Psychotropic substances

Therapeutic products

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

Each PSIL (TP) 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 (TP) 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 (TP). 

 Active ingredients

You will need to apply for an Approval to Import Active Ingredient that is a Psychotropic Substance [PSIL (API)].

Each PSIL (API) is specific to:

• One active ingredient. If your company intends to imort more than one active ingredient, you are required to submit an application for each active ingredient.

• A single import consignment only (one-time) and is valid for six months. The PSIL(API) 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 active ingredient dealer's licence or approvals to import the active ingredient into Singapore before applying for the PSIL (API). 

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. PSIA is not applicable to diagnostic test kits which are classified as medical devices.

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 Form A Poisons Licence.

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.

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 the relevant therapeutic product dealer's licence.

Active ingredient

You will need to apply for an approval to export active ingredients that are psychotropic substances [PSEL (API)].

Each PSEL (API) is specific to:

• One active ingredient. If your company intends to export more than one active ingredient, you are required to submit an application for each active ingredient.

• A single export consignment only (one-time) and is valid for six months. The PSEL (API) will be invalidated upon the date of export or date of licence expiry, whichever is earlier.

To apply for a PSEL (API), you must also hold the relevant active ingredient dealer's licence.

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)]. However, for diagnostic test kits which are classified as medical devices, PSEL (non-TP) is not applicable.

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 Form A Poisons Licence.