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Feedback to patient ADR reports

This document aims to provide National Competent Authorities (NCAs) with a proposed text for feedback to patients’ Adverse Drug Reaction (ADR) reports.

What does this document cover?

1. Introduction

2. Feedback to patients – deliverable overview

3. Acknowledgement, general and individual feedback

 - Acknowledgement feedback

 - General feedback

 - Individual feedback

4. Member State examples

5. Lareb research of feedback to patients

6. Feedback to patients – proposed text

Annexes: Feedback examples from Netherlands Pharmacovigilance Centre Lareb, State Institute for Drug Control (SUKL), Norwegian Medicines Agency (Statens legemiddelverk, NOMA), Hungarian National Institute of Pharmacy and Nutrition (OGYÉI)

Target audience

The target audience is primarily pharmacovigilance staff working at EU NCAs.


15 page pdf.

Click here to access this document.

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