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Procedure

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)”.

Who can apply?

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

What 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.

Application form and guidelines

• EudraLex - Volume 6 Notice to Applicants and Regulatory Guidelines for Medicinal products for Veterinary use
• EudraLex - Volume 7 Scientific guidelines for medicinal products for veterinary use

How can I apply?

• On line
  App on line: Portale CESP
  

How 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".

How much does it cost?

Rate: 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.

How do I know the outcome?

• Certified email

Outcome Publication

not present

Relevant 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 implementing Directive 2004/28/EC as amended;
• Decree of the Ministry of Labour, Health and Social Politics of 5 November 2009, Annex 1;
• Ministerial Decree of 19 July 1993, Medicinal Products section, point 5 – Official Journal – General Series No. 172 of 24 July 1993.

Consulta il Trovanormesalute

Contact 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
  

Referent Office for Legal proceedings

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

FAQ

Not present

App Online

• Portale CESP

Thematic Site

• Medicinali e dispositivi veterinari

Office

• Direzione Generale della Sanità Animale e dei Farmaci veterinari (DGSAF)

Last modified date: 11 July 2022