How to register for a controlled drug import and distribution license in Singapore (A complete guide)

As the medical industry flourishes, achieving excellence and venturing into countries with business-friendly environment is crucial for pharmaceutical enterprises. 

Singapore, renowned for its economic stability and transparency, is a prime choice. Obtaining a license to import, export, whosale or even manufacture drugs in Singapore is a vital step for businesses to comply with regulations and secure lasting advantages. 

In this article, we will provide insight to help you find out the requirements and how to apply for a controlled drug license in Singapore for import, export, whosale purposes.

1. An overview of all types of controlled drugs license in Singapore

1.1. Who regulates Singapore’s healthcare sector?

In Singapore, the Health Sciences Authority (“HSA”) serves as the regulatory body overseeing the healthcare products industry. Specifically, the Health Products Regulations Group, within the HSA, enforces laws in this sector. 

This group includes clusters like Pre-market, Vigilance, Compliance & Enforcement (covering audit, licensing & certification), and Medical Devices.

In other words, HSA is the government agency responsible for reviewing and approving drug and medial-related products before they are imported, or sold whosale in Singapore.

1.2. Types of import and whosale licenses in Singapore that you should know

According to the Singapore medical licensing framework by HSA, companies wishing to engage in the importation and wholesale distribution of therapeutic products in Singapore need to hold the appropriate products dealer's licenses. These 2 lisences are:

1. Importer's license for therapeutic product (“TPIL”) and/or;
2. Wholesaler's license for the therapeutic product (TPWL).

Based on your company activity, whether you outsource the import and wholesale activities to another company or be involved in both import and wholesale of therapeutic products, you may or may not need to get the licenses

In addition,  if you are dealing with the importation, distribution, exportation or manufacturing of controlled drugs, you may need to get licenses for those too 

• Controlled drug import license (“CDIL”);
• Controlled drug whosale license (“CDWL”);
• Controlled drug export license (“CDEL”);
• Controlled drug manufacturing license (“CDML”).

In this article, we will mainly focus on the 2 popular types of licenses which are TPIL and TPWL

2. Benefits for getting Singapore drug import and whosale license

Acquiring a medicine import license (TPIL) and medicine distribution license (TPWL) in Singapore offers numerous advantages:

In summary, obtaining a drug import and distribution license in Singapore is a key step for businesses, offering legal compliance, reputation enhancement, market expansion, and support for research and development activities.

3. Who can apply for a drug import and distribution license in Singapore?

The Responsible Person (“RP”) is a crucial figure named in the license of your company involved in importing or distributing drugs in Singapore. Appointed by the business, the RP ensures adherence to Good Distribution Practice (GDP) standards, implementing and maintaining an effective quality management system.

For a drug import and distribution license in Singapore, every company must assign 1 RP (can be more than one), who must meet GDP standards:

• Be capable and qualified to perform duties at a licensed importer and/or wholesaler.
• Hold relevant degrees in Pharmacy, Pharmaceutical Sciences, Applied Chemistry with Pharmaceutical Sciences, Health and Pharmaceutical Technology, etc.
• Possess knowledge of physicochemical properties and stability of drugs.
• Be trained in GDP, understanding its requirements, and proficient in maintaining and implementing the quality system according to GDP standards.

Moreover, if the business deals with Pharmacy-only medicines or Prescription Only Medicines ("POM") for use in Singapore or unregistered therapeutic product, the individual business representative (RP) named in the license must be a registered pharmacist. 

4. Requirements for importing and distributing drugs in Singapore

Businesses will need to obtain relevant licenses, respectively, to your company activities regarding therapeutic products in Singapore.

5. How to renew your drug import and whosale license in Singapore?

The validity period of a drug import and whosale license in Singapore varies based on the type and source of the drug:

• You can not renew the controlled drug import license (CDIL). You need to  apply for new license upon expiration;
• Renewal of licenses for distributing or manufacturing controlled drugs is essential for uninterrupted business operations;
• The drug wholesale/distribution license is initially valid for 12 months. Auto-renewal is available for GIRO users, otherwise, you have to renew manually;
• If you fail to review the distribution license promptly, the license will be deemed invalid. Successful renewal extends the license for another 12 months from the previous expiry date.

6. What are the requirements to apply for the import and whosale license for therapeutic products in Singapore?

To apply for an import and wholesale license for therapeutic products in Singapore, you have to comply with these requirements first:

• Set up a company in Singapore to register for a drug import and distribution license.
• Hold a Good Distribution Practice (GDP) certificate issued by the HSA, ensuring compliance with quality and safety standards in drug distribution.
• Employ professional and experienced staff in the pharmaceutical industry, possessing relevant certificates and degrees.
• Adhere to Singapore's drug import and distribution regulations, covering aspects such as quality, safety, drug labeling, and packaging.

7. How can we help you register for a drug import and whosale license

As a reputable corporate service provider with 10 years of experience in supporting foreign businesses importing and distributing drugs in Singapore, we can assist your businesses throughout the complex process of registering for drug import and distribution licenses in Singapore (TPIL, TPWL) and maintain compliance with those requirements above.

Here's how we can help your business:

• 1

  Singapore company registration

• 2

  Corporate support and advisory

• 3

  Documentation preparation

• 4

  License application

• 5

  Application monitoring

8. FAQs about Singapore drug import and distribution license

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