Senin, 07 Oktober 2013

Home Industry Certification Procedure


Food product that consumed to people must be safe from dangerous ingredients, such chemical, biological, and physical contamination. To ensure food security to the consumer, then it need a system for coaching and registration.

Especially to the producers, to have Home Industry Certificate (SPP – IRT) and the requirement as follows :
1.      Submit application : To Local Government Cq. Head of city health department (Dinkes Kabupaten/Kota)
2.      Requirements :
1.1    Owner / Insurer have SIUP / TDI from Trade Ministry, Food Safety education certificate by City Health department (Sertifikat Penyuluhan Keamanan Pangan dari Dinkes Kabupaten/Kota) or minimum 1 (one) person have the Certificate (PKP Certificate) – if they don’t have it, the company must appoint one of their staff according to His/Her job to attend the Food Safety education training.
1.2    Production facility has been inspected by  teh City Health Department (Dinas Kesehatan Kabupaten/Kota) the result report of Facility Inspection with minimum result is enough.
1.3    The product cannot in form : Milk and it’s processed, Meat, fish, fowl and it’s processed that needs to be processed and frozened. Canned food with low acid (PH >4,5) baby food, alcoholic drink, bottled water (AMDK) other kind of food that must be qualified with Food SNI  requirement, set by BPOM.
2.      Information about PKP Certificate. Certificate number consist of 3 (three) columns and 9 (nine) digits, exp: 123/4567/89
-          First three number on column 1, show labour sequence , second four numbers on column II show Provinsi dan Kabupaten kota, last two numbers on column III, show publication year.
3.      Home Industry Food Production Certificate (SPP – IRT) is given to 1 one kind of product, it consist of  12 twelve digits :
-          First 1 one number show type of packaging code
-          2 two second number show type of product sequence number
-          4 four third number show provinsi and Kabupaten kota code
-          2 two forth number show product sequence number which already obtain SPP-IRT
-          Last three number show PP-IRT at Kabupaten kota connected to Home Industry be include in food label exp: P – IRT No. 20634710202

Information :
2 = Plastic packaging
06 = Food group of Flour and it’s processed, product type is Biscuit
3471 = Province code is DIY, kota Yogyakarta
02 = sequence number which already obtain SPP-IRT
025 = Last three number show PP-IRT at Kabupaten kota connected to Home Industry (Yogyakarta)
5.   Revocation and cancellation SPP-IRT by DinKes kabupaten Kota if the owner or insurer has done a   violation in food regulation, the owner doesn’t match to the name that is written on the SPP-IRT, food product proven injured or harmfull for consumer.
6.   Alteration and increasement food type. SPP-IRT owner or insurer alteration must be reported to Dinkes Kabupaten Kota.  ***
7.   Province code, Kabupaten kota
8.   Home industry product food type code.
      01   = Meat and it’s processed
      02   = Fish and it’s processed
      03   = Fowl and it’s processed
      04   = Vegetable and it’s processed
      05   = Coconut and it’s processed
      06   = Flour and it’s processed
      07   = Fried Oil and it’s processed
      08   = Jam and it’s processed
      09   = Sugar, honey, brown sugar, syrup
      010 = Chocolate, coffee, tea
      011 = Kinds of spice
      012 = Kinds of herbs spice
      013 = Light drinks
      014 = Fruits and it’s processed
      015 = Grains and roots and it’s processed
      016 = Ice, Rock Ice, Ice Juice, Stick Ice
9.   Packaging code
      1. Glass P-IRT/MD
      2. Plastics P-IRT/MD
      3. Carton / Paper P-IRT/MD
      4. Tetrapack must MD
      5. Can must MD
      6. Alumunium foil P-IRT/MD
      7. Composite must MD
      8. Double P-IRT/MD
      9. Others P-IRT
10. Home Industry that have SP Number for produced product, it still apply exp: Dep. Kes RI SP.  No. 382/ 12.03 / 2000
Source : Balai Besar POM Yogyakarta

