Insights

In Italy, the advertising of prescription-only medicines is subject to strict regulation. While communication to healthcare professionals is permitted, every promotional message must be carefully evaluated prior to dissemination. To ensure compliance with the applicable legislation, the Italian Medicines Agency (AIFA) made available a Q&A document that provides some guidance on the boundaries of promotional activities.

Regulatory Framework

Promotional materials must always be scientifically accurate, non-misleading, and limited to the information authorized for the product in scope. AIFA’s indication’s purpose is to provide guidance on key aspects such as the appropriate use of clinical data, the mandatory inclusion of SmPC references, and the prohibition of unsupported claims.

When assessing an advertising campaign, the following considerations are essential:

• Scientific Accuracy: All promotional statements must align with the Summary of Product Characteristics (SmPC) of the medicinal product.
• Digital Channels: Online tools, such as websites or e-detailing platforms, are subject to the same rules as traditional media. However, special care must be taken with respect to the method of distribution.
• Regulatory Compliance: Companies must fulfill various regulatory requirements to ensure full compliance with the regulatory framework.

RPN supports pharmaceutical companies in interpreting and applying AIFA’s requirements, reviewing promotional materials, and developing effective and compliant strategies.

Contact us at info@rpngroup.com to discover how RPN can guide your company through regulatory challenges in pharmaceutical advertising.