Published Date: 15.07.2014 Table of Contents Chapter I. 2 Introduction. 2 1.1 Introduction. 2 Chapter II. 2 Structures and Processes. 2 2.1 Principles for assigning additional monitoring status to a medicinal product 2

APPENDIX I – Definitions Published Date: 12.06.2014Table of Contents EU Reference date, Union reference date. 3 Adverse event (AE), Adverse experience. 3 Adverse reaction, Adverse drug reaction (ADR), Suspected adverse (drug) reaction, Adverse

Publish Date: 12.06.2014 İçindekilerAB Referans tarihi, Birlik referans tarihi ................................................................................... 3Advers olay (AO), Advers deneyim........................................................................................... 3Advers reaksiyon, Advers ilaç reaksiyonu (AİR), Şüpheli advers (ilaç) reaksiyon, Advers etki,İstenmeyen etki .......................................................................................................................... 3Asgari raporlanabilirlik kriterleri ...............................................................................................

Publish Date: 12.06.2014 İyi FarmakovijilansUygulamaları (İFU)KılavuzuModül I – Advers ilaçreaksiyonlarının yönetimi vebildirimiTÜRKİYE İLAÇ VE TIBBİ CİHAZ KURUMU12.06.20141İçindekilerBÖLÜM IAmaç, Kapsam ve Tanımlar1.1. Amaç ……………………………………………………………………………………... 41.2. Kapsam …………………………………………………………………………………... 41.3.Tanımlar ………………………………………………………………………………….. 41.3.1. Advers reaksiyon ………………………………………………………………... 41.3.2.

Published Date: 12.06.2014 Table of Contents Chapter I Purpose, Scope and Definitions 1.1       Purpose  4 1.2       Scope  4 1.3       Definitions. 4 1.3.1       Adverse reaction. 4 1.3.2       Individual case safety report (ICSR) 4 1.3.3