BPOM

Practice Area DGLaw Indonesia

Kategori Practice Area

BPOM is the abbreviation of the Food and Drug Supervisory Agency.
This institution has the same tasks as the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) with the main task being to supervise all distribution of medicines and food throughout Indonesia.
BPOM is a non-ministerial government agency that carries out government affairs in the field of drug and food control.

The following are the BPOM requirements as follows:

Director’s Identity (E-KTP, NPWP, HP Number, email)
Identity of the person in charge (E-KRP, cellphone number, email)
Complete Company Documents (Deed, SK, NPWP)
CPKB (How to Make Good Cosmetics)
Lengkap Factory Documents
Complete Raw Material Documents
Complete Product Documents (product type, product classification, label claims, composition, processing process, specific process, product status, company status, food type, food category, type name, trade name, packaging type, net weight)
Supporting Documents: 1) Supporting Documents for domestic products: laboratory analysis results (only for medium and high risk products), composition, production process, explanation of shelf life, explanation of expiration date, material specifications, label design. Supporting documents for foreign products: health certificate/sale-free certificate, letter of appointment (LOA), GMP/HACCP/ISO 22000 certificate, product photo, translated label (if necessary)
For domestic products: NPWP, business permit (NIB), production facility audit results (PSB)
For Import Production: NPWP, business permit (API/SIUP/IT), distribution facility audit results (PSB), health certificate/free sale certificate, letter of appointment, GMP/ISO 22000/HACCP certificate

Every domestically produced processed food business actor or imported products in retail packaging is required to obtain a distribution permit.

Business actors who have or are just starting a processed food business are required to have a distribution permit. This regulation applies to all processed food, whether produced domestically or imported for trade in mandatory retail packaging.

This is stated in the Regulation of the Head of the Food and Drug Monitoring Agency (BPOM) number 27 of 2017. Distribution permits for processed food traded in Indonesia can be issued by regents/mayors through the One Stop Integrated Service Unit/OSS Application or the POM Agency according to the food category. and risk level.

For every processed food produced domestically or imported for trade in retail packaging, food business actors are required to have a distribution permit. The obligation to have a distribution permit is excluded for certain processed foods produced by home industries. Home industries are required to have a Home Industry Food Production Certificate/SPP-IRT (PIRT number).

The distribution permit for processed food issued by the POM consists of BPOM RI MD (for food produced domestically) and BPOM RI ML (for food produced abroad). As reported on the BPOM page, of course to obtain a distribution permit you need to pay attention to the requirements, including:

Separate production location (separate from household);
Processed food is produced manually, semi-automatically, automatically or with certain technologies such as UHT, pasteurization and retort;
Food type:
- Food produced domestically/imported is sold in retail packaging;
- Fortified food;
- SNI mandatory food;
- Government program food;
- Food intended for market testing;

Technical regulations: Head of BPOM Regulation number 27 of 2017 concerning Processed Food Registration. Registration is submitted for every processed food including those that differ in terms of:

Type of food;
Packaging type;
Composition;
Label design;
Name and/or address of producer in Indonesia;
Name and/or address of importer/distributor;
Name and/or address of overseas manufacturer.

Next, the steps for registering BPOM processed food go through two stages, including registering a company account and registering processed food products. Processed food registration is carried out electronically/web-based via http://e-reg.pom.go.id/.

Company Account Registration

Domestic Product (MD) Requirements:

Taxpayer Identification Number (NPWP);
Business Identification Number (NIB), if via OSS route;
Business License (IUI/IUMK/SKDU);
Production facility audit results (PSB) recommended by the local POM Center;
For alcoholic beverage products, you must use the IUI issued by the Central BKPM.

Imported Product Requirements (ML):

NPWP;
Trading Business License (SIUP)/Import Identification Number (API)/Determination Letter as Registered Importer (IT) for alcoholic beverages;
Distribution facility audit results (PSB) recommended by the local POM Center;
Letter of appointment (LOA) ratified by a notary, local chamber of commerce, or representative of the Republic of Indonesia abroad;
GMP/HACCP/ISO 22000 certificate/Audit certificate from local government.

Food Product Registration

Low and Very Low Risk Processed Food Requirements:

Composition;
Production process;
Production code explanation;
Explanation of shelf life/expiry period;
Label design;
Nutrient analysis results (except for micro and small businesses);
Material specifications.

Medium and High Risk Processed Food Requirements:

Composition;
Production process;
Production code explanation;
Explanation of shelf life/expiration;
Label design;
Analysis results (microbial contamination, heavy metals, nutrients, certain BTP);
Material specifications.

Food Additives (BTP) Product Requirements:

Composition;
Production process;
Production code explanation;
Explanation of shelf life/expiration;
Label design;
Analysis results (for mixed and flavored BTP);
Material specifications;
BTP producer permit (Domestic production).

Practice Area DGLaw Indonesia

BPOM

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