Licensing and Certification of Importers and Wholesalers

  1. Overview of Importer's and Wholesaler's Licences

Overview of Importer's and Wholesaler's Licences

Understand the licensing requirements before you import and wholesale active ingredients in Singapore.

Overview

Under our current activity-based licensing framework, your company needs to hold active ingredient importer’s licence and wholesaler’s licence to import and wholesale active ingredients in Singapore, respectively.

In the details below, “relevant health products” refer to the following:

 

Import or wholesale of active ingredients for manufacturing health products for local clinical use

An importer’s licence (full scope) for active ingredients and a wholesaler’s licence for active ingredients  are required to import and wholesale active ingredients, respectively, for use in manufacturing relevant health products for local clinical use.  

Your company must comply with the  Good Distribution Practice (GDP) standard before these licences are granted to you.

Import of active ingredients solely for export, non-clinical purposes or as research materials or reference standards

Companies which are only conducting the following restricted activities require an importer’s licence.  A wholesaler's licence for active ingredients is not required. In this case, you may choose to apply for an importer’s licence for restricted activities only, at a lower fee:

  • Importing active ingredients solely for export only.
  • Importing active ingredients for manufacturing relevant health product(s) for non-clinical purposes.

  • Importing active ingredients for purposes other than for the manufacture of relevant health products (e.g., for research, reference standards, etc.).

You should ensure that activities that you intend to conduct are indicated during your application submission.

Import and wholesale by licensed active ingredients manufacturers

If you hold a valid manufacturer's licence for active ingredients, you do not need an:

  • Active ingredient importer’s licence to import active ingredients required for carrying out the manufacture of your active ingredients in accordance with your manufacturing licence for active ingredients. This includes active ingredients required for further manufacturing in Singapore, such as repackaging activities.
  • Active ingredient wholesaler’s licence to wholesale the active ingredient that you have manufactured in accordance with your manufacturer's licence for active ingredients.

Responsible Person

A “Responsible Person” (RP) needs to be named in the active ingredient 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 active ingredients intended for manufacturing relevant health products for local clinical use. 

 

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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Next Apply for active ingredient importer's and wholesaler's licence