In order to be marketed in Italy, a medicinal product must be granted a Marketing Authorisation (MA) by AIFA or the European Commission. The MA is issued following a scientific assessment of the quality, safety and efficacy requirements of the medicinal product.

In order to obtain the MA, the applicant is obliged to submit an application consisting of a dossier containing information on chemical-pharmaceutical, preclinical and clinical aspects, structured according to a standardised format (CTD – Common Technical Document). The data and studies submitted to support the application for MAs shall comply with guidelines defined at European level.

The authorisation procedures provided for in European legislation are:

• national procedure
• Mutual recognition procedure and decentralised procedure
• centralised procedure
• parallel import

Except in certain specific cases, the MA has a 5-year validity and is renewable for a further five years or indefinitely.