EULAR 2023 | ACCREDITATIONS
EULAR applied for AIFA accreditation (review in process).
Important information for Sponsors and Corporate Partners:
Dear Sponsors and Corporate Partners,
According to Italian law, Pharmaceutical Companies wishing to participate in a medical congress in Italy (with a sponsorship, exhibition, symposium, participants) have to be registered in Italy and have to request an authorization to AIFA (Italian Drug Agency) /Ministry of Health within 60 days before the starting date of the event.
In order to simplify the request of authorization, Pharma Companies not registered in Italy, which have a branch or a representation in Italy could contact directly the Italian affiliate to ask them for a support for the submission of the application on your behalf, this is possible for Pharmaceutical Companies with an affiliated branch in Italy.
A) AIFA Authorization is mandatory:
- If your company produces, sells or commercializes and promotes drugs/medicines authorized for marketing and related to the topics covered during the event.
- If the company participates with a drug that is not authorized in Italy but is authorized in Europe or in another country, the company is subject to AIFA authorization. The company that will submit an application to AIFA will have to enter the drug as a foreign drug. In this case, the information material of medicinal products without or awaiting a Marketing Authorization in Italy has to clearly and visibly contain a wording that the product (or the new therapeutic indication) is not authorized in Italy.
B) AIFA authorization is NOT necessary:
- When a Company promotes only medical devices or food supplements during a congress (products without Marketing Authorization);
- When a Company sponsors a meeting about topics not related to the use of any of its pharmaceutical products; in this case the Company is not allowed to expose or distribute any kind of advertising material during the meeting (Section 9 art. 124 D.L. n.219/06)
If your company needs AIFA Authorization, but it is not registered to AIFA, it has not a SIS Code, (identification code assigned by AIFA to identify each Company ) and it has not an Italian affiliate, it has to start with AIFA procedure.
If you require further information, we recommend you the following contact at AIM Group – Ms. Cristina Ghidoli.
CME Project Leader
EULAR applied for accreditation to UEMS (EACCME).