Heads of Medicines Agencies (HMA): Changes in the Procedural guidance for validation in DCP and MRP - Input from the public consultation

 A proposal to clarify the technical validation in the CP, DCP and MRP was raised from industry through a Change Request to TIGes

Also, the need to simplify the technical validation for DCP and MRP was raised from the authorities with a proposal to leave the technical validation for RMS to handle

This was encouraged by CMDh and MA

The Procedural Advice for Automatic Validation needs to be updated and a proposal was published at the CMDh website for public consultation

To find more information please click here

http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/About_CMDh/Contact_with_Representatives_Organisations/Meeting_IP_Nov_2011/SE-Technical_validation.pdf