Additional Information about PIRT (from DINKES another city)
1.      Lisencing regulation : The lisencing is about PIRT – Home Industry Lisencing
2.      Requirements : Comply to Food safety counseling, fill up application form, copy of ID, Picture ID 3x4, attach label design
3.      Procedure : After submit the application for PIRT certificate to The Head of local Health Departement. Will be documents checking (1 one day), and wait for the counsel for food safety conducted every 3 three months (1 one to 3 three months the applicants must attend to the counseling (1 one day) Production facility checking (in 1 one to 14 forteen days). The applicants pay the fee. The certificates will issued in 1 one day, total time 6 six days to 3 three months
4.      Validity period : No limits
5.      Exceptions : Cannot approved if  the product related to Milk, meat, fish, fowls and it’s processed that needs to be processed and keep in cold storage. Canned food, baby foos, alchoholic drinks, bottled water (AMDK) oter food that must applied to other food SNI set by BPOM

6.      Administrative sanction : Broke the regulation in food area, the Owner name is not match with the food safety certificate, and the product is not suitable for consumption.

Obtaining Import Letter (SKI) of Drugs and Drugs Ingredient online

I. Registration Step

   - Every Pharmaceutycal Industry, Pharmaceutical Wholesaler, Pharmaceutical Raw Material Wholesalers can register through e-registration at BPOM site, online.
   - The technical person in charge entry their : Name, Work Permit Letter, email, phone/mobile number
   - Attached the Company Lisence : Lisence number, Validity date, warehouse address.

II. Verification Step
BPOM (Indonesian FDA) will do verification covering :
1. Filling manual form Check list : Tools information, Pharmaceutical Raw Material Wholesalers    lisence, date and time the documents submitted.
2. Electronic verification for documents completion
3. Clasification (ATC, CAS, HS) is applied to :
-    Drugs raw materials
-    Imported drugs
III. Evaluation Step

A.    To Finished drugs covering :

1. Distributuion Lisence number
2. Certificates of Analysis (COA)
3. Certificates of Pharmaceutical Product (CPP)
4. Bets Release Certificates (BRC), for Vaccine
5. Invoice
6. AWB

B.     To drugs ingredients covering :

1. Certificates of Analysis (COA)
2. Invoice
3. AWB (airways bill)

IV. Import Notification Endorsment step

Before the endorsement, will be Re-checking documents, then the authorized officials will do the manual signaturing and electronic to finished drug product and drug raw materials.

Importation Service Level Agreement (SLA) of Finished drug & Drug raw materials
1. Check list form
2. Completion documents
3. Product classification
4. Distribution Lisence number
5. Finished drug Certificates of Analysis
6. Certificates of Pharmaceutycal Products, Bets Release Certificates
7. Finished drug invoice
8. Finished drug AWB
Drug raw material  evaluation
9.  1.9 hours, 0.9 hours, 0.4 hours, 0.7 hours

V. Finished drug Import Notification, Drug raw materials 1.4 hours
1. COA of Drug raw materials
2. Drug raw materials Invoice – Producer & qty
3. Drug raw materials AWB – Receiver importers
4. Import notification finished drug
5. Import notification drug raw materials

Plot of Drugs and Drug raw materials importation

Explanation :
1. Importer register
2. Data input
3. Entry CAS, ATC, HS
4. Data saved in BPOM server
5. The officer filling checklist form
6. Checking documents completion
7. Drug classification, stage I for drug raw materials
7.1 Finished drug Distribution Lisence number is match : Not expired, product packaging
7.2 COA , producer name, batch analysis fulfilled the requirement
7.3 Match with CPP
7.4 Finished drug – Vaccine
7.5 BRC fulfilled the BPOM requirement
7.6 Invoice : COO & qty – packaging form
7.7 AWB: the receiver is an importer

8. Pharmaceutical Raw Material Wholesalers lisence has passed the expiry date
8.1  COA : Producer name, batch analysis fulfilled  the requirements, source
8.2  Invoice : producer, qty
9.   Import notification manually and electronic
10.  DJBC site
11.  Complaint
12.  Fill in the complaint form
13.  Manual documents evaluation
14.  Qualify

Completion timeline :
The import notification service (SKI) can be finished in 1(one) working day since data received completely.
Note : Application form can be submitted before the goods arrive at the port.

