4. Supply of Ingredients

Ingredients Regulation Overview for Ingredient Manufacturers
Indonesia

This section provides information on any notification, registration, or importation requirements for the ingredient categories in scope.

4.1 As Drug Substances for Drug Manufacture (B2B)

Drug Substances: efficacious or non-efficacious substances used in drug processing with the same standard and quality as pharmaceutical raw materials including reference substances. This definition includes both APIs and excipients.

4.1.1 Registration requirements

There is no requirement for an overseas manufacturer of drug substances to be registered in Indonesia.

4.1.2 Importation

4.1.2.1 Overview of Process

For a foreign manufacturer to supply drug substances in Indonesia they must authorize a local agent to make the application for importation approval (via a Border Import Certificate- SKI Border) on their behalf. The SKI Border must be obtained before the goods can be released by Indonesian customs. 

The local agent (SKI Border Applicant) must have a pharmaceutical industry or pharmaceutical wholesaler business license. If the applicant is a pharmaceutical industry, the importation of drug substances by the applicant may only be for in-house production needs and not for general distribution. If the applicant is a pharmaceutical wholesaler, a certificate of Good Distribution Practice is also required. 

The SKI Border Applicant must register through the Online Single Submission Institution providing the required supporting documents. 

Once registration is approved, the SKI Border Applicant must apply for an import certificate each time the goods are imported by electronic submission of the required documents and payment of the fee. 

Within six hours of receipt of the documents and payment, documents are evaluated to determine fulfillment of the administrative requirements and requirements for safety, efficacy/benefit, and quality. On approval, the SKI Border is issued electronically.

4.1.2.2 Documents Required from the Ingredient Supplier

To support the registration of the local agent as the SKI Border Applicant, the Ingredient Supplier must grant them power of attorney in import, providing the power of attorney in the form of a general deed notarized by a notary.  

Documents required from the Ingredient Supplier for a SKI Border application are:

1. Certificate of Analysis
2. Material safety data sheet and/or material specifications letter
3. Current GMP certificate of the manufacturer, which covers the substance to be imported.

4.1.3 Change Notification

A change to the API trade name would not have a regulatory impact on the supply of the ingredient as an import permit with particulars of the goods is required each time they are imported. 

4.2 In Pharmaceutical Products Produced by Indonesian Manufacturers (B2C)

4.2.1 Registration of Drug Product

4.2.1.1 Registration Requirements

For drugs to be distributed in Indonesia, they must have a Marketing Authorization (MA) obtained through the registration process. The applicant for the MA must be a business entity that has a Pharmaceutical Industry license in Indonesia to carry out drug product or drug substances manufacturing activities and they must hold a valid GMP certificate in accordance with the registered type and dosage form. 

The API is assessed as part of the drug registration process. 

4.2.1.2 Registration Procedure

The registration process takes place in two stages. All documents are required to be submitted in Indonesian or English by the applicant via an electronic process (https://new-aero.pom.go.id/).

Pre-registration is required and acts as screening for the registration process. This process includes determining the Registration Category, the evaluation pathway and fee, and the assessment of the completeness of registration documents. Registration documents are prepared by the applicant in accordance with the ASEAN Common Technical Dossier (ACTD) or ICH CTD format.

Registration can be completed after the pre-registration process has been completed with the results (Hasil Praregistrasi, HPR) issued. A full evaluation of the submitted documents is performed to assess efficacy, safety, quality, product information, and/or label in accordance with the category of registration determined. Additional information may be requested of the applicant for evaluation. Approval of the MA is granted to applicants meeting the requirements.

4.2.1.3 Documents to be Provided by Ingredient Supplier

For APIs

New Drug Applications

For APIs not previously used in approved drugs in Indonesia, the following documentation is required from the Ingredient Supplier:

1. GMP Certificate covering the API supplied
2. Drug Master File including Letter of Access
3. CoAs to support specification

DMF submission process to be confirmed.

Generic Drug Applications

1. GMP Certificate covering the API supplied
2. Demonstration of compliance with pharmacopeial monograph - e.g. CEP

For Excipients

1. CoA 
2. Compliance with Pharmacopoeia requirements or other equivalent information 

4.2.1.4 Cost and Timelines 

Pre-Registration

Cost: 1,000,000 IDR (approx. $60 USD)

Pre-registration results are published within a maximum of 40 days from receipt of the application and are valid for one year from the date of issuance. If further information is required, the evaluation timeline is “clocked off” and the applicant has 20 days to provide the requested data. 

Registration

Registration cost ranges between 2,000,000 IDR (approx. $120 USD) to 30,000,000 IDR (approx. $1850 USD) depending on the classification. Costs vary within the drug categories and evaluation pathways. Timelines depend on the evaluation pathway determined in the pre-registration process. 

