Overview of what businesses need to know about drug import and distribution licenses in Singapore 2026
Singapore 
Updated on January 16 
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content
- 1. Why is a license to import and distribute drugs required in Singapore?
- 2. Regarding the Health Sciences Authority ("HSA") in Singapore
- 3. Difference between drug import and distribution license and GDP certificate in Singapore
- 4. Conditions for being granted a license to import and distribute drugs in Singapore
- 5. Process and procedures for establishing a pharmaceutical business in Singapore
- 6. What should businesses do to renew or cancel their license to import and distribute drugs in Singapore?
- 7. Common mistakes that cause drug import and distribution license applications to be rejected
- 8. How does GLA support pharmaceutical businesses in Singapore?
- 9. Frequently asked questions about drug import and distribution licenses in Singapore
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Businesses in need Expanding pharmaceutical business to the Singapore market , Asia's leading prestigious pharmaceutical center, the first step that cannot be skipped is to register for a license to import and distribute drugs at the Singapore Health Sciences Authority (HSA).
Although it sounds simple, in reality this process requires businesses to meet many strict standards from:
- Build a quality management system according to Good Distribution Practice (GDP) standards, to
- Appoint a Responsible Person (RP) with appropriate expertise and experience.
Even a small error in the application can cause the approval process to be delayed or denied.
In this article, GLA will guide businesses in detail on the process of registering for a license to import and distribute drugs in Singapore according to regulations in 2025, helping businesses save time, reduce legal risks and effectively deploy pharmaceutical activities in Singapore.
1. Why is a license to import and distribute drugs required in Singapore?
Singapore is one of the most developed and regulated pharmaceutical markets in Asia. With a world-class healthcare ecosystem, it is not only pharmaceutical distribution center of the region, Singapore is also “gateway” to the ASEAN market for foreign businesses.
The Singapore Government prioritizes the development of the biopharmaceutical and pharmaceutical manufacturing industry as a key sector, attracting international investment and promoting research and development (R&D) activities.
To support businesses, Singapore has invested in building specialized infrastructure for the pharmaceutical industry, typically Tuas Biomedical Park, helping businesses quickly establish and deploy pharmaceutical production activities that meet international standards.
Any import, distribution or trading of drugs in Singapore is license required HSA-issued certification, to ensure quality, safety and increased transparency throughout the supply chain.
Benefits when Enterprises own a license to import and distribute drugs from HSA:
- Legalize all business activities in Singapore.
- Import, export and legal distribution of drugs in the logistics and healthcare system.
- Increase reliability when cooperating with hospitals, clinics, pharmacies and global pharmaceutical companies.
2. Regarding the Health Sciences Authority ("HSA") in Singapore
The Health Sciences Authority in Singapore is Health Sciences Authority (HSA) under the Singapore Ministry of Health (MOH), responsible for management all import, distribution and production activities pharmaceuticals, medical devices and health products.
Any business that wants to establish a pharmaceutical company in Singapore or import, distribute, or cooperate in pharmaceutical trade in Singapore must HSA authorization required valid.
HSA Official Website
Singapore regulates pharmaceutical activities based on a multi-layered legal framework that includes:
- Medicines Act (Chapter 176): Provides for five-year protection of confidential information and supporting data in new drug registration applications.
- Health Products Act: Management of medical equipment, health products and import and distribution activities.
- Poison Act: Qmanagement of active pharmaceutical ingredients, laboratory reagents or veterinary products.
- Guidelines & Circulars: HSA provides detailed guidance on the implementation and management of pharmaceuticals in Singapore.
3. Difference between drug import and distribution license and GDP certificate in Singapore
3.1 What is the license to import and distribute drugs in Singapore?
Import and distribution is two completely separate activities, each activity requires a separate license for the drug to be legally circulated in Singapore.
- Therapeutic Products Importer's Licence (“TPIL”) is a mandatory requirement for any business wishing to bring drugs from abroad into the Singapore market.
- Therapeutic Products Wholesaler's Licence (“TPWL”) allows businesses to store, distribute and transport drugs within Singapore territory.
In addition, in the case of businesses trading in medical equipment, the following licenses are required depending on the activity:
- Medical Device Import License (Importer's Licence (“IP”)): This is a license to import medical devices into Singapore. This type of license only allows businesses to import, not to be stored or distributed.
- Medical Device Wholesaler's License (“WL”): Allows businesses to stock and distribute medical devices to third parties or provide commercial samples. Not required if selling directly to end users.
- Medical Device Manufacturing License (Manufacturer's Licence (“ML”)) Allows manufacturing, processing, packaging and labeling of medical devices. WL is not required if distributing self-manufactured products.
3.2 What is GDP certification?
The Good Distribution Practice("GDP")) certification is a certification issued by HSA, Confirm that the business has a system for storing, transporting and distributing drugs that meet safety, quality and traceability standards.
This is voluntary program help businesses comply with international standards for drug distribution and enhance reputation in the supply chain, but no replacement Pharmaceutical Distribution Worker's License (TPWL) to operate legally in Singapore.
Good Distribution Practice Certificate
This certificate is not an import or distribution license, but confirmation The company's distribution system meets national standards, helping drugs reach consumers safely and legally.
