DECREE OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL
No. HK.00.05.34.03747

CONCERNING
ADDITIONAL REQUIREMENTS OF PHARMACEUTICAL INDUSTRIAL BUSINESS LICENSE

THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL,

Considering:

• a. that a tendency exists to produce drugs that are not in compliance with requirements of effectiveness, quality, safety and usefulness and fake drugs by irresponsible parties;
• b. that in order to protect the public from circulation of the drugs that are not in compliance with requirements of effectiveness, quality, safety and usefulness and fake drugs, a selective preventive action needs to be taken in the form of additional requirements on application for pharmaceutical industrial business license;
• c. that based on the consideration as contemplated in letters a and b above, it is deemed necessary to stipulate additional requirements on application for pharmaceutical industrial business license with a Decree of the Head of the National Agency of Drug and Food Control;

In View of:

• 1. Law No. 23/1992 on Health (Statute Book of 1992 No. 100, Supplement to Statute Book No. 3671);
• 2. Government Regulation No. 72/1998 on Safety of Pharmaceutical Products and Medical Devices (Statute Book of 1998 No. 138, Supplement to Statute Book No. 3781);
• 3. Government Regulation No. 25/2000 on Authorities of the Government and Authorities of the Provinces As Autonomous Regions (Statute Book of 2000 No. 54, Supplement to Statute Book No. 3952);
• 4. Presidential Decree No. 103/2001 on Status, Duties, Functions, Authorities, Organizational Structure and Activity of Non Departmental Government Institution;
• 5. Decree of the Minister of Health No. 245/Menkes/SK/V/1990 on Provisions and Implementing Procedures of Granting of Pharmaceutical Industrial Business License;
• 6. Decree of the Head of National Agency of Drug and Food Control No. 02001/SK/KBPOM dated February 26, 2001 on Organization, Duties and Function of The National Agency of Drug and Food Control;

DECIDES

To Stipulate:

THE DECREE OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL ON ADDITIONAL REQUIREMENTS OF PHARMACEUTICAL INDUSTRIAL BUSINESS LICENSE.

First:

As to any application for pharmaceutical industrial business license, in addition to being required to meet requirements as provided for in Decree of the Minister of Health No. 245/Menkes/SK/V/1990 on Provisions and Implementing Procedures of Granting of Pharmaceutical Industrial Business License, must also meet the additional requirements;

Second:

The additional requirements as contemplated in Firstly dictum is that All Commissioners, Shareholders, and Members of the Board of Directors in accordance with notarial deed and All Managers of a business entity as applicant of pharmaceutical industrial business license are never:

• a. involved in violation of statutory provisions in pharmaceutical sector and/or;
• b. punished with sanction as contemplated in Articles 72 and 74 of the Government Regulation No. 72/1998 on Safety of Pharmaceutical Products and Medical Devices and Article 18 letter d of the Decree of the Minister of Health No. 245/Menkes/SK/V/1990 on Provisions and Implementing Procedures of Granting of Pharmaceutical Industrial Business License.

Third:

This Decree comes into force as of the stipulation date, provided that if, later, any error is found in this decree, it will be revised accordingly.

Stipulated in: Jakarta
On: November 30, 2001
NATIONAL AGENCY OF DRUG AND FOOD CONTROL
sgd.
H. SAMPURNO
NIP. 140087747

COPIES are sent to the Distinguished:

• 1. Minister of Health of the Republic of Indonesia
• 2. Minister of Home Affairs and Regional Autonomy;
• 3. The Head of Investment Coordinating Board;
• 4. Governors throughout Indonesia;
• 5. Regents/Mayors throughout Indonesia;
• 6. The Heads of Provincial Health Service Offices throughout Indonesia;
• 7. The Heads of Head Center/POM Center throughout Indonesia;
• 8. The Heads of Health Service Offices of Regencies/Municipalities;
• 9. Association of Indonesian Pharmaceutical Companies;