EMA fields in every export
The medicine record covers the medicine name, international non proprietary name, active substance, therapeutic area, ATC code where published, marketing authorisation holder, authorisation status, authorisation date and the procedure type.
Status history is kept rather than overwritten. A medicine that was authorised, then suspended, then reinstated has a history that a current status field destroys, and the transitions are precisely what regulatory and competitive teams watch for.
Document records carry the document type, title, publication date and the medicine it belongs to. Where a client needs the content, assessment report text is extracted with its section structure preserved, because the indication section and the discussion section answer different questions and a flat text blob answers neither well.
Safety information is collected as its own record type: referrals, their trigger, the committee involved and the outcome with its date.
Provenance is recorded per row: the page or document each value came from, so any value can be traced back to where it was published.