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Last modified date: 11 March 2024

Authorization to carry out health advertising of veterinary medicinal products


ProcedureProcedure

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?Who can apply?

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


What do I need?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 guidelinesApplication form and guidelines


How can I apply?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?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?How much does it cost?

Rate: 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?How do I know the outcome?

  • Certified email

Outcome PublicationOutcome Publication

not present


Relevant lawRelevant law

  • Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC
  • Legislative Decree n. 218, 7 December 2023 "Adaptation of national legislation to the provisions of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC, pursuant article 17 of  law 4 agosto 2022, n. 127".
  • Guidelines of 17 February 2010 on the use of new media for health advertising;
  • Note of 9 November 2012 on the advertising of veterinary medicinal products – new procedure;
  • Note of 26 May 2014 on the advertising of veterinary medicinal products through Internet;
  • Note of 20 March 2015 on the advertising of veterinary medicinal product: modification of deadlines for the issuance of advertising message authorizations;
  • Note of 31 October 2016 the advertising of veterinary medicinal product: current procedure update;
  • Note of 13 April 2017: issuance of single copy authorization documents
  • Note of 6 April 2018: update of guidelines to the use of new media in health advertising of veterinary products
  • Note of 1 August 2019: advertising of veterinary medicinal product
  • Note of 18 July 2022: advertising of veterinary medicinal product: primacy of sales - use of the term effective
  • Note of 27 July 2023: advertising of veterinary medicinal product - use of the term protection and similar

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Contact usContact 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 proceedingsReferent Office for Legal proceedings

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



TemiThematic Site


Referent Office for Legal proceedingsOffice