BPOM, Halal, PKRT, SNI and AMDAL – Frequently Asked Questions

Question 1

What is BPOM and which products need its approval?

Accepted Answer

BPOM (Badan Pengawas Obat dan Makanan) is Indonesia’s Food and Drug Authority. It oversees medicines, traditional medicines, health supplements, cosmetics and processed foods. Products in these categories generally need BPOM registration or notification, and a marketing authorization number, before they can be legally distributed in Indonesia.

Question 2

Can a foreign company register products with BPOM directly?

Accepted Answer

In most cases, no. Registration is generally filed through an Indonesian legal entity, such as a local importer or distributor, which holds the marketing authorization and is responsible for the product locally. We can help you choose the right structure and prepare the application.

Question 3

What documents and how much time are needed for BPOM registration?

Accepted Answer

Required documents depend on the product category and risk level. They typically include company legal documents, product formulation, manufacturing information, labeling and, for imports, documents from the manufacturer. Processing time varies by category and by how complete the application is, so we recommend starting early and preparing documents before filing.

Question 4

Is halal certification mandatory in Indonesia?

Accepted Answer

Halal certification is part of Indonesia’s national Halal Product Assurance framework, established under Law No. 33 of 2014 and further implemented through Government Regulation No. 42 of 2024. Under this framework, products that enter, circulate and are traded in Indonesia are required to be halal certified, with mandatory dates phased in by product category. Please check the current deadline for your product category.

Question 5

Do imported products also need halal certification?

Accepted Answer

Yes. Imported products that fall under the mandatory categories also need to comply. Foreign producers generally have to register their products and halal certificates with Indonesia’s halal authority, and recognition of a certificate issued by a foreign halal body depends on a recognition arrangement with that body. We can advise on the route that applies to your product.

Question 6

What is the halal certification process?

Accepted Answer

In outline: the business submits an application with product, ingredient and production process information; a halal inspection body reviews and audits the product; the halal fatwa is determined; and the halal certificate is issued. Some low-risk businesses may qualify for a simpler self-declaration route. A new certificate or review may be needed if ingredients or the production process change.

Question 7

What is PKRT and what products does it cover?

Accepted Answer

PKRT stands for Perbekalan Kesehatan Rumah Tangga, commonly translated as Household Health Supplies. Under the Ministry of Health’s framework, PKRT covers tools, materials or mixtures intended to support the maintenance and care of human health in households and public facilities. Typical examples include household cleaning and disinfecting products and similar supplies.

Question 8

Do I need a PKRT distribution permit before selling in Indonesia?

Accepted Answer

Yes. PKRT products generally need a distribution permit from the Ministry of Health before they can be marketed in Indonesia. The requirements depend on the product’s class and risk level, and the permit is normally applied for by a qualified Indonesian company.

Question 9

How is PKRT different from BPOM registration?

Accepted Answer

They are separate regimes handled by different authorities. PKRT falls under the Ministry of Health, while BPOM oversees medicines, traditional medicines, health supplements, cosmetics and processed foods. Some products sit close to the boundary, so we help you confirm the correct category before filing.

Question 10

What is SNI?

Accepted Answer

SNI stands for Standar Nasional Indonesia, or Indonesian National Standard. SNI standards are established by Badan Standardisasi Nasional (BSN), Indonesia’s national standardization body. Many SNI standards are voluntary, while others are made mandatory by regulation for specific products.

Question 11

Which products must carry the SNI mark?

Accepted Answer

Only products covered by a regulation that makes SNI mandatory must carry the SNI mark. The list of covered products is set by the relevant ministries and can change, so it is important to check the HS code and product type before importing or manufacturing.

Question 12

How do I obtain SNI certification for my product?

Accepted Answer

Generally, a product is tested against the applicable SNI and assessed by an accredited conformity assessment body, after which an SNI certificate is issued and the SNI mark may be used. Foreign manufacturers exporting to Indonesia can also be required to obtain certification. We coordinate the process with the right bodies.

Question 13

What is AMDAL?

Accepted Answer

AMDAL stands for Analisis Mengenai Dampak Lingkungan Hidup, Indonesia’s environmental impact assessment framework. It concerns the significant environmental impacts of a planned business or activity and supports decision-making on whether, and under what conditions, that activity may proceed.

Question 14

Does my business or project need an AMDAL?

Accepted Answer

AMDAL is required for businesses and activities that are likely to have a significant environmental impact, as defined by regulation. Smaller-impact activities usually fall under lighter instruments, such as UKL-UPL or a statement of environmental management ability (SPPL). The right instrument depends on the business type, scale and location, and we can help you determine it.

Question 15

How long does the AMDAL process take, and what does it involve?

Accepted Answer

It typically involves scoping, preparing the environmental study documents, review by the competent authority, and the resulting environmental approval, which is linked to the business licence. Timing depends on the project’s scale, complexity and the completeness of the studies, so early planning is strongly recommended.

什么是PKRT？涵盖哪些产品？

在印尼销售前需要办理PKRT流通许可吗？

PKRT与BPOM注册有何不同？

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