WHODrug Cross Reference ATC 5
European Medicines Agency (EMA) requirements may be complied with by efficient assignment of the ATC 5th level codes.
To comply with European Medicines Agency (EMA) requirements, Article 57(2) of Regulation (EC) No 726/2004, marketing authorisation holders must submit to the EMA information on all medicinal products for which they hold a marketing authorisation in the EEA. Medicinal product data shall be submitted to the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) with the most specific ATC code. WHODrug Cross Reference (CR) ATC 5 can be used for efficient assignment of the ATC 5th level codes for XEVMPD submission.
WHODrug CR ATC 5 consists of a mapping table (ASCII text file) with the ATC level 5 code corresponding to each WHODrug code where applicable*.
Key Features
- Provides the connection between the available 4th level ATCs in WHODrug and 5th level ATCs based on the active ingredient given.
- 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.
- Ensures correct ATC 5th level assignments – 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 - WHODrug CR ATC 5 is only available as an add-on to an existing WHODrug Global subscription, it is not included in the WHODrug Global subscription nor can it be purchased without a subscription. For more information please contact us.
*Note that 5th ATC level assignments are not included in WHODrug Global for one main reason: ATC level five is used to identify active substances. Since not all active substances have an officially assigned ATC code, WHODrug utilises another feature to uniquely identify active substances –the Drug Code.