Different evaluation pathways are applicable depending on the categorization of the drug:

4.2.1.5 Renewal Frequency and Cost

Marketing Authorization is valid for 5 years. Renewal registration is determined to be eligible for the 10-day evaluation pathway and must be submitted no sooner than 12 months and not later than two months before the expiration date. The extension will be approved through the submission of registration renewal documents, provided no changes to the product have been made. 

Required documents from the Ingredient Supplier are:

1. GMP Certificate covering the API/s supplied
2. Certificate of Analysis for API/s

Renewal registration is 1,000,000 IDR (approx. $60 USD) for generic drugs and 5,000,000 (approx. $300) for drugs with trade names. 

4.2.2 Importation

Not applicable to locally manufactured products.

4.2.3 Change Notification Relating to API Trade Name Change

A change to the API trade name would have no regulatory impact. 

4.3 As Active Substances for Health Supplements (B2B)

Health Supplement Substances mean active substances that have efficacy/benefit as well as additional substances (excipients) used in the manufacture of health supplements.

4.3.1 Registration Requirements

There is no requirement for an overseas manufacturer of Health Supplement substances to register their ingredients for supply in Indonesia.

4.3.2 Importation

4.3.2.1 Overview of Process

For a foreign manufacturer to supply health supplement substances in Indonesia, they must authorize a local agent to make the application for importation approval via a Post Border Import Certificate (SKI Post Border) on their behalf. This must be obtained no later than seven days from the issuance of the goods release letter. 

The local agent (SKI Post Border Applicant) must register through the Online Single Submission System providing the required supporting documents. A SKI Post Border Applicant is not required to have a pharmaceutical industry license. 

Once registration is approved, the SKI Post Border Applicant must apply for an import certificate each time the goods are imported by electronic submission of the required documents and payment of the fee. 

Within six hours of receipt of the documents and payment, documents are evaluated to determine fulfillment of the administrative requirements and requirements for safety, efficacy/benefit, and quality. On approval, the SKI Post Border is issued electronically.

4.3.2.2 Documents Required from the Ingredient Supplier

To support the registration of the local agent as the SKI Post Border Applicant, the Ingredient Supplier must grant them power of attorney in import, providing a power of attorney in the form of a general deed notarized by a notary. 

Documents required from the Ingredient Supplier in an import certificate application are:

1. Certificate of Analysis
2. Material safety data sheet and/or material specifications letter
3. Health certificate and/or Certificate of Free Sale from the government/authorized institution in the country of origin

4.3.3 Change Notification

A change to the ingredient trade name would not have a regulatory impact on the supply of the ingredient as an import permit with particulars of the goods is required each time they are imported.

4.4 As Health Supplements Produced by Indonesian Manufacturers (B2C)

4.4.1 Registration of Health Supplement

4.4.1.1 Registration Requirements

For health supplements to be supplied in Indonesia, they must have a valid distribution permit. The application for a distribution permit must be submitted by a Business Actor with a business registration number in Indonesia. For registration of domestic products, a Business Actor must be a company in the pharmaceutical industry, traditional medicine industry, or food industry.

4.4.1.2 Registration Procedure

New domestic registrations are classified as Category 1, 2, or 3 depending on the number and type of active ingredients, claims, and whether the safety profile of the ingredients is known.

Similarly to drug product registration, a new application consists of a pre-registration stage prior to the registration stage. Pre-registration provides the classification of the registration category, determination of the application fee, and a screening of the completeness of submitted documents. Once the pre-registration has been approved, the full registration application is submitted.

Registrations are submitted online by the Business Actor via the e-registration portal.

4.4.1.3 Registration Documents to be Provided by Ingredient Supplier

Certificates of Analysis are provided for the active substances or excipients supplied.

4.4.1.4 Cost and Timelines

Pre-registration takes a maximum of 15 days from application. If pre-registration is approved, the registration application must be submitted within 20 days.   

Evaluation of category 1–3 products takes 30–50 days after receipt of complete registration documents and payment.

4.4.1.5 Renewal Frequency and Cost

A distribution permit is valid for five years. Re-registration must be submitted at the earliest 180 days before expiry, and at least one day before expiry. 

4.4.2 Importation

Not applicable to locally manufactured products.

4.4.3 Change Notification

A change to the active substance trade name would not require the submission of a variation registration.  

4.5 As Active Ingredients for Veterinary Medicines

4.5.1 Registration

Registration of the active ingredients is not required.

4.5.2 Importation

4.5.2.1 Overview of Process

An import permit is required for the importation of raw materials for veterinary medicines. 

