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Regulation Of The Minister Of Health No. 3 2015 2015

Original Language Title: Peraturan Menteri Kesehatan Nomor 3 TAHUN 2015 Tahun 2015

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REPUBLIC OF INDONESIA NEWS

No. 74, 2015 FRANKKES. Narcotics. Psychotropic. Precursors Pharmaceuticals. Reporting. Extermination. Storage. The circulation. Revocation.

REPUBLIC OF INDONESIA HEALTH MINISTER REGULATION

NUMBER 3, 2015

ABOUT

CIRCULATION, STORAGE, ANNIHILATION, AND REPORTING OF NARCOTICS, PSYCHOTROPIC, AND PHARMACEUTICAL PRECURSORS

WITH THE GRACE OF GOD YANG MAHA ESA

THE HEALTH MINISTER OF THE REPUBLIC OF INDONESIA,

DRAWS: A. that Regulation Minister Health Number 28 /Menkes/Per/I/1978 on Narcotics Storage, Health Minister Regulation No. 688 /Menkes/Per/VII/1997 on Psychotropic Circulation, and Health Minister Regulation Number 912/Menkes/Per/VIII/1997 about The Annual Needs and Psychotropic Reporting need to be adjusted to the development and needs of the law;

b. that under consideration as referred to in the letter a and to carry out the provisions of Article 14 paragraph (3), Section 36 of the paragraph (2), Section 42, and Article 44 of the Law Number 35 Year 2009 on Narcotics, and Section 9 of the paragraph (3), Article 14 of the paragraph (6) and Article 15 paragraph (2) of the Government Regulation No. 44 Year 2010 on the Precursors, need to establish a Health Minister Regulation on

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Circular, Storage, Extermination, and Narcotics Reporting, Psychotroics, and Pharmaceutical Precursors;

Given: 1. Law No. 5 Year 1997 on Psychotropic (Sheet State Of Republic Of Indonesia In 1997 Number 10, Addition Of Sheet Republic Of Indonesia Number 3671);

2. Law No. 35 Year 2009 on Drugs (sheet State of the Republic of Indonesia Year 2009 Number 143, Additional Gazette of the Republic of Indonesia No. 5062);

3. Law Number 36 Year 2009 on Health (State Gazette of Indonesia Year 2009 Number 144, Additional Gazette Republic of Indonesia Number 5063);

4. Law No. 44 Year 2009 concerning Hospital (Indonesian Republic of Indonesia Year 2009 Number 153, Additional Gazette Republic of Indonesia Number 5072);

5. Government Regulation No. 72 Year 1998 on Pharmacy Supplies and Health Tools (State Gazette Indonesia Year 1998 Number 138, Additional Gazette Republic of Indonesia Number 3781);

6. Government Regulation No. 51 of 2009 on Kefarmasian Works (Gazette of the Republic of Indonesia Year 2009 Number 124, Additional Gazette of the Republic of Indonesia No. 5044);

7. Government Regulation No. 44 Year 2010 on Precursors (State Sheet Indonesia Year 2010 Number 60, Additional Gazette Republic of Indonesia Number 5126);

8. Government Regulation No. 40 Year 2013 on Implementation of Law No. 35 Year 2009 on Drugs (sheet State of the Republic of Indonesia Year 2013 Number 96, Additional Gazette of the Republic of Indonesia No. 5419);

9. Government Regulation Number 27 Of 2014 On The Management Of State/regional Goods (sheet Of State Of The Republic Of Indonesia In 2014 Number 92, Additional Gazette Of The Republic Of Indonesia Number 5533);

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10. Ministry of Health Regulation Number 1144 /Menkes/Per/lll/2010 on the Organization and the Working Services of the Ministry of Health (News of the Republic of Indonesia 2010 Number 585) as amended by the Regulation of the Minister of Health Number 35 Year 2013 (State News of the Republic of Indonesia 2013 No. 741);

11. Regulation of Health Minister Number 1799 /Menkes/Per/XII/2010 on Pharmaceutical Industry (State News Indonesia 2010 Number 721) as amended with the Regulation of Minister of Health Number 16 Year 2013 (State News of the Republic of Indonesia) 2013 No. 442);

12. Health Minister Regulation No. 1148 /Menkes/Per/VI/2011 on the Great Merchant of Pharmacy (State News of the Republic of Indonesia 2011 Number 370) as amended by the Regulation of the Minister of Health No. 34 of 2014 (Republic News of the Republic of Indonesia) Indonesia Year 2014 Number 585);

13. Ministry of Health Regulation No. 10 Year 2013 on Import and Export of Narcotics, Psychiatry, and Precursors of Pharmacy (State News of the Republic of Indonesia 2013 No. 178);

14. Regulation of Health Minister Number 9 of 2014 on the Clintons (State News of the Republic of Indonesia 2014 Number 232);

DECIDED:

SET: THE HEALTH MINISTER ' S REGULATIONS ON CIRCULATION, STORAGE, DESTRUCTION, AND REPORTING NARCOTICS, PSYCHOTROPIC, AND PHARMACEUTICAL PRECURSOR.

