South Korea: Guidebook on Registration Data Sharing and Cost Sharing

South Korea: Guidebook on Registration Data Sharing and Cost Sharing

$ 649 affiliate publication
ADD TO CART
BUY NOW
Free Sample
Basic Information
  • Translated By:ChemLinked
  • Release Date:Feb 28, 2015
    Implement Date:Feb 28, 2015
      
  • Pages:77
    Format:Electronic Edition (Adobe PDF)
    Language:EN
  • Created On:Sep 02, 2020
    Last Updated On:Feb 28, 2015
     
Background

The Guidance (70+ pages) provides approaches and cost for data sharing for joint registration under the Act on the Registration and Evaluation of Chemical Substances (K-REACH). It also contains experts experience from the pilot project of registration of PEC substances.

Contents

Chapter 1 Introduction

1. Meaning and purpose

2. Structure of guidebook

Chapter 2 Major legal matters

1. Overview

2. Method for submitting data when applying for registration of phase-in substance

3. Joint use of phase-in registration application data

4. Special case on vertebrate animal test data

Chapter 3 How to submit data when applying for registration of phase-in substances

1. Identification of chemical substances

2. Formation of consortium among obligators of joint submission of registration application data

3. Selection of lead registrant

4. Data sharing for joint submission of registration application data

5. Confirming individual submission of registration application data

Chapter 4 Joint use of existing data

1. Method of joint use of existing registration application data

2. Special cases on vertebrate animal test data

Chapter 5 Calculation and sharing of costs

1. Fair and transparent basis

2. Evaluation of test data

3. Method of cost sharing

2. Excerpt from the relevant legislation

3. Sample Agreement for Joint Submission of Chemical Substance Registration Application Data