Licensing Requirements for Importing, Storing and Distributing Temperature-Sensitive Health Products in Indonesia

The import, storage, and distribution of temperature-sensitive health products in Indonesia are subject to a combination of business licensing, product registration, import controls, and technical requirements.

The specific requirements depend primarily on the regulatory classification of the product and the activity being conducted. Pharmaceutical preparations, medical devices, health supplements, and processed foods are regulated under different frameworks, although each may require both business-level licensing and product-level authorization before the products can be lawfully circulated in Indonesia.

For temperature-sensitive products, such as vaccines, biological products, certain pharmaceutical preparations, diagnostic devices, reagents, health supplements, and chilled or frozen foods, compliance also extends to storage and distribution conditions intended to preserve the safety, quality, and integrity of the product throughout the supply chain.

1. Regulatory Framework for Temperature-Sensitive Products

Indonesia’s health regulatory framework establishes general requirements for the safety, quality, and distribution of health-related products.

Law No. 17 of 2023 on Health requires parties involved in the production, processing, and distribution of food and beverages to comply with applicable safety, quality, and nutritional standards. These obligations extend to the activities involved in production and distribution, including storage and transportation.

The same law also regulates the circulation and distribution of pharmaceutical preparations, medical devices, and household health supplies through further implementing regulations.

Government Regulation No. 28 of 2024 on the Implementation of Law No. 17 of 2023 on Health provides that pharmaceutical preparations, medical devices, and household health supplies may only be circulated after obtaining the applicable business licensing in the form of marketing authorization (izin edar). Their distribution and delivery must also be conducted by appropriately licensed facilities and in accordance with Good Distribution Practices.

Accordingly, the regulatory analysis for a temperature-sensitive product should not begin with the cold-chain requirements alone. The first question is whether the business and the product itself have the required authorization to be imported and circulated in Indonesia. The storage and distribution requirements then operate as part of the broader compliance framework.

2. Import Licensing for Temperature-Sensitive Products

The requirements for importing temperature-sensitive products depend on the regulatory category of the product.

Pharmaceutical preparations, health supplements, medical devices, and processed foods are subject to different product registration and import-control mechanisms. An importer must therefore identify the applicable product category before determining the licences and approvals required for the importation.

Pharmaceutical Preparations and Health Supplements

Pharmaceutical preparations may only be circulated after obtaining the applicable marketing authorization under Government Regulation No. 28 of 2024. Import-related distribution may only be undertaken by facilities that are licensed under the applicable pharmaceutical regulatory framework.

For imported health supplements, product registration and marketing authorization are also required under the applicable Food and Drug Authority regulations. Food and Drug Authority Regulation No. 32 of 2022 on Criteria and Procedures for the Registration of Health Supplements establishes registration requirements for imported supplements and requires supporting information concerning the safety, benefits, and quality of the product.

For temperature-sensitive supplements, the product registration dossier may also need to demonstrate product stability over the relevant shelf life. This is particularly important where temperature conditions may affect the quality or stability of the product.

Accordingly, temperature sensitivity does not replace the ordinary product registration requirements. Rather, it adds greater importance to the technical evidence and controls demonstrating that the product remains within the required quality parameters throughout its intended shelf life.

Medical Devices and Household Health Supplies

Medical devices and household health supplies are also subject to licensing and distribution requirements under the health regulatory framework.

Government Regulation No. 28 of 2024 requires distribution of pharmaceutical preparations and medical devices to be conducted by appropriately licensed facilities. For imported medical devices, the applicable product must have the required marketing authorization from the Minister of Health before being brought into circulation in Indonesia.

Importers must also comply with the applicable import procedures, including the use of the Indonesia National Single Window where required and the relevant customs requirements.

These requirements apply to temperature-sensitive medical devices as well. The fact that a medical device requires controlled temperature storage does not create a separate exemption from the general marketing authorization requirement. Instead, the temperature requirement forms part of the technical conditions that must be observed when the product is imported, stored, and distributed.

Processed Food

Temperature-sensitive processed foods, including chilled and frozen foods, are subject to the food safety and food circulation framework.

Government Regulation No. 86 of 2019 on Food Safety requires processed food produced or imported for trade in retail packaging to have the applicable business licensing before circulation.

For imported processed foods, the applicable marketing authorization must be obtained and the product must satisfy the relevant requirements concerning safety, quality, and shelf life. Imported processed food is also subject to shelf-life requirements at the time of importation.

The fact that a food product is refrigerated or frozen does not remove it from the general food circulation requirements. Instead, its temperature conditions become part of the requirements that must be maintained during storage, transportation, and distribution.

3. Food and Drug Authority Import Controls

Certain products subject to Food and Drug Authority supervision are also subject to specific import-control procedures.

Food and Drug Authority Regulation No. 27 of 2022 on the Supervision of the Entry of Drugs and Foods into Indonesia establishes the Import Certificate (Surat Keterangan Impor or SKI) regime, including SKI Border and SKI Post-Border procedures.

