ter of the pharmaceutical precursors called ET Precursor Pharmaceuticals is a large pharmaceutical trader who gets clearance as a pharmaceutical precursor exporter.
17. The Pharmaceutical Industry is an enterprise that has the permission of the Minister of Health to conduct drug-making or drug-making activities.
18. The next major pharmaceutical company called PBF is a legal entity that has permission for the procurement, storage, distribution of drugs and/or drug materials in large quantities according to the provisions of the laws.
Nineteen. 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.
Twenty. The head of the Food and Drug Administration (CUP), called Head of the Agency, is the Head of the Agency whose duties and responsibilities in the field of drug and food supervision.
21. The Director General is the Director General on the Ministry of Health responsible in the areas of pharmacist coaching and health tools.
22.Minister is the minister who organizes government affairs in the health field.
Article 2
Import and Export Narcotics, Psychiatcotropic, and/or Precursors of Pharmacy can only be done for the benefit of health care or science and technology development.
BAB II
IMPORT OF NARCOTICS, PSYCHOTROPIC, AND PHARMACY PRECURSORS
The Kesatu section
General
Section 3
(1) Narcotics Import can only be carried out by 1 (one) state-owned PBF companies that have had a special permit as an importer of the Minister.
(2) The Minister delegates the granting of special permission as referred to paragraph (1) to the Director General.
(3) In terms of state-owned PBF companies as referred to in paragraph (1) cannot carry out its function in conducting Narcotic Import, the Director General may grant special permission to other state-owned PBF companies.
Section 4
(1) Psychotropic Substances and/or Precursors of Pharmacy can only be done by the Pharmaceutical Industry, PBF, or Science Institute.
(2) The Pharmaceutical Industry and PBF as referred to in paragraph (1) must have a permit as an IP Psychiatcotropic/IP Precursor Pharmacy or as an IT Psychiatcotropic/IT Precursor Pharmacy of the Minister.
(3) The Science Institute as referred to in paragraph (1) does not require permission as an importer of Psychiatcotropic and/or Precursors of Pharmacy.
(4) The Minister delegated the grant of permission as referred to in paragraph (2) to the Director General.
Second Part
Import Implementation
Section 5
(1) Importation Of Narcotics, Psychotropic, and/or Precursors of Pharmacy can only be implemented after obtaining SPI from the Minister.
(2) SPI as referred to in paragraph (1) applies to each time of import execution.
(3) The Minister delegated the awarding SPI as referred to paragraph (1) to the Director General.
Section 6
A state-owned PBF Corporation with special permission as a Narcotics importer can only channel the Narcotics that are imported into the Pharmaceutical Industry who have had a special permit to produce Narcotics or Science Institute Knowledge.
Section 7
(1) the IP of Psychiatcotropic and/or IP Precursor Pharmaceuticals can only import psychcotropic and/or Precursors of Pharmacy for the needs of its own production processes and are prohibited from trading and/or moving.
(2) The Science Institute can only import psychotropic and/or Precursors of Pharmacy for its own needs and is prohibited from trading and/or moving.
Section 8
(1) IT Psychiatcotropic and/or IT Precursor Pharmaceuticals can only import psychcotropic and/or Precursors of Pharmacy based on orders from the Pharmaceutical Industry or Science Institute.
(2) Psychotropic and/or Precursors of the Pharmacy as referred to in paragraph (1) are mandatory directly to the Pharmaceutical Industry or the testing of the Service Science Institute.
(3) The Pharmaceutical Industry or a testing science institution is prohibited from trading and/or moving to Psychotropic Substances and/or Precursors of Pharmacy.
Section 9
(1) The Pharmaceutical Industry which has had a special permit to produce Narcotics, is required to deliver an annual requirement plan for the production process signed by the Program's most slow-slow Production Pharmacist. January every year.
(2) Psychiatric Psychiatric and/or IP Precursors of Pharmacy are required to deliver an annual requirement plan for the production process signed by the Slower Production Charge of 10 January each year.
(3) IT Psychiatcotropic and/or IT Precursor Pharmaceuticals is required to deliver an annual requirement plan for the ordered Pharmaceutical Industry, which is signed by the PBF's slowest PBF-charge pharmacist every year on January 10 each year.
Article 10
In any implementation of imports, a state-owned PBF Company that has special permission as a Narcotics importer, IP Psychotropic/IP Precursor Pharmacy, and IT Psychiatry/IT Precursor Pharmaceuticals must show the original sheet of letter consent import to local customs officers and excise for charging import realization control cards.
