Updating of summary of product characteristics prompted by changed ATC codes for 2010

03 March 2010

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 2010. The changes have been implemented pursuant to WHOCC’s updates of the ATC codes for human and veterinary medicinal products.

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.

For further information, please contact the Licensing Division at god-afdelingspostkasse@dkma.dk.

Danish Medicines Agency, 22 February 2010