MAA
MAA short for Marketing Authorization Application
MAA short for Marketing Authorization Application
Marketing Authorisation Holder (MAH)
In matching IDMP´s required data with customer´s data there will be several systems identified which hold IDMP relevant data.
In case of Marketing Authorisation Holders (MAHs) this will be Regulatory Information Systems (RIMs) which must be focused on. The RIM will be source for most of regulatory input, partly for substances, marketing and a small part of the packaging data. But more details may be needed from other systems.
Master Data Management will help assembling these data from the different sources, augmenting them by further data, preparing them for submission and matching the internaly used vocabularies against IDMP´s controlled dictionaries.
IDMP will not only become standard for regulatory purposes. Furthermore it will also become the standard model used for systems in Pharmaceutical Information Systems, Drug Dictionaries, Clinical Decision Support, Hospital Information and Patient Information. So the impact of IDMP on providers of such systems is significant!
It is important to create a common understanding for the project across the company. So typically all departments should be involved. The steps could be:
The ISO IDMP standard will not only be the standard for regulatory affairs, but it will also become the standard model for pharmaceutical information systems used in in public information systems for patients, in clinical decision support in hospitals and in e-health.
IDMP1 offers structured data for medicinal products mapped against the IDMP´s required structure and controlled vocabularies. Its IDMP Drug Dictionary is an excellent starting point to define the structured representation of S(m)PC documents´content (e.g. for clinical particulars).