Government Regulation Number 44 In 2010

Original Language Title: Peraturan Pemerintah Nomor 44 Tahun 2010

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Read the untranslated law here: http://peraturan.go.id/inc/view/11e44c4f1764ff60a589313231383530.html

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Back COUNTRY SHEET Republic of INDONESIA No. 60, 2010 (Additional explanation in the State Gazette of the Republic of Indonesia Number 5126) GOVERNMENT REGULATION of the REPUBLIC of INDONESIA NUMBER 44 in 2010 ABOUT the PRECURSORS with the GRACE of GOD ALMIGHTY the PRESIDENT of the Republic of INDONESIA, Considering: that in order to implement Article 44 of the Act No. 5 of 1997 on psychotropic substances and article 52 Act No. 35 of 2009 about Narcotics, the need to establish government regulation of Precursors;
Remember: 1. Article 5 paragraph (2) of the Constitution of the Republic of Indonesia in 1945;
2. Act No. 5 of 1997 on psychotropic substances (Gazette of the Republic of Indonesia number 10 in 1997, an additional Sheet of the Republic of Indonesia Number 3671);
3. Act No. 35 of 2009 about Illegals (Gazette of the Republic of Indonesia Number 143 in 2009, an additional Sheet of the Republic of Indonesia Number 5062);
Decide: define: GOVERNMENT REGULATION of PRECURSORS.
CHAPTER I GENERAL PROVISIONS article 1 In this Regulation the definition: 1. the Precursors are substances or materials beginners or chemicals that can be used in the manufacture of narcotic drugs and psychotropic substances.
2. Narcotic Drugs are substances or drugs derived from plant crops or not, whether synthetic or semi synthetic, which can cause a decrease or alteration of consciousness, loss of taste, reduce to eliminate pain, and can lead to dependency, which is differentiated into the groups attached as in the law on narcotics.
3. Psychotropic substances are substances or drugs, either natural or synthetic instead of Narcotics, psychoactive nutritious through selective influence on the arrangement of the Center nerve causing characteristic changes in mental activity and behavior.
4. Production activities or process of preparing, processing, create, produce and package and/or change the form of a precursor.
5. The cycle is any activity or series of activities of channeling or delivery of Precursors both within the framework of trade, not trade or pemindahtanganan.
6. Transport is any activity or series of activities in order to move the Precursors from one place to another by means of, or any mode of transportation in order of production and circulation.
7. the Transito was transporting Precursors from one country to another through and/or in transit on the territory of the Republic of Indonesia that there are Customs Offices with or without changing the means of transport. 8. the Minister is the Minister who organized a Government Affairs in the field of health.
Article 2 the precursors in the regulations Setting the Government covers all activities relating to the procurement and use of Precursors for the pharmaceutical industry, pharmaceutical industry, and the development of science and technology.

Article 3 Setting Precursors aim to: a. protect the public from the dangers of the misuse of Precursors;

b. prevent and eradicate illicit traffic in Precursors;

