The advertising of medical devices is regulated by article 21 of the Legislative Decree of the 24 February 1997. In particular, it prohibits advertising to the public of the devices that can be sold only on prescription or be used with the assistance of a physician or other healthcare professional. It also states that advertising to the public for devices other than those mentioned above is subject to authorization by the Ministry of Health.

To this end, the manufacturer, or company responsible for marketing a product, requests the authorization to conduct health advertising, submitting an application plus duty stamp with all the information about the company itself, the advertised product, the type of advertising and its means of communication.

With the Circular of 28 July 2010, the Ministry of Health has activated, as of October 1 2010, an experimental procedure for the licensing of advertising via certified PEC e-mail. The experimental phase was completed on the 31 December 2010. Following a satisfactory evaluation of the trial period the Ministerial Department has confirmed the possibility of companies involved of sending the requests for authorization of health advertising via PEC, as opposed to the traditional paper process. The Ministry invites companies to favour this procedure, in that it is able to guarantee greater speed in receipt of the applications and the communication of ministerial measures.

With regard to this sector, Di Renzo Regulatory Affairs has set up a unit consisting of a pharmacist and an administrative employee.

The services we are able to offer are:

• Consultancy on current legislation
• Examination of the documentation provided by the company, before the submission to the Ministry of Health
• Preparation of the application, submission to the Ministry of Health and tracking the bureaucratic procedure
  Graphic design, if required