3.3 Responsible Person (“RP”) Requirements
Every company with a license to import (TPIL) or distribute (TPWL) drugs in Singapore is required to nominate at least one Responsible Person (RP). RP must be qualified personnel to maintain the quality management system (QMS) according to Good Distribution Practice (GDP) standards.
For products such as prescription or over-the-counter drugs, RP must be a registered pharmacist.
Required conditions of Responsible Person (RP):
- Understand and apply GDP or GMP in operations.
- Manage or supervise the import, distribution, storage, and retrieval of products.
- Ensure that the Quality Management System (QMS) is maintained effectively.
4. Conditions for being granted a license to import and distribute drugs in Singapore
To be licensed to import and distribute drugs in Singapore, Enterprises must meet a series of strict conditions set by HSA, to ensure that:
- Drug import, storage and distribution activities.
- Drug transport.
To be carried out safely, transparently and in compliance with international standards, businesses need to meet the following conditions:
- Legal company formation in Singapore, registered with ACRA and have a clear business address.
- Registration for a Therapeutic Products Importer's Licence (“TPIL”) if the business import drugs from foreign countries into Singapore.
- Apply for a Therapeutic Products Wholesaler's Licence (“TPWL”) if the business stores, distributes or wholesales drugs within Singapore.
- Appoint an individual to take on the role of RP Responsible for overseeing product import, distribution, warehousing and traceability activities.
- Building and maintaining a QMS system effective and meeting GDP standards on drug distribution, ensuring that drugs maintain their quality and safety from the time of import until they reach consumers.
- Full compliance with regulations on the quality, labeling, packaging, storage conditions and transportation of drugs in Singapore.
5. Process and procedures for establishing a pharmaceutical business in Singapore
To conduct pharmaceutical business in Singapore, businesses need to carry out two main procedures: establishing a company and registering for import and distribution licenses with the Health Sciences Authority (HSA). The basic process includes the following steps:
Businesses must have legal entity in Singapore are eligible to apply for a license to import and distribute drugs.
GLA provides a full range of services Singapore company registration, including legal registration, company address, and business profile.
Documents to be prepared include:
- Company information and warehouse address.
- Responsible Person (RP) arrangement.
- Import/Distribution Operations Plan.
- Management system according to GDP (Good Distribution Practice) standards.
- Additional forms and documents as directed by HSA.
The business has Singapore company registration, can proceed to submit applications for import and distribution licenses for drugs through HSA's official online service portal.
Online application submission helps businesses save time, reduce paperwork and ensure transparent processing of applications.
Once the application for a licence is approved by HSA, the Singapore business will be granted:
- Therapeutic Products Importer's License (TPIL): allow the import of drugs from foreign countries into Singapore.
- Therapeutic Products Wholesaler's License (TPWL): allows storage, distribution and transportation of drugs within the domestic distribution system.
This license is legal basis for businesses to officially launch pharmaceutical business operations in Singapore.
After being granted a license, the business is responsible for:
- Maintain GDP compliance and ensure the quality management system (QMS) operates effectively.
- Update information promptly with HSA when there are changes in business location, organizational structure, or Responsible Person (RP).
- Conduct internal assessments periodically to ensure that all drug import, storage and distribution activities meet safety, traceability and quality standards.
- License renewal periodically as required by HSA to maintain legal validity.
Strict compliance not only helps businesses avoid legal risks, but also strengthens their reputation and sustainable operating capacity in the Singapore market.
6. What should businesses do to renew or cancel their license to import and distribute drugs in Singapore?
6.1 Renew a license
The import and distribution license of drugs issued by HSA is valid for 12 months from the date of approval.
Singapore companies need to monitor the license expiration date and apply for renewal. Expired licenses cannot be renewed and new applications need to be submitted.
Businesses can renew their licenses in two ways:
- Auto-renewal via GIRO: The fee will be deducted 30 days before the license expires.
- Manual renewal: If not participating in GIRO, businesses must manually submit renewal applications through the HSA portal to ensure their licenses are renewed on time.
6.2 Cancel a license
Singaporean companies can apply to cancel their drug import and distribution licenses when no longer conducting business , and no longer needed maintain license.
License cancellation process:
- Submit a license cancellation request through HSA's online service portal.
- Receive email notification of cancellation processing results for businesses.
- Once the cancellation is approved, the business name will be removed from the list of licensed distributors/importers on the HSA website.
Note to GIRO: Businesses participating in the automatic renewal program through GIRO need to cancel their licenses at least 30 days before the fee deduction date to avoid unwanted renewal fees.
7. Common mistakes that cause drug import and distribution license applications to be rejected
During the application process for a license to import and distribute drugs in Singapore, HSA often reject or return the application If you find the following common errors:
Incomplete or incorrectly formatted records on the Pharmaceutical Regulatory Information System (Pregulatory Information System).
The common mistake is missing documents obligatory, incorrect information, or file/document is not in the correct format that HSA requires.
When this happens, HSA cannot fully review the application and will reject it or return it for correction.
