On its website the Danish regulatory agency has recently addressed the difficulties marketing authorisation holders generally have to face concerning updates of an ASMF. According to the agency, when a variation application is submitted, this is - in most cases - only for the open part (applicant's part) of the ASMF and not for the restricted part. One of the reasons for this may be that the API supplier has failed to inform the marketing authorisation holder of changes made in the manufacturing process.
The Danish Agency recommends applying for changes to an ASMF as a single type II variation. This allows the processing of all changes to both the open part and the restricted one to be applied for simultaneously in one single application. Situations are thus avoided in which the applicant's part and the restricted part within the same version of the ASMF are not approved at the same time. Any unnecessary discussion about categorisation of changes is avoided.
The agency stresses how important cooperation between the marketing authorisation holder and the API manufacturer is: indeed, both are obliged to precisely describe the changes and the different versions. In cases with no changes to the restricted part, the marketing authorisation holder must clearly state which version of the restricted part the modified applicant's part belongs to.
To access the Danish Agency website and the article please see "Obligations regarding updates of Active Substance Master Files (ASMF/DMF)".
Note: The ECA Conference "Handling Changes and Variations" on 15/16 March in Vienna, Austria, will discuss the most significant aspects of the European Variation Regulation.
The question of ASMF and DMF updates will be addressed during the ECA Course "CTD, CEP and ASMF" on 17/18 April 2012 in Heidelberg, Germany.
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)