Marketing authorisation holders of medicinal products authorised under the Decentralised Procedure and the Mutual Recognition Procedure should be aware that some ATC codes have been changed in 2014.
The changes are implemented pursuant to WHOCC’s updates of the ATC codes for humane medicinal products and can be found in Medicine Prices from 20 January 2014 as well as updates of the veterinary ATC codes that can be found in Medicine Prices at a later time.
If changes have been made to the ATC code or text of a medicinal product authorised under the Decentralised Procedure or the Mutual Recognition Procedure, the marketing authorisation holder must apply for an update of the summary of product characteristics, cf. the Guideline on variations to marketing authorisations for medicinal products