The CMDh has approved a new template for applicants to provide their responses during DC procedures
The CMDh guidance document “Applicant’s Response document in Mutual Recognition and Decentralised Procedures for Marketing Authorisation Applications” has been updated to reflect the use of the new template. According to chapter “Presentation / content of the Response document” – the applicant should use the dedicated CMDh template “The applicant’s joint Quality/Non-clinical/Clinical/Module 1 response” for each response prepared throughout the DCP.
Both the updated guideline and the new template were published on the CMDh website on March 3, 2022. The new template allows the applicant to provide responses to clinical, nonclinical, quality and Module 1 issues in one joint document or as separate documents per Module. Remember that the response document(s) should be provided both in pdf format in Module 1 and in Word format in the ‘working document’ folder.
The document provides guidance on how to use the new template and will become mandatory as of 1 April 2022 for all upcoming responses, also for already ongoing procedures.
If you have any questions about obtaining a Marketing Authorisation (MA) in DCP procedure or any other Regulatory Affairs topics, please contact us.