DECISION OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL,
No. HK.00.05.35.02771

CONCERNING
MONITORING AND CONTROL OF PRECURSORS

THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL,

Considering:

that as an implementation of thirdly dictum of the Decree of the Head of National Agency of Drug and Food Control No. HK.00.05.35.02770 on Addition of Precursor Types, it is necessary to stipulate 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. 10/1995 on Customs Affairs (Statute Book of 1995 No. 75, Supplement to Statute Book No. 3612);
• 3. Law No. 5/1997 on Psychotropics (Statute Book of 1997 No. 10, Supplement to Statute Book No. 3671);
• 4. Law No. 7/1997 on Ratification of United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 (to Statute Book of 1997 No. 17, Supplement to Statute Book No. 3673);
• 5. Law No. 22/1997 on Narcotics (Statute Book of 1997 No. 67, Supplement to Statute Book No. 3698);
• 6. 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. 3/2002;
• 7. 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;
• 8. Decision of the Head of National Agency of Drug and Food Control No. 02001/SK/KBPOM on Organisation and Work Procedure of National Agency of Drug and Food Control.
• 9. Decision of the Head of National Agency of Drug and Food Control No. HK.00.05.35.02770 on Addition of Precursor Types 2002.

DECIDES:

To stipulate:

Decision of the Head of National Agency of Drug and Food Control on Monitoring and Supervision of Precursors.

Article 1

(1) Monitoring and Supervision of Precursors, is conducted to all types of precursors.

(2) Monitoring and supervision as contemplated in paragraph (1) shall be conducted through:

• a. Granting of Import Approval Letter every time of importing;
• b. Granting of Export Approval Letter every time of export;
• c. Export notification from the government of exporting country (pre export notification).
• d. Obligation to maintain records and reports for precursor management facility;

(3) Monitoring and supervision as contemplated in paragraph (2) shall be conducted by the National Agency of Drug and Food Control to the types of precursors as listed in group I in attachment 1.

(4) Monitoring and supervision to types of precursors as listed in group II in attachment 1 shall be conducted by the relevant agency.

Article 2

Import of precursors can only be conducted by importers, namely pharmaceutical or chemical industry, wholesalers of pharmaceutical raw materials and chemical importer that has obtain license to import in accordance with the prevailing provisions.

Article 3

(1) Every pharmaceutical or chemical industry using precursor, importer or exporter precursors, is obliged to appoint a technical personnel as person responsible.

(2) The person responsible as contemplated in paragraph (1) for pharmaceutical or chemical industry is a person in charge of production.

(3) The person responsible of importer and exporter for pharmaceutical raw materials is a Pharmacist, whereas for exporter of pharmaceutical finished product is at least an Assistant Pharmacist.

(4) The person responsible appointed by chemical importer and exporter importer is a responsible person appointed by the company.

Article 4

Any change of responsible person for management of precursors group I in attachment 1 is obliged to be reported to the National Agency of Drug and Food Control.

Article 5

(1) Pharmaceutical or chemical industries using precursor may only import precursors for own use.

(2) Wholesalers of pharmaceutical raw materials who import precursors may only import precursors in accordance with order from the precursor users.

Article 6

(1) Importers of precursors Group I in attachment 1 are obliged to submit application for Import Approval in writing every time importing precursors by using format attachment 2.

(2) Exporters of precursors group I in attachment 1 are obliged to submit application for Export Approval in writing every time exporting precursors by using format attachment 4.

(3) In case the written applications as contemplated in paragraphs (1) and (2) are approved, the Head of National Agency of Drug and Food Control stipulates Import Approval or Export Approval in accordance with sample format in attachments 3 and 5 with copy to other competent authorities.

(4) Importer or exporter of precursors group I in attachment 1 is obliged to submit report every time importing or exporting precursors not later than 7 (seven) days as of receipt or delivery of the precursors to the National Agency of Drug and Food Control by using format attachments 6 and 7.

Article 7

(1) Each pharmaceutical or chemical industry using precursor, importer or exporter of precursors is obliged to make and maintain records and to submit report on activities relating to the precursors.

(2) The notebook of precursors and related documents are obliged to be maintained for 5 (five) years.

Article 8

In order to monitor and control of precursors, the National Agency of Drug and Food Control may conduct, either severally or jointly with other related agencies:

• a. on-site inspection and or sample taking in precursor management facilities;
• b. examination of records, letters or documents related with precursors;
• c. evaluation and follow-up.

Article 9

(1) The person responsible as contemplated in Article 3 paragraph (3) is obliged to deliver monthly report of production, distribution and usage of precursors to the National Agency of Drug and Food Control by using format in attachments 8, 9, 10, and 11.

(2) Other provisions regarding recording and reporting of precursors are specified in attachments 6 up to 11 to this decision.

Article 10

(1) In addition to imposition of criminal sanctions in accordance with provisions in the prevailing law, the Head of National Agency of Drug and Food Control and or the Leaders of other related Agencies are, in the framework of precursor control, authorized to take administration actions to the facilities and management of precursors who commit in violation of any provisions in this decision.

(2) Administration actions as contemplated in paragraph (1) above, can take the forms of:

• a. Verbal warning;
• b. Written warning;
• c. Suspension of activity;
• d. License revocation.

Article 11

Other matters that are not already provided fro in this decision will be regulated later.

Article 12

Upon stipulation of this Decision, the Decision of the Director General of Drug and Food Control No. HK.00.06.6.03181 on Monitoring of Psychotropic Precursors is declared as null and void.

Article 13

This decision comes into effect as of the stipulation date.

Stipulated in: JAKARTA
On: 4 September 2002
THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL
Sgd.
H. SAMPURNO
NIP. 140087747