|Download document||Concept paper on the need to revise the guideline on the clinical development of fixed-dose combinations of medicinal products regarding dossier content requirements|
|Status||draft: consultation open|
|Consultation start date||01/03/2013|
|Consultation end date||31/05/2013|
|Email address for email@example.com|
The current guideline contains a section describing the legal basis applicable to fixed-dose-combination (FDC)-product marketing-authorisation application. There is a need to revise the current version of this guideline in order to suppress regulatory aspects from the guideline and restrict it to the scientific requirements for clinical development of fixed combinations, regardless of the chosen legal basis.