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)
a) The therapeutic product to be imported must be the same in all aspects as the product that is currently registered in Singapore.
- The chemistry, manufacturing and controls (CMC) standards must be the same as the registered therapeutic product in Singapore; and
- The package insert supplied with the product must be the same as the currently approved for the registered therapeutic product in Singapore.
b) The therapeutic product must not contain any controlled drug specified under the Misuse of Drugs Act and its Regulations.
c) Importation must be carried out within 6 months from the date of the approval of the application.
d) The approval is only valid if the therapeutic product is still registered in Singapore at the point of importation.
e) The imported batches may be subject to testing by HSA under the Product Quality Surveillance Programme; and failure to meet the CMC standards as approved by HSA for the registered therapeutic product will result in the cancellation of the approval for the special consignment.
Please note that each application is limited to only one consignment of a specific batch of one therapeutic product (registration number specific).
You will need to submit the following documents as supporting documents in your application:
a) A colour scanned copy of the documentary evidence issued by the regulatory authority of the exporting country which confirms that the exporting company is licensed to carry out export business for pharmaceutical products in the exporting country.
b) Proof of approval of the therapeutic product in the exporting country:
- Approval letter issued by the drug regulatory authority of the exporting country; or
- Reference to any register / listing published by the authority on its website. The information stated on the website must be in English, and must allow the confirmation of the product’s identity and product’s ownership. Such proof of approval must be provided in the form of website screenshot and URL (of the website) for confirmation that the therapeutic product to be imported is registered in the exporting country.
c) A copy of the supplier’s invoice from the exporting country indicating the batch number of the therapeutic product to be imported.
d) A certificate of analysis (CoA) of the consignment batch to be imported issued by either:
- The finished product manufacturer of the therapeutic product to be imported; or
- A testing laboratory accredited by the Singapore Accreditation Council (SAC) to perform the specific test(s) in accordance with the accreditation scope as specified in the Schedule of Accreditation listed on the SAC website. The submitted test report should bear the SAC-SINGLAS logo; or
- An overseas testing laboratory that is accredited by the International Laboratory Accreditation Cooperation (ILAC) to perform the specific test(s) in accordance with the accreditation scope. The submitted test report should bear the ILAC mark alongside with logo of an accreditation body.
e) Documentary evidence that the therapeutic product to be imported is supplied with the same container closure system (CCS) as that approved for the registered product. Such evidence can be in the form of either:
- Product label which states the type of CCS used; or
- Proof of approval from the exporting country which states the approved CCS information.
f) Documentary evidence that the therapeutic product to be imported has the same requirement for storage condition as that approved for the registered product. Such evidence can be in the form of either:
- Product label which states the recommended storage condition of the product; or
- Proof of approval from the exporting country which states the approved storage condition of the product.
g) Documentary evidence that the therapeutic product to be imported has the same shelf-life as that approved for the registered product. Such evidence can be in the form of either:
- The product’s outer carton which reflects both the manufacturing and expiry date of the imported product; or
- Proof of approval from the exporting country which states the approved shelf-life of the product.
- CoA issued by the finished product manufacturer which includes the manufacturing date and accompanied by the product’s outer carton which states the expiry date.
h) A declaration letter stating that the consignment product will be supplied with the Singapore approved package insert.
i) A letter of undertaking for assuming responsibility for the quality, safety and efficacy of the consignment 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.
Your company will be notified of the outcome of the application via the preferred mode of contact selected in the application.
A non-refundable application fee of $266 per consignment is applicable at the point of submission.
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).