ccordance with the provisions of the laws.
18. Exporter Registered Precursor Pharmacy, next called the ET Precursor Pharmaceuticals, is a PBF that gets clearance as an exporter of Pharmaceutical Precursors under the provisions of the laws.
Nineteen. The Institution of Science is the institution of education and training as well as the research and development institutions organized by the government or the private sector that can use Narcotics, Psychiatcotropic and Precursors of Pharmacy for the benefit of the sciences. the development of science and technology as per the provisions of the laws.
Twenty. Surveillance Results analysis, later called the AHP, is the result of the audit of the Head of the Food and Drug Administration against plans for import/export needs, the realization of production, and/or the use of Narcotics, Psychiatry or the Precursors of Pharmacy, and It is the basis of the issuer of the Import and Export Agreement.
21. The Director is the Chairman of the directorate responsible in the areas of Narcotics, Psychiatcotropic and Precursors of Pharmacy under the Office of the Non-Ministry led by the Head of the Agency.
22. The Director General is the Director General in charge of the Kefarmasian coaching field and the Health Tools that are under the ministry headed by the Minister.
23. 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.
24.Minister is the minister who organizes government affairs in the health field.
BAB II
REQUIREMENTS
Section 2
(1) Narcotics, Psychotropic, and Precursors of Pharmacy can only be imported or exported with the goal for the benefit of health care and/or the development of science and technology.
(2) Narcotics, Psychotropic, and Precursors of Pharmacy can only be imported or exported under SPI or SPE from the Minister.
(3) Before applying for SPI or SPE, importers or exporters must obtain AHP from the Head of the Agency.
(4) The AHP as referred to in paragraph (3) may only be used for 1 (one) times the submission of SPI or SPE.
(5) AHP as referred to in paragraph (4) as the base of the Minister for publishing SPI or SPE.
(6) Head of the Agency delegated AHP publishing to the Deputy Field Control of the Terapetic Products and NAPZA.
Article 3
(1) The AHP applicant for the purpose of Narcotics importation must be a state-owned PBF company which has obtained a special permit as a Narcotics importer of the Minister.
(2) The AHP applicants for the purpose of psychotropic importation are:
a. Psychotropic IP;
B. IT Psychotropic; or
C. Institute of Science.
(3) The AHP applicant for the purpose of importing Precursors of Pharmacy is:
a. Pharmacy IP Precursors;
B. IT Precursors Pharmacy; or
C. Institute of Science.
Section 4
(1) The AHP applicant for the purpose of Narcotics Export must be a state-owned PBF company which has obtained a special permit as a Narcotics exporter from the Minister.
(2) The AHP applicant for the purposes of the Psychiatric Export is:
a. Psychotropic EP; or
B. ET Psychotropic.
(3) The AHP applicant for export purposes Precursors Pharmacy is:
a. EP Precursors Pharmacy; or
B. ET Precursors Pharmaceuticals.
BAB III
ORDER THE APPLICATION
The Kesatu section
Applicant Registration
Section 5
(1) The applicant who will apply for AHP must register itself to the Head of the Agency.
(2) The applicant as referred to in paragraph (1) may be one of the petitioners as referred to in Section 3 and Section 4.
Section 6
(1) The registration as a applicant as referred to in Section 5 is submitted to the Head of the Agency by attaching supporting documents.
(2) The invocation is performed manually or electronically submitted via the Drug and Drug Administration website at http://www.pom.go.id or http://e-napza.pom.go.id subsite.
(3) The request manually as referred to in paragraph (2) can only be done if the process of electronically is not functional.
(4) The example of the registration format as the applicant as referred to in paragraph (1) is set forth in Annex I which is an inseparable part of this Regulation.
(5) The supporting document as referred to in paragraph (1) consists of:
a. a special permission of Narcotics importers for the state-owned PBF company;
B. permission as a psychotropic IP and/or permission as a Pharmaceutical Precursor IP;
c. permission as an IT Psychiatcotropic and/or permission as the IT Precursor Pharmacy;
D. Narcotics export special permission for the state-owned PBF company;
e. permission as an EP of Psychiatcotropic and/or permission as a Pharmaceutical Precursor EP; dan/or
f. permission as ET Psychiatcotropic and/or permission as the ET Precursor Pharmacy.
(6) Registration as an electronically performed applicant as referred to in paragraph (1) which is equipped with supporting data will obtain User ID and Password.
Section 7
(1) The registration as the applicant as referred to in Section 6 is performed only 1 (one) times, as long as there is no change of the applicant data.
(2) The applicant must submit a notification of the change of the applicant data or submit the registration again in the event of a change to the provisions as set forth in Annex II which is an inseparable part of This rule.
(3) Notice of the change of the applicant data or the registration back as referred to in paragraph (2) is performed in accordance with the provisions referred to in Article 6.
Second Part
Submission Requests
Section 8
(1) The registered AHP request as referred to in Article 6 may apply for AHP to the Head of the Agency by attaching supporting documents.
