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Authorization to carry out health advertising of veterinary medicinal products


Italiano|English

La proceduraProcedure

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).

Chi può richiederloWho can apply?

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

Cosa serve per richiederloWhat 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.

ModuliApplication form and guidelines

Come si presenta la richiestaHow 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.

Quanto tempo ci vuoleHow 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.

Quanto costaHow much does it cost?

Fee: 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

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

Come viene comunicato l'esitoHow do I know the outcome?

  • Certified email

Dove viene pubblicato l'esitoOutcome Publication

not present

NormativaRelevant law

Go to Trovanormesalute

ContattiContact 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

Ufficio responsabile del procedimentoReferent Office for Legal proceedings

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

FAQQ&A

not present

TemiThematic site

Ufficio responsabile del procedimentoOffice


Data ultimo aggiornamento: 07 dicembre 2022


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