EN PL

MHRA: Publication of assessment reports for European Article 45 and 46 paediatric work-sharing procedures

13.08.2010
In July/August 2010, CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures) published paediatric assessment reports following completion of eight Article 45 work-sharing procedures. The work-sharing assessment reports include recommendations for changes in the product information for the several active substances.