Updating of summaries of product characteristics due to changed ATC codes for 2016

Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2016.

The changes are implemented pursuant to WHOCC’s updates of the ATC codes for human medicinal products and can be found in Medicine Prices from 1 February 2016 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 national procedure, the decentralised procedure, or the mutual recognition procedure, the marketing authorisation holder must apply for an update of the summary of product characteristics, see the Guideline on variations to marketing authorisations for medicinal products