(2) The AHP application submission is performed manually or electronically via the Drug and Drug Administration website with http://www.pom.go.id or http://e-napza.pom.go.id subsite.
(3) The invocation of the application manually as referred to in paragraph (2)v>
14. Importer Listed Precursor Pharmacy, next called IT Precursor Pharmaceuticals, is PBF that gets permission to import Precursor Pharmaceutical to be distributed to the Pharmaceutical Industry and science agencies as the end users of the Precursors Pharmaceuticals on the provisions of laws.
15. The exporter of psychotropic producers, called the psychedelic EP, is the Pharmaceutical Industry that is licensed as a Psychotropic Exporter, as per the provisions of the laws.
-16. Exporter of Pharmaceutical Precursors, which is next called the Precursor Pharmaceutical EP, is the Pharmaceutical Industry that is licensed as the exporter of Pharmaceutical Precursors under the provisions of the laws.
17. Registered Exporter Psychotropic, later called ET Psychiatcotropic, is a PBF that is granted permission as a psychotropic exporter in a can only be done if the process of electronically is not functional.
(4) An example of the AHP request format as referred to in paragraph (2), for the purpose of import or export as set forth in Annex III which is an inseparable part of this Regulation.
(5) The supporting document as referred to in paragraph (1) for the purpose of import, as set forth in Annex IV which is an inseparable part of this Regulation.
Section 9
(1) Against the request with supporting data as referred to in Section 8 is verified by the Director.
(2) Verify as referred to in paragraph (1) is conducted within a term of 4 (4) business days.
(3) If in the term as contemplated on a paragraph (2) required additional and/or clarification of data, the Director delivered additional requests and/or data clarification to the applicant electronically using the example the format as set forth in Appendix V which is an inseparable part of this Regulation.
(4) The slowest 7 (seven) business days after receiving a request as contemplated in paragraph (2), the applicant must submit an additional and/or clarification of the data.
(5) In terms of the required installer proficiency in the supporting data can be conducted a local check.
(6) In terms of additional and/or clarification of the data as referred to in paragraph (2), and/or the installer of the information proficiency as referred to in paragraph (5), then the calculation of the verification time is terminated (clock off).
(7) The verification of the verification time will be continued (clock on) after the applicant cees the additional and/or clarification of the data, and/or the results of local examinations.
(8) If the applicant does not submit the additional and/or clarification of the data as referred to in paragraph (3), and the inconsiscation of the local examination results, then the AHP request was declared rejected.
Third Part
Decision granting
Section 10
(1) Head of the Head of the Agency against the AHP plea, given by considering:
a. the result of verification of the application and the supporting data; and/or
B. The results of the installation of information in the supporting data may be conducted on a local examination.
(2) The decision as referred to in paragraph (1) may be:
a. publishing AHP; or
B. Rejection.
(3) AHP publishing decision as referred to in paragraph (2) letter a, given the slowest 4 (four) business days after the verification results and/or results of correcting information in the supporting data may be checked Local.
(4) Decision rejection decisions as referred to in paragraph (2) letter b, given the slowest 4 (four) workdays based on:
a. Verification results are not eligible;
B. do not submit additional and/or clarification of data as referred to in Article 9 of the paragraph (8); and/or
c. The conflict between the information in the supporting data as referred to in Article 9 of the paragraph (5) with the results of local examinations.
(5) An example of the AHP publishing format is listed in Appendix VI which is an inseparable part of this Regulation.
(6) AHP as referred to in paragraph (1) applies 6 months since it is published.
Fourth Quarter
Request Fees
Section 11
(1) The AHP Request is charged as a State Reception (PNBP) under the terms of the laws.
(2) In the event of a AHP request is rejected under a letter of rejection of the request as referred to in Article 9 of the paragraph (8) and Article 10 of the paragraph (4), the cost of which has been paid is not retracted.
BAB IV
REPORTING
Section 12
Against the AHPs used to apply for SPI and SPE as referred to in Article 11 of the paragraph (1) is mandatory to the Head of the Agency.
BAB V
TRANSITION PROVISIONS
Section 13
At the time this Regulation applies, the AHP application that has been submitted before the enactment of this Regulation, is processed in accordance with the previous provisions.
BAB VI
CLOSING PROVISIONS
Section 14
These rules begin to apply on the date of the promulctest.
So that everyone knows it, ordering the invitational of this Regulation with its placement in the News of the Republic of Indonesia
Specified in Jakarta
on May 10, 2013
THE HEAD OF THE DRUG AND FOOD SUPERVISORS
REPUBLIC OF INDONESIA,
LUCKY S. SLAMET
It is promulred in Jakarta
on 24 May 2013
MINISTER OF LAW AND HUMAN RIGHTS
REPUBLIC OF INDONESIA,
AMIR SYAMSUDIN
Attachment:
bn729-2013lamp