c. prevent the occurrence of leaks and lapses Precursors; and d. ensure the availability of Precursors for the pharmaceutical industry, pharmaceutical industry, and the development of science and technology.
CHAPTER II CLASSIFICATION and TYPE of PRECURSOR of article 4 (1) Precursors are classified in a precursor of Table I and table II Precursor.
(2) the type of precursor of Table I and table II Precursor type as listed in the Appendix and part of which is inseparable from government regulation.
(3) additions and changes the type of precursor of Table I and table II in the annex referred to in paragraph (2) is fixed by the Minister after coordinating with the Minister concerned.
CHAPTER III of the PLAN of ANNUAL NEEDS of the article 5 (1) the Minister is coordinating with related Ministers devised a plan for the purposes of Precursors needs pharmaceutical industry, pharmaceutical industry, and the development of science and technology every year.
(2) the plan needs as referred to in paragraph (1) are drawn up based on the amount of inventory, estimates of needs and the use of Precursors nationwide.
(3) the Minister plans based on the needs as referred to in paragraph (2) reporting to international bodies in the field of narcotics.
(4) further Provisions regarding the procedures for drafting the plan needs Precursor referred to in subsection (1) and paragraph (2) is set by the Minister and/or the Minister related in accordance with those powers.
CHAPTER IV PROVISION of Part One General article 6 (1) Procure Precursor made through domestic production and imports.
(2) Precursor referred to in subsection (1) may only be used for the purposes of the pharmaceutical industry, pharmaceutical industry, and the development of science and technology.
(3) the potential tools that can be abused in the procurement and use of Precursor referred to in subsection (1) and paragraph (2) is set by the Minister and/or the Minister related in accordance with those powers.
The second part of production article 7 (1) Precursors can only be produced by an industry that has had a permit in accordance with the provisions of the legislation.
(2) the production of a precursor to the pharmaceutical industry should be done by means of the production of the good in accordance with the provisions of the legislation.
(3) a precursor for the pharmaceutical industry should meet the standards of Pharmacopoeia Indonesia and other standards.
(4) a precursor for the pharmaceutical industry must meet the requirements in accordance with the provisions of the legislation.
Article 8 (1) a compulsory precursor to Any labeled on each container or packaging.
(2) the Label on the container or packaging of Precursor referred to in subsection (1) may take the form of the writing, the image, the combination of text and images, or any other form that is included on the packaging or included in the packaging, affixed to, or form part of the container and/or the packaging.
(3) further Provisions concerning the requirements and procedures for labeling Precursor referred to in subsection (1) and paragraph (2) is set by the Minister and/or the Minister related in accordance with those powers.
The third part of retention of article 9 (1) a compulsory Precursor is stored on a secure storage place and separate from other storage.
(2) a stored Precursor referred to in subsection (1) must be proven legally acquired in accordance with the provisions of the legislation.
(3) further Provisions regarding the procedures for storage as referred to in subsection (1) is set by the Minister and/or the Minister related in accordance with those powers.
Chapter V IMPORT and EXPORT Approval is considered part of the import and Export Approval of article 10 (1) import and export of Precursors can only be done by a business entity that has a business license of the importer or exporter.
(2) import and export of Precursors should be equipped with a valid document in accordance with the provisions of the legislation.
(3) Each conducting import and export of Precursors must obtain a letter of approval of the Import or Export Approval Letter.
(4) further Provisions concerning the requirements and procedures for obtaining the letter of approval of the Import or Export Precursors for Approval: a. the pharmaceutical industry is regulated by the Minister;
b. pharmaceutical industry is regulated by the Minister of the organizing Affairs of the Government in the field of trade; or c. the development of science and technology which uses in the field of pharmaceutical Precursors are regulated by the Minister, or the use of Precursors in the field of pharmacy is non administered by the Minister of the organizing Affairs of the Government in the field of trade.
The second part of the transport section 11 (1) every transport of Precursors should be accompanied and complemented by a legitimate Precursor transport documents.
(2) the provisions on the transport of Precursor referred to in subsection (1) is set by the Minister and/or the Minister related in accordance with those powers.
The third part Transito article 12 (1) Transito Precursors must be equipped with an import approval document or a valid export approval in accordance with the provisions of the legislation.
(2) any changes to the destination country export Precursors in Transito, is subject to approval of: a. the Government of the exporting country Precursors;

b. the Governments of importing countries or the original purpose of export of Precursors; and c. the Government of the country of destination change export Precursors.
(3) further Provisions regarding the procedures for obtaining the approval referred to in subsection (2) is set by the Minister and/or the Minister related in accordance with those powers.
Article 13 (1) Packaging and packaging back Precursors on a Transito can only be done on the packaging damaged Precursors.
(2) Packaging and packaging back Precursor referred to in subsection (1) must be carried out under the supervision and responsibility of the competent authority.
(3) the provisions on packing and packaging back Precursor referred to in subsection (1) and paragraph (2) is set by the Minister and/or the Minister related in accordance with those powers.
CHAPTER VI CIRCULATION Part is considered the distribution of articles 14 (1) Precursor to the pharmaceutical industry are manufactured in the country may only be distributed to the pharmaceutical industry, distributors, and end users.
(2) Precursor to the imported pharmaceutical industry can only be transmitted to a non pharmaceutical, industry and end users.
(3) a precursor for the pharmaceutical industry can only be distributed to the pharmaceutical industry and distributors.
(4) Pharmaceutical raw material Wholesalers, distributors or registered importer can transmit a precursor to the development of institutions of science and technology.
(5) any activity the distribution of Precursor referred to in subsection (1) until subsection (4) must be equipped with document distribution.

