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Regulations Of The Food And Drug Supervisory Agency Number 45 By 2013

Original Language Title: Peraturan Badan Pengawas Obat dan Makanan Nomor 45 Tahun 2013

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STATE NEWS
REPUBLIC OF INDONESIA

No. 1534, 2013 THE SUPERVISORS OF THE DRUG AND THE FOOD. The ULP. -Stuff.-Services. Government.


THE RULES OF THE HEAD OF THE DRUG AND FOOD SUPERVISORS
REPUBLIC OF INDONESIA
Number 45 YEAR 2013
ABOUT
BARANG/SERVICE PROCUREMENT SERVICE UNIT
IN THE DRUG AND DRUG SUPERVISORS ENVIRONMENT

WITH THE GRACE OF THE ALMIGHTY GOD

THE HEAD OF THE DRUG AND FOOD SUPERVISORS
REPUBLIC OF INDONESIA,

Weighing: that to implement the provisions of Article 14 and Article 130 of the paragraph (1) of the Presidential Regulation No. 54 of 2010 on the Procurement of Goods/Services as have been the last several times amended by the Presidential Regulation Number 70 Years 2012, it is necessary to establish the Chief Financial and Drug Administration Regulation on the Goods/Services Procurement Services in the Environmental Protection and Drug Administration;

Remembering: 1.   The decision of the President Number 103 of 2001 on the position, duties, functions, functions, authority, organizational structure and work order of the non-department government agencies as amended last by the Presidential Regulation No. 3 of 2013;
2. The Presidential Decree No. 110 of 2001 on the Unit of Organization and Duty of Eselon I Institute of Non-Department Government as it has been several times amended last with the Presidential Regulation Number 4 of 2013;
3. Presidential Regulation No. 54 of 2010 on Governing Goods/Government Services as it has been several times amended last with Presidential Regulation No. 70 of 2012;
4. Decision Head of the Food and Drug Administration Number 02001 /SK/KBPOM 2001 on the Organization and the Working Board of the Food and Drug Administration as amended by the Decision of Head of the Board of Drug Administration and Food Number HK.00.05.21.4231 Year 2004;
5. Decision Head of the Food and Drug Administration Number 05018 /SK/KBPOM 2001 on the Organization and Tata Technical Managing Unit in the Environment of Drug Administration and Food as it has been several times amended last with Regulation Head of the Food and Drug Administration Board HK.00.05.21.3546 Year 2009;
6. Chief Regulation of the Supervising Board of Drug and Food Number HK.04.1.21.11.10.10750 Year 2010 on Implementing The Procurement Services of Goods/Services in the Environment of the Drug and Food Supervising Board;
7. The Principal Program of the Government of the Government of the Government of the Government Number 5 of the Year 2012 concerning the Governing Unit;
8. Rule of the Head of the Policy Institute of Governing Goods/Government Number 6 Year 2012 on Technical Guidance of the Presidential Regulation No. 70 of 2012 on the Second Amendment to the Presidential Regulation No. 54 of 2010 on the Absence Of Goods/Services Government;
9. Ordinance of the Minister of State Personnel and Bureaucratic Reform Number 77 of 2012 on the Functional Functional Office of the procurement of goods/Jasa;
10.Regulation with the head of the Government of the Government and the Head of the Government Service No. 1 Year 2013 and the Number 14 Year 2013 on the Terms of Implementation Regulations Minister of the State apparatus and the Reformation Bureaucracy No. 77 of 2012 on the Functional Functional Manager Of The Goods/Jasa;

DECIDED:

Establish: REGULATION OF THE HEAD OF THE DRUG AND FOOD SUPERVISORS ABOUT THE BARANG/SERVICE PROCUREMENT SERVICES UNIT IN THE SUPERVISORS OF THE DRUG AND FOOD SUPERVISORS.

