Medicinali e dispositivi veterinari

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Procedure

The procedure refers to the authorization to carry out health advertising of veterinary medicinal products not subject to medical prescription.

The authorization to carry out health advertising of veterinary medicinal products not subject to medical prescription is granted upon application, indicating the authorization type, veterinary medicinal product and the advertising type and medium.

Each application must refer to a single advertising, namely a single text (even if used for several advertising media, e.g. a text to be used as a roadside billboard or a poster at pharmacies). In the case of a tv or film commercial, the vignette with the ad sequencing envisaged must also be enclosed.

An advertising message can promote different products, provided that the holder is a single company.

The advertising media are identified according to the following types:
 

• short-film;
• broadcast;
• daily and periodical press;
• text at shops, e.g. signs/posters in the window, leaflets and flyers;
• roadside billboards and posters;

Internet (for the Social networks specify the type: Facebook -Instagram -YouTube channel).

Who can apply?

Marketing authorization holders of veterinary medicinal products, their legal representatives or delegated persons or companies.

What do I need?

The application is submitted by Certified E-mail (CEM) and the following must be provided:

• application for advertising with a self-declaration that the 16,00 Euro duty stamp has been paid (see template below); 
• copy of receipt of payment;
• copy of the marketing authorization Decree;
• copy of product information (package leaflet, labels and summary of product characteristics) in the latest approved version;
• copy of the advertising message stamped and signed;
• 1 duty stamp sent by self-certification or scanned.

Application form and guidelines

• Modello di autocertificazione (file format doc, file format odt)

How can I apply?

• Certified email (PEC)
  Certified email: dgsa@postacert.sanita.it
  Email subject: MDV-PUB-A01- application for health advertising, including the name of the product, type and the advertising medium
  Further instructions: This kind of submissione is allowed only by another Certified email.
  

How long does it take?

45 days from the application, excluding clock-stops (any interruptions of the authorization procedure to submit additions to documents).

Applications validated within 8 working days before the scheduled date of each meeting are subject to the evaluation of the Section for the granting of health advertising authorizations.

The Decree is valid for 2 years.

To extend the period of validity, an application must be submitted 90 days before the authorization expires. If the message is the same as the one approved, the authorization number remains unchanged.

The Decree, the extension note and the relevant annexes are provided by certified e-mail (CEM), where available, and by e-mail to the contact point designated by the company concerned.

How much does it cost?

Fee: 380,10 Euro for each marketing authorization, advertising message and type of advertising medium

Payment method

• Through online payment via the integrated Online Payment connected with PagoPA
  Causale: Health advertising (company name, product name, advertising medium).

How do I know the outcome?

• Certified email

Outcome Publication

not present

Relevant law

Go to Trovanormesalute

Contact us

• Referent Name: Luciana Bindi
  Address: Viale G.Ribotta 5, 00144 ROMA
  Email: l.bindi@sanita.it
  
• Referent Name: Lisa Recchia
  Address: Viale G.Ribotta 5, 00144 ROMA
  Email: l.recchia@sanita.it
  

Referent Office for Legal proceedings

Direzione Generale della Sanità Animale e dei Farmaci veterinari (DGSAF)
Ufficio 4 - Medicinali veterinari

Q&A

not present

Thematic site

• Recognition of health professions qualifications

Office

• Direzione Generale della Sanità Animale e dei Farmaci veterinari (DGSAF)

Data ultimo aggiornamento: 11 marzo 2024