Fee and Services
The fee apply according to the regulation

Administration Requirements

Importing finished goods
a.  Application letter
b. Power of attorney from product owner if the importer is not product owner
c.  Invoice packing list
d.                   Bill of lading (B/L) or Air Ways Bill (AWB)
e.  Purchase Orders(PO) or Proforma invoice(PI)
f.  Certificate of Analysis (COA) special for Cosmetic finished goods not required.
g. Applicant Tax ID number (NPWP)
h. Applicant Limited Importer Identification Number (APIT)
i.   Aproval registration letter (for Traditional Medicine, Cosmetic, and complemeter/Supplemen product).
j.  Import goods notice

Importing raw materials
a.  Application letter
b. Letter of statement for usefulness or distributing
c.  Invoice and packing list
d.                   B/L or AWB
e.  PO or PI
f.  COA
g. Applicant Tax ID number
h. Applicant Limited Importer Identification Number (APIT)
i.   Import goods notice
j.   Material Safety data sheet (MSDS) – if any

Individual / Self usage (Traditional medicine, Cosmetic & complement product)
a.  Application letter to BPOM
b. Application letter signed by requestor
c.  Letter of statement from requestor not to trade it
d.                                                                                                                                                                                                                  Special for Traditional medicine and food supplemen must be lab tested for narcotics/psychotropic. Sample ask to custom office and put in sealed envelope.
e.  Copy ID or passport(for Foreigners)
f.  Supporting data from Doctors / Traditional doctors
g. Good packaging/label product
h. B/L, or AWB if through port
i.   Invoice and packing list
j.   Goods qty limitation
k. Individual / self usage

Traditional medicine and Food supplemen
a)The product that used for severe desease or to increase immunity, limited only for 3 months usage
b)      The product that used for degeneratif desease, cronic limited only for 6 months usage

a)Powder/ Compact Powder
*        range 20 – 100 gr, qty 4 – 7 pcs
*        range 100 – 500 gr, qty 3 – 5 pcs
*        range > 500 gr, qty 2 – 3 pcs
b)      Fluid / Viscous fluid
*        range 20 – 100 ml/gr, qty 4 – 7 pcs
*        range 100 – 500 ml/gr, qty 3 – 5 pcs
*        range > 500 ml/gr, qty 2 – 3 pcs
c)   Cream, gel / paste
*     range 10 – 50 ml/gr, qty 6 – 8pcs
*     range 50 – 100 ml/gr, qty 4 – 6 pcs
*     range 100 – 200 ml/gr, qty 3 – 5 pcs
*     range >200ml/gr, qty 2 – 3 pcs

d)    Lipstic = 3 pcs
e)     Bar soap = 10 pcs
Note :  The quantity less than the above doesn’t need Import notification

Market test (Cosmetic), exhibition, research, registration sample (Traditional medicine, Cosmetic & Medical equipment)
a.             Application letter from importer/ produser
b.            Statement letter from applicants not to sale it
c.             Product composition
d.            B/L or AWB
e.             Invoice and packing list
f.             Proposal
g.            Goods qty limitation

1)            Qty evaluated according to proposal
2)            Registration sample for :
a)      Packaging < >
b)      Packaging > 15 ml to 25 ml, max 40 bottles/pcs
c)      Packaging > 25 ml to 150 ml, max 20 bottles/pcs
d)     Packaging > 150 ml to 500 ml, max 10 bottles/pcs
e)      Packaging > 500 ml, max 5 bottles/pcs


