Requirements for Active Ingredients Notification

Under the Health Products (Active Ingredients) Regulations 2023, you do not need to apply for dealer licences for the manufacture, import and wholesale supply of active ingredients for use in the manufacture of a relevant health product (i.e., therapeutic product, Class 2 cell, tissue or gene therapy product, or medical device) for clinical research/clinical trial use, regardless of whether the clinical research/clinical trial is conducted in Singapore or overseas.

This is provided an active ingredient notification is made to HSA prior to the import or supply of active ingredients, as summarised in the table below:

Activity

Who should submit Active Ingredients notification

When Active Ingredients notification should be submitted

Import of Active Ingredients

for the purpose of manufacturing a relevant health product in SIngapore, and
the relevant health product is intended only for clinical research/clinical trial use(whether in Singapore or overseas)

Importer of the active ingredient

Before importing the active ingredient

Supply of Active Ingredients by a local manufacturer of the Active Ingredient(s)

for the purpose of manufacturing a relevant health product in Singapore, and
the relevant health product is intended only for local clinical research/clinical trial use

Local manufacturer of active ingredient

Before supply of the active ingredient by the local manufacturer of the active ingredient

You do not need to make an active ingredient notification if you are already an importer or local manufacturer who holds a valid licence that allows you to import or supply the active ingredient for use in the manufacture of a health product.

Submit an active ingredients notification

Active ingredients notification form

Additional requirements

If the active ingredient comprises any of the following substances, additional requirements apply, as indicated in the table below:

Substance	Additional requirement(s)
Controlled drugs and psychotropic substances	Licences for controlled drugs and psychotropic substances
Radiopharmaceuticals	The import, export, possession, use, transport and disposal of radioactive material is regulated under the Radiation Protection Act by the National Environment Agency.

Dealer's duties and obligations

The active ingredients regulations are intended to ensure supply chain integrity. It is critical for local importers and wholesalers of active ingredients used to manufacture relevant health products in Singapore to ensure proper record keeping, labelling , disposal and transportation of the active ingredients.

Refer to the Health Products (Active Ingredients) Regulations 2023 for more information.