A newly established pharmaceutical company, applying for a license to import drugs into Singapore, entered the wrong drug name in PRISM, resulting in the application being rejected by HSA, and the company had to supplement and resubmit all documents.
The Responsible Person (RP) does not meet the standards
HSA requires RP to be a person have professional competence , and practical experience, responsible for ensuring quality, safety and regulatory compliance throughout the supply chain, businesses may encounter situations including:
- RP does not have the appropriate qualifications.
- RP does not have sufficient experience or knowledge to maintain Quality Management System (QMS) according to GDP standards.
- The records do not demonstrate the role and responsibility of RP in managing drug import and distribution.
Lack of GDP certification or substandard storage facilities
One of the common errors that causes HSA to refuse to issue a distribution permit (TPWL) is that the business no certification provided Good Distribution Practice (GDP) valid or the warehouse facility does not meet the standard.
HSA requires proof that businesses have a system for storing, transporting and distributing medicines that meets safety standards, ensures quality and has full traceability.
Real life example: A client at GLA was refused a TPWL licence by HSA due to the storage facility not having adequate temperature and humidity control.
GLA supported the completion of the dossier, guided the adjustment of the warehouse facility according to GDP standards, and finally the TPWL license was successfully approved by HSA.
Unable to prove the legal origin of imported drugs
One of the main reasons why HSA refuses to grant a license to import or distribute drugs is that the business failure to provide complete documentation confirm the legal origin of the drug.
Enterprises must submit invoices, export licenses, and quality certificates from the manufacturer to prove that the drugs are legally produced and exported.
A client at GLA was once refused a TPIL license by HSA because it did not submit a valid invoice and export license for the imported drug.
After receiving support from GLA, the business was guided to standardize all legal documents, complete the application and resubmit. As a result, HSA approved the TPIL license, allowing the business to continue importing legal drugs into Singapore.
8. How does GLA support pharmaceutical businesses in Singapore?
GLA accompanies businesses throughout the entire process of establishing and operating a pharmaceutical company in Singapore, helping to minimize legal risks and ensuring that applications are quickly approved by HSA.
- Legal advice and Singapore company registration from choosing the right type of business, registering the legal entity with ACRA and providing office rental services in Singapore.
- Prepare application documents for import and distribution license of drugs ensuring correct format according to PRISM standards.
- Consulting on personnel selection to ensure professional standards and management experience, meeting HSA requirements.
- Support for adjusting records, supplementing legal documents, improving warehouse facilities to standardize the QMS system
- Providing services for hiring appointed directors and corporate secretaries.
- Support counseling open a physical bank account, digital bank account
- Consulting and supporting businesses to register for international payment gateways such as: PayPal, Stripe, etc.
9. Frequently asked questions about drug import and distribution licenses in Singapore
1. Can foreign enterprises register for drug import and distribution licenses in Singapore?
Foreign enterprises cannot register for import and distribution licenses for drugs in Singapore on their own.
Only companies that are duly registered in Singapore with ACRA can apply for a license.
If a foreign enterprise does not have a legal entity in Singapore, it is necessary to appoint a local representative (Local Authorized Agent) to act as its representative and carry out procedures with the Singapore Health Sciences Authority (HSA).
GLA supports businesses Open a company in Singapore Full package from consulting, preparing documents and monitoring licenses to ensure transparency and compliance with HSA regulations.
2. Is Good Distribution Practice (GDP) certification required when applying for a license?
Depending on the type of license and scope of activities of importing or distributing drugs:
If a business applies for a pharmaceutical distribution permit (TPWL) for warehousing and wholesale distribution, it is required to comply with GDP standards.
If a business only applies for a drug import license (TPIL) without warehousing or wholesale distribution, GDP is not required from the outset, but HSA may still require a quality management system to demonstrate the safety of the drug.
3. Can one license be used to import or distribute different types of drugs?
Yes, if those products are all within the HSA approved activities scope of the licence.
However, if a business wants to expand into product groups outside its current scope (e.g. prescription drugs, unregistered drugs), it will need to update or supplement its license.
4. If the company or Responsible Person (RP) address changes, do I need to notify HSA?
Businesses must update change information within 14 days of any change in address, facilities, or responsible person (RP).
Failure to update may result in license suspension or revocation.
5. Does HSA conduct periodic inspections of storage facilities?
HSA conducts regular inspections of storage facilities to ensure businesses comply with Good Distribution Practice (GDP) standards and regulations on medicine storage.
Highlights- All import and distribution of drugs in Singapore requires a license issued by HSA.
- Two separate types of licenses: Drug Import License (TPIL) and Drug Distribution License (TPWL)
- GDP certification does not replace licensing; GDP only demonstrates that the distribution system meets safety and quality standards.
- Enterprises must appoint a professionally qualified Responsible Person (RP) to manage the QMS and comply with GDP.
- TPIL and TPWL permits are valid for 12 months and require renewal before expiry.
This article was published by GLA on 01/12/2025. Copyright and accompanying content are intellectual property of GLA. All rights reserved.
The guidance and content are for general information only and are not intended to provide specific guidance and advice on accounting, tax, legal or other professional advice. Readers should consult professional advisors on specific issues.
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