Form

Response template for applicants

Download MHRA's Request for Further Information (RFI) response template, with guidance on how to complete it.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 3 March 2023

Documents

Applicant's response template

MS Word Document, 65.5 KB

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Details

The applicant should prepare the responses to the MHRA questions as they have been introduced in the Request for Further Information (RFI) or the Commission on Human Medicines (CHM) Letter, by compiling them verbatim into this response template.

Please note that this response template is only required for initial marketing authorisation applications. However, applicants can also use the template for variation applications, if preferred.

All sections (i.e. the questions, the applicant’s response, and the assessor’s comment box) should be replicated as many times as the number of questions under each relevant heading. ASMF related questions (even if included in the list of questions) should be answered separately from this response template.

The response document should be provided both in PDF format in Module 1 and in current Word (. docx) format in the working documents folder, with a confirmation on the cover letter that both versions are identical.

Published 3 March 2023