active substance master file
- Guideline or reference source
- EMA Glossary of terms
- Definition
- Documentation providing detailed information on the manufacturing of the active substance of a medicine. NOTE: For the EU and CA, this is split in an Applicant's part and a Restricted part. An ASMF is similar to a US DMF for an active substance.
- Abbreviation for
- ASMF
- Related Term
- applicant's part
- drug master file
- European drug master file
- letter of access
- restricted part
- vaccine antigent master file
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