to Indonesian
a. That some provisions in the Application Guidelines for Good Drugs Production Procedure that is determined based on Decree of the Head of Drug and Food Controller Agency Number HK.00.05.3.0027 of 2006, it is necessary to be adjusted with the development and progress of science and technology in the manufacture of drugs and substances of drug;
b. based on the considerations as intended in paragraph a, it is necessary to stipulate the Regulation of the Head of Drug and Food Controller Agency concerning the Amendment to Decree of the Head of Drug and Food Controller Agency Number HK.00.05.3.0027 of 2006 concerning Application Guidelines for Good Drug Production Procedure of 2006;
1. Law Number 36 of 2009 concerning Health (Statute Book of the Republic of Indonesia Number 144 of 2009, Supplement to Statute Book of the Republic of Indonesia Number 5063);
2. Government Regulation Number 72 of 1998 concerning Safety of Pharmaceutical Preparation and Medical Devices (Statute Book of the Republic of Indonesia Number 138 of 1998, Supplement to Statute Book Number 3781);
3. Presidential Decree Number 103 of 2001 concerning the Status, Duties, Function, Authority, Organizational Structure, and Work Flow of Non Ministerial Government Agencies as amended several times, the latest by Presidential Decree Number 64 of 2005;
4. Presidential Decree Number 110 of 2001 concerning Organization Unit and Duties of First Echelon of Non Ministerial Government Agencies as amended several times, the latest by Presidential Decree Number 52 of 2005;
5. Decree of the Minister of Health of the Republic of Indonesia Number 43/Menkes/SK/II/1988 dated February 2, 1988 concerning Guidelines for Good Drug Production Procedures;
6. Decree of the Head of Drug and Food Controller Agency Number 02001/SK/KBPOM of 2001 concerning the Organization and Administration of Drug and Food Controller Agency, as amended by Decree of the Head of Drug and Food Controller Agency Number HK.00.05.2I.4231 of 2004;
7. Decree of the Head of the Drug and Food Controller Agency Number HK.00.05.3.0027 of 2006 concerning the Application Guidelines for Good Drug Production Procedure Year 2006;
8. Decree of the Head of the Drug and Food Controller Agency of the Republic of Indonesia Number HK.00.06.1.34.0387 of 2009 concerning Establishment of National Team of Good Drug Production Procedure(CPOB);
REGULATION OF THE HEAD OF DRUG AND FOOD CONTROLLER AGENCY CONCERNINT AMANDMENT TO DECREE OF THE HEAD OF THE FOOD AND DRUG CONTROLER AGENCY NUMBER HK.00.05.3.0027 OF 2006 CONCERNING APPLICATION GUIDELINES FOR GOOD DRUG PRODUCTION PROCEDURE YEAR 2006.
Several provisions in the attachment of Decree of the Head of Drug and Food Controller Agency Number HK.00.05.3.0027 of 2006 concerning Application Guidelines for Good Drug Production Procedure Year 2006 are amended as follows:
1. The provisions of CHAPTER 1 are amended to read as intended in Attachment I that is an integral part of this Regulation.
2. In between CHAPTER 6 and CHAPTER 7 is inserted Supplement of CHAPTER 6 to read as intended in Attachment II that is an integral part of this Regulation.
3. In between CHAPTER 7 and CHAPTER 8 is inserted Supplement of CHAPTER 7 to read as intended in Attachment III that is an integral part of this Regulation.
4. Provisions in ANNEX 1 shall be amended to read as intended in Attachment IV that is an integral part of this Regulation.
5. After ANNEX 7 is supplemented ANNEX 8, ANNEX 9, ANNEX 10, ANNEX 11, ANNEX 12, and ANNEX 13 which reads as intended in Attachment V, Attachment VI, Attachment VII, Attachment VIII, Attachment IX and Attachment X which are an integral part of this Regulation.
This Regulation shall come into force on the date of promulgation.
For public cognizance, this Regulation shall be promulgated by placing it in the State Gazette of the Republic of Indonesia.
Stipulated in Jakarta
on September 22, 2010
HEAD OF DRUG AND FOOD CONTROLLER AGENCY,
Signed,
KUSTANTINAH
Promulgated in Jakarta
on September 27, 2010
MINISTER OF JUSTICE AND HUMAN RIGHTS,
signed,
PATRIALIS AKBAR
STATE GAZETTE OF THE REPUBLIC OF INDONESIA NO. 470 OF 2010