Section 11
(1) State-owned PBF Companies carrying out Narcotic Imports of Narcotics are required to conduct Narcotics checks imported after getting to the warehouse.
(2) Narcotics Examination as referred to in paragraph (1) is required to be witnessed by the authorized officer of the body who has a duty and responsibility in the area of the supervision of medicine and food.
Third Part
Requirements and Methods of Obtaining Importer Permissions
Section 12
(1) To obtain permission as a Psychotropic Importer or Precursors of Pharmacy, Pharmaceutical Industry or PBF is applying to the Director General online via http://e-pharm.kemkes.go.id with an accompanying supporting documents, including:
a. photocopy of the Pharmaceutical Industry aan end user. Psychotropic.
Twelve. Importer Listed Precursor Pharmacy is next called 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 End user of the pharmaceutical precursor.
Thirteen. The next exporter of psychotropic producers is the pharmaceutical industry which is licensed as a psychotropic exporter.
14. The next exporter of pharmaceutical manufacturers, the Precursor Pharmaceutical EP, is a pharmaceutical industry that is licensed as an exporter of pharmaceutical precursors.
15. The next-listed exporter of psychotrotropic is called ET Psychiatcotropic is a large pharmaceutical trader who is licensed as a psychotropic exporter.
-16. The listed expor le="text-align: center;"> Section 18
(1) IT Psychiatcotropic or IT Precursor Pharmaceuticals may apply for SPI Psychiatcotropic or SPI Precursor Pharmacy for the benefit of the development of science and technology, diagnostic reagensia and laboratory reagents Based on orders from the Institute of Science.
(2) The Psychotropic SPI or SPI Precuration of Pharmacy as referred to in paragraph (1) is submitted to the Director General
online via
http://e-pharm.kemkes.go.id with a supporting document, including :
a. order of order from the Science Institute;
B. a statement letter of the needs of the Psychotropic or Precursors of Pharmacy signed by the leadership of the Institute of Science;
c. Photocopy of mail order (
purchasing order) to the exporter;
D. photocopy of the IT certificate of an IT Psychiatry or IT Precursor Pharmacy;
e. research protocol for research purposes;
f. a statement letter has not yet conducted Import of Psychiatcotropic or Precursors of Pharmacy for the purposes of the Institution of Science in question or the final Import realization report and final stock; and
G. Surveillance analysis.
(3) In order for verification of documents submitted online, the applicant must submit a photocopy of the supporting document as referred to in paragraph (2) to the Director General for the longest 3 (three) business days after a online application received.
(4) Most recently within 7 (7) business days since the supporting document as referred to in paragraph (3) is accepted, the Director General publishes the approval or rejection of SPI with a clear reason.
(5) The form of the SPI Psychiatric Document or SPI Precursors of the Pharmacy as referred to in paragraph (4) is listed in Form 7 and Form 9 as attached.
Article 19
(1) In addition to carrying out Psychotropic Substances or Precursors of Pharmacy through IT Psychiatry or IT Precursor Pharmacy, the Institute of Science can carry out imports directly.
(2) The Science Institute that will carry out the Psychotropic Importation or Precursors of Pharmacy directly as referred to in paragraph (1) must apply for SPI to the Director General by attaching it:
a. letter of request;
B. a statement letter of the needs of the Psychotropic or Precursors of Pharmacy signed by the leadership of the Institute of Science;
c. Photocopy of mail order (
purchasing order) to the exporter;
D. research protocol for research purposes;
e. a statement letter has not yet been to Import Psychotropic Substances or Precursors of Pharmacy for the purposes of the Institute of Science or the final Import realization report and final stock; and
f. Surveillance analysis.
(3) Most recently within 7 (7) business days since the document as referred to in paragraph (1) is accepted, the Director General publishes the approval or rejection of SPI with a clear reason.
(4) The form of the SPI Psychiatry document or SPI Precursors of Pharmacy as referred to in paragraph (2) is listed in Form 10 and Form 11 as attached.
BAB III
EXPORT OF NARCOTICS, PSYCHOTROPIC, AND PHARMACY PRECURSORS
The Kesatu section
General
Section 20
(1) Narcotics Export can only be carried out by 1 (one) state-owned PBF companies that have had special permission as exporters from the Minister.
(2) The Minister delegates the granting of special permission as referred to paragraph (1) to the Director General.
(3) In terms of state-owned PBF companies as referred to in paragraph (1) may not exercise its function in conducting Narcotics Export, the Director General may grant special permission to other state-owned PBF companies.