For products covered by these provisions, the importer must obtain the applicable import certificate and satisfy the relevant requirements before the products enter Indonesia or are circulated, depending on the applicable import-control classification.

For pharmaceutical products, importation may generally only be conducted by the holder of the relevant marketing authorization or an authorized party meeting the applicable requirements. Where an authorized party conducts the importation, the relevant responsibilities concerning the product and its circulation remain subject to the applicable regulatory framework.

Importers are also required to maintain the safety and quality of the products and comply with applicable remaining shelf-life requirements. The importer must have the required NIB and complete the relevant registration and supporting documentation through the applicable electronic import system.

For temperature-sensitive products, these import controls operate alongside the requirements for maintaining the prescribed temperature conditions. An import certificate does not, by itself, authorize the importer to disregard the storage or transportation conditions applicable to the product.

4. Licensing for Storage and Cold-Chain Facilities

Storage is an important part of the regulatory framework because temperature-sensitive products can be affected by conditions such as temperature fluctuations, inadequate refrigeration, or interruptions in the cold chain.

For food products, the food safety framework regulates facilities involved in the production and circulation of food, including storage activities forming part of the circulation process.

For pharmaceutical preparations and medical devices, Government Regulation No. 28 of 2024 requires distribution to be conducted by appropriately licensed pharmaceutical management facilities, manufacturers, and distributors.

Accordingly, a company cannot simply use an ordinary unregulated warehouse to store temperature-sensitive pharmaceutical products or medical devices where the applicable regulatory framework requires storage to be undertaken by a licensed facility.

The storage facility must instead form part of the appropriately licensed business operation and satisfy the technical standards applicable to the products being stored.

Cold-Chain Storage for Pharmaceutical Products

The pharmaceutical framework contains more specific requirements for facilities handling products requiring controlled temperatures.

Pharmaceutical service facilities storing cold-chain products must maintain suitable refrigeration equipment for the temperature range required by the product. For products requiring storage at 2–8°C, this may include an appropriate pharmaceutical chiller, while products requiring freezing conditions require suitable freezer equipment.

Temperature-monitoring equipment must also be available and appropriately calibrated, with temperature monitoring carried out at the frequency required under the applicable pharmaceutical service standards.

The facility must also have appropriate contingency arrangements to maintain the required temperature conditions in the event of a power interruption or other operational disruption. Storage arrangements should allow adequate air circulation, and products should be periodically inspected to identify products that are no longer suitable for use.

These requirements form part of the broader pharmaceutical service and Good Distribution Practices framework applicable to the handling of temperature-sensitive pharmaceutical products.

Storage of Health Supplements

Companies marketing health supplements must also maintain storage facilities that satisfy the applicable regulatory requirements.

For imported or temperature-sensitive supplements, appropriate storage conditions are particularly relevant to maintaining the quality and stability demonstrated during the product registration process.

The storage arrangements therefore need to be consistent with the conditions applicable to the registered product and the requirements imposed by the Food and Drug Authority.

5. Distribution of Temperature-Sensitive Products

Distribution requirements depend on whether the company is conducting wholesale distribution, delivery from a pharmaceutical service facility, or distribution of processed food.

For pharmaceutical preparations and medical devices, Government Regulation No. 28 of 2024 distinguishes distribution from delivery and limits these activities to appropriately licensed facilities.

Wholesale Distribution of Pharmaceutical Preparations and Medical Devices

Wholesale distribution of pharmaceutical preparations and medical devices must be carried out by facilities holding the applicable business licensing.

The distributor must also comply with Good Distribution Practices (Cara Distribusi yang Baik). These requirements are particularly important for temperature-sensitive products because the product must remain within its required temperature range throughout the distribution process.

For products such as vaccines, biological products, and certain temperature-sensitive medical devices or reagents, the distribution system may therefore require validated temperature-controlled transportation, appropriate temperature-monitoring equipment, and procedures for responding to temperature excursions or other disruptions to the cold chain.

These technical measures form part of the broader Good Distribution Practices requirements rather than constituting a substitute for the underlying business licence or product marketing authorization.

Delivery from Pharmacies and Other Pharmaceutical Facilities

Delivery of pharmaceutical preparations and medical devices is regulated separately from wholesale distribution.

Government Regulation No. 28 of 2024 provides that delivery may only be conducted by appropriately licensed pharmaceutical or healthcare facilities.

For temperature-sensitive products, delivery must maintain the required storage conditions until the product reaches the recipient. Where insulated containers and icepacks or coolpacks are required, the delivery method must be capable of maintaining the prescribed temperature and preventing direct contact between the product and the cooling material where this could affect the product.

Temperature conditions may also need to be checked before dispatch and upon receipt, depending on the applicable pharmaceutical service standards.

The purpose of these requirements is to preserve the integrity of the cold chain between the licensed facility and the recipient.

Distribution of Processed Food

Processed food, including chilled and frozen products, must also remain compliant with applicable food safety and quality requirements during distribution.

Food businesses involved in storage and distribution must maintain facilities and handling processes that are appropriate for the nature of the food product. For temperature-sensitive food, this includes maintaining the conditions necessary to prevent deterioration and preserve the safety and quality of the product.

