CTD Non-Clinical Yes No No, N/A Comments module requested 4 Studies/literature data Module 5 CTD Clinical Yes No No, N/A Comments module requested 5 Studies/literature data Specific NATIONAL REQUIREMENTS (cf. Data requested for New Applications in the MRP and DCP”) “Additional YES NO Comments: Status of the application
CTD module Non-Clinical Yes No No, requested N/A Comments 4 Studies/literature data Module 5 CTD module Clinical Yes No No, requested N/A Comments 5 Studies/literature data Specific NATIONAL REQUIREMENTS (cf. “Additional Data requested for New Applications in the MRP and DCP”) YES NO Comments: Status of the application
CMDh_368_2017_Rev01_12_2017.docx