BAB I
UMUM CONDITIONS
Section 1
In this Regulation referred to:
1. Non-Production of Goods/Services in the Environmental and Drug Administration Environment, which is then called the ULP, is a unit of the organization of the Food and Drug Administration that serves to carry out the procurement of goods/services in the Drug Administration environment. And Food.
2. Procurement of Goods/Services in the Food and Drug Administration Environment, which is further referred to as the Absence Of Goods, is an activity to acquire Goods/Services by the Food and Drug Administration that the process begins from planning The need to complete the entire activity to acquire the goods.
3. Electronic Provisioning Services, subsequently called LPSE, is a managing unit that facilitates the ULP on the procurement of goods/services in the environment of the Food and Drug Administration electronically.
4. User of the Budget, next abbreviated PA, is the Head of the Food and Drug Administration.
5. Power of the Budget User, which next abbreviated KPA, is the official set by the PA to use the State Budget and Shopping Budget.
6. Commitment Enforcement Officials, further abbreviated PPK, are the officials responsible for the implementation of the Goods/Services.
7. The ULP Working Group, which is next called Pokja ULP, is a working group with gasal members, at least 3 (three) people certified procurement experts and can be augmented according to the complexity of the work, which is in charge of the carrying out the selection of goods procurement providers/services in the environment of the Food and Drug Administration.
8. Officials are personnel who have a Certificate of Granting Goods/Services assigned to carry out the procurement of barang/services, through direct procurement.
9. The Certificate of Enability of Goods/Services is a sign of a proof of recognition from the government of the competence and the ability of the profession in the field of barang/merit procurement.
10. Service Provider/Services is an enterprise or individual person who provides consulting services/other services/services.
11. The Acquisition Document is a document set out by the ULP/Officials Absence Containing the information and conditions that the parties should be adhered to in the barang/service procurement process.
12. The National Procurement Portal is the gateway to the electronic information system associated with the national security of the Goods/Services managed by the LKPP.
13. The government's internal supervising officer, subsequently called APIP, is the AUP Inspectorate of the Board of Trustees of Drug and Food that conducts surveillance through auditing, revivities, evaluation, monitoring, and other surveillance activities against the host. task and function of the organization.
14. The Integrity Pact is a letter of statement that contains a pledge to prevent and not conduct collusion, corruption, and nepotism in the Absence Of Goods/Services.
15. Goods are either tangible or intangible, movable, or non-mobile, which may be traded, used, used, or used by the User.
16. Construction work is all work related to the execution of building construction or other physical forms.
The service of the Consultancy Service is a professional service that requires a particular skill set in the field of science, which is a brainware that is concerned.
18. Other services are services that require a particular ability that priorates skills (skillware) in a widely recognized governance system in the world of effort to complete a job or any work and/or Providing services other than the services of the Consultancy Service, the implementation of Construction Work and the procurement
19. The Working Unit, which is next called Satker, is a unit of the line organization that carries out activities and has the authority and responsibility of budgeting use in the environment of the Food and Drug Administration.
20. Head of the Agency is the head of the non-ministry ' s government agency responsible in the area of supervision of medicine and food.

BAB II
FORMATION, TASK, AND ULP AUTHORITY
The Kesatu section
Formation
Section 2
(1) The ULP is a working unit in the environment of the Food and Drug Administration that specifically handles the procurement of goods/services through all types of auction/selection.
(2) The ULP as referred to in paragraph (1) is permanent and integrated with structural on the Bureau of Planning and Finance, the Primary Secretariat of the Food and Food Control Board.

Section 3
(1) The ULP is formed and set by the Head of the Agency.
(2) The Head of the Agency in forming the ULP as referred to in paragraph (1) considers the following:
a.   volume, amount of funds, and other types of procurement/jasa;
B.   lean/number of job spreads;
c. availability of human resources in the procurement field;
D.   availability of the means and mastery of information technology and communication; and
e.   The efficiency and effectiveness of job execution.
(3) The ULP consists of:
a.   ULP Head;
B.   ULP Secretariat; and
C.   Pokja ULP.

