Singapore HSA Finalises Guidance On Electronic Labelling Of Therapeutic Products

HSA, 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, HSA has published the finalised guidance on e-labelling of TP in Singapore 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.  

Registrants of Therapeutic Products (TP) who have a secure online system may distribute the HSA-approved PI and/or PIL in the form of an e-PI/PIL. The e-PI/PIL may be distributed with or without physical printed copies contained in the products. 

Product registrants are responsible for ensuring that the e-labels published on its websites are aligned to the most up-to-date product information as approved by HSA. Upon approval of any label update by HSA, the e-label should be updated within 30 days.  

Product Registrants who have plans to implement e-labelling are required to submit their proposal to HSA using the online notification form before the actual implementation. 

Product registrants may include proposals for e-labelling in the dossier submission for new TP registrations (NDA/GDA). Changes to current approved labels solely to incorporate e-labelling without any changes to the approved product information may be submitted via a Do-and-Tell MIV-2 variation. 

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’srolesand responsibilities. 

  • Updated Appendix 7: Points to Consider for Singapore Labelling 

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