Conditions for using this special access route (SAR)
The special consignment scheme is intended to ensure continued availability of a registered therapeutic product, where there is a supply disruption due to the inability of the product registrant to supply stock as per registered in Singapore. In such situations, product registrants need approval from us to bring in a consignment of a registered therapeutic product intended for another market to mitigate stock-out situations.
You must be the product registrant and meet all the application requirements below.
- You are required to provide justifications for the clinical need of the special consignment and the assessment of the availability of registered alternatives in Singapore by submitting a clarification letter.
- The consignment should be the same as the Singapore registered product in all quality aspects, including but not limited to formulation, container closure system, manufacturing process, quality and manufacturing controls, storage condition, shelf life, drug substance and drug product manufacturing site(s) and specifications.
- In the case where it is practically not feasible to supply batches that are identical to the Singapore registered product in all quality aspects, the quality of the batches to be imported must meet monograph standards or has obtained prior approval from a competent regulatory agency. The recognised monographs include The British Pharmacopoeia, the European Pharmacopoeia, the Japanese Pharmacopoeia or the United States Pharmacopoeia.
- The remaining shelf-life of the consignment batch should be at least 50% of the approved shelf-life at the time of supply in Singapore.
- Each unit of the consignment must be supplied with the Singapore approved labels, including package insert (PI). In the case where it is not practically feasible to supply the product in the Singapore approved outer/inner carton labels, the product registrant must ensure that the carton labels comply with the labelling requirements specified in Appendix 7 of the Drug Registration Guide and must be in English.
- The maximum quantity allowed per consignment is 6-months stock estimated based on past sales data.
The estimated processing time for each application is approximately 20 working days from the date of application submission. Depending on the complexity, we may require more time to process some applications.
How to apply
Submit your completed application form116 KB, with the accompanying clarification letter, Certificate of Analysis of the consignment batch and the current registered drug product specifications via email to HSA_TP_SC@hsa.gov.sg
Changes cannot be made to an approved special consignment application. You will need to submit a new application for any changes e.g. change the batch or request for additional quantity of the consignment product.
For any enquiries, please contact the Therapeutic Products Branch (TPB) at email: HSA_TP_SC@hsa.gov.sg