BAB I

provisions of UMUM

Article 1

In Regulation of this Minister referred to:

1. Narcotics are substances or drugs that are derived from plants or not plants, both synthetic and semi-synthetic, which can lead to a decrease or change of consciousness, loss of taste, reduced to the loss of pain, and can

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gives rise to a dependency, which is distinguished into the group as attached to the Act on Narcotics.

2. Psychotropic is a raw substance or drug, both natural and synthetic, not narcotic, which is psychoactive through the selective influence of the central nervous arrangement which causes a distinctive change in mental and behavioral activity.

3. A pharmaceutical precursor is a novice or chemical substance that can be used as a feedstock/helper material for the purposes of industrial pharmaceutical production or product between, ruahan products, and so-containing ephedrine products, pseudoephedrine, norephedrine/phenylpropanolamine, ergotamine, ergometrine, or Potasium Permanganat.

4. Copying is any drug distribution activity, Narcotropic and Pharmaceutical Precursors in the framework of health care or science interests.

5. Submission is any activity providing narcotics, psychotropic and pharmaceutical precursors, either between the dismay or to the patient in the course of health care.

6. The Pharmaceutical Industry is an enterprise that has the permission of the Minister of Health to conduct drug or drug-making activities.

7. The next major pharmaceutical company, PBF, is a legal entity that has permission for the procurement, storage, distribution of drugs and/or drug materials in large amounts according to the rules of the invitation-invitation.

8. Government Pharmaceutical installations are a means of storing and channelling the Government's pharmaceutical and health tools, both the Central Government and the Local Government, the Indonesian National Armed Forces/Police, the State-owned Enterprises, and the Agency. Area-owned businesses in the framework of health care, which in the Law on Narcotics and Psychiatry are called Sarana Storage of Government Pharmaceutical Supplies.

9. Hospital Pharmacy Installation is a functional managing unit that organizes all the pharmacies of the Hospital in the Hospital.

10. Pharmacy installation of the Clintons is part of the clinic, which in the Act on Narcotics and Psychiatry is called the Medicine Hall, which is responsible for organizing, coordinating,

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set up, and oversaw the entire pharmaceutical service activities as well as carrying out pharmacist technical coaching.

11. A pharmacy is a means of service to the pharmacies where the pharmacist practices are performed by the Apoteker.

12. A drugstore is a means that has a permit to store free drugs and free drugs for sale to retail.

13. The Institution of Science is an institution of education and training as well as a government or private research and development institute that can use narcotics, psychotropic, and pharmaceutical precursors to the benefit of the sciences. the development of science and technology.

14. The next importer of the psychotrotropic IT is a large pharmaceutical trader who is licensed to import psychotropics to distribute to the pharmaceutical industry and science as the end user. Psychotropic.

15. Importer Listed Precursor Pharmacy next abbreviated IT Precursor Pharmaceuticals is a large pharmaceutical trader who gets permission to import pharmaceutical precursors to be distributed to the pharmaceutical industry and science agencies as a the end user of the pharmacy precursors.

16. The Head of the Hall is the Chief Technical Officer of the Food and Drug Administration environment.

17. The head of the Agency is the Head of the Non-Ministry Government, which has the task of carrying out government duties in the area of drug and food supervision.

18. The Director General is the Director General of the Ministry of Health whose duties and responsibilities in the field of pharmacist coaching and health care.

19.

Article 2

Circular, storage, extermination and reporting of Narcotics, Psychiatcotropic, and Precursors of Pharmacy in this Minister's Regulation. include Narcotics, Psychiatry, and Precursors of Pharmacy for the benefit of health care or the development of science and technology.

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BAB II

CIRCULATION

Part Kesatu

General

Section 3

The circulation of Narcotics, Psychotroics, and Precursors of Pharmacy is made up of Surrender and Cruciation.

Article 4

Narcotics, Psychotropic, and Precursors of the circulated Pharmaceuticals must meet safety, efficacy, and quality requirements.

Article 5

(1) Narcotics, Psychiatcotropic, and Precursors of Pharmacy in the form of a drug so can only be circulated after obtaining edar permission from the Minister.

