What does ASMF mean in UNCLASSIFIED

An Active Substance Master File may only be submitted by the manufacturer or one of its legal representatives. The applicant must have full responsibility for the quality and safety of all active substances contained in a medicine.

A list of documents required to be included in the ASMF will need to be submitted along with an accompanying cover letter in line with EMA requirements. After submission, EMA will review all documentation within 40 days and may request further information before deciding whether to accept or reject it.

An ASMF should be updated any time there are changes made to the manufacturing process or analytical procedures, or if new information becomes available that could impact on product quality or safety. It should also be reviewed at least once a year to ensure accuracy and compliance with relevant regulations and best practices.

An ASMF must provide detailed information on how active pharmaceutical ingredients are manufactured, controlled and analyzed during each stage of production. It should also include laboratory data demonstrating that raw materials comply with regulatory standards, as well as stability data showing that finished products remain safe and effective over their shelf life.

If an ASMF is rejected by EMA due to insufficient information or incorrect data then a re-submission must be made outlining amendments necessary for acceptance within 30 days from rejection date. Failure to do so risks having applications delayed or rejected altogether.

Yes - The European Medicines Agency has developed detailed guidance on what is needed when submitting an ASMF including full instructions on writing cover letters and compiling documents correctly in accordance with their requirements. It can also help applicants avoid potential pitfalls associated with incorrect submissions which risk delay or refusal of applications.

After being received by EMA, it typically takes up to 40 working days for them to assess whether it meets their criteria before making either acceptance or rejection decision known via official confirmation letter.

Yes – There is usually a fee payable directly to EMA upon acceptance of your files. The exact amount depends on nature/complexity/volume involved but tends not exceed EUR 4200 per file.