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"A"

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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