Module 6

03/10/2024

MHRA Regulations for Pharmacovigilance EU Regulations for Pharmacovigilance Origin of Report Origin of Report

MRP/National

All Serious

CAP

MHRA Yellow Card

MHRA

All Serious

RMS*

All Serious ICH compliant electronic ICSR

All suspected ADRs

MRP/National

MHRA EMA

X

RMS X

No Need to Report

CAP

MR/National

All Serious Unexpected

Non-EU

Non-EU

CAP

19

* Also includes Referrals

19

Pharmacovigilance in a MAH

• MAHs aim to run efficient, effective, high quality pharmacovigilance systems which are compliant with regulatory obligations • MAHs must comply with the expectations of Health Authorities world wide • Quality improvements should be mainly internally driven through active gap analysis or optimisation detection via robust and meaningful metrics

Data for evaluation Robust decisions Implement actions

Independence Transparency Consistency

20

20

10