Criteria for when a seperate ASMF/DMF should be submitted

Criteria for when a Separate ASMF/DMF should be Submitted

A common question often arises as to what differences in API-details may be included in a single ASMF/DMF and under what circumstances should a separate ASMF/DMF be submitted.

The IPRP performed a Gap Analysis of the ASMF systems in the various IPRP jurisdictions and a questionnaire was also circulated among members to ascertain the criteria for issuing a new ASMF.

The following common criteria have been identified by the IPRP for when a separate ASMF/DMF should be submitted. The list is indicative only and not exhaustive.  Ultimately, the legislation or regulation in force in each country takes precedence.  Nonetheless, this information is deemed useful to ASMF/DMF holders and other regulators.