The applicable business licensing and food circulation requirements therefore need to be considered together with the operational conditions necessary for refrigerated or frozen distribution.

6. Good Distribution Practices and Cold-Chain Controls

For pharmaceutical products and medical devices, Good Distribution Practices provide an important technical framework for maintaining product quality during distribution.

For temperature-sensitive products, the distribution system should be capable of maintaining the required temperature throughout storage, handling, transportation, and delivery.

This generally requires appropriate temperature-controlled equipment, monitoring systems, documented procedures, and contingency arrangements. Where the product requires a specific temperature range, the relevant equipment and transportation method must be suitable for maintaining that range under normal operating conditions.

Temperature monitoring is particularly important because a product may remain physically intact even after exposure to unsuitable temperatures. The regulatory concern is therefore not limited to visible damage but also extends to whether the product has remained within the conditions under which its safety and quality were established.

The specific technical requirements depend on the product category and applicable sectoral standards. They should therefore be assessed against the applicable Good Distribution Practices and product-specific requirements rather than treated as a single cold-chain standard applicable to every product.

7. Ongoing Compliance for Temperature-Sensitive Products

Compliance does not end once the product has been imported or the relevant business licence has been issued.

Companies handling temperature-sensitive health products must continue to maintain the conditions applicable to the product throughout storage and distribution. This includes compliance with the applicable marketing authorization, business licence, Good Distribution Practices, storage requirements, transportation conditions, and reporting or monitoring obligations.

For pharmaceutical and medical products, the relevant facility must maintain the systems and equipment necessary to preserve product quality. For health supplements and other products under Food and Drug Authority supervision, the company must also ensure that the products remain consistent with the conditions under which they were registered.

For food products, operators must continue to meet the applicable safety, quality, and circulation requirements throughout the supply chain.

The common principle is that the authorization to import or circulate a product does not remove the obligation to maintain the conditions necessary to preserve its safety and quality.

8. Sanctions for Non-Compliance

Operating without the required licence or failing to comply with the applicable product and cold-chain requirements may result in administrative measures and, depending on the violation, other legal consequences.

For pharmaceutical preparations, medical devices, and household health supplies, the applicable regulatory framework provides for enforcement measures that may include warnings, suspension or freezing of business licensing, administrative fines, and revocation of the relevant licence. Depending on the circumstances, authorities may also require products to be withdrawn or otherwise dealt with in accordance with the applicable regulatory provisions.

For food and beverages, violations of applicable safety and product information requirements may result in administrative and, in certain circumstances, criminal sanctions under the Health Law and food safety framework.

For pharmacies and other pharmaceutical service facilities, failure to comply with applicable storage and delivery standards may also constitute a breach of pharmaceutical service requirements and may expose the relevant facility and responsible personnel to the sanctions available under the health regulatory framework.

The consequences therefore depend on the nature of the product, the activity being conducted, and the particular regulatory requirement that has been breached.

9. Key Licensing Considerations for Importers and Distributors

A company intending to import, store, and distribute temperature-sensitive health products in Indonesia should assess the regulatory requirements at both the business and product levels.

The first step is to identify the regulatory classification of the product, since pharmaceutical preparations, medical devices, health supplements, and processed foods are subject to different licensing and registration frameworks. The company must then determine the business activities it will undertake, including importation, warehousing, wholesale distribution, retail distribution, or delivery.

The company should also establish whether the product requires marketing authorization and whether the importation is subject to an SKI Border, SKI Post-Border, or another import-control mechanism. The relevant business licence and NIB must be in place for the business activity, while the storage and distribution facilities must satisfy the technical requirements applicable to the product.

For temperature-sensitive products, the licensing assessment should also address the cold-chain arrangements from importation through final delivery. This includes the suitability of storage equipment, temperature monitoring, transportation conditions, contingency arrangements, and procedures for maintaining product quality when temperature conditions are disrupted.

Conclusion

The import, storage, and distribution of temperature-sensitive health products in Indonesia are governed by a combination of business licensing, product marketing authorization, import controls, and technical standards.

The applicable requirements depend on both the regulatory category of the product and the business activity being undertaken. Pharmaceutical preparations, medical devices, health supplements, and processed foods are subject to different regulatory regimes, and the required licences and approvals should therefore be identified on a product-by-product and activity-by-activity basis.

For temperature-sensitive products, compliance extends beyond obtaining an import or marketing authorization. The company must also ensure that its storage facilities, transportation systems, and distribution processes are capable of maintaining the conditions required for the product throughout the supply chain.

A company planning to import and distribute such products in Indonesia should therefore assess the applicable business licence, product marketing authorization, import certificate requirements, facility licensing, Good Distribution Practices, and cold-chain requirements before commencing commercial operations.

This article provides a general overview of the licensing and regulatory framework applicable to the import, storage, and distribution of temperature-sensitive health products in Indonesia and is intended for informational purposes only. Specific requirements may vary depending on the product classification, intended use, business activity, storage conditions, distribution model, and applicable regulatory framework.

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