In March 2023, HSA updated Guidance on Import and Supply of An Unregistered Therapeutic Product For Patients’ Use.
See Pharma To Market insider: https://www.pharmatomarket.com/singapore-hsa-updates-unregistered-therapeutic-product-import-and-supply-guidance-and-forms/?utm_source=rss&utm_medium=rss&utm_campaign=singapore-hsa-updates-unregistered-therapeutic-product-import-and-supply-guidance-and-forms
Minor revision was made by HSA to the same guidance two months later (in May 2023). HSA added clarification on the consignment approval in Annex A of the guidance as below:
– For Buffer-Stock application type, the consignment approval validity period is extended from previous 6 months to 12 months.
– Included clarifying statement that the approved quantities may be imported in separate consignments within the validity period.
For more details, please refer to latest guidance at the following link: https://www.hsa.gov.sg/docs/default-source/hprg-tpb/guidances/tpb-gn-004-005-import-and-supply-of-an-unregistered-therapeutic-product_19-may-2023.pdf