Section 4
(1) The ULP carries out the procurement of goods/services including:
a.   Procurement of Goods/Other Construction/Services items at a rate of Rp 200,000.00 (two hundred million rupiah); and
B.   Procurement of the Consultancy Service at a value above Rp 50,000.000.00 (fifty million rupiah).
2. (2) Other Business/Construction Services/Services with less/equal value of Rp 200,000.00 (two hundred million rupiah) or Absence of Consultancy Services at a rate of Rp 50,000.000.00 (fifty million rupiah) is performed by -Freight-Services on each other's satker.

The Second Part
The task and the authority
Section 5
The ULP has the duty and authority in accordance with the provisions of the laws.

BAB III
ORGANIZATION
The Kesatu section
General
Section 6
(1) The ULP head, the ULP Secretariat, and members of Pokja ULP were appointed and dismissed by the Head of the Agency after going through the selection process implemented by the Assessor Team.
(2) The judging team as referred to in verse (1) consists of the elements of the office of staffing officials, the KPA, and the Inspector.
(3) The Rapture and termination of the ULP device as it is called on the paragraph (1) is not bound to the budget year.
(4) Civil Servants in the Environmental Monitoring Agency environment and the Food assigned in the ULP may be appointed in the functional office of the procurement of goods/services under the provisions of the laws.

The Second Part
ULP head
Section 7
(1) The ULP chief must meet the requirements as follows:
a.   status as a civil servant;
B.   have technical and managerial qualifications;
c. have the ability to take decisions;
D.   have moral integrity, honest, disciplined and responsible for carrying out tasks;
e.   signing the Integrity Pact;
f.    have experience as a barang/barang/procurement committee;
G.   understand the entire type of work that is the task of Pokja Pengadaan;
h.   understand the contents of the document, the method and procedure of the Procurement; and
i.    Other terms are defined in the rules of employment for equal terms.
(2) The ULP chief is prohibited from multiple positions as:
a.   PPK;
B.   (PPSPM) Signatory Officials Pay (PPSPM);
C.   Treasurer; and
D.   APIP.
(3) The head of the ULP as referred to in paragraph (1) can be captured and served as a member of Pokja ULP.

The Third Part
ULP Secretariat
Section 8
(1) The ULP Secretariat is below and is responsible to the Chief ULP.
(2) The Secretariat is led by a secretary.
(3) The ULP Secretariat as referred to in paragraph (1) can be captured and served as a member of Pokja ULP.

Section 9
The ULP Secretariat as referred to in paragraph (1) has the task:
a.   carrying out the management of financial affairs, staffing, entrepreneurship, equipment, and household of ULP;
B.   inventory the packages to be reed/remod;
c. prepare supporting documents and information required Pokja ULP;
D.   facilitate the implementation of the Goods/Services Provider selection implemented by Pokja ULP;
e.   Coordinate and coordinate the disclaiers that are delivered by the Goods/Jasa;
f.    Manage the procurement system and the procurement management data information system to support the implementation of the Item/Jasa;
G.   Manage the IBM Cloud Service
h.   conduct an evaluation of the implementation of the procurement process; and
i.    prepare and coordinate the technical team and the ULP Secretariat in the process of Absence Of Goods/Services.

The Fourth Part
Pokja ULP
Section 10
(1) Pokja ULP resides in each Satker in the environment of the Food and Drug Administration.
(2) Pokja ULP is the acting element of partial tasks and functions of the ULP in the implementation of the Goods/Services which are below and are responsible to the ULP Chief.
(3) The placement and assignment of ULP personnel into Pokja as referred to in paragraph (2) is governed by the Head of the ULP by considering the competency and record of the traces of Pokja ULP.

Section 11
(1) Members of each Pokja ULP number are gasal, consisting of at least 3 (three) persons and can be augmented by the needs and complexity of the work.
(2) Pokja ULP Devices as referred to in paragraph (1) consists of:
a.   Duplicate member;
B.   member of the secretary to the member; and
C.   Members.

