1. Raw Material

 

□ Regulation on Importation Control of Drug Material, Traditional Medicine Material, Health Supplement Material and Food Material in Indonesia

 

□ Legal basis

Regulation of BPOM(The Indonesia National Agency of Drug and Food Control) Number:

28 Year 2013 on Raw Materials for Drug, Traditional Medication, Health Supplement, and Food Importation Monitoring.

 

□ Import Regulation

 

 ○ Drug Material, Traditional Medicine Material, Health Supplement Material, and Food Material that can be imported into the territory of Indonesia must fulfil the requirements of safety, special virtue/benefit, and quality.

 

 ○ Importation of Drug Material, Traditional Medicine Material, Health Supplement Material, and Food Material is performed by industry or importer of Drug and Food according to provisions of the regulating legislation.

 

 ○ Importation of Drug Material, Traditional Medicine Material, Health Supplement Material, and Food Material must also obtain approval from the Head of the Agency (BPOM) in the form of SKI which is valid for 1time importation.

 

 ○ SKI is valid for the importation of Drug Material, Traditional Medicine Material, Health Supplement Material, and Food Material in the Free Trade and Free Port Area.

 

 ○ To get SKI:

  - Applicant that will apply for SKI must register using the Single Sign On mechanism to obtain an account in the form of user ID and password.

  - The Single Sign On mechanism is to obtain login access to the Agency of Drug and Food Control in-house (including Main Office/POM Office) and the Indonesia National Single Window portal.

  - Registration is conducted through the website of the Agency of Drug and Food Control at http://www.pom.go.id or through the sub site http://www.e-bpom.pom.go.id.

  - Applicant performs data entry electronically and submits the supporting documents by uploading it into the e-bpom application.

  - Registration shall be equipped document as follows:

   · Original Application Letter signed by the Director or the Proxy of Director and duly stamped;

   · Duly stamped Original Letter of Statement of the Responsible Person;

   · Photocopy of Import Identification Number (API);

   · Photocopy of Trading Business Permit (SIUP);

   · Photocopy of the Tax Identification Number (NPWP);

   · Photocopy of Importation Letter of Authorization in the form of General Certificate by Notary, in the case where the application is a company that has been authorized for import;

   · Permit of PBF (Pharmaceutical Wholesaler), for PBF that has been authorized by the pharmaceutical industry to conduct importation of drug;

   · List of HS Code that will be imported.

 

 ○ For verification purposes, the applicant must show the original documents.

 

 ○ In case the verification result is complete and correct, applicant will be given a user ID and password.

 

 ○ Registration of applicant only needs to be performed 1time, as long as there is no change in applicant data.

 

 ○ SKI is issued based on application. SKI application must equipped with the following electronic documents:

  - Certificate of analysis;

  - Safety and/or material specification data sheet;

  - Statement letter of intended use;

  - Invoice

  - packing list;

  - Bill of lading or Air Way Bill; and

  - Proof of payment of Non-Tax State Revenue(PNPB).

 

 ○ Specific to SKI application for:

  - Drug Material of special virtue, it must also be equipped with Good Manufacturing of Drug Certificate (CPOB) that is still valid from the local Authorized Agency.

  - Drug Materials Originating from Biological Product, must also be equipped with information of the origin of the material.

  - Drug Material origination from Biological Product in the form of vaccine, must also be equipped with summary batch/lot protocol issued by the producer.

 

 ○ Specific to SKI application for Food Material, must also be equipped with the following documents:

  - Health certificate and/or certificate of free sale that is still valid from government/authorized agency in the country of origin;

  - Distribution report of BTP that was imported previously; and/or

  - Other certificate/information letter that is required according to provisions of the regulating legislation.

 

 ○ SKI is published in electronic form and does not require wet stamp and signature(paperless).

 

 ○ SKI can be printed by the applicant or any other agency stakeholders through a system of Indonesia National Single Window(INSW) http://www.insw.go.id/

 

 

2. Drug and Food

 

□ Regulation on Importation Control of Drug and Food in Indonesia

 

□ Legal basis:

Regulation of BPOM(The Indonesia National Agency of Drug and Food Control) Number:

29 Year 2013 on Importation Control of Drug and Food

 

□ Import Regulation:

 

 ○ Drug and Food that can be imported into the territory of Indonesia for circulation is Food and Drug that has obtained circulation permit.

 

 ○ Importation of Drug and Food also has to obtain approval from the Head of the Agency (BPOM).

 

 ○ Approval from the Head of the Agency is in the form of SKI which is only valid for one time importation.

 

 ○ Drug and Food imported into the territory of Indonesia must have a shelf life of at least:

  - 1/3 of the shelf life for Drug, Traditional Medicine, Quasi Medicine, Health Supplement, and Cosmetics;

  - 9months prior to Expiration Limit, for Biological Product;

  - 2/3 of the shelf life, for Processed Food

 

 ○ SKI also applies for the importation of Drug and Food into the Free Trade and Free Trade Area

 

 ○ Importation of Drug and Food can only be performed by the holder of Circulation Permit or its proxy.

 

 ○ To get SKI:

  - Applicant that will apply for SKI must register using the Single Sign On mechanism to obtain an account in the form of user ID and password.

  - The Single Sign On mechanism is to obtain login access to the Agency of Drug and Food Control in-house (including Main Office/POM Office) and the Indonesia National Single Window portal.

  - Registration is conducted through the website of the Agency of Drug and Food Control at http://www.pom.go.id or through the sub site http://www.e-bpom.pom.go.id.

  - Applicant performs data entry electronically and submits the supporting documents by uploading it into the e-bpom application.

  - Registration shall be equipped document as follows:

   · Original Application Letter signed by the Director or the Proxy of Director and duly stamped;

   · Duly stamped Original Letter of Statement of the Responsible Person;

   · Photocopy of Import Identification Number (API);

   · Photocopy of Trading Business Permit (SIUP);

   · Photocopy of the Tax Identification Number (NPWP);

   · Photocopy of Importation Letter of Authorization in the form of General Certificate by Notary, in the case where the application is a company that has been authorized for import;

   · Pharmaceutical Industry Permit in case of Drug importation;

   · Permit of PBF (Pharmaceutical Wholesaler), for PBF that has been authorized by the pharmaceutical industry to conduct importation of drug;

   · List of HS Code that will be imported.

 

 ○ For verification purposes, the applicant must show the original documents.

 

 ○ In case the verification result is complete and correct, applicant will be given a user ID and password.

 

 ○ Registration of applicant only needs to be performed 1time, as long as there is no change in applicant data.

 

 ○ SKI is issued based on application. SKI application must equipped with the following electronic documents:

  - Approval of Circulation Permit

  - Certificate of analysis;

  - Invoice

  - Packing list;

  - Bill of lading or Air Way Bill; and

  - Proof of payment of Non-Tax State Revenue(PNPB)