DECISION OF THE HEAD OF NATIONAL AGENCY
OF DRUG AND FOOD CONTROL OF THE REPUBLIC OF INDONESIA
No. PO.01.01.31.03660

ON
SPECIAL ARRANGEMENT FOR DISTRIBUTION AND DELIVERY OF BUPRENORFIN

THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL OF THE REPUBLIC OF INDONESIA,

Attachment

Considering:

• a. that procurement of Buprenorfin is required in detoxification therapy and opioid dependence care;
• b. that Buprenorfin can be misused and used fallaciously;
• c. that Buprenorfin has a psychotropic effect that potentially causes addiction risk;
• d. that based on the foregoing considerations, it is deemed necessary to stipulate a Special Arrangement for Distribution and Delivery of Buprenorfin with a Decision of the Head of National Agency of Drug and Food Control;

In view of:

• 1. Law No. 23/1992 on Health Affairs (Statute Book of 1992 No. 100, Supplement to Statute Book No. 3495);
• 2. Law No. 5/1997 on Psychotropics (Statute Book of 1997 No. 10, Supplement to Statute Book No. 3671);
• 3. Presidential Decree No. 103/2001 on Status, Duties, Functions, Authorities, Organisational Structure and Work Procedures of Non Departmental Government Institutions as amended by Presidential Decree No. 46/2002;
• 4. Presidential Decree No. 110/2001 on Organisation Unit and Duties of Echelon I in Non Departmental Government Institutions, as amended by Presidential Decree No. 5/2002;
• 5. Regulation of the Minister of Health No. 688/MENKES/PER/1997 on Psychotropic Circulation;
• 6. Regulation of the Minister of Health No. 949/MENKES/PER/VI/2000 on Finished Drug Registration ;
• 7. Decision of the Head of National Agency of Drug and Food Control No. HK.00.05.3.00914/2002 on Drug Importation through Special Channel;

Bearing in mind:

• 1. Decision of National Committee for Finished Drug Assessment No. PO.01.01.3.311.1071 dated 11 September 2001 on Usefulness and Safety Evaluation Results of KOMNAS POJ;
• 2. The Usefulness and Safety Evaluation Results of the National Committee for Finished Drug Assessment is to accept circulation of Buprenorfin in Indonesia on conditional basis;

DECIDES:

To stipulate:

DECISION OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL ON SPECIAL ARRANGEMENT FOR DISTRIBUTION AND DELIVERY OF BUPRENORFIN.

CHAPTER 1
GENERAL PROVISION

Article 1

Meant in this decision as:

(1) Buprenorfin is a psychotropic in the form of finished drug that is categorized into Psychotropic of Group Ill as contemplated in Article 2 paragraph (2) and paragraph (3) of Law No. 5/1997 on Psychotropics.

(2) Hospital is a hospital or psychiatric clinic that addresses opioid addictions.

CHAPTER II
DISTRIBUTION

Article 2

(1) Distribution and delivery of Buprenorfin must comply with provisions in Law No. 5 of 1997 on Psychotropics.

(2) In addition to being required to comply with provisions as contemplated in paragraph (1), the distribution and delivery of Buprenorfin must comply with the provisions as stipulated in this decision.

Article 3

(1) Distribution of Buprenorfin may only be conducted by pharmaceutical factories or pharmaceutical wholesalers who imports to the appointed pharmaceutical wholesaler or directly to hospital.

(2) The appointed pharmaceutical wholesaler as meant in paragraph (1) shall be the pharmaceutical wholesaler that is appointed by the pharmaceutical factory or pharmaceutical wholesaler that imports by virtue of an appointment letter the copy of which is sent to the National Agency of Drug and Food Control.

(3) Distribution of Buprenorfin from the appointed pharmaceutical wholesaler as meant in paragraph (2) must be directly to the hospital.

Article 4

Distribution of Buprenorfin as contemplated in Article 3 may only be conducted based on order placement that is signed by:

a. pharmacist in the drug-store of the hospital.

b. the hospital responsible doctor who is not owner of drug-store.

CHAPTER Ill
DELIVERY

Article 5

(1) Delivery of Buprenorfin may only be conducted by the hospital to the doctor prescribing Buprenorfin.

(2) Doctor prescribing Buprenorfin as meant in paragraph (1) shall be only a doctor who has received training in Buprenorfin organized by relevant professional organization.

(3) Buprenorfin must be given directly by the doctor or under supervision of the doctor to the patient to be taken directly and not allowed to be taken home.

CHAPTER IV
REPORTING

Article 6

The importing factory or pharmaceutical wholesaler or the appointed pharmaceutical wholesaler is obliged to report any procurement and circulation of Buprenorfin to the National Agency of Drug and Food Control o a monthly basis by using sample Form I.

Article 7

(1) The doctor is obliged to make medical report of patients who use Buprenorfin.

(2) The pharmacist in the drugstore of the hospital or the doctor responsible for hospital as contemplated in Article 5 is obliged to make records of receipt and usage of Buprenorfin and to report it to the National Agency of Drug and Food Control and its copy is sent to the Drug and Food Control Centre (Balai Pengawasan Obat dan Makanan) and Health Service Office Level I on a monthly basis, with sample Form II.

CHAPTER V
SANCTIONS

Article 8

In addition to being subjected to criminal sanctions in accordance with the prevailing statutory regulations, violation of any provisions in this decision is subjected to administrative sanctions in the form of:

• a. Written warning.
• b. Circulation license freezing.
• c. Circulation license revocation.
• d. Other administrative sanctions in accordance with the prevailing statutory regulations.

CHAPTER VI
CLOSING PROVISION

Article 9

This Decision shall come to effect as of the stipulation date.

Stipulated in: JAKARTA
On: 2 December 2002
The Head of the National Agency of Drug and Food Control
Sgd.
H. SAMPURNO

Attachment to DECISION OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL OF THE REPUBLIC OF INDONESIA
No. PO.01.01.31.03660