According to the Legislative Decree 219/06, it is possible to develop promotional material for Healthcare Professionals (HCPs) and for general public according to the following requirements:
- Prescription-only medicinal products can be promoted only to HCPs prior silent approval by AIFA.
- Non-prescription medicinal products (SOP), Over-the-Counter medicinal products (OTC) and Medical Devices can be promoted to the public prior formal authorization by the Ministry of Health.
There are several aspects that have to be considered by companies before proceeding with the promotional material development (e.g. distribution channel of the promotional material, submission fees, lifetime).
Some key regulatory requirements include:
- Promotional material directed to HCPs must be referenced with verifiable sources (e.g. Summary of Product Characteristics, scientific publications)
- Changes to the Summary of Product Characteristic (SmPC) must be quickly implemented in the affected promotional materials compliance failure can lead to penalties and legal actions by the competitors.
A careful regulatory review of the promotional materials before the submission to the Authority facilitates a straightforward approval process avoiding comments.
RPN Regulatory team is available to support companies during the whole process, from the initial material review to the submission to the Italian Authorities for approval.