Regardless of the format chosen – press, social network, website, radio or short film – advertising of medical devices aimed at the public must be authorised by the Ministry of Health.

The approval process lasts 45 days and envisages the payment of a fee of € 380.10 for each text, for each product and for each means of dissemination.
Therefore: 1 press text, relating to 3 products, 1 means of dissemination (for example post on social networks) = € 1,140.30

SANCTIONS AND RULES

In order to obtain authorisation, compliance with requirements that vary according to the means of dissemination is essential.
To clarify, the Ministry of Health has published 7 documents on different dates, each of which adds information to the previous one. All 7 are therefore valid at the same time and available here.

In detail:

• • Guidelines of 17/02/2010
• • Guidelines of 28/03/2013
• • Guidelines of 20/12/2017
• • Use of testimonials of 20/12/2017
• • Integration for advertising on Facebook of 24/10/2019
• • Advertising of condoms of 06/10/2020
• • Statement advertising surgical masks of 21/10/2020

Clearly it is impossible to hope to summarise its content in an article, but it is important to know that the level of detail of the specifications in the guidelines is quite high.
For example, if advertising for medical devices is done with a Facebook post, reactions and comments must be disabled. Or again, advertising on Instagram can only be done with swipe up stories that refer to the manufacturer’s site. And not with a post.

In short, to avoid submitting non-compliant texts to the Ministry or managing advertising in the wrong way, we suggest that you contact us.

Although many companies do not even know that they have to ask for authorisation, not having it exposes them to a considerable economic risk. Advertising medical devices without authorisation can result in a penalty from € 2,582 to € 15,493 (Legislative Decree 219/2006).

VALIDITY

Legislative Decree 219/2006 also specifies the period of validity of the authorisation, equal to 2 years.
It remains valid that the Ministry may consider a shorter period of validity applicable for example in the event that the text contains the words “new” or “novelty”; in which case the authorisation has a duration of one year.

HOW TO APPLY

The detailed procedures are specified on the website of the Ministry of Health, and a request can be send by certified e-mail.

Address: dgfdm@postacert.sanita.it
Subject: DM-PUB-A01
Also insert in the subject line: Request for authorisation of health advertising, product name, means of dissemination, company protocol

To attach to the request: copy of the payment certificate, stamped copy of the advertising text with two € 16 revenue stamps, copy of the identity card of the person submitting the request.

ADVERTISING OF HEALTHCARE PROFESSIONALS

Only advertising addressed to the public requires authorisation. Advertising addressed to health professionals does not.

In fact, a pop-up window often appears when visiting the website of a manufacturer of medical devices, that says: “I declare that I am a health worker.”
One click and you’re in.