CRED 8 Presentations

01/07/2024

Module 1.0 Notes to Reviewers (NtR) (CP, MRP/DCP)

A NtR is not mandatory but can be provided with the following intention: i) to highlight information that will help navigation throughout the dossier for specific modules. ii) to provide the rationale for any sections that have not been completed or deemed not applicable for the MAA. Other items that can be mentioned in a NtR: • Approval of trade name (through Name Review Group (NRG) if CP or nationally if MRP/DCP). • Data which will be submitted during review with prior agreement from the EMA if CP/other HAs if MRP/DCP. • Minor errors/corrections which came to light after reports had been finalized. • Anything that is non-standard within the submission that needs further explanation.

The Organisation for Professionals in Regulatory Affairs

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Module 1.1 Table of contents Module 1.2 Application form

Table of contents is not required to be created separately for eCTD submission as inherent in the eCTD backbone. Application form (eAF) is the same for CP and MRP/DCP: • Follow EMA guidance notes before you complete each section for CP ( Module 1 - Administrative information application form (europa.eu) ) and Heads of Agencies MAA User Guide ( Heads of Medicines Agencies: eSubmission (hma.eu)) for MRP/DCP. • It is a good practice to validate the electronic application form to ensure that all mandatory fields are completed. • Need to give a clear picture of all manufacturing and packaging sites and the functions which take place at each site. • Many annexes required – justify any omissions in Notes to Reviewers. • Please note that DADI (Digital Application Dataset Integration Project) is replacing current eAFs with new web-forms. Go live was 4 Nov 2022. CAP Variations to start 6m transition period Q2 2024 then mandatory from Q4 2024. (http://esubmission.ema.europa.eu/cessp/cessp.htm)

The Organisation for Professionals in Regulatory Affairs

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