Section 12
(1) To be appointed a member of Pokja ULP must meet the requirements as referred to in Article 7 of the paragraph (1) and the paragraph (2).
(2) In addition to having to meet the requirements as referred to in paragraph (1), the members of Pokja ULP must also have the Government's Certificate of Granting Of Goods/Services.

Section 13
(1) In carrying out its duties, the chairperson of Pokja ULP and each member of Pokja ULP has the same authority in the decision making which is set based on the most votes.
(2) The Provider of Goods/Services Providers by Pokja ULP cannot be harassed by the ULP Chief.
(3) Members of Pokja ULP may be in charge and become the Acting Officer outside of the ULP.

Section 14
(1) In terms of procurement of goods/services are special and/or require special expertise, ULP may use a team or technical explanation expert (aanwijzer) team.
(2) The team or the expert power as it is referred to in paragraph (1) is set by the Committer Composition Officer.

BAB IV
WARNING
Section 15
ULP members stop or be dismissed if:
a.   resigning;
B.   passed away;
c. unable to perform the task constantly for 3 (three) months due to illness or without clear reason;
D.   Breaking/misusing the task; or
e.  Convicted of committing crimes of crimes threatened with prison felon 5 (five) years or more, based on court rulings that have obtained a fixed legal force.

BAB V
THE ulp WORKING RELATIONSHIP
Section 16
(1) The ULP in carrying out its mandatory duty is to coordinate and establish a working relationship with:
a.   The satker that will utilize the goods/services held and other related work units;
B.   LPSE; and
C.   Government Goods Procurement Policy/Government Services (LKPP).
(2) The work relationship as referred to in paragraph (1) the letter a is performed with:
a.   delivering periodic reports of the development of the execution;
B.   Conduct periodic consultation with the needs of the solution regarding the procurement process;
c. provide guidelines and directions to Satker in the drafting of government procurement of goods/services; and
D.   carry out the guidelines or instructions for the implementation of the procurement implementation of the PA.
(3) The work relationship as referred to in paragraph (1) the letter b relates to the use of the Electronic Absence System (SPSE).
(4) The work relationship as referred to in paragraph (1) of the letter c is performed with:
a.  hold consultations according to the need in order to resolve the issues encountered in the procurement process;
B.   perform LKPP guidelines and instructions in terms of barang/jasa;
c. coordination in the execution of tasks; and
D.   provide input to the LKPP for the formulation of strategy and barang/service procurement policies.

Section 17
PPK on the Satker organizers of the goods/services are required to deliver the goods/services procurement package to the ULP which is equipped with the least support data, including:
a.   Activity Operations Guide (POK);
B.   Working Reference framework (KAK) /Technical Specification;
c. Its own estimate price; and
D.   Contract design.

BAB VI
FINANCING
Section 18
The financing arising in the course of the implementation of the ULP task is charged on the Budgeting Implementation (DIPA) List of Drug and Drug Supervising Bodies in accordance with the laws of the law.

BAB VII
TRANSITION PROVISIONS
Section 19
(1) The provision of the Goods/Services is being implemented prior to the effective date of this Regulation, which may be continued by keeping guidelines on the previous terms.
(2) The terms of the Agreement, which are signed prior to the effective date of this Regulation, remain in effect until the end of the Agreement or the Agreement.
(3) Continuous Goods/Services for the 2014 budget year include the procurement of security services, cleaning service services, and internet services, may be conducted by the Procurement Goods/Services Committee in question before this Regulation is in effect.

BAB VIII
CLOSING PROVISIONS
Section 20
The Food and Drug Administration Head Regulation came into effect on 1 January 2014.

In order for everyone to know it, order the invitational of this Regulation with its placement in the News of the Republic of Indonesia.

Set in Jakarta
on December 17, 2013
THE HEAD OF THE DRUG AND FOOD SUPERVISORS
REPUBLIC OF INDONESIA,

ROY A. SPARRINGA

Promulgated in Jakarta
on December 23, 2013
MINISTER OF LAW AND HUMAN RIGHTS
REPUBLIC OF INDONESIA,

AMIR SYAMSUDIN