Section 21
(1) Psychotropic Export and/or Precursors of Pharmacy can only be done by the Pharmaceutical Industry or PBF.
(2) The Pharmaceutical Industry or PBF as referred to in paragraph (1) must have a permit as an EP of the Psychiatric Pharmacy/EP Precursor Pharmacy or as a ET Psychiatcotropica/ET Precursor Pharmacy of the Minister.
(3) The Minister delegated the grant of permission as referred to in paragraph (2) to the Director General.
Second Part
Export Implementation
Section 22
(1) The Export Of Narcotics, Psychotropic, and/or Precursors of Pharmacy can only be implemented after obtaining the SPE from the Minister.
(2) The SPE as referred to in paragraph (1) applies to each time the implementation of Export.
(3) The Minister delegated the awarding of the SPE as referred to in paragraph (1) to the Director General.
Section 23
(1) In order of implementation of Export, an exporter who has a special permit as a Narcotics exporter, an EP Psychiatric Pharmacy/EP Precursor Pharmaceuticals, or ET Psychicotropic/ET Precursor Pharmaceutical is required to pass the information in writing to Director General with stews to the Head of the Board containing:
a. estimate of export execution date;
B. the type of transport (laut/air) including the name and flight number/name and ship number;
c. Delivery details (port/airport name importers and transit if any); and
D. estimated date of arrival in the importer country.
(2) The information as referred to in paragraph (1) delivered the slowest 7 (seven) business days prior to the date of implementation of the export.
Third Part
Requirements and Terms of Obtaining Exporter ' s Permission
Section 24
(1) To obtain permission as an EP of the Psychotropica/EP Precursor Pharmacy, or ET Psychicotropic/ET Precursor Pharmacy, Pharmaceutical Industry or PBF applied to the Director General online through http://e-pharm.kemkes.go.id with supporting documents available, including:
a. photocopy of the Pharmaceutical Industry or PBF business permit;
B. photocopy of the Company List of Companies (TDP);
c. photocopy of the Tax Required Subject Number (NPWP); and
D. The photocopy of the Apoteker's License for the Responsible Job.
(2) In order for the verification of the document submitted online, the applicant must submit a photocopy of the supporting document as referred to in paragraph (1) to the Director General for the longest 3 (three) business days after a online application received.
(3) Most recently in the term 7 (seven) business days since the supporting document as referred to in paragraph (2) is accepted, the Director General publishes the consent or rejection of the permission with a clear reason.
(4) The form of permission as an EP of Psychotropica/EP Precursors of Pharmacy or ET applicant must submit a photocopy of the supporting document as referred to in paragraph (2) to the Director General for the longest 3 (three) business days after a online application received.
(4) Most recently within 7 (7) business days since the supporting document as referred to in paragraph (3) is accepted, the Director General publishes the approval or rejection of SPI with a clear reason.
(5) The form of the SPI Narcotics document as referred to in paragraph (4) is listed in Form 5 as attached.
BAB VII
COACHING AND SUPERVISION
Section 34
The coaching and oversight of the implementation of the Regulation of the Minister is exercised by the Minister and the Head of the Agency in accordance with the duties, functions and authority of each according to the provisions of the laws.
BAB VIII
SANCTION
Section 35
(1) The violation of the provisions in the Ministerial Regulation is subject to administrative sanction.
(2) administrative sanctions as referred to in paragraph (1) are:
a. written warning;
B. temporary termination of activities; or
c. revocation of permit as an importer or exporter of Narcotics, Psychiatry, and/or Precursors of Pharmacy as set out in this Minister's Regulation.
(3) The revocation of the permit as Importers or Exporter Of Narcotics, Psychotropic and/or Precursors of Pharmacy as referred to in paragraph (2) is carried out by the Director General.
BAB IX
TRANSITION PROVISIONS
Section 36
(1) Permission as an importer/exporter of Psychiatcotropic and/or Precursors of Pharmacy, or the application of SPI/SPE Narcotics, Psychiatcotropic, and/or Precursors of Pharmacy that have been submitted before the enactment of the Regulation of this Minister remain are processed under the rules or conditions specified before the enactment of this Minister ' s Regulation.
(2) Importer or SPI/SPE importers issued under the rules or conditions specified before the enactment of the Regulation of this Minister are declared to remain in effect until the expiring term is expired.
