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Guidance documents for Therapeutic Products (e-labelling) – SINGAPORE

Updated: Aug 21, 2021

The Therapeutic Products Branch (TPB) finalized guidance on e-labelling of therapeutic products (TPs) 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.

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 (short link preferred) on the product carton that links to a secure online hosting platform.

This link will give you the List of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in therapeutic products.

Updated Appendix 7: Points to Consider for Singapore Labelling

Appendix 7a: Guidance on Electronic Labelling for Therapeutic Products for information on e-labelling requirements, registrant’s roles and responsibilities.

You can Notification for Implementation of Electronic Labelling by filling this form

The new guidance is effective from 30 April 2021.

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