The Active Substance Master File (ASMF) is a document that the manufacturer of the active substance is required to submit to the Italian Medicines Agency (AIFA) in relation to the active substances contained in the medicinal products for which a marketing authorisation application is submitted. The ASMF shall contain all information concerning the active substance’s manufacturing process, characterisation and physico-chemical properties, as well as procedures and requirements for quality control and stability data.
For the compilation and submission of an ASMF and its subsequent updates, please follow the Guideline on Active Substance Master File Procedure - CHMP/QWP/227/02 Rev4/Corr https://www.ema.europa.eu/en/active-substance-master-file-procedure-scientific-guideline.
Applicants who intend to use the documentation relating to an ASMF in support of their marketing authorisation application, and applicants who submit an application for a marketing authorisation variation to introduce or amend an ASMF, shall be responsible, at the time of submitting such application, for verifying that the active substance manufacturer has already filed the ASMF and/or the documentation for its updating to AIFA. If the ASMF is missing, the MA/variation application is considered invalid.
In addition, marketing authorisation holders (MAHs)/applicants are informed that, in accordance with Directive 2001/83/EC as amended, the procedure for submitting the ASMF cannot be used for biological active substances.
The ASMF Holders will be required to submit ASMFs and relevant updates to the Marketing Authorisation Office as follows:
- use of the electronic Common Technical Document (eCTD) to organise the content of the ASMF into modules, sections and documents (further information is available at http://esubmission.ema.europa.eu/ectd/
- submission of the dossier and subsequent updates through the Common European Submission Portal (CESP). To register: https://cespportal.hma.eu/Account/Register
- confirmation of the successful submission to CESP by sending an e-mail to: email@example.com. In the subject of the e-mail, the following should be specified: MAH, active substance, type of submission, CESP submission ID.
ASMF holders are informed that, as of 9 November 2023, a single payment is due when the ASMF is submitted for the first time. Therefore, no further payments shall be due for the submission of subsequent ASMF updates, in line with Ministerial Decree of 13 September 2023 amending and supplementing Ministerial Decree of 6 December 2016. (per portale aifa inserire link alle tariffe)
Payment thereof shall be made exclusively through AIFA’s POL system.
Please see https://www.aifa.gov.it/tariffe
Once the regularity of the documentation submitted (first submission/update) has been checked or once the requests for clarifications/integration have been fulfilled, the Marketing Authorization Office will forward the “Communication of valid submission of an ASMF/ASMF update” together with the assigned identification code (Case number). This communication will be forwarded exclusively through the document registration and management system ("DocsPA") used by the Agency.
The payment of the stamp duty is no required.
Published on: 09 November 2023