Medicines Healthcare Products Regulatory Agency
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.
All sections (i.e. the questions, the applicants response, and the assessors 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.