1. Import notification for FOOD
Regulation based on :
§  LAW No. 7 year 1996 about food
§  Government Regulation No. 28 year 2004 about Security, quality, and food nutrition
§  Government Regulation No. 17 year 2001 about rate of  Non Tax state revenue applicable on BPOM
§  Presidential decree No.54 year 2002 about Coordination Team of  Enhancement export Import goods flows
  1. Completion Time – Completion in 1 (one) working day
1 (One) working day – Importers input the data by today at 08:00 am – 12am west Indonesian time,  the Import notification can be done by tomorrow (work day) at 08:00am – 4 pm west Indonesian time.
  1. Fee rate – According to the applicable regulation.
  2. Requirement application :
3.1  Raw Materials / Food additional materials
-          Application letter from importers
-          Product specification
-          Health certificates / Free sale from country of origin
-          COA
-          Phytosanitary certificate (for Farm products), Radiation free certificate (for milk products from Europe), GMO certificate (for soybean, corn, tomatos, potato, and its processed), COO (for meat), Import Approval Certificates from Agriculture dept. ( for Animal product), Free residue 3-MCPD Analysis Certificates (for HVP, Isolated Soy protein, Soy Sauce).
-          Invoice, B/L, AWB
-          Expiry date

Pharmaceutical Wholesaler

Pharmaceutical Wholesaler is one of  Pharmaceutical goods distribution facility. The Wholesaler can open a branch in some places, will be called Wholesaler branch. As long as it has acknowledgement from local Health Departmement where it stands, and The branch also only ba able to distribute pharmaceutical goods in it’s acknowledgement territory.

Few things related to Pharmaceutical Wholesaler lisencing and its branch are :
1. Pharmaceutical Wholesaler lisence issued by Directorate General area Managing and Supervision
2. Pharmaceutical Wholesaler lisence apply for 5 (five) years and can be extended
3. Pharmaceutical Wholesaler may open a branch will be called Pharmaceutical Wholesaler                branch
4. Pharmaceutical Wholesaler branch must have acknowledgement from Head of local Health Departement
5. Pharmaceutical Wholesaler branch acknowledgement apply as long as Pharmaceutical Wholesaler branch lisence apply

Requirements for Pharmaceutical Wholesaler lisencing are:
1.      A business entities (Perseroan Terbatas or Koperasi)
2.      Tax ID (NPWP)
3.      Have a fulltime Indonesian pharmacist as a technical insurer
4.      The commissioner/ board directors/ management never involve directly or non directly in pharmaceutical regulation violation
5.      Have a suffice installation and equipments to support procurement, storage, and drugs distribution, and to ensure the performance of task and function Pharmaceutical Wholesaler
6.      Control a building as a strorage place with a suffice equipment to ensure the security and quality of the drugs
7.      Have a room to store the drugs separately from other room
8.      Pay the fee for lisencing

      Pharmaceutical Wholesaler lisence not apply if :
1.      The license is expired and not extended
2.      The Pharmaceutical Wholesaler in suspended, activity stopped temporarily
3.      The Pharmaceutical Wholesaler license revoke

       Pharmaceutical Wholesaler branch acknowledgement not apply if :
1.      The license is expired and not extended
2.      The Pharmaceutical Wholesaler branch in suspending, activity stoped temporary
3.      The Pharmaceutical Wholesaler branch acknowledgement revoke

There are 2 kinds of  Pharmaceutical Wholesaler which is, Drugs Wholesaler and Drugs raw material Pharmaceutical Wholesaler. According to Government Regulation No.51 year 2009 about pharmaceutical occupation, what is called distribution facility is the media use to supply or distribute pharmaceutical goods in order for trade, non trade or hand over.