The applicant must hold a veterinary medicine business license. Submission of the import permit application is online to the Director General of Animal Husbandry and Animal Health through the head of the Plant Variety Protection and Agricultural Licensing (PPVTPP) Center. Assessment is within 30 days.

4.5.2.2 Documents Required from the Ingredient Supplier

1. Certificate of Analysis
2. MSDS

4.5.3 Change Notification

A change to the trade name of the active ingredient would have no regulatory impact.

4.6 In Veterinary Medicines Produced by Indonesian Manufacturers (B2C)

4.6.1 Registration

4.6.1.1 Overview of Process

Veterinary medicines must be registered before supply in Indonesia. The registration application is submitted online by the registrant who must be an Indonesian entity, holding a valid Veterinary Drug Business License.

The active ingredients are assessed as part of the registration process but do not require a separate application. 

The key steps of the registration process are:

1. Document submission and verification by the verification team of the Director General of Livestock and Animal Health Services (DGLAHS).
2. Submission of samples to the National Veterinary Drug Assay Laboratory (BBPMSOH) for testing of product and active ingredients (35 days for up to two ingredients, additional 35 days for each extra active ingredient).
3. Assessment by the Veterinary Drug Registration Committee (PPOH) (generic drugs) or Veterinary Drug Commission (KOH) (new drugs i.e. containing a new active ingredient, existing active ingredients with new indication, a new combination of existing active ingredients, or new formulation including additional substance). 
4. Establishment of the veterinary drug registration number granted by the DGLAHS.

The required documentation is submitted online via an application form with information on the drug composition, manufacturing, control, ingredients, stability, manufacturer, pharmacology, and clinical trials. 

4.6.1.2 Documents Required from Ingredient Supplier

The following information on the ingredients must be indicated in the application:

1. Description and specification of all raw materials
2. Identification and assay of all raw materials
3. Purity and content limit requirements of all raw materials accompanied by raw material certificate of analysis
4. Sterility, pyrogenicity, and potency if applicable for raw materials
5. The most recent certificate of analysis for all raw materials, signed and stamped by the person responsible for QC.

In line with GMP requirements, it is the responsibility of the drug product manufacturer to control the raw materials used. However, if the ingredient supplier certificate of analysis is used to demonstrate compliance with some aspects of the specification, this would need to be provided by the ingredient supplier. 

The active ingredients are tested by the National Veterinary Drug Assay Laboratory as part of the registration process, but the samples would be submitted by the drug product manufacturer.

4.6.1.3 Cost and Timeframes

On top of the 35 days or more required for laboratory testing of the product and ingredients as indicated in Section 4.6.1.1 above, the registration process is 50 working days for generic drugs and 120 working days for new drugs. Registration cost is 5,000,000 IDR (approx. 300 EUR/USD).

4.6.1.4 Renewal Frequency and Cost

A veterinary drug registration number is valid for 10 years.

4.6.2 Importation

Not applicable to locally manufactured products.

4.6.3 Change Notification

A change to the trade name of the API would have no regulatory impact.

4.7 Other Requirements

Halal certification is becoming mandatory for products in Indonesia. However, implementation is a gradual process. It will be required for all health supplements by October 2026, for OTC medicines by October 2029, and for prescription medicines by 2034.

4.8 References

1. Criteria and Procedures for Drug Registration Number 24 of 2017

https://peraturan.go.id/files2/peraturan-bpom-no-24-tahun-2017_terjemah.pdf

2. Regulations of the Drug and Food Control Agency Number 32 of 2022 about Criteria and Procedure for Health Supplement Registration 

3. Public Services Directorate of Drug Registration Rates Codes

https://new-aero.pom.go.id/img/KODE-JENIS-DAN-TARIF-PNBP.pdf?v=20240416104258

4. Regulation of the Indonesian Food and Drug Authority Number 27 of 2022 on Importation Control of Food and Drugs into the Territory of Indonesia.

https://jdih.pom.go.id/download/product/1496/27/2022

5. Regulation of the Indonesian Food and Drug Authority Number 28 of 2023 about changes to the Regulations Number 27 of 2022 on Importation Control of Food and Drugs into the Territory of Indonesia

6. Regulation of the Indonesian Food and Drug Authority Number 26 of 2022 on Importation Control of Food and Drug Substances into the Territory of Indonesia

https://peraturan.go.id/files2/peraturan-bpom-no-26-tahun-2022_terjemah.pdf

7. Guide on Application of Veterinary Drug Registration

https://www.qia.go.kr/downloadwebQiaCom.do?id=23894

8. Center for Plant Variety Protection and Agricultural Licensing

https://sippn.menpan.go.id/pelayanan-publik/8165621/sekretariat-jenderal-kementerian-pertanian/izin-pemasukan-dan-pengeluaran-obat-hewan