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Two CMDh guidance documents recently changed

Applicant’s response template

The CMDh recently discussed and agreed a new template for applicants to provide their responses during DCPs. The use of the template became mandatory as of 1 April 2022 for all upcoming responses, also for already ongoing procedures. 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. The response document(s) should be provided both in pdf format in Module 1 and in current Word format in the working doc folder. Guidance on the use of the new template has been included in the document. The CMDh guidance document “Applicant’s response document in MRP and DCP for MAAs” has also been updated to reflect the use of the document. It is foreseen that the use of the new template will facilitate the work of applicants and of the RMS.

The new template was published on the CMDh website:

CMDh_436_2022_clean_Rev.0_2022_03_-_Joint_response_template_for_the_applicant_format_corrected.docx (live.com)

 

RMS Validation Checklist in DCP

The CMDh recently discussed and agreed an update of the RMS validation checklist in DCP. The checklist has been amended to take into account the updated application form concerning a section on medical devices and companion diagnostics and to include the latest information with regard to Brexit in line with Commission Notice 2021/C 524/02. Also, some editorial changes have been included.

The updated document was published on the CMDh website:

CMDh_368_2017_Rev.5_2022_03__RMS_variation_checklist_in_DCP.docx (live.com)