Early Access to Medicines Scheme (EAMS) Abridged Risk Management Plan (RMP) Template - Version 1.1 - Guidance Structure

Sep 2, 2026

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Guidance explains how to prepare an abridged Early Access to Medicines Scheme (EAMS) risk management plan (RMP) for medicines used under EAMS in the UK. It clarifies when an abridged RMP can be used (when an approved UK RMP exists for the relevant authorised indication) and when the full EAMS RMP template is required. The document outlines required RMP sections, including product overview, safety specification focusing on Module SVIII, an EAMS-specific pharmacovigilance plan, further efficacy study plans when required by MHRA, and risk minimisation with cross-references to the approved RMP.

LanguageEnglish

CategoryForms

FormatDOCX

Pages22

Reading Time8 min

AccessFree to download

Table of Contents

Part I: Product(s) Overview

Part II: Safety specification

Part II: Module SVIII - Summary of the safety concerns

Part III: Pharmacovigilance Plan

Part IV: Plans for further efficacy studies

Part V: Risk minimisation measures

Part VI: Annexes

Guidance on the Early Access to Medicines Scheme (EAMS) abridged risk management plan (RMP) All EAMS applications require an EAMS RMP. The template below is for an abridged EAMS RMP and can be used in the case that there is an RMP approved for the product in an authorized indication in the UK that is relevant to the use through EAMS. This would usually apply for a drug authorized for marketing for which the important safety concerns can be expected to be the same to those in its use through EAMS. The RMP approved for the authorized product in the UK must be submitted alongside the abridged EAMS RMP. In the case where the drug does not have a marketing authorization in the UK in an appropriate indication, the full EAMS RMP template should be used In brief, the structure of the EAMS RMP is as follows Part I: Product overview Part II: Safety specification – only “Module SVIII - Summary of the safety concerns” is required in this Part Part III: Pharmacovigilance Plan – this section is specific for EAMS Part IV: Plans for further efficacy studies - This section must be completed in the event that any efficacy or effectiveness studies are required by MHRA as part of the terms of the positive opinion. If such post-opinion studies are not a requirement, a simple cross reference to the accompanying approved RMP for the marketing authorisation can be accepted. Part V: Risk minimization plan – If routine risk minimization only is needed and no additional risk minimisation, a simple cross reference to the accompanying approved RMP for the marketing authorisation can be accepted. Part VI: Annexes – Any annexes which are identical to those in the accompanying approved RMP for the marketing authorisation can be omitted and replaced with a cross reference to the relevant annex of the accompanying approved RMP. Blue highlighting – indicates a notable difference compared with the EU RMP rev 2 In addition to the green text in the template below, please refer to MHRA guidance on pharmacovigilance procedures, GVP V, the EU RMP rev 2 template and the HYPERLINK "https://www.gov.uk/guidance/apply-for-the-early-access-to-medicines-scheme-eams" Guidance on applying to the EAMS for further reference. Early Access to Medicines Scheme (EAMS) abridged risk management plan (RMP) template (version 1.1) Data lock point for this RMP Version number Date of final sign off Version number of last agreed RMP: Version number QPPV Name QPPV Signature Table of Contents TOC \o "1-3" \h \z \u HYPERLINK \l "_Toc59634426" Table of Contents PAGEREF _Toc59634426 \h 3 HYPERLINK \l "_Toc59634427" Part I: Product(s) Overview PAGEREF _Toc59634427 \h 4 HYPERLINK \l "_Toc59634428" Part II: Safety specification PAGEREF _Toc59634428 \h 5 HYPERLINK \l "_Toc59634429" Part II: Module SVIII - Summary of the safety concerns PAGEREF _Toc59634429 \h 5 HYPERLINK \l "_Toc59634430" Part III: Pharmacovigilance Plan PAGEREF _Toc59634430 \h 6 HYPERLINK \l "_Toc59634431" III.1 Routine pharmacovigilance activities PAGEREF _Toc59634431 \h 6 HYPERLINK \l "_Toc59634432" III.2 Additional pharmacovigilance activities PAGEREF _Toc59634432 \h 7 HYPERLINK \l "_Toc59634433" III.3 Table of on-going and planned additional PhV activities PAGEREF _Toc59634433 \h 7 HYPERLINK \l "_Toc59634434" Part IV: Plans for further efficacy studies PAGEREF _Toc59634434 \h 8 HYPERLINK \l "_Toc59634435" IV.1 Summary of Post-opinion efficacy development plan PAGEREF _Toc59634435 \h 8 HYPERLINK \l "_Toc59634436" Part V: Risk minimisation measures PAGEREF _Toc59634436 \h 10 HYPERLINK \l "_Toc59634437" V.1 Summary table of risk minimisation measures PAGEREF _Toc59634437 \h 10 HYPERLINK \l "_Toc59634438" V.2 Details of Additional risk minimisation measures (if applicable) PAGEREF _Toc59634438 \h 10 HYPERLINK \l "_Toc59634439" Part VI: A

FAQs

When can the abridged EAMS RMP template be used instead of the full template?

The abridged template can be used when an RMP is already approved for the product in a relevant UK authorised indication and the important safety concerns are expected to be the same under EAMS.

What is required in Part II for the abridged RMP?

Part II requires only Module SVIII - Summary of the safety concerns, with a summary of each safety concern identified in previous Modules of Part II.

What determines whether Part IV must include plans for further efficacy studies?

Part IV must be completed if MHRA requires efficacy or effectiveness studies as part of the terms of the positive opinion; otherwise a cross-reference to the accompanying approved RMP for marketing authorisation can be used.

Sep 2, 2026

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