Propofol 1% Injection

<Administrative Information>

Dongkook Pharmaceutical Co., Ltd.

33-19, Yongso 2-gil, Gwanghyewon-myeon,
Jincheon-gun, Chungcheongbuk-do, Korea

Rev. 1
Date of issue:

June 2015

CTD Module 1
Administrative
Information

Ver.1
Dongkook Pharmaceutical Co., Ltd.
Propofol 1% Injection

May 2015
Page 1

1.

Administrative Information

1.1

Table of Contents

1.2
1.2.1
1.2.2
1.2.3
1.2.4
1.2.5

Application form
Certificate of a Pharmaceutical Product according to WHO recommendations
Certificate of Good Manufacturing Practice according to WHO recommendations
Manufacturing Authorization
Power of Attorney
Records in other countries with the date and number of registration certificate

1.3
1.3.1
1.3.2
1.3.3
1.3.4
1.3.5

Summary of the product characteristics

Summary of Product Characteristics
Label and Instructions for Administration or Patient information leaflet
Layout color graphics of primary and secondary Packaging
Models of primary and secondary packaging
Summary of Product Characteristics in countries where the product is authorized

1.4
1.4.1
1.4.2
1.4.3

Information about the experts

Information on chemical-pharmaceutical experts compartment
Information about non-clinical experts compartment
Information about clinical experts compartment

1.5
1.5.1
1.5.2

Specific requirements for different types of applications

Information on bibliographic data
Information on small claims

1.6
1.6.1

Environmental Risk Assessment

Medicinal products containing or produced from genetically modified

1.7
1.7.1

Information on the applicants pharmacovigilance

Detailed description of the pharmacovigilance and risk management system
to use pharmaceutical product
Documents showing that the applicant has qualified person responsible for
Pharmacovigilance in Moldova

1.7.2