Overview of importer, wholesaler and manufacturer's licences

Understand the licensing requirements before you import, wholesale and manufacture therapeutic products in Singapore.

Importers and wholesalers

Overview

Under our current activity-based licensing framework, your company needs to hold the relevant therapeutic products dealer’s licences to import and wholesale therapeutic products in Singapore.

Import or wholesale of therapeutic products for clinical use

An importer’s licence for therapeutic products (TPIL) and a wholesaler’s licence for therapeutic products (TPWL) are required to import and wholesale therapeutic products respectively. Your company must comply with the Good Distribution Practice (GDP) standard before these licences are granted to you.

If you are the product registrant and have outsourced the import and wholesale activities (including the invoicing to another company), you do not need to hold these licences yourself. The above licensing requirements and GDP compliance apply to the company that you have outsourced the activities to.

If your company is involved in both import and wholesale of therapeutic products, you may bundle the applications for both the importer's licence (TPIL) and wholesaler's licence (TPWL), so that a lower bundled application fee can be applied. This is not applicable if your company’s importer’s licence is for restricted activity only.

Import and wholesale of unregistered therapeutic product for patient's use

For the import and wholesale of an unregistered therapeutic product for patient’s use, apart from the TPIL and TPWL, a consignment approval from our Therapeutic Products Branch will also be required prior to the import.

Import of therapeutic products solely for supply to ships/aircrafts, export, or non-clinical use

Companies which are only conducting the following restricted activities require an importer's licence for therapeutic product (TPIL). A wholesaler's licence for therapeutic product (TPWL) is not required. In this case, you may choose to apply for an importer's licence for restricted activity only, at a lower fee.

  • Importing therapeutic products solely for supply to ships/aircraft leaving Singapore.
  • Importing therapeutic products solely for export only.
  • Importing therapeutic products for non-clinical use.

If your company is applying for an importer's licence for restricted activity, you may choose to apply for a term (annual) or consignment (one-time only) importer's licence according to your company's operational needs. You should ensure that activities that you intend to conduct are indicated during your application submission.

Supply of therapeutic products for veterinary use

HSA-licensed retail pharmacies and wholesalers may continue to supply TP for animal use based on valid veterinary prescriptions and signed (purchase) orders from licensed veterinarians, veterinary clinics, feedmills, farms and registered wholesalers which are supplying TP solely for veterinary use.

For any enquiry or feedback relating to veterinary products, please contact animal_feedback@nparks.gov.sg.

Import or wholesale of unregistered therapeutic products for use as clinical research materials in clinical trials only

You do not need to apply for an importer's licence (TPIL) or a wholesaler's licence (TPWL) for therapeutic products.

However, you will need to submit a Clinical Research Material (CRM) notification to our Innovation Office & Clinical Trials Branch prior to the import and supply of an unregistered therapeutic product for use as CRM in a clinical trial.

Import and wholesale by licensed therapeutic products manufacturers

If you hold a valid manufacturer's licence for therapeutic products (TPML), you do not need a:

  • Therapeutic product importer’s licence (TPIL) to import therapeutic products required for carrying out the manufacture of your therapeutic product in accordance with your TPML. This includes therapeutic products required for further manufacturing in Singapore, such as repackaging activities.
  • Therapeutic product wholesaler’s licence to wholesale the therapeutic product that you have manufactured in accordance with your TPML.

Responsible Person

A "Responsible Person" (RP) needs to be named in the importer’s or wholesaler’s licence. This person is employed and appointed by the licensee to implement and maintain an effective quality management system that meets the Good Distribution Practice (GDP) standard.

The RP named in the importer's or wholesaler's licence must be a registered pharmacist if your company deals in any of the following:

  • Pharmacy-only medicines (P) or prescription-only medicines (POM) for local use.
  • Unregistered therapeutic products for patients' use.

Refer to our Guidance Notes on Duties of Responsible Persons Named in the Importer's Licence and Wholesaler's Licence140 KB for more information.

Manufacturers

Overview

All local manufacturing facilities engaged in the manufacture or assembly of therapeutic products must have a valid manufacturer's licence for therapeutic product (TPML). Your company must comply with the Good Manufacturing Practice (GMP) standard before the TPML is granted to you.

If you hold a valid TPML, you do not need a:

  • Form A Poisons Licence (FAPL) to import and store products containing poisons required for carrying out the manufacture of your therapeutic products in accordance with your TPML. This includes active pharmaceutical ingredients or products required for quality control testing such as test reagents.
  • Therapeutic product importer’s licence (TPIL) to import therapeutic products required for carrying out the manufacture of your therapeutic products in accordance with your TPML. This includes therapeutic products required for further manufacturing in Singapore such as repackaging activities.
  • Therapeutic product wholesaler’s licence to wholesale the therapeutic products that you've manufactured in accordance with your TPML.

Responsible Person

Two responsible persons (RPs) need to be named in the manufacturer’s licence as follows:

  • A RP for production/assembly
  • A RP for quality operations

The RP must be employed and appointed by the licensee to implement and maintain an effective quality management system (QMS) that meets Good Manufacturing Practice standard.

The RP named in the manufacturer’s licence must have:

  • Adequate knowledge and relevant working experience of the activities to be carried out and of the procedures to be performed under the license.
  • Practical experience in the production supervision or in quality control testing.

Dealing in controlled drugs or psychotropic substances?

If you are dealing in products containing controlled drugs or psychotropic substances, you will also need to apply for the relevant dealer's licences for controlled drugs or psychotropic substances respectively.

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