Conditions for using this special access route (SAR)
Under the Health Products Act, the import and supply of registered therapeutic products must be conducted by licensed dealers authorised by the therapeutic product registrants. Dealers intending to import or wholesale a registered therapeutic product, but are not authorised by the registrant to do so, are required to apply for approval from us.
Each application is restricted to only one therapeutic product, and is registration number specific. A separate application is required for each additional therapeutic product. The therapeutic product to be imported must be, in all aspects, the same as the pharmaceutical drug that is currently registered and marketed in Singapore.
Each approval is granted to a single consignment of the specified batch of the therapeutic product made in the application. Importation must be carried out within one year from the date of the approval, subject to the validity of the corresponding Importer’s Licence.
A supplier may continue to supply the therapeutic product by retail sale after its registration is cancelled, before its product expiry date, if:
- The product registration is cancelled due to a failure to pay the retention fee within the prescribed time.
- The application for the cancellation of the product registration has been approved by us.
- You took possession of the therapeutic product before the registration cancellation.
- We do not direct a recall of the therapeutic product from the market.
- 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.
- 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 $258.
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).
More details on submission requirements may be found in our Guidance on Therapeutic Products Registration