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.
The source of the news: http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON090982
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