The Obligation of Pharmaceutical Wholesaler and it’s branch :
1.      Pharmaceutical Wholesaler or Pharmaceutical Wholesaler branch must have a technical insurer pharmacist in procurement, storing, and distributing the durgs or drugs raw material.
2.      Insurer pharmacist must have lisence according to the applicable regulation
3.      The pharmacist cannot have double position like as a management or branch management.
4.      Every technical insurer pharmacist substitution, the management has to report to the Head of local Health Departement, at the latest 6 (six) working days. regulation)

(related to Drugs Good distribution Practice)
5.      Pharmaceutical Wholesaler or Pharmaceutical Wholesaler branch in terms of  procurement, stroring, and distributing drugs or drugs raw materials must apply to Drugs Good distribution Practice, which already set by the Minister of Health.
6.      The application of Drugs Good distribution Practice follow a technical guidance set by The Head of National Agency for Food and drugs Control
7.      Pharmaceutical Wholesaler or Pharmaceutical Wholesaler branch which already apply to Drugs Good distribution Practice, will be given the certificate from The Head of National Agency for Food and drugs Control

(related with documentation)
8.      Pharmaceutical Wholesaler or Pharmaceutical Wholesaler branch in terms of procurement, storing and distributing drugs or drogs raw material according to Drugs Good distribution Practice guidance
9.      Documentation can be done electronically
10.   Documentation must be able to be check anytime by the officer

(related with restriction)
11.  Pharmaceutical Wholesaler or Pharmaceutical Wholesaler branch restricted to sale drugs or drugs raw material in retail
12.  Pharmaceutical Wholesaler or Pharmaceutical Wholesaler branch restricted to serve or receive prescription

Pharmaceutical Wholesaler or Pharmaceutical Wholesaler branch only be able to supply to :
1.      Another Wholesaler
2.      Another Wholesaler branch
3.      Pharmaceutical Service Fasility :
-          Pharmacy
-          Clinic
-          Public Health Service Center
-          Drugs Store
-          Joint Practice
-          Hospital pharmacy installation
4.      Government, if  the government need it according to applicable regulation
5.      Pharmacetical Wholesaler only able to distribute limited in the acknoldegement province
6.      Science Institute

For Drugs raw material Wholesaler have the Obligation which are:
1.      Laboratory , that has the ability to  test drugs raw materials according to the regulation set by the authority
2.      Special warehouse for storage

Pharmaceutical Wholesaler or Pharmaceutical Wholesaler branch distribute drugs based on order from insurer pharmacist. Exception to order for science institution prominence, purcahase order signed by the head of institution. For distribution of drugs or drugs raw material consider as strong drugs, PO must be signed by insurer pharmacist or managing pharmacist. Pharmaceutical Wholesaler or Pharmaceutical Wholesaler branch that supply, storing and distribute narcotics must have a special lisence according to aplicable regulation. Pharmaceutical Wholesaler or Pharmaceutical Wholesaler branch that repackage from it’s original packaging of drugs raw material must do a quality control testing and have repackage room.

Pharmaceutical Wholesaler can only conduct drugs from another pharmaceutical industry or another wholesaler
Pharmaceutical Wholesaler can only conduct drugs raw materials from another pharmaceutical industry or another wholesaler and only through importation . Importation  must be done by according by the regulation
Pharmaceutical Wholesaler can only conduct drugs raw materials from the Main Wholesaler
Pharmaceutical Wholesaler can be functioned as education and training center

Warehouse and office of  Pharmaceutical Wholesaler or it’s branch  can be separate as long as it’s not reduce the efectivity of the internal supervision from management and the insurer, and the warehouse must have an pharmacist insurer.
Pharmaceutical Wholesaler can have warehouse increase or warehouse modification as long as it approve by General Director of Pharmaceutical and medical devices development (Dirjen Bidang Pembinaan Kefarmasian dan Alat kesehatan)  of Health Ministry. Additional warehouse only to keep and distribute some of Main Wholesaler or it’s branch.
Pharmaceutical Wholesaler branch also can do the above if approved from The Head of Local Health Departement.

Every Pharmaceutical Wholesaler and it’s branch must make a report every 3 months, addressed to General Directorat with Cc to Head of BPOM, Head of  Dinkes Provinsi, Head of Balai POM.
Exception for Pharmaceutical Wholesaler and it’s branch that distribute narcotics and psychotropic must make a monthly report of narcotics and psychotropic distribution according to the regulation.