(2) To obtain a Narcotics edar permit, Psychiatcotropic, and The precursors of the pharmacy in the form of a drug so as referred to in verse (1) must go through registration on the Food and Drug Administration.

(3) The provisions of the manner of the manner in order to get edar permission as referred to in paragraph (1) are executed. in accordance with the provisions of the laws.

Section 6

(1) The Pharmaceutical Industry which produces Narcotics and PBF or Government Pharmaceutical Installation that channels Narcotics is required to have special permission from the Minister in accordance with the provisions of the laws.

(2) Special permissions as referred to in paragraph (1) are:

a. Special Permission of Drug Production;

b. Special Permission Importation Narcotics; or

c. Special Clearance Narcotics.

(3) The Sciences Institute which acquired, planted, stored, and used Narcotics and/or Psychotroics for the benefit of science and technology must have the permission of the Minister accordingly. The rules of the invitation-invite rule.

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Article 7

The circulation of Narcotics in the form of a drug so used in therapeutic and rehabilitation programs is carried out in accordance with the provisions of the laws.

Second Section

Paragraph

paragraph 1

General

section 8

Narcotics, psychotropic, and Pharmaceutical Precursors are required to meet the Good Drug Distribution Way in accordance with the rules of the law. It's

Article 9

(1) Narcotic, Psychotropic, and Pharmaceutical Precursors can only be performed based on:

a. order letter; or

b. Usage Report and Drug Request Sheet (LPLPO) for the order of Puskesmas.

(2) The order letter as referred to in paragraph (1) the letter may only apply to each Narcotics, Psychotropic, or Pharmaceutical Precursors.

(3) Narcotics Order Letters can only be used for 1 (one) Narcotics.

(4) Psychiatric Order Letters or Precursors of Pharmacy can only be used for 1 (one) or some type of Psychiatry or Pharmaceutical Precursors.

(5) Letter the order of the order, as referred to in the paragraph (3) and the paragraph (4) must be separated from other items.

paragraph 2

Narcoction of Narcotics Group I

section 10

(1) Drug-based Drug Enforcement I can only be carried out by a State-owned PBF company which has a Special Narcotics Import License to the Institute of Science Knowledge for the benefit of the development of science and technology, including for laboratory needs.

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(2) Narcotics Poets as referred to in paragraph (1) may only be performed on the basis of a letter of order from the Apotecher in charge and/or the Head of the Science Institution by using the example as listed in Form 1 attached.

paragraph 3

Narcotropic, psychotropic and

Precursors of Pharmacy In the Form of the Default Materials

Article 11

(1) Narcotics sorting in the form of raw materials can only be performed by a State-owned PBF company that has a Narcotics Import Special Permission to the Industry Pharmacy and/or Science Institute.

(2) Narcotics Poets as referred to in paragraph (1) may only be carried out on the basis of a letter of order from the Apoteker responsible for the production and/or the Head of the Science Society with use an example as set forth in Form 1 attached.

Article 12

(1) Psychotropic Substances in the form of raw materials can only be performed by PBF which has permission as an IT Psychiatcotropic to the Pharmaceutical Industry and/or Institute of Science.

(2) Psychotropic Substances as contemplated on paragraph (1) may only be performed on the order of the order of the production and/or the Head of the Science Institution by using the example as set forth in Form 2 attached.

Section 13

(1) Pharmacy Precursors are substances/chemicals/chemicals or products between/products can only be performed by PBF which has the IT permit Precursor Pharmacy to the Pharmaceutical Industry and/or the Science Institute.

(2) The Alignment Pharmacy Precursors as referred to in paragraph (1) can only be done based on an order letter from the Apoteker responsible for the production and/or the Head of the Science Institute by using the example as set forth in Form 3 attached.

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Paragraph 4

Narcotic, Psychotropic and

Precursors of Pharmacy In Drug Form So

Section 14

(1) Narcotics, Psychiatry, and Pharmaceutical Precursors in the form of a drug so can only be done by:

a. Pharmaceutical Industry to PBF and Government Pharmaceutical Installation;

b. PBF to other PBF, Pharmacies, Hospital Pharmacy Installations, Clinic Pharmacy Installation, Government Pharmacy Installation and Science Institute;

c. The PBF belongs to the State that has a Narcotics-Import Special Permission to the Pharmaceutical Industry, for Narcotic copying;

d. Installation of the Central Government Pharmacy to the Regional Government Pharmaceutical Installation, Government-owned Hospital Pharmacy, and the Indonesian National Army Pharmacy Installation, and the

e. Regional Government Pharmaceutical installations to the Local Government's Installation of the Hospital, the Local Government's Installation Clinic, and the Puskesmas.

