to Indonesian
That to implement provisions in Article 44 of Law No. 5/1997 concerning Psychotropic and Article 52 of Law No. 35/2009 concerning Narcotics, it is necessary to stipulate Government Regulation concerning Precursors;
1. Article 5 paragraph (2) of the 1945 Constitution;
2. Law No. 5/1997 concerning Psychotropic (Statute Book No. 10/1997, Supplement to Statute Book No. 3671);
3. Law No. 35/2009 concerning Narcotics (Statute Book No. 143/2009, Supplement to Statute Book No. 5062);
COVERNMENT REGULATION CONCERNING PRECURSORS.
In this Government Regulation:
1. Precursor is a basic substance or material or a chemical that can be used in the production of narcotic and psychotropic.
2. Narcotic is a substance or medicine that originating from a plant or non plant, either synthetic or semi-synthetic, that can lead to a drop or change of consciousness, loss of sense, reduce or eliminate pain and can cause dependency, distinguished into classifications as attached to the Law concerning Narcotics.
3. Psychotropic is a substance or drug, either natural or synthetic except narcotics, that has psychoactive effect through a selective influence on central nerves system that has a specific impact on mental activities and behaviour.
4. Production is an activity to prepares, processes, makes, produces and packs and/or modifies precursor.
5. Circulation is any activity or a series of activities to distribute or deliver precursors, within the framework of trade, non trade or transfer to another party.
6. Transportation is any activity or a series of activities to move Precursors from one place to another by any way, mode or means of transportation within the framework of production and circulation.
7. Transit is the transportation of Precursors from one country to another by passage of and/or stopover in the territory of the Republic of Indonesia where a customs office is located with or without a change in transportation means.
8. Minister is the minister who deals with government affairs in the health field.
Precursor regulation in this Government Regulation shall cover all activities related with the procurement and use of Precursors for Pharmaceutical industry, non pharmaceutical industry, and scientific and technological development.
Purpose of Precursor regulation are:
(1) Precursors shall be classified into Precursors of Table I and Precursors of Table II.
(2) The types of Precursors of Table I and the types of Precursors of Table II are contained in the Attachment as an integral part of this Government Regulation.
(3) The addition and alteration of the types of Precursors of Table I and Table II in the Attachment as intended in paragraph (2) shall be stipulated by the Minister after coordinating with relevant Ministers.
(1) The Minister in coordination with relevant ministers shall draw up a plan for precursor needs in the annual interests of pharmaceutical industries, non-pharmaceutical industries arid scientific and technological development.
(2) The plan for precursor needs as intended in paragraph (1) shall be drawn up based on the amount of stocks, the estimate of needs and the use of Precursors on a national scale.
(3) The Minister shall report the plan of needs as intended in paragraph (2) to the international board in the field of Narcotics.
(4) Further provisions on the procedure of drawing up the plan for precursor needs as intended in paragraph (1) and paragraph (2) shall be regulated by the Minister and/or relevant ministers according to their respective authority.
(1) Precursors shall be procured by way of domestic production and import.
(2) The Precursors as intended in paragraph (1) can only be used for the purpose of pharmaceutical industries, non non-pharmaceutical industries and scientific and technological development.
(3) Potential devices that can be abused in the procurement and use of precursors as intended in paragraph (1) and paragraph (2) shall be regulated by the Minister and/or relevant ministers according to their respective authority.
(1) Precursors can only be produced by industries that have obtained permits according to the laws and regulations.
(2) The production of precursors for pharmaceutical industries shall be done by way of good production according to the laws and regulations.
(3) Precursors for pharmaceutical industries shall meet the Indonesia Farmakope standard and other standards.
(4) Precursors for non-pharmaceutical industries shall meet qualifications according to the laws and regulations.
(1) Every precursor shall be labelled on its box or pack.
(2) The label on the box or pack of precursor as intended in paragraph (1) can be in the form of writing, picture, a combination of writing and picture, or other form attached to, inserted into, or stuck on the box or pack or part of the box and/or pack.
(3) Further provisions on the requirements and procedures of labelling Precursors as intended in paragraph (1) and paragraph (2) shall be regulated by the Minister and/or relevant ministers according to their respective authority.
(1) Precursors shall be stored in safe storage places inseparable from other storage places.
(2) Precursors stored as intended in paragraph (1) shall be proven that they have been obtained legally according to the laws and regulations.
(3) Further provisions on the procedures of storing as intended in paragraph (1) shall be regulated by the Minister and/or relevant ministers according to their respective authority.
(1) The import and export of Precursors can only be done by corporate bodies holding importer or exporter business permits.
