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

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)”.

An ASMF can only be submitted in support of an MAA or MAV. The submission of the relevant documentation by the ASMF holder to the National Competent Authority must be synchronised to arrive at approximately the same time as the MAA or the MAV i.e. not more than one month before and not after the intended MAA/MAV submission date.

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

• 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.

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.

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.

If the documentation is complete, a letter confirming the deposit odf the Active Substance Master File will be sent.

• 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 7 December 2023, no. 218 "Adaptation of national legislation to the provisions of 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, pursuant article 17 of  law 4 agosto 2022, n. 127".