(2) In addition to other PBF, Apotek, Hospital, Installation of Government Pharmacy and the Science Institute as referred to in paragraph (1) letter b, PBF may channel the Precursors of the free drug group restricted to the Drug Store.

Article 15

Narcotics, Psychotroics, and Precursors of Pharmacy in the drug form so by the Pharmaceutical Industry to PBF can only be done by Industry Pharmacy of edar clearance owners.

Article 16

(1) Narcotics, Psychiatcotropic, and Precursors of Pharmacy in the form of a drug so can only be done on the basis of a letter of order from the Apoteker in charge or the Head of the Science Society for research and development needs, using examples as set forth in Form 1, Form 2 and Form 4 attached.

(2) Excluded from the provisions as referred to in paragraph (1), for the channation to Government Pharmaceutical installation, order mail can be signed by the Apoteker who appointed.

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(3) In terms of the Precursors of Pharmacy Precursors of PBF to the Drug Store, can only be performed on an order letter from the Pharmacian Technical Power using the example as set forth in Form 4. Attached.

Section 17

(1) Narcotics, Psychotropic, and Precursors of Pharmacy performed by the Pharmaceutical Industry, PBF, or Government Pharmaceutical Installations should be supplemented by:

a. order letter;

b. the invoice and/or the item ' s introduction letter, at least load:

1. Narcotic, Psychotropic, and Pharmaceutical Precursors;

2. form of supplies;

3. power;

4. packaging;

5. number;

6. date of expiry; and

7. batch number.

(2) Narcotics, Psychotropic, and Pharmaceutical Precursors, as referred to in verse (1) through transport services can only carry Narcotics, Psychotroics, and Precursors of Pharmacy according to the number of The tecantum in the mail order, invoice, and/or delivery letter of the goods brought during delivery.

Third Section

submission

paragraph 1

General

section 18

(1) The surrender of Narcotics, psychotropic, and Pharmacy precursors can only be done in the form of a drug so.

(2) In terms of The submission as referred to in verse (1) is done to the patient, must be exercised by the Apoteker at the pharmacist services facility.

(3) The Surrender as referred to in verse (2) is performed directly according to the standard Farcationist service.

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(4) Excluded from the provisions as referred to in paragraph (2), the submission of the Precursors of the Pharmacy which includes the restricted free drug group at the Drug Store is carried out by the Farmasian Technical Power.

Paragraph 2

Narcotics and Psychotropic Surrender

Article 19

(1) Narcotics and/or Psychotropic surrender may only be performed by:

a. Pharmacy;

b. Puskesmas;

c. Hospital Pharmacy Installation;

d. Clinic Pharmacy Installation; and

e. doctor.

(2) Apotek as referred to in paragraph (1) the letter a can only give up Narcotics and/or Psychotroics to:

a. Other pharmacies;

b. Puskesmas;

c. Hospital Pharmacy Installation;

d. Clinic Pharmacy Installation;

e. doctor; and

f. patients.

(3) Surrender Narcotics and/or Psychotroika as referred to in paragraph (2) letters a up to the letter d can only be done to meet the lack of the amount of Narcotics and/or Psychotroika based on the prescribed prescription.

(4) Surrender as referred to in paragraph (3) must be based on a written request letter signed by the appener of the charge by using the example as set forth in Form 5 attached.

(5) Apotek, Puskesmas, Hospital Pharmacy Installation, and Pharmacy Pharmacy only can handing Narcotics and/or Psychotroics to patients based on the doctor ' s prescription.

Article 20

(1) The Surrender of Drugs and Psychiatcotropic by Apotek to Doctors can only be done in terms of:

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a. The doctor runs the individual practice by giving Narcotics and Psychotropic a syringe through the injection; and/or

b. The doctor execues a task or practice in a remote area that is not apocrying or in accordance with the provisions of the laws.

(2) Surrender as referred to in paragraph (1) must be based on a written request letter signed by a physician addressing the patient by using an example as set forth in Form 6 attached.

Article 21

(1) The Submission Of Narcotics and Psychotroika by doctors to patients can only be done in terms of:

a. The doctor runs the individual practice by giving Narcotics and Psychotropic substances through the injection;

b. The doctor helps the sick in an emergency by giving Narcotics through the injection;

c. The doctor helps the sick in an emergency by giving the psychotropic a psychotropic; or

d. Doctors are running errands in remote areas where no Apotek is based on the assignment of the authorized officer.

(2) The assignment letter as referred to in paragraph (1) the letter d included as a Narcotics storage permit and Psychotropic for medicinal purposes.

