Regulatory Updates
Regulatory Update for Therapeutic Product Registration (30 June 2026)
Audiences
Industry member
Product type
Therapeutic Products
30 June 2026
Extension of e-labelling to P and GSL medicines
The Therapeutic Products Branch (TPB) will be extending the application of electronic labelling (e-labelling) to Pharmacy-only (P) and General Sale List (GSL) medicines with effect from 30 June 2026.
This is in addition to Prescription-only medicines (POM), for which e-labelling is already applicable. Companies may opt to replace the physical Patient Information Leaflet (PIL) with e-PIL.
Please refer to Appendix 7A: Guidance on Electronic Labelling for Therapeutic Products for the eligibility criteria and documentary requirements applicable to P and GSL medicines.
