Senin, 07 Oktober 2013

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.

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