If a medicinal product is not yet authorized in Italy, it is not possible to do promotional activities except for those of an institutional nature.
The three main scenarios described below can be outlined:
- Before the EC decision on the EU Marketing Authorisation
Since the topics of the event do not concern any authorised medicinal product, related to the concerned company:
- no request of sponsorship can be done
- the company can sponsor disease awareness events only through institutional activities
- no promotional activities can be performed
- Italian HCPs cannot be invited as participants.
- Following the EC decision and before the national Marketing Authorisation by AIFA
Since the topics of the events concern a medicinal product centrally approved, related to the concerned company:
- request of sponsorship is mandatory and only disease awareness events can be performed
- no promotional activities can be performed (i.e. no booth/ no promotional materials)
- Italian HCPs can be invited as participants.
- Following the national Marketing Authorisation by AIFA
Since the topics of the events concern the medicinal product registered in Italy, related to the concerned company:
- request of sponsorship is mandatory
- promotional activities can be performed, provided that promotional materials have been deposited at AIFA and 10 days elapsed after the AIFA deposit without any comments raised by the Italian Authorities. Commercial materials are allowed.
- Italian HCPs can be invited as participants
Regulatory Pharma Net (RPN) can provide any regulatory assistance on meetings/events planning and sponsorship.
Feel free to contact us at info@regulatorypharmanet.com