Europe – European Medicines Agency active-substance-master-file-number request form

Mandatory administrative details for obtaining an EMEA ASMF number

Where the ASMF holder already holds an ASMF that has been assigned an EMEA ASMF reference number and wishes to register another ASMF for the same active substance, e.g. a substantially different route of synthesis (see Annex 1 Assignment of a new ASMF Reference Number), this should also be clearly stated in the Additional information field…