New Initiatives for Registration of Therapeutic Products 30 Apr 2021

TPB, in consultation with industry stakeholders, launched an e-labelling pilot trial for therapeutic products (TP) in August 2019.  The objective of e-labelling is to facilitate efficient and timely dissemination of the latest approved PI/PIL to healthcare professionals in an eco-friendly manner. Companies have the option to disseminate the approved product information in an electronic format (ePI/ePIL) via a machine-readable code (e.g. QR code) or url (shortlink preferred) on the product carton that links to a secure online hosting platform.

Following the generally positive feedback on this initiative from industry stakeholders and healthcare professionals, TPB is pleased to inform that the finalised guidance on e-labelling of TP in Singapore has been published and will take effect from 30 April 2021. As part of HSA’s calibrated approach, only prescription-only medicines will be eligible for e-labelling. HSA will continue to review the feasibility of extending e-labelling to non-prescription TP. 

Please refer to the following guidance documents for more information.

• Appendix 7a: Guidance on Electronic Labelling for Therapeutic Products for information on e-labelling requirements, registrant’s roles and responsibilities. Click here ↗ (opens in new tab) for the notification form.

• Updated Appendix 7: Points to Consider for Singapore Labelling