Paragould 3

The Recursors of the Pharmaceutical Precursors

Article 22

(1) The Precursors of the Pharmaceutical Precursors can only be performed by:

a. Pharmacy;

b. Puskesmas;

c. Hospital Pharmacy Installation;

d. Clinic Pharmacy Installation;

e. doctor; and

f. Drugstore.

(2) Apotek can only hand over Precursors of the hard-drug group Pharmacy to:

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a. Other pharmacies;

b. Puskesmas;

c. Hospital Pharmacy Installation;

d. Clinic Pharmacy Installation;

e. doctor; and

f. patients.

(3) Apotek, Puskesmas, Hospital Pharmacy Installation, and Installation Pharmacy Pharmacy can only submit the Precursors of the hard-drug group Pharmacy to patients based on the doctor's prescription.

(4) Precuration of the class of Pharmaceutical Precursors The hard drugs as referred to in verse (2) letters a up to the letter d can only be done to meet the lack of the number of Precursors of the pharmaceutical group of hard drugs based on the accepted prescription.

(5) Precursors of the Pharmaceutical Precursors free drug group restricted by Apotek to other Apotek, Puskesmas, Installation Hospital Pharmacy, Pharmacy Pharmacy Installation, and Drug Store can only be done to meet the daily needs of the daily needs of the restricted free drug group Precursors required for treatment.

(6) The Precursor Pharmacy Precursor by A pharmacy to a doctor may only be performed if it is necessary to perform tasks/practices in remote areas that are not Apotek or in accordance with the provisions of the laws.

Article 23

(1) Surrender as referred to in Section 22 of the paragraph (4), paragraph (5), and paragraph (6) must be based on a written request letter signed by the pharmacist/Pharmacian Technical Power of the charge or physician of the handle patients using examples as set forth in Form 7, Form 8, and Form 9 attached.

(2) Excluded from the provisions as referred to in paragraph (1), the submission of the Free drug group Precursors is limited by Apotek to the Drug Store, can only be done based on a request letter written signed by the Farmasian Technical Power using the example as set forth in Form 8 attached.

(3) The Precursors of the Precursors of the Pharmacy of the free drug group to the patient must pay attention to the confusion the amount submitted in accordance with the therapeutic needs under the provisions of the laws.

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BAB III

STORAGE

Part Kesatu

General

Section 24

Narcotics storage, Psychotropic, and Pharmaceutical Precursors at production facilities, distribution facilities, and facilities The pharmacist ministry must be able to maintain the safety, efficacy, and quality of Narcotics, Psychotroics, and Precursors of Pharmacy.

Article 25

(1) Narcotics, Psychotropic, and Pharmaceutical Precursors can be a warehouse, room, or special closet.

(2) The premises of Narcotics are prohibited from being used to store items other than Narcotics.

(3) Psychiatric Storage is prohibited for storing items other than psychcotropic.

(4) Precursors of Pharmacy Precursors in the form of raw materials are prohibited from being used to store goods in addition to the Precursors of the Pharmacy in the form of raw materials.

Article 26

(1) The special warehouse as referred to in Article 25 of the paragraph must meet the requirements as follows:

a. Walls are made of walls and only have doors equipped with iron bars with 2 (two) different key fruits;

b. The ceiling can be made of concrete walls or iron bars;

c. if there are windows or vents should be equipped with iron bars;

d. The warehouse should not be entered by someone else without the permission of the charge Apoteker; and

e. The warehouse key is controlled by the responsible pharmacist and other employee.

(2) The special room as referred to in Article 25 of the paragraph (1) must be eligible as follows:

a. walls and ceilings are made of powerful materials;

b. if there are windows or vents should be equipped with iron bars;

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c. has one door with 2 (two) different key fruits;

d. Special space key is controlled by the designated Responsible Pharmacist/Apoteker and the other employees of which are being used; and

e. should not be entered by someone else without the permission of the designated Apoteker/Apoteker.

(3) The special Lemari as referred to in Article 25 of the paragraph (1) must be eligible as follows:

a. made of a strong material;

b. is not easily moved and has 2 (two) different keys;

c. must be placed in a special room at the corner of the warehouse, for Government Pharmaceutical Installation;

d. is put in a safe and invisible place by the general, for the pharmacy, the Pharmacy Installation Of Hospitals, Puskesmas, Pharmacy Pharmacy Installations, and the Science Institute; and

e. Special closet key is controlled by the designated Apoteker/Appeller and other employees are being used.

Article 27

Narcotics Storage, Psychotroics, and Precursors of Pharmacy are required to meet the Good Drug Production Way, Cara Good Drug Distribution, and/or the standard of pharmacist services in accordance with the provisions of the laws.