BAB X
CLOSING PROVISIONS
Section 37
At the time the Minister ' s Ordinance came into effect:
a. Health Minister Regulation No. 785 /Menkes/Per/VII/1997 on Export and Imports of Psychiatry; and
b. Health Minister Regulation Number 168 /Menkes/Per/II/2005 about the Precursors of Pharmacy, along which concerns the Import and Export of the Pharmaceutical Precursors;
revoked and declared not applicable.
Section 38
The rules of the Minister are in effect on the date of promulgations.
For each person to know it, order the invitation of the Order of the Minister with its placement in the News of the Republic of Indonesia.
Specified in Jakarta
on January 18, 2013
HEALTH MINISTER
REPUBLIC OF INDONESIA,
HEY, HEY, HEY, HEY.
It is promulred in Jakarta
on 30 January 2013
MINISTER OF LAW AND HUMAN RIGHTS
REPUBLIC OF INDONESIA,
AMIR SYAMSUDIN
Attachment:
bn178-2013lamp
btain an extension of SPE, a state-owned PBF that has special permission as a Narcotics exporter, a Psychiatric Pharmaceutical/EP Precursor Pharmaceuticals, or ET Psychicotropic/ET Precursor Pharmaceuticals apply to the Director General
online via
http://e-pharm.kemkes.go.id by mentioning the extension reason and accompanying supporting documents, including:
a. Native SPE; and
B. photocopies of special permission letters as Narcotics exposition, Psychiatric EP/EP Precursor Pharmacy, or ET Psychotropic/ET Precursor Pharmacy.
(3) The extension of the SPE as referred to in paragraph (2) must be submitted at least 10 (ten) days prior to the expiration of the SPE period.
(5) Most recently within 7 (7) business days since the supporting document as referred to in paragraph (3) is accepted, the Director General publishes the approval or rejection of the extension of the SPE with a clear reason.
(1) In the event of a change in the supporting data presented under the provisions of Article 15, Section 17, Section 18, Section 19, and Section 27, then SPI or SPE must be updated.
(2) The order of updating SPI or SPE applies mutatis mutandis following the provisions of Article 15, Section 17, Article 18, Article 19, and Section 27.
(1) Against the request of permission as an importer/exporter of Psychiatcotropic and/or Precursors of Pharmaceuticals or its banners and applications of SPI/SPE Narcotics, Psychiatcotropic, and/or Precursors of Pharmaceuticals or its banners, as well as pleas Surveillance Results Analysis, charged as state acceptance not tax on the provisions of the laws.
(2) In the event of a permit as referred to in the paragraph (1) rejected, then the fee payable is not retracted by the applicant.
A state-owned PBF Company carrying out Import and/or Narcotics Export, or Pharmaceutical Industry, PBF, Science Institute carrying out import and/or export of Psychiatcotropic and/or Precursors of Pharmacy is required to record and Keep records of the income and expense of Narcotics, Psychotropic Substances, or Precursors of the Pharmaceutical that are in its control.
(1) State-owned PBF companies that have received special permission as importers/Narcotics exporters are required to deliver a report of the realization of the Import/Export of Narcotics to the Director General online and/or written every time Import/Export
(2) PSYCHOTROPIC/IP PRECURSORS PHARMACY, IT PSYCHOTROPIC/IT PRECURSORS PHARMACY, EP PSYCHOTROPICA/EP PHARMACEUTICAL PRECURSORS, ET PSYCHOTROPIC A/ET THE PHARMACEUTICAL PRECURSOR is required to deliver a report of the realization of the Import/Export of Psychotropic and/or Precursors Pharmacy to the Director General online and/or written each time Import/Export.
(3) Reports as referred to in paragraph (1) and paragraph (2) are received at least 3 (3) days for Narcotics and 7 (7) days for Psychotropic Substances and Precursors of Pharmacy since the receipt of Narcotic, Psychotropic and/or Precursors of Pharmacy by importers or in the export of Narcotics, Psychiatry and/or Precursors of Pharmacy by stews to the Head of the Agency.
(4) The form of a written report as referred to in paragraph (3) is set forth in Form 21, Form 22, Form 23, Form 24, and Form 25 as attached.
(1) Science Institution that carries out Psychotropic Substances and/or Pharmaceutical Precursors both directly or through IT Psychiacy/IT Precursor Pharmaceuticals are required to convey the realization of the Psychotropic Import report and/or Precursors of Pharmacy to the Director General by stews to the Head of the Agency in writing each time Import.
(2) The report as referred to in paragraph (1) is received at least 7 (7) days from the receipt of the Psychiatric Import and/or the Precursors of Pharmacy with stews to the Head of the Agency.
