HSA 将电子标签适用扩展至 P 和 GSL 药品，2026 年 6 月 30 日生效

Regulatory Update for Therapeutic Product Registration (30 June 2026)

AI 导读

HSA 治疗产品部门将电子标签（e-labelling）的适用扩展至药房专售（P）和一般销售目录（GSL）药品，自 2026 年 6 月 30 日起生效。此前电子标签已适用于处方药（POM），企业可选择以电子版患者信息说明书（e-PIL）替代纸质版。P 和 GSL 药品的适用条件与文件要求见附录 7A《治疗产品电子标签指南》。

推荐理由

材料说明电子标签适用范围扩展至 P 与 GSL 药品并给出生效日期，附录 7A 列出适用条件可供回查核对。

正文 · 原文

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.