Coaching Developtment
1.      Local Government will do coaching to any activity related to drugs and drugs raw material distribution
2.      Purpose of Coaching  :
-          To ensure availability, equity, affordability of drugs or drugs raw material for health effort
-          To protect community from the danger of  using  drugs or drugs raw materials unproperly, or not qualified to quality requirements, security and expediency.

Rabu, 05 Juni 2013

Penerbitan Surat Keterangan Impor OBAT JADI dan BAHAN BAKU OBAT secara elektronik

I. Tahap Registrasi

- Setiap Industri Farmasi, PBF, PBBBF melakukan registrasi elektronik yang dapat dilakukan 
 di portal BPOM ataupun di tempat masing-masing menggunakan internet
- Penanggungjawab memasukkan: Nama, SIK, e-mail, telp –mobile
- Cantumkan Ijin Perusahaan: No, Tgl berlaku no. ijin, alamat gudang

II. Tahap Verifikasi

Badan POM akan melakukan verifikasi meliputi:

1. Dilakukan pengisian manual Form Check List: yaitu Informasi sarana, Ijin PBBBF,
    tgl dokumen dan jam dokumen diserahkan

2. Verifikasi elektronik terhadap kelengkapan dokumen

3. Klasifikasi (ATC, CAS, HS) dilakukan terhadap:

- Bahan Baku Obat (BBO)
- Obat Jadi Impor

III. Tahap Evaluasi

A. Terhadap Obat Jadi, meliputi:
1. Nor Ijin Edar
2. Certificate Of Analysis (COA)
3. Certificate of Pharmaceutical Product (CPP)
4. Bets Release Certificate (BRC) khusus vaksin
5. Invoice
6. AWB

B. Terhadap Bahan Baku Obat, meliputi:

1. Certificate Of Analysis (COA)
2. Invoice
3. AWB

IV. Tahap Pengesahan SKI

Sebelum pengesahan SKI dilakukan Re-check dokumen, kemudian pejabat yang
berwenang melakukan penandatanganan secara manual dan elektronik terhadap produk 
Obat Jadi dan BBO.

SLA importasi Obat Jadi & BBO

1. Form Check List
2. Kelengkapan dokumen
3. Klasifikasi produk
4. NIE
5. COA obat jadi
7. Invoice obat jadi
8. AWB obat jadi

Evaluasi BBO

1,3 jam 0,9 jam 0,4 jam 0,7 jam 0,7 jam
Surat Keterangan Impor
Ob Jadi BBO 1,4 Jam
2. Invoice produk BBO – produsen & jumlah
3. AWB produk BBO - penerima Importir
4. Surat Keterangan Impor Obat Jadi
5. Surat Keterangan Impor BBO

Alur IMPORTASI Obat dan Bahan Baku Obat

1. Importir melakukan registrasi
2. Input data
3. Entry CAS, ATC, HS
4. Data tersimpan di server Badan POM
5. Petugas mengisi Form Checklist
6. Periksa kelengkapan dokumen
7. Klasifikasi obat, tahap I untuk BBO
7.1 NIE Obat Jadi sesuai: belum ED, kemasan edar
7.2 COA: Nama Produsen, analisa bets memenuhi requirement
7.3 Sesuai dengan CPP
7.4 Produk Obat Jadi Vaksin
7.5 BRC memenuhi requirement dari POM setempat
7.6 Invoice: COO dan jumlah – bentuk kemasan
7.7 AWB: penerima merupakan importir
8. Ijin PBBBF sudah lewat ED
8.1 COA: Nama Produsen, analisa bets memenuhi requirement, source
8.2 Invoice: produsen, jumlah
9. SKI secara manual dan elektronik
10. Portal DJBC
11. Complaint
12. Isi Form Complaint
13. Evaluasi Dokumen manual
14. Memenuhi syarat

Jangka Waktu Penyelesaian :
Pelayanan Surat Keterangan Impor (SKI) selesai dalam jangka waktu 1 (satu) hari kerja sejak
data diterima secara lengkap.
Catatan : Berkas permohonan rekomendasi dapat diajukan sebelum barang tiba di pelabuhan

Biaya atas Jasa Pelayanan
Biaya atas jasa pelayanan SKI sesuai dengan peraturan perundangan yang berlaku.

