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Updating of summaries of product characteristics due to changed ATC codes for 2014

15 January 2014, Updated 26 February 2014

Marketing authorisation holders of medicinal products authorised under the Decentralised Procedure, the Mutual Recognition Procedure as well as the National 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, the Mutual Recognition Procedure or the National 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