Marketing authorisation status in the assessment of ATC and DDD requests
Published Thursday June 11 2026

To support a scientifically robust and consistent assessment of requests within the ATC/DDD methodology, the criteria applied in relation to the marketing authorisation (MA) status of the medicinal products on which an ATC/DDD request is based have been updated.

Requests for ATC code assignment may be based on one or more medicinal products for which MA has been granted or for which an MA application has been formally submitted to a competent medicines regulatory authority. Different considerations apply depending on whether MA has already been granted or an MA application remains under assessment.

For the establishment of a complete ATC code at the fifth level to be considered, the request must be based on one or more medicinal products for which MA has been granted.

To facilitate the timely establishment of a complete ATC code after MA has been granted, requests based on medicinal products for which an MA application remains under assessment by a competent medicines regulatory authority may also be considered for classification within an existing fourth-level ATC group. Such an assessment will normally require sufficient supporting information, such as the latest available complete version of the Summary of Product Characteristics (SmPC), prescribing information (PI), or equivalent product information.

In such cases, applicants should provide an update once the outcome of the MA application is known. Where MA is subsequently granted, the establishment of a complete ATC code at the fifth level may then be considered.

Requests involving DDD assignment may be assessed only when they are based on one or more medicinal products for which MA has been granted.

Requests for ATC code assignment cannot be considered if no MA application has been formally submitted to a competent medicines regulatory authority for any of the medicinal products on which the request is based.

If you have questions or require further clarification regarding the ATC/DDD methodology, the submission process, or the relevant documentation requirements, please contact the ATC/DDD Centre at whocc@fhi.no or WHO at atc-ddd@who.int.