Persyaratan Administrasi:
Pemasukan produk jadi:
a. Surat Permohonan
b. Surat Kuasa dari pemilik produk bila pengimpornya bukan pemilik produk
c. Invoice dan Packing List
d. Bill of Lading (B/L) atau Air Ways Bill (AWB)
e. Surat pesanan atau Perform Invoice
f. Sertifikat Analisa / CoA (khusus untuk produk jadi kosmetik tidak dipersyaratkan)
g. NPWP Pemohon
h. APIT Pemohon
i. Surat persetujuan pendaftaran (untuk produk jadi obat tradisional, kosmetik dan
produk komplemen/suplemen)
j. Pemberitahuan Impor Barang (PIB)

Pemasukan Bahan Baku
a. Surat Permohonan
b. Surat Pernyataan kegunaan atau pendistribusian
c. Invoice dan Packing List
d. Bill of Lading (B/L) atau Air Ways Bill (AWB)
e. Surat pesanan atau Perform Invoice
f. Sertifikat Analisa
g. NPWP Pemohon
h. APIT Pemohon
i. Pemberitahuan Impor Barang (PIB)
j. Material Safety Data Sheet (MSDS) (Jika ada)

Perorangan / pemakaian sendiri ( OT, Kos & PK )
a. Surat yang dialamatkan ke Badan POM dari kantor pos/ Bea Cukai
b. Surat Permohonan ditandatangani oleh pemohon
c. Surat pernyataan dari pemohon untuk tidak diperjualbelikan
d. Khusus untuk produk OT dan Suplemen makanan dilakukan pengujian laboratorium terhadap 
    narkotika/ psikotropika .  Sampel Uji diminta kepada pihak kantor pos/ Bea Cukai dan 
    dimasukkan kedalam amplop / sampul yang disegel
e. Fotokopi KTP pemohon atau identitas lain yang syah ( paspor untuk WNA )
f. Data pendukung dari dokter / pengobat tradisional ( sinshe )
g. Kemasan/label produk yang jelas
h. Bill of Lading (B/L) atau Air Ways Bill (ABW) jika melalui pelabuhan.
i. Invoice dan Packing List
j. Pembatasan jumlah barang
1. Perorangan / pemakaian sendiri

Produk OT dan Suplemen makanan
a) Produk yang digunakan untuk penyakit akut atau untuk meningkatkan daya tahan tubuh 
    dibatasi hanya untuk pemakaian 3 bulan
b) Produk yang digunakan untuk penyakit degeneratif , kronis dibatasi hanya untuk
     pemakaian 6 bulan.

a) serbuk / serbuk kompak
* ukuran 20 – 100 gram , jumlah 4– 7 buah
* ukuran 100 – 500 gram, jumlah 3 – 5 buah
*ukuran > 500 gram , jumlah 2 -3 buah
b) Cair / cairan kental
* ukuran 20 – 100 ml / gram, jumlah 4 – 7 buah
* ukuran 100 – 500 ml/ gram , jumlah 3 -5 buah
*ukuran > 500 ml/ gram , jumlah 2 -3 buah
c) Krim, gel/ pasta
* ukuran 10 – 50 ml / gram jumlah 6– 8 buah
* ukuran 50 – 100 ml/ gram jumlah 4 – 6 buah
* ukuran 100 – 200 ml/ gram jumlah 3 – 5 buah
*ukuran > 200 ml/ gram jumlah 2 – 3 buah
d) Lipstik = 3 buah
e) Sabun padat = 10 buah

Catatan :
Jumlah kurang dari tersebut diatas tidak memerlukan SKI.

