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Last modified date: 07 December 2022

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 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?

If the application is submitted by Certified E-mail (CEM), 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, or alternatively by regular mail.


How much does it cost?How much does it cost?

Rate: 380,10 Euro for each marketing authorization (e.g. spot-on solution, spray solution, collar etc.), any text for each type of advertising medium


Payment method

  • Bank Transfer
    Institute: Banca d'Italia
    Current account heading: Ministero della Salute Direzione Generale della sanità animale e dei farmaci veterinari
    IBAN: IT88Q 01000 03245 3480 20258211 – Bank Identifier Code (BIC):BITAITRRENT. For payments from abroad the BIC code must be specified.
    Reason for payment: 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 No. 193 of 6 April 2006 (published on the Official Journal No. 121 of 26 May 2006) implementing Directive 2004/28/EC on the Community code relating to veterinary medicinal products, as amended; 
  • Decree of 14 June 2002 (Official Journal, General Series, No. 193 of 19 August 2002) on the advertising to the general public of veterinary medicinal products;
  • 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 the Internet;

Consulta il Trovanormesalute

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