Marketing autorisation Status
Published Thursday June 11 2026

To support a scientifically robust and consistent assessment of medicinal products within the ATC/DDD methodology, the assessment approach for requests involving medicinal products and marketing authorisation (MA) status has been further refined.

Requests for ATC code assignment are assessed based on medicinal products with marketing authorisation (MA) granted by a competent medicines regulatory authority.

For the establishment of a complete ATC code (at the fifth level), medicinal products with granted MA are required.

To facilitate timely assignment of a complete ATC code following MA approval, requests based on medicinal products for which an MA application has already been submitted may still be considered for possible classification within an existing ATC fourth level, particularly where sufficient supporting information is available (e.g., complete Summary of Product Characteristics (SmPC) or equivalent documentation). In such situations, applicants are subsequently requested to provide information regarding the outcome of the MA application. Where MA is granted, establishment of a complete ATC code may subsequently be considered where relevant.

Requests involving DDD assignment are assessed based on medicinal products with a granted marketing authorisation.

If you have questions or require further clarification regarding the ATC/DDD methodology, submission process, or documentation requirements, please feel free to contact the ATC/DDD Centre at whocc@fhi.no.