Test Market ( Kosmetik ), Pameran, riset , sampel registrasi (OT, Kos & PK)
a. Surat Permohonan dari importir/ produsen
b. Surat pernyataan dari pemohon untuk tidak diperjualbelikan
c. Komposisi produk
d. Bill of Lading (B/L) atau Air Ways Bill (ABW)
e. Invoice dan packing list
f. Proposal
g. Pembatasan jumlah barang

1) Test Market ( Kosmetik ) Pameran, riset ( OT, Kos & PK )
Jumlah dievaluasi menurut proposal
2) Sampel Registrasi untuk :
a) Kemasan <>
b) Kemasan >15 ml s/d 25 ml, maksimal 40 botol /pcs
c) Kemasan >25 ml s/d 150 ml, maksimal 20 botol /pcs
d) Kemasan >150 ml s/d 500 ml, maksimal 10 botol /pcs
e) Kemasan >500, maksimal 5 botol /pcs

Perijinan yang dikeluarkan oleh : DIREKTORAT INSPEKSI DAN SERTIFIKASI PANGAN :

Dasar Kebijakan Perijinan:
• UU No. 7 Tahun 1996 tentang Pangan
• PP No. 28 Tahun 2004 tentang Keamanan, Mutu dan Gizi Pangan
• PP No. 17 tahun 2001 tentang Tarif atas Jenis Penerimaan Negara Bukan Pajak (PNBP) yang berlaku pada
  Badan POM
• KEPPRES No. 54 tahun 2002 tentang Tim Koordinasi Peningkatan Kelancaran Arus Barang Ekspor dan Impor

b. Janji pelayanan

1. Jangka Waktu Penyelesaian
    Jangka waktu penyelesaian pengurusan Surat Keterangan Impor Pangan selesai dalam 1 (satu)
    hari kerja.
1 (satu) hari kerja : importir menginput data hari ini jam 08.00 – 12.00 WIB, 
   Surat Keterangan Impor sudah selesai dan dapat diambil besok hari jam 08.00 – 16.00 WIB.

2. Biaya atas Jasa Pelayanan
    Sesuai dengan peraturan perundangan yang berlaku.

3. Persyaratan Permohonan
3.1. Bahan Baku / Bahan Tambahan Pangan
- Surat permohonan dari importir
- Spesifikasi Produk
- Sertifikat Kesehatan / Free Sale dari pemerintah asal
- Sertifikat Analisis
- Sertifikat Phytosanitary (untuk Produk Pertanian), Sertifikat Bebas Radiasi (untuk produk susu asal negara Eropa),   Sertifikat GMO (untuk kedelai, jagung, tomat, kentang, dan hasil olahannya), Sertifikat Origin (untuk bahan yang     berasal dari daging), Sertifikat Persetujuan Pemasukan dari Ditjen Peternakan (untuk bahan yang berasal dari         daging), Sertifikat Analisis Residu 3-MCPD (untuk HVP, Isolated Soy Protein, Soy Sauce)
- Invoice, B/L / AWB
- Expire Date
3.2. Produk Retail (ML)
- Surat permohonan dari importir
- Fotokopi Nomor Pendaftaran
- Spesifikasi Produk
- Sertifikat Kesehatan / Free Sale dari pemerintah asal
- Sertifikat Analisis
- Sertifikat Phytosanitary (untuk Produk Pertanian), Sertifikat Bebas Radiasi (untuk produk susu asal negara Eropa),   Sertifikat GMO (untuk kedelai, jagung, tomat, kentang, dan hasil olahannya), Sertifikat Origin (untuk bahan yang     berasal dari daging), Sertifikat Persetujuan Pemasukan dari Ditjen Peternakan (untuk produk asal hewan),               Sertifikat Analisis Residu 3-MCPD (untuk HVP, Isolated Soy Protein, Soy Sauce)
- Invoice, B/L / AWB
- Expire Date