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Promotional materials in Italy

As provided for by Legislative Decree no. 219 of 24 April 2006, implementing Directive 2001/83/EC, the advertising of human medicines to the public is only possible for those drugs that were conceived to be used without a doctor’s intervention on the diagnosis, prescription or monitoring during treatment and, if necessary, after a pharmacist’s advice.

For the promotion of such medicines (SOPs and OTCs), a special authorisation should be applied to the Ministry of Health.

On the other hand, promotional messages addressed to health operators should be previously authorised by the Italian Medicine Agency (AIFA). These promotional materials should comply with the regulations in force and be submitted electronically to the AIFA Medical Scientific Information Unit (IMS).

Di Renzo Regulatory Affairs has a special unit dedicated to the promotion of medicinal products for human use and to Scientific Information, and can assist companies in the review of their promotional materials and in the authorisation procedure at the AIFA or Ministry of Health.