To advertise medicinal products in Italy, companies must comply with the specific provisions of the pharmaceutical legislation.
Prescription medicines cannot be advertised to the general public: promotional materials can only address health professionals, provided that they have been submitted to the Italian Medicine Agency (AIFA) and that the concerned product has already been approved to be sold in Italy.
OTC product can be advertised to public with an authorisation to be obtained from the Italian Ministry of Health.
Materials to be disseminated at congresses and other events also requires to be preliminarily submitted to the AIFA.
Di Renzo Regulatory Affairs can take on the role of Responsible Person for the Scientific Service, complying with all obligations in the field of pharmaceutical advertising.
We are able to assess, revise and submit promotional materials intended for health operators as well as websites’ content in compliance with the regulations in force.
We assist companies in the management of pharmaceutical sales representatives (ISF), taking care of the verification of their qualifications according to the Italian requirements, their Regional registration to access healthcare facilities (including ID cards), and the periodic ISF data transmission as provided for by the law.
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