to Indoinesian
that the provisions for Registration of Medicine as governed in Regulation of the Minister of Health No. 1010/Menkes/Per/XI/2008 need to be amended and improved again with Regulation of the Minister of Health.
1. Strong Medicine Ordinance (Statute Book No. 419/1949);
2. Law No. 23/1992 concerning Health (Statute Book of 1992 No. 100, Supplement to Statute Book No.3495);
3. Law No. 5/1997 concerning Psychotropic (Statute Book No. 10/1997, Supplement to Statute Book No.3671);
4. Law No. 22/1997 concerning Narcotics (Statute Book No. 67/1997, Supplement to Statute Book No. 3698);
5. Law No. 8/1999 concerning Consumer Protection (Statute Book of 1999, Supplement to Statute Book No. 3821);
6. Government Regulation No. 72/1998 concerning the Safeguarding of Pharmaceutical Preparations and Health Devices (Statute Book No. 138/1998, Supplement to Statute Book No. 3778);
7. Government Regulation No. 38/2007 concerning the Sharing of Administrative Affairs between the Government, Provincial Governments and Regency/Municipal Governments (Statute Book No. 82/2007, Supplement to Statute Book No. 4737);
8. Presidential Regulation No. 9/2005 concerning the Position, Task, Organizational Structure and Work Mechanism of State Ministries as amended several times, the latest by Presidential Regulation No. 94/2006;
9. Regulation of the Minister of Health No. 1575/Menkes/Per/XI/2005 on the Organizational Structure and Work Mechanism of the Health Ministry as has been amended by Regulation of the Minister of Health No. 1295/Menkes/Per/XIl/2007.
AMENDMENT TO THE REGULATION OF THE MINISTER OF HEALTH No. 1010/MENKES/PER/XI/2008 CONCERNING THE REGISTRATION OF MEDICINES
To amend provisions in Article 10 of Regulation of the Minister of Health No. 1010/Menkes/Per/XI/2008 concerning Registration of Medicine to become as follows:
"Article 10
(1) Imported Medicine shall be registered by domestic pharmaceutical industry that has obtained written approval from overseas pharmaceutical industry.
(2) Written approval as intended in paragraph (1) should include transfer of technology provided that within a period of 5 (five) years at the latest must have been produced domestically.
(3) Exceptions to the provisions as intended in paragraph (2) are medicines are protected by copy right.
(4) Overseas pharmaceutical industry as intended in paragraph (1) must comply with the CPOB requirements.
(5) Compliance with CPOB requirements for pharmaceutical industry as intended in paragraph (4) must be proven by justified document or as needed for local examination by competent official.
(6) Document as intended in paragraph (5) must be supported by data from the latest inspection conducted within the last 2 (two) years issued by local competent official.
(7) Provision on procedures for local examination as intended in paragraph (5) shall be stipulated by the Head of Agency concerned."
This Regulation shall come into force as from the date of stipulation.
Stipulated in Jakarta
on December 1, 2008
THE MINISTER OF HEALTH,
signed,
Dr. Dr. SITI FADILAH SUPARI, Sp. JP (K)
Jakarta, November 24, 2008
Number: OFFICE MEMORANDUM
Attachment: 1 (one) Draft RKM)
Subject: REPORT
To the honorable,
EXECUTIVE DEPARTMENT OF HEALTH
in JAKARTA.
Sincerely,
This attachment is reported to the Executive as follows:
1. Terms of Registration in Medicine has been set in Regulation of the Minister of Health No. 1010/Menkes/Per/XI/2008, Namur need to do some changes;
2. The changes referred to because of some errors in the designation clause in Article 10;
3. For the purposes of discussion has been carried over with the technical unit (DG Binfar and Legal Bureau) to fix and refinement as the draft attached;
4. For further along the process of settlement was submitted draft improvements intended to obtain approval Leader.
This was conveyed for the love attention tarima pronounced.
DIRECTOR GENERAL
BINA PHARMACEUTICAL AND MEDICAL EQUIPMENT,
Dr. KUSTANTINAH, Apt, M.App. Sc