety information;
• a red exclamation mark, visually highlighting the need to pay attention to the content.

This composition connects the symbol to pharmacovigilance activities and to the specific relevance of the information conveyed through DHPCs.

The uniform use of the same pictogram may, over time, support an immediate association between the symbol and official communications on medicinal product safety.

The instructions presented by AIFA indicate that the pictogram should accompany DHPCs in Italy across the different channels used for their distribution.

In particular, the symbol is placed:

• in the header of the communication;
• in the upper left-hand section of the outer envelope, in the case of paper-based distribution;
• in the body of the email, before the beginning of the text, in the case of electronic distribution.

This continuity allows recipients to identify the nature of the communication from the envelope or upon opening the email, before they even consult the attached document.

Using the same element across different media therefore contributes to a uniform experience in receiving DHPCs in Italy, regardless of the channel used.

To maintain uniformity and recognisability, the pictogram must be used in its official format, without changes to its graphic composition.

In the presentation delivered at the AFI Symposium, the indicated dimensions were 3.09 centimetres in width and 3.44 centimetres in height.

The following elements must also be preserved the original proportions, the arrangement of the graphic elements, the designated colours, the legibility of the logo and exclamation mark, an adequate clear space around the symbol.

The pictogram must not be distorted, recomposed, recoloured, or integrated with additional graphic elements.

Its use is reserved for Note Informative Importanti di Sicurezza, the Italian denomination for DHPCs, and must not be extended to promotional materials or other types of communication.

Standardisation is essential to ensure that the symbol maintains a clear identity over time and continues to be uniquely associated with safety communications issued or distributed in this context.

The new pictogram does not change the scientific or regulatory content of DHPCs. Instead, it affects the way these communications are presented and recognised by healthcare professionals in Italy.

Applying a uniform symbol to the communication, the outer envelope, and the email message makes it possible to maintain the same visual identity across the different distribution channels. This allows the recipient to recognise the nature of the communication before reading its full content.

The initiative highlights an important aspect of risk communication: the effectiveness of a safety message depends on the robustness of the information conveyed, but also on its visibility and on the ability to distinguish it immediately from other communications.

With the new pictogram, AIFA introduces a common element designed to make DHPCs in Italy more recognisable and to reinforce attention to information that may affect prescribing, monitoring, and the clinical management of medicinal products.