Second Quarter

Narcotics or Psychotropic Storage

Article 28

(1) The Pharmaceutical Industry which Narcotics manufactures must have a Narcotics repository in place of a special warehouse, consisting of:

a. The special warehouse Narcotics in the form of raw materials; and

b. The special warehouse Narcotics in the form of a drug so.

(2) The warehouse specifically as referred to the verse (1) is in the possession of the responsible Apothecary.

Article 29

(1) The Pharmaceutical Industry which produces Psychiatcotropic must have Psychiatric storage is a special warehouse or special space, consisting of:

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a. special warehouse or Psychotropic specialty space in the form of raw materials; and

b. special warehouse or Psychotropic special room in the form of a drug so.

(2) Special warehouse or special space as referred to in paragraph (1) is in the possession of the responsible apologist.

Article 30

(1) PBF is channelling Narcotics must have a Narcotics repository in a special warehouse.

(2) In terms of the PBF channelling Narcotics in the form of raw materials and drugs so, a special warehouse as referred to in the verse (1) must consist of:

a. The special warehouse Narcotics in the form of raw materials; and

b. The special warehouse Narcotics in the form of a drug so.

(3) The warehouse specifically for Narcotics storage as referred to in verse (1) and verse (2) is in the possession of the responsible appener.

Article 31

(1) the PBF Psychotropic storage must have a special warehouse or a special room.

(2) In terms of PBF channelling psychotropic form in the form of raw materials and medicine, a special warehouse or special space is intended. on paragraph (1) must consist of:

a. special warehouse or Psychotropic specialty space in the form of raw materials; and

b. Special warehouse or Psychotropic space in the form of a drug so.

(3) Special warehouse or special room for psychiatric storage as referred to in verse (1) and verse (2) is in the possession of the Apoteker in charge.

Article 32

(1) Government Pharmaceutical Installation that stores Narcotics or Psychotroics must have a Narcotics or Psychotropic repository of a special room or special closet.

(2) Special rooms or special closets Narcotics or Psychotropic sites, as referred to in paragraph (1) are in the control of the designated Apoteker or the designated Apoteker.

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Article 33

(1) Pharmacy, Hospital Pharmacy Installation, Puskesmas, Clinic Pharmacy Installation, and Science Institute must have a Narcotics or Psychotropic repository in a special closet.

(2) Special Lemari as referred to in paragraph (1) is in the mastery of the responsible Apotecher.

Article 34

Individual practice physicians who use Narcotics or Psychotroics for treatment purposes must save Narcotics or psychotropics in a safe place and have keys that are under mastery doctor.

Third Section

Storage Precursor Pharmacy

Article 35

(1) Pharmaceutical Industry that uses the Precursors of Pharmacy in the form of raw materials to produce the Precursors of Pharmacy or PBF that channel the Precursors Pharmaceuticals in the form of raw materials must have a pharmacy Precursor repository of a special warehouse or special room.

(2) The special warehouse or special room as referred to in paragraph (1) is in the possession of the Apoteker in charge.

Article 36

(1) The Pharmaceutical Industry which produces the Precursors of Pharmacy in form of a drug so, a PBF that channels the Precursors of Pharmacy in the form of a drug so, or the Government Pharmaceutical Installation must keep the Pharmaceutical Precursors in the form of a drug so in a safe storage facility based on risk analysis.

(2) Pharmacy, Puskesmas, Hospital Pharmacy Installation, Clinic Pharmacy Installation, and Science Institute must store Precursors of Pharmacy in the form of a drug so in a safe drug storage facility based on risk analysis.

BAB IV

ANNIHILATION

section 37

Drug Destruction, psychotropic, and Precursors The pharmacy is only done in terms of:

a. produced without meeting the standards and requirements that apply and/or not be reprocessed;

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b. has expired;

c. It is not eligible for use on health care and/or for the development of science, including the remainder of use;

d. cancelled edarnya clearance; or

e. related to criminal conduct.

Article 38

(1) Annihilation as referred to in Article 37 of the letter a up to the letter d is exercised by the Pharmaceutical Industry, PBF, Government Pharmacy Installation, Pharmacy, Hospital Pharmacy Installation, Installation of the Pharmacy Clinic, Institute of Science, Doctor or Drug Store.

(2) Narcotics, Psychiatry, and Precursors of Pharmacy that meet the extermination criteria as referred to in Article 37 of the letter a up to the letter d located in the Puskesmas should be returned to the local Local Government Pharmacy Installation.

