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Submission of an Active Substance Master File (ASMF) for a pharmacologically active substance for veterinary use


La proceduraProcedure

For the purposes of obtaining the marketing authorization for a veterinary medicinal product, the applicant shall submit, for the active substances contained in it, all the information on the manufacturing process, characterization and physical and chemical properties, quality control procedures and requirements, stability data. The manufacturer of the active substance can directly provide the Ministry of Health with such information through document “Active Substance Master File (ASMF)”.

Chi può richiederloWho can apply?

Manufacturers of active substances, their legal representatives, natural and legal persons holding the documentation.

Cosa serve per richiederloWhat do I need?

  • Application with duty stamp on the application/cover letter;
  • Proof of the payment of the fee;
  • Documentation supporting the application: ASMF (open part, closed part, quality overall summary and the expert CV);
  • Letter of access (only in case the ASMF is related to the veterinary medicine).

Where the manufacturer submits the “Active Substance Master File (ASMF)”, it is possible not to provide the applicant/marketing authorization holder of the veterinary medicinal product with detailed information on the following:

a) detailed description of manufacturing process;

b) description of quality control during manufacture;

c) description of process validation.

In this case, the manufacturer shall confirm in writing to the applicant that he will ensure batch-to-batch consistency and will not modify the manufacturing process and the specifications without informing the applicant. The information and documents supporting the request for such modification shall be submitted to the competent authorities, as well as to the applicant if they concern the section of the Active Substance Master File provided to the latter.

ModuliApplication form and guidelines

Come si presenta la richiestaHow can I apply?

Quanto tempo ci vuoleHow long does it take?

30 days

If the documentation presented is not complete and the deposit fee is not paid, a letter of request for integration of documentation and/or fee will be sent.

Nel caso in cui la documentazione risulti completa sarà inviata la lettera di conferma di deposito del "Master File della Sostanza Attiva".

Quanto costaHow much does it cost?

Fee: Euro 524,20

Stamp duty: 1 marca da € 16,00 sulla domanda

Payment method

  • Through online payment via the integrated Online Payment connected with PagoPA
    Causale: Assessment and keeping of the production and control documentation for a pharmacologically active raw material manufactured in Italy and abroad.

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

  • Certified email

Dove viene pubblicato l'esitoOutcome Publication

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NormativaRelevant law

Go to Trovanormesalute

ContattiContact us

  • Referent Name: Anna Soriero
    Address: Viale G. Ribotta 5, 00144 Roma
    Telephone: 06.59943601
    Email: a.soriero@sanita.it
  • Referent Name: Loredana Tagliaferri
    Address: Viale G. Ribotta, 5 00144 Roma
    Telephone: 06.59942539
    Email: l.tagliaferri-esterno@sanita.it

Ufficio responsabile del procedimentoReferent Office for Legal proceedings

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


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App Online

TemiThematic site

Ufficio responsabile del procedimentoOffice

Data ultimo aggiornamento: 11 luglio 2022