CMDh News - September 2015
At its September 2015 meeting, the Co-ordination Group for Mutual Recognition Procedure and Decentralised Procedure for Human Medicinal Products (CMDh) endorsed by consensus the PRAC recommendation for variations to marketing authorisations for several active substances.
The CMDh adopted the PRAC review conclusions for several active substances requiring changes in the product information or introduction of other risk minimisation measures.
Following the publication of the list of safety concerns per approved Risk Management Plans (RMPs) of active substances per product in April, the CMDh agreed to update the related cover note to provide guidance for Member States and MAHs on how to submit information for updates of the list. Templates for providing the information will also be made available.
Further information is accessible under the link below.