(3) Government Pharmaceutical Installation that carries out extermination must perform the removal under the provisions of laws in the State/Region Property management field.

(4) Eradication Of Narcotics, Psychotropic, and Precursors of Pharmacy in association with criminal acts as referred to in Article 37 of the letter e exercised by the government authorities in accordance with the provisions of the rule of law- invitation.

Article 39

Destruction Of Narcotics, Psychotropic, and Precursors of Pharmacy must be done with:

a. not polluting the environment; and

a. no harm to the public health.

Article 40

The Destruction Of Narcotics, Psychotropic, and Precursors of Pharmacy is carried out with stages as follows:

a. In-charge of a production facility/distribution facility/community leaders/private practice/private practice/physician practice.

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1. Ministry of Health and Food and Drug Administration, for the Central Government Pharmaceutical Installation;

2. Provincial Health Services and/or Great Hall/Local Food and Drug Administration, for Importers, Pharmaceutical Industry, PBF, Science Institute, or Provincial Pharmaceutical Installation of the Province; or

3. County/City Health Services and/or Great Hall/local Food and Drug Administration, for Pharmacies, Hospital Pharmacy Installations, Clinic Pharmacy Installations, County/City Government Pharmaceutical Installations/City, Doctor, or Drug Store.

b. Ministry of Health, Food and Drug Administration, Provincial Health Service, Great Hall/Local Food and Drug Administration, and County Health Service/City assign officers in its neighborhood to witness extermination according to the letter a plea as a witness.

c. The extermination witnessed by the assigned officer, as referred to in the letter b.

d. Narcotics, Psychiatcotropic and Precursors of Pharmacy in the form of raw materials, intermediate products, and ruahan products must be conducted sampling for the benefit of testing by authorized officers prior to extermination.

e. Narcotics, Psychiatcotropic and Precursors of Pharmacy in the form of a drug so must be exercised organically correct truths by witnesses prior to extermination.

Article 41

In terms of Narcotics Destruction, Psychotropic, and Precursors Pharmacy is carried out by a third party, required to be witnessed by Narcotics, Psychotropic, and Pharmaceutical Precursors and witnesses as referred to in Article 40 of the letter b.

Section 42

(1) Recharge of production facilities/bulk distribution facilities/Pharmacian service facilities/leaders of individual practices carrying out Narcotics, Psychiatry, and Precursors of Pharmacy must make Extermination Event News.

(2) The news of the extermination event as referred to in verse (1), the least contains:

a. days of the month and year of extermination;

b. Extermination site;

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c. The name of the production facility is the distribution facility/pharafield services/private practice physician/doctor of the individual practice;

d. the name of the health officer who is the witness and the other witness/means of it;

e. name and number of Narcotics, Psychotroics, and Precursors of the destroyed Pharmacy;

f. way of extermination; and

g. The signature of a production facility is a production facility/distribution facility/head of the institution/host of individuals and witnesses.

(3) The event of the extermination event as referred to in paragraph (1) is made in the triple (three) and its release is delivered to the Director General and the Head of the Board using the example as set forth in Form 10 attached.

BAB V

LOGGING AND REPORTING

Part Atu

Pencatatan

Section 43

(1) Pharmaceutical Industry, PBF, Government Pharmaceutical Installation, Pharmacy, Puskesmas, Hospital Pharmacy Installation, Clinic Pharmacy Installation, Science Institute, or physician practice individuals who do produce, Cruciation, or Surrender Narcotics, Psychotropic, and Precursors of Pharmacy are required to create Logging in and/or Narcotics, Psychotropic, and Pharmaceutical Precursors.

(2) Drug Stores performing the handover of Precursors of Pharmacy in the form of a drug so it is mandatory to make records regarding income and/or expenses Pharmacy precursors in the form of a drug so.

(3) Seekers as referred to the paragraph (1) and the paragraph (2) is at least composed of:

a. name, supply form, and the power of Narcotics, Psychotropic, and Precursors of Pharmacy;

b. supply amount;

c. date document number and acceptance source

d. the amount received;

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e. the date of the document number and the direction of the invader/invader;

f. The amount is distributed/called;

g. batch number and expiry of any receipt or inclusion/absorber; and

h. paraf or the identity of the designated officer.

(4) Seekers performed as referred to in paragraph (1) and paragraph (2) must be made in accordance with the receipt document and the presentation document including import documents, export documents and/or Submission document.

Section 44

All records documents, receipt documents, copying documents, and/or submission documents including Narcotics, Psychotropic documents, and Compulsory Pharmacy Precursors are kept separately at least short 3 (three) years.

