SKI

Distribution
Warehouse BPOM (Certificate
License
Audit (PSB) Registration of
BPOM
Importation)

1. Warehouse Audit (PSB) by Balai Besar POM

Before registering to BPOM (National Agency for Drug and Food Control), Company has to
submit application to audit their distribution or production facilities (Warehouse) to the
Head of Balai POM. The report of said Warehouse audit will be issued by the Head of Balai
POM to the Company (cc-ed to Inspector Director and Food Certification).

The warehouse audit for POM Registration will only be done 1 (one) time for each
Registration for the same type of food. In the event that the type of food that being
registered is different from the previous type of food, another warehouse audit is required.

2. Food Registration at POM Website

After passing the warehouse audit, do online registration to http://e-reg.pom.go.id .

From the registration process to get a username and password will take no longer than 10
days. After the account is registered and active, submit documents.

Required documents:

Food that will be registered have to meet the criteria of safety, quality, and nutrition,
including:
a. safety parameters, namely physical contamination, the maximum limit of microbial
contamination, and chemical contamination as well as the requirements of BTP
(food additives) and auxiliary materials in accordance with specified requirements;
b. quality parameters, namely the fulfilment of quality requirements in accordance
with applicable standards and requirements; and
c. nutritional parameters in accordance with the established requirements.

The registered foods also have to meet the requirements of the Label, how to produce the
food, how to distribute the food and how to retail the food that is in accordance with the
provisions of the legislation.
 If the Registration of Food which produced in other countries and imported into the territory
of Indonesia is submitted by Importers or Distributors, they have to get an appointment
from the company in the country of origin of the product. The importer or distributor must
fulfill the following requirements:
a. has a permit in the field of food importation for importers or a permit in the field of
food distribution/trade for distributors;
b. has an appointment letter in the form of an agreement from the company in the
country of origin; and
c. meet the requirements for good food distribution in accordance with statutory
provisions.

The appointment letter in the form of an agreement must include the clause of:
a. granting the right to the company designated for registration of Food Distribution
Permit;
b. the appointment is exclusive or non-exclusive; and
c. the validity period of the appointment.

The appointment letter has to be legalized by a notary, the local chamber of commerce, the
local government, or a Representative of the Republic of Indonesia abroad. Food Producers
in the country of origin must meet CPPOB requirements for the types of Food that are
registered, as evidenced by the results of checks on the fulfilment of CPPOB (Right Way of
Producing Processed Food) requirements and the proper method of distribution of
Processed Food. The fulfilment of CPPOB requirements is proven by GMP/HACCP/ISO-
22000/PMR certificates/similar certificates issued by authorized/accredited institutions
and/or audit results from the local government.

3. BPOM Distribution License

The distribution license will be issued by the Head of POM if the results of the assessment,
registration data and supporting data are declared complete and correct. Issuance of the
distribution license is accompanied by a draft of Label that has been approved and has a
Circular Number.

The distribution license is applied for 5 (five) years and can be extended through Re-
Registration. Food that will be distributed has to comply with the safety, quality, and
nutrition parameter, and Label requirements that has been approved at the time of
Registration. Food Labels that will be distributed have to comply with the draft Labels that
has been approved at the time of Registration.

The issuance of distribution license depends on the completeness of the required

documents. Each document fulfilment /submission process will be evaluated for the
completeness of the requirements, which takes no later than 35 days per evaluation
process.
 BPOM submits the food distribution license as fulfilment of Commitment of Commercial or
Operational Permits no later than 1 day through OSS system.
4. SKI (Certificate of Importation) Registration

Submission of applications is made through OSS to obtain NIB and fulfil the Commitment to
Certificate of Importation of Drugs and Food in accordance with the provisions of the
legislation regarding electronically integrated licensing services. Company must fulfil
commitments by submitting the required documents through the BPOM which is integrated
with the OSS system.

BPOM will evaluate all required documents for the Certificate of Importation that submitted
by Company. The evaluation will take no later than 1 day since the application is received
completely and correctly.

The BPOM issues the Certificate of Importation based on the evaluation results that stated
the Company has fulfilled the requirements of Commitment of Commercial or Operational
Permits no later than 1 (one) day through the OSS system.

Required documents:
a. Administrative documents:
1) statement letter;
2) invoice; and
3) proof of payment of non-tax state revenue in accordance with statutory
provisions.
b. Technical documents:
1) certificate of analysis;
2) distribution license approval for the products;
3) the name and product packaging listed on the invoice must be the same as the
product name and packaging listed on the distribution license;
4) material safety data sheet for raw materials;
Alur Pendaftaran SKI: