Insights

The Italian Medicines Agency (AIFA) has issued updated guidelines for the classification of non-prescription medicines (SOP and OTC), introducing clearer criteria aligned with the European framework and replacing the previous 1997 circular.

The guidelines confirm the distinction between:

• OTC medicines, intended for self-medication and freely accessible to the public;
• SOP medicines, which require the supervision of a pharmacist to ensure appropriate use.

To be classified as OTC, a medicine must have a well-established efficacy and safety profile, based on known active substances and at least five years of use in Europe or the United Kingdom. Indications should be limited to mild, short-term conditions suitable for self-management, with simple routes of administration and a broad safety margin.

Special attention is given to risk assessment, including misuse, overdose, interactions, and adverse effects, particularly for vulnerable populations.

The new guidelines also clarify the regulatory pathways for classification and reclassification.

Requests can be submitted either at the time of marketing authorisation or post-approval, with specific procedural requirements depending on the product’s authorisation route and the type of change requested.

This update represents an important step toward greater regulatory clarity and safer self-medication practices.

RPN is available to support you in the strategic and regulatory evaluation of your products for SOP or OTC classification. Contact us to explore the most suitable pathway for your portfolio.