On 30 April 2021, the Health Sciences Authority (HSA) Therapeutic Products Branch published its finalized guidance on the e-labelling of therapeutic products (TPs) in Singapore. The new guidance is effective from 30 April 2021.
Product registrants interested in implementing e-labelling may file a notification form with the HSA online here. This online notification form should be submitted at least two months prior to actual implementation.
In more detail
On 30 April 2021, the HSA Therapeutic Products Branch published its finalised guidance on the e-labelling of TPs in Singapore. The new guidance is effective from 30 April 2021.
The documents, namely the updated Appendix 7 and 7a, may be found here.
The e-labelling initiative was first launched as a pilot trial in August 2019. It entails placing a machine-readable code or website URL on the TP’s packaging, which will link to a secure online system that publishes the package inserts and patient information leaflets in a digital format. This dispenses with the need to rely on a hardcopy insert typically contained within the packaging of the TP.
For further background on the e-labelling initiative, please see our December 2019 healthcare newsletter here.