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)”.
Manufacturers of active substances, their legal representatives, natural and legal persons holding the documentation.
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.
Application form and guidelines
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".
Fee: Euro 524,20
Stamp duty: 1 marca da € 16,00 sulla domanda
Payment method
not present
Go to Trovanormesalute
Referent Office for Legal proceedings
Direzione Generale della Sanità Animale e dei Farmaci veterinari (DGSAF)
Ufficio 4 - Medicinali veterinari
not present
App Online
Thematic site
Office
Data ultimo aggiornamento: 11 luglio 2022