Psychotropic substances

Find out about the licensing requirements to import or export psychotropic substances in Singapore.

Overview

Depending on the type of product you are dealing in, you are required to apply for an approval or an authorisation to import or export products containing psychotropic substances.

Import

Import requirements

Products containing psychotropic substances

Requirements

Therapeutic products

You will need to apply for an Approval to Import Therapeutic Products Containing Psychotropic Substances (PSIL).

Each PSIL is specific to:

  • One product. If your company intends to import more than one product, you are required to submit an application for each product.
  • A single import consignment only (one-time) and is valid for six months. The PSIL will be invalidated upon the date of import or date of licence expiry, whichever is earlier.

Depending on the type of activities you are conducting, you must also hold the relevant therapeutic product dealer's licences or approvals to import the products into Singapore before applying for the PSIL. 

Active pharmaceutical ingredients, laboratory reagents or veterinary products

It is not mandatory to apply for a Confirmation of Authorisation to Import a Psychotropic Substance (PSIA) unless requested by the authority from the exporting country. 

Each PSIA is specific to:

  • One product. If your company intends to import more than one product, you are required to submit an application for each product.
  • A single import consignment only (one-time) and is valid for six months. The PSIA will be invalidated upon the date of import or date of licence expiry, whichever is earlier.

To apply for a PSIA, you must also hold a valid Form A Poisons Licence.

Diagnostic test kits

It is not mandatory to apply for a Confirmation of Authorisation to Import a Psychotropic Substance (PSIA) unless requested by the authority from the exporting country. 

Each PSIA:

  • Can be utilised for multiple consignments of the list of products and specified quantity that has been approved by us.
  • Is valid for one year.
  • Is invalidated upon the date of final import or date of licence expiry, whichever is earlier.

To apply for a PSIA, you must also hold a valid medical device importer’s licence or approval (if the test kit is classified as a medical device) or a valid Form A Poisons Licence.

Documents required

You need the following information or items to complete your application, where applicable:

Documents required for import

Applicable for

Consignment approval of an unregistered therapeutic product for patient's use. Import of an unregistered therapeutic product for patient’s use.
Purchase order from overseas customer. An unregistered therapeutic product or active pharmaceutical ingredient imported solely for re-export.
List of psychotropic substances. The list should contain the following information:
  1. The name of the diagnostic test kit
  2. The quantity of diagnostic test kit to be imported
  3. The concentration and volume of each psychotropic substance contained within each diagnostic test kit.
Import of diagnostic test kits.


Export

Export requirements

Products containing psychotropic substances

Requirements

 

 

Therapeutic product

 

 

You will need to apply for an approval to export therapeutic products containing psychotropic substances (PSEL (TP)).

Each PSEL (TP) is specific to:

  • One product. If your company intends to export more than one product, you are required to submit an application for each of the products.
  • A single export consignment only(one-time) and is valid for six months. The PSEL(TP) will be invalidated upon the date of export or date of licence expiry, whichever is earlier.

To apply for a PSEL (TP), you must also hold a valid therapeutic product wholesaler’s licence.

 

 

Active pharmaceutical ingredients, laboratory reagents or veterinary products

 

 

You will need to apply for an export licence for psychotropic substances (PSEL (non-TP)).

Each PSEL (non-TP) is specific to:

  • One product. If your company intends to export more than one product, you are required to submit an application for each of the products.
  • A single export consignment only(one-time) and is valid for six months. The PSEL(non-TP) will be invalidated upon the date of export or date of licence expiry, whichever is earlier.

To apply for a PSEL (non-TP), you must also hold a valid Form A Poisons Licence.

 

 

Diagnostic test kits

 

 

You will need to apply for an export licence for psychotropic substances (PSEL (non-TP)).

Each PSEL (non-TP):

  • Can be utilised for multiple consignments of the list of products and specified quantity that has been approved by us.
  • Is valid for one year.
  • Is invalidated upon the date of final export or date of licence expiry, whichever is earlier.

To apply for a PSEL (non-TP), you must also hold a valid medical device wholesaler's licence or approval (if the test kit is classified as a medical device) or a valid Form A Poisons Licence.

 

Documents required

You need the following information or items to complete your application, where applicable:

  1. Import authorisation to import psychotropic substances. This document is issued by the competent authority in the importing country to the company intending to import psychotropic substances. You may obtain this copy from your overseas customer.
  2. List of psychotropic substances (applicable only to diagnostic test kits). The list should contain the following information:
    • The name of the diagnostic test kit.
    • The quantity of diagnostic test kit to be exported.
    • The concentration and volume of each psychotropic substance contained within each diagnostic test kit.

Fees and turn-around-time

Refer to psychotropic substances fees and turn-around-time for more information.

How to apply

Submit your application through PRISM. Ensure you have the following before you access the e-service:

If you encounter technical issues, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily).

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