Importers who are neither the registrants nor authorised by the registrant and intend to import a registered therapeutic product under Regulation 5(1)(b)(vii) of the Health Products (Therapeutic Products) Regulations 2016 will need to apply for an approval for each consignment of the registered therapeutic product to be imported.
Conditions for using this special access route (SAR)
The therapeutic product to be imported must be the same in all aspects as the product that is currently registered in Singapore
The batch of the therapeutic product to be imported must meet the approved release specifications of the product that is currently registered in Singapore.
Importation must be carried out within one year from the date of the approval of the application.
The approval is only valid if the therapeutic product is still registered in Singapore at the point of importation.
Please note that each application is limited to only one consignment of a specific batch of one therapeutic product (registration number specific).
- Your company needs to be registered in Singapore with the Accounting and Corporate Regulatory Authority (ACRA) to apply for this SAR.
- In addition to the consignment approval, your company must hold a valid importer's licence and a wholesaler's licence for the import and wholesale of the therapeutic product.
You will also need to apply for the licence to import and wholesale controlled drugs or for an approval to import therapeutic products containing psychotropic substances if your unregistered therapeutic product contains a controlled drug or a psychotropic substance, respectively.
- A declaration by the exporting company indicating its status as a licensed pharmaceutical dealer in the exporting country.
- A colour scanned copy of the documentary evidence that the therapeutic product to be imported is registered in the exporting country.
- A copy of the supplier's invoice from the exporting country indicating the batch number of the therapeutic product to be imported.
- A certificate of analysis of the therapeutic product batch to be imported, from either of the following:
- Packaging and labelling of the following:
- Pharmaceutical drug to be imported.
- Locally-registered therapeutic product.
- A letter of undertaking to assume responsibility for the quality, safety and efficacy of the therapeutic product batch to be imported.
The target turn-around-time
is 14 working days, excluding stop-clock time when we request for clarification or additional information.
The application fee is $266.
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).