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.

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.

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.