Insights

In Italy, pharmaceutical companies are required to fulfill several key periodic obligations concerning promotional activities. Two of the main activities mandated by the current regulations are:

1. Communication to AIFA Regarding Sales Representatives’ visits data

According to Article 122 of Legislative Decree 219/2006, all pharmaceutical companies must submit to the Italian Medicines Agency (AIFA) data regarding the activities performed by their Scientific Sales Representatives (Informatori Scientifici del Farmaco, ISF) during the previous year.

• The data collection is compiled and sent through the digital AIFA tool "IMS – Informazione Medico Scientifica," which facilitates centralized management of all necessary information.
• The submission deadline is generally January 31^st every year. For companies based abroad, an important aspect to be taken into account is that this responsibility is fulfilled by the Local Representative or dealer (Concessionario di Vedita) in Italy.

2. Self-Certification of Promotional Expenses and relevant 7% contribution

According to Italian legislation, by April 30th of each year, pharmaceutical companies must self-certify to AIFA the expenses incurred for promotional activities in the preceding year. In this context:

• Contribution Amount: The calculation shall be done taking into consideration several aspects like promotional materials production costs and Congresses and meetings management costs. Companies are required to pay 7% of the total declared expenditure to AIFA by the same deadline.

RPN is available to support companies in fulfilling these obligations by providing comprehensive support for the preparation and submission of declarations. Our aim is to ensure the accurate completion of the declarations involved in both periodic activities, and our expertise ensures compliance with Italian regulations while minimizing administrative burdens for pharmaceutical companies.

For further information or support, do not hesitate to contact RPN.