European Medicines Agency (EMA) requirements may be complied with by efficient automation of the ATC 5th level assignment.
To comply with European Medicines Agency (EMA) requirements, WHODrug Cross Reference (CR) ATC 5 may be used for efficient assignment of the ATC 5th level codes.
WHODrug CR ATC 5 consists of a mapping table between the WHODrug codes and ATC 5th level codes. The product delivers the ATC level 5 code corresponding to the WHO Drug code and also indicates where no fifth level ATC code is assigned.
Complies with EMA regulatory requirements – EMA’s article 57 requires the assigned ATC code to be on the most specified level; where applicable the 5th level is required to be assigned.
Increases efficiency in XEVMPD submission.
Builds automated assignment of ATC code on the 5th level – with WHODrug Cross Reference ATC 5 you can set up automated assignments of ATC 5th level codes in the XEVMPD drug classification field.
Ensures correct ATC 5th level assignment – WHODrug Cross Reference ATC 5 ensures and follows the requirements for article 57 as well as the guidelines from the WHO Collaboration Centre for Drug Statistics Methodology.
Please note- This is not a stand-alone product, and is available only with a subscription to WHODrug Global