Medical device’s advertising addressed to public (called “health advertising”) is subject to authorization by Ministry of Health, pursuant to art. 21 of Legislative Decree no. 46/97 and subsequent amendments.
Companies can make health advertising, after asking for permission, if medical devices are used without prescription or assistance from medical personnel or other healthcare professional. For latter it is forbidden to advertise to public.
Manufacturer or marketing manager must make an application with a revenue stamp addressed to Ministry of Health, which contains all the data of applicant, the characteristics of medical device that Companies want to advertise and the type of publicity. This application must be accompanied by the advertising printed matter and by medical device’s technical documentation. Costs for Ministry of Health are Euro 314.54 and will vary if advertises messages regard more medical devices, or if they will be transmitted through multiple media (e.g. television – press – window signs – etc…). Authorization for health advertising is achieved after about 45 days, after submission of the request (through opt-out procedure). Within this period, Ministry of Health may requires changes to the advertising message, or additional specifications to the documentation. Authorizations are valid for 24 months (Article 118, paragraph 12 of Decree. 219/06).
Assistance provided by Qua.Ser Ltd to Companies requesting health advertising consists of the following activities:
- preparation of all necessary documentation;
- providing all instructions for due payments;
- recommendation on any changes concerning the advertising;
- delivery of documents to the Ministry of Health;
- assistance to Ministry of Health if requested.