(6) Further provisions regarding the distribution of Precursor referred to in subsection (1) until subsection (5) is set by the Minister and/or the Minister related in accordance with those powers.
The second part of the submission of Article 15 (1) submission of Prekusor circulation in order to do the recording.
(2) the provisions concerning the submission of a further Precursor referred to in subsection (1) is set by the Minister and/or the Minister related in accordance with those powers.
CHAPTER VII of the RECORDING and REPORTING of article 16 (1) every person or entity that manages a mandatory Precursor to make record keeping and reporting.
(2) the recording referred to in paragraph (1) contains at least: a. the amount of Precursors that are still in stock;

b. amount and abundance of Precursors that are submitted; and c. the necessity or usefulness of the Precursors by the customer.
(3) the recording referred to in paragraph (2) compulsory reported periodically.
(4) Provisions on record keeping and reporting as referred to in subsection (1) until subsection (3) are arranged in a coordinated by the Minister and/or the Minister related in accordance with those powers.
CHAPTER VIII article 17 SUPERVISORY Oversight of the use of Precursors is done with integrated guidance and control.

Article 18 (1) the Minister, the Minister, and other institutions that have the task and function of supervision of all activities related to Precursors in coordinated conduct surveillance in accordance with those powers. (2) Supervision as referred to in subsection (1) is directed to: a. be a precursor to the interests of pharmaceutical and non-pharmaceutical industry;
b. satisfy the interest of education, the precursor of the development of science and technology, and health services; c. Prevention of occurrence of irregularities and leakage of Precursors;

d. protection of the public from the dangers of the misuse of Precursors; and e. illicit Precursors.
(3) the implementation of the supervision referred to in subsection (1) done by the supervisor in accordance with the provisions of the legislation.
(4) in conducting the surveillance referred to in paragraph (3), the officer's supervisor is authorized to: a. conduct the local checks and/or take the example of the Precursors in the means of production, distribution, storage and circulation; b. check the letters/documents pertaining to a precursor; and c. perform a safeguard against Precursors that do not meet the conditions stipulated in this Regulation.
(5) the clerk of the Trustees in performing any activity oversight must be equipped with a letter of assignment in accordance with the provisions of the legislation.
(6) the provisions on supervision referred to in subsection (2) is set by the Minister and/or the Minister related in accordance with those powers.
Article 19 (1) a Precursor originate from plants or animal products can be specified by the Minister as an ingredient that are under scrutiny.
(2) in determining the Precursor referred to in subsection (1), the Minister for coordinating with related Ministers.
Article 20 (1) in the framework of supervision, Ministers and Ministers of related administrative actions can take.
(2) the Administrative Acts referred to in subsection (1) may include: a. the oral reprimand;

b. a written reprimand;

c. suspension of activities; or d. the revocation.
(3) the provisions concerning administrative action more as intended in paragraph (1) and paragraph (2) is set by the Minister and/or the Minister related in accordance with those powers.
CHAPTER IX TRANSITIONAL PROVISIONS Article 21 pharmaceutical industry, pharmaceutical industry, Pharmaceutical raw material Wholesalers, distributors or importers are registered, and the development of science and technology, adapt to the provisions of this Regulation for a period of not longer than one (1) year from the date of the enactment of this Regulation.

CHAPTER X the CLOSING PROVISIONS Article 22 this Regulation comes into force on the date of promulgation.

In order to make everyone aware of it, ordered the enactment of this Regulation with its placement in the State Gazette of the Republic of Indonesia.

Established in Jakarta on April 5, 2010 the PRESIDENT of the Republic of INDONESIA, SUSILO BAMBANG YUDHOYONO Enacted in Jakarta on April 5, 2010 the MINISTER of LAW and HUMAN RIGHTS Republic of INDONESIA, PATRIALIS AKBAR ANNEXES: GROUP and TYPE of PRECURSOR fnFooter ();