(2) The import and export of precursors shall be equipped with legal documents according to the laws and regulations.
(3) Any import and export of precursors shall obtain an import approval or export approval.
(4) Further provisions on the requirements and procedures of obtaining permits for the import or export of precursors for:
(1) Any transportation of precursors shall be accompanied and equipped with legal documents for the transportation of precursors.
(2) Further provisions on the transportation of precursors as intended in paragraph (1) shall be regulated by the Minister and/or relevant ministers according to their respective authority.
(1) The transit of precursors shall be equipped with legal documents of import permit or export permit according to the laws and regulations.
(2) Any change in the country of destination for the export of precursors in transit shall obtain approval from:
(3) Further provisions on the procedures of obtaining permits as intended in paragraph (2) shall be regulated by the Minister and/or relevant ministers according to their respective authority.
(1) The packing or re-packing of precursors in transit can only be done to precursors with damaged packs.
(2) The packing or re-packing of precursors as intended in paragraph (1) shall be done under the supervision and responsibility of authorized officials.
(3) Further provisions on the packing and re-packing of precursors as intended in paragraph (1) and paragraph (2) shall be regulated by the Minister and/or relevant ministers according to their respective authority.
(1) Domestically produced precursors for non-pharmaceutical industries can only be distributed to non-pharmaceutical industries, distributors and end users.
(2) Imported precursors for non-pharmaceutical industries can only be distributed to non-pharmaceutical industries, and end users.
(3) Precursors for pharmaceutical industries can only be distributed to pharmaceutical industries and distributors.
(4) Pharmaceutical Raw Material Wholesalers, distributors or registered importers can distribute precursors to scientific and technological development agencies.
(5) Any distribution of precursors as intended in paragraph (1) up to paragraph (4) shall be equipped with distribution documents.
(6) Further provisions on the distribution of Precursors as intended in paragraph (1) up to paragraph (5) shall be regulated by the Minister and/or relevant ministers according to their respective authority.
(1) The delivery of precursors for the purpose of circulation shall be recorded.
(2) Further provisions on the delivery of precursors as intended in paragraph (1) shall be regulated by the Minister and/or relevant ministers according to their respective authority.
(1) Any individual or body managing precursors shall record and report the precursors.
(2) The record as intended in paragraph (1) shall at least cover:
(3) The record as intended in paragraph (2) shall be reported periodically.
(4) Further provisions on the recording and reporting as intended in paragraph (1) up to paragraph (3) shall be regulated in an coordinated way by the Minister and/or relevant ministers according to their respective authority.
The supervision of the use of Precursors shall be done in an integrated way with development and control.
(1) The Minister, relevant ministers, and other agencies that have the task and function of supervising all activities related to Precursors shall conduct supervision in a coordinated way according to their respective authority.
(2) The supervision as intended in paragraph (1) shall be directed towards:
(3) The supervision as intended in paragraph (1) shall be done by supervisors according to the laws and regulations.
(4) In conducting the supervision as intended in paragraph (3), supervisors shall have the authority to:
(5) In conducting supervision, supervisors shall be equipped with a letter of assignment according to the laws and regulations.
(6) Further provisions on the supervision as intended in paragraph (2) shall be regulated by the Minister and/or relevant ministers according to their respective authority.
(1) Precursors originating from plant or animal products can be stipulated by the Minister as materials under surveillance.
(2) In stipulating the precursors as intended in paragraph (1), the Minister shall coordinate with relevant ministers.
(1) Within the framework of supervision, the Minister and relevant ministers can take administrative measures.
(2) The administrative measures as intended in paragraph (1) can be in the form of:
(3) Further provisions on the administrative measures as intended in paragraph (1) and paragraph (2) shall be regulated by the Minister and/or relevant ministers according to their respective authority.
Pharmaceutical industries, non-pharmaceutical industries, pharmaceutical raw material wholesalers, distributors or registered importers, and scientific and technological development agencies shall adjust to this Government Regulation no later than 1 (one) year after the promulgation date of this Government Regulation.
This Government Regulation shall come into force as from the date of promulgation.
For public cognizance, this Government Regulation shall be promulgated by placing it in the Statute Book of the Republic of Indonesia.
Stipulated in Jakarta
on April 5, 2010
THE PRESIDENT OF THE REPUBLIC OF INDONESIA,
signed,
DR. H. SUSILO BAMBANG YUDHOYONO
CLASSIFICATION AND TYPE OF PRECURSORS
TABLE I
TABLE II
PRESIDENT OF THE REPUBLIC OF INDONESIA
signed,
DR. H. SUSILO BAMBANG YUDHOYONO