Singapore HSA Updates Guidance on Unregistered Therapeutic Product Import and Supply

In March 2023, HSA updated Guidance on Import and Supply of An Unregistered Therapeutic Product For Patients’ Use.

See Pharma To Market insider:

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:

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