Second Quarter

Reporting

Article 45

(1) Pharmaceutical industry that produces Narcotics, Psychiatry, and Precursors of Pharmacy are required to create, store, and deliver product reports and products such as Narcotics, Psychiatry, and Precursors of Pharmacy each month to the Director-General.

(2) PBF conducting Narcotics, Psychiatry and Precursors of Pharmacy in the form of a drug so it is mandatory to create, store, and report on the report of admission and distribution of Narcotics, Psychiatcotropic, and Precursors of Pharmacy in the form of a drug so every month to the Head of Health Service Provinces with head of the Head/Head of the Hall.

(3) The Pharmaceutical Installation of the Central Government is required to create, store, and report on the report of admission and the distribution of Narcotics, Psychiatry, and Precursors of Pharmacy in the form of drugs so to Director General with Head of the Head of the Agency.

(4) The Local Government Pharmaceutical Installations are required to create, store, and report on the report of admission and the distribution of Narcotics, Psychiatry, and Precursors of Pharmacy in the form of drugs so to Head of the Provincial Health Service/Local City/City with a gust to the local Hall Chief.

(5) The Reporting as referred to in paragraph (1) to the paragraph (4) is at least composed of:

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a. name, form of supply, and the power of Narcotics, Psychotropic, and/or Precursors of Pharmacy;

b. the initial and end-of-month supply count;

c. date of document number and acceptance source;

d. the amount received;

e. the date of the document number and the destination of the distribution;

f. the amount is channeled; and

g. batch number and expired any receipt or delivery and supplies of early and final.

(6) Pharmacy, Hospital Pharmacy Installation, Clinic Pharmacy Installation, Science Institute, and individual practice physicians are required to create, store, and deliver the report of admission and submission/use of Narcotics and Psychiatcotropic, each month to the County/City Health Service Chief with the local Hall Chief.

(7) Reporting as referred to paragraph (6) the most A little bit of:

a. name, form of supply, and the power of Narcotics, Psychotropic, and/or Precursors of Pharmacy;

b. initial and end-month inventory count;

c. the amount received; and

d. the amount submitted.

(8) Puskesmas is required to create, store, and deliver reports of admission and submission/use of Narcotics and Psychiatry in accordance with the provisions of the laws.

(9) Reports as referred to in paragraph (1) to the paragraph (4) and paragraph (6) may use the Narcotics, Psychotropic, and/or Pharmaceutical Reporting Systems electronically.

(10) The report as referred to in paragraph (1) up to the verse (4) and paragraph (6) delivered the slowest any of the next 10 months.

(11) Further provisions on the manner of Narcotics reporting, psychcotropic, and/or Precursors of Pharmacy are governed by the Director General.

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BAB VI

COACHING AND SUPERVISION

Article 46

Minister, Head of the Board, Head of Hall, Head of Provincial Health Service, and Head of the District Health Service/City conduct coaching and supervision against the implementation of the Regulation of this Minister in accordance with their respective duties, functions, and authority.

Article 47

The violation of the provisions in the Regulation of the Minister is subject to administrative sanction in accordance with the provisions of the invitational regulations.

BAB VII

TRANSITIONAL provisions

Article 48

At the time This Minister's rules are in effect, every Pharmaceutical Industry, PBF, Government Pharmaceutical, pharmacy, and puskesmas, hospital pharmacy installations, clinic pharmacy installations, or the science agency in doing narcotics storage, psychotropic, and drug-based pharmacies, and ... and/or Precursors the Pharmacy must adjust to the storage provisions as provided in this Minister Regulation the slowest 3 (three) years since the Regulation of the Minister came into effect.

BAB VIII

provisions CLOSING

Article 49

At the time the Regulation of the Minister came into force:

1. Health Minister Regulation Number 28 /Menkes/Per/I/1978 on Narcotic Storage;

2. Ministry of Health Law Number 688 /Menkes/Per/VII/1997 on Psychotropic Circulation; and

3. Health Minister Regulation No. 912/Menkes/Per/VIII/1997 on Annual Needs and Psychotropic Reporting,

revoked and declared to be not valid.

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Article 50

The rules of the Minister are valid.

For everyone to know, ordered the invitation of the Minister of the Union with its placement in the News of the Republic of the Republic of the Republic of the Republic of the Republic of the Republic of the Republic of the Republic of Indonesia.

Specified in Jakarta

on 5 January 2015

MINISTER OF HEALTH

REPUBLIC OF INDONESIA,

NILA FARID MOELOEK

Reundated in Jakarta

on 16 January 2015

MINISTER OF LAW AND HUMAN RIGHTS

THE REPUBLIC OF INDONESIA,

YASONNA H. LAOLY

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