On January 15, 2025, the Pharmacy and Poisons (Amendment) (No. 5) Regulation 2024 (the 'Regulation') passed in the Legislative Council (LegCo), amending the Pharmacy and Poisons Regulations (Cap. 138A) to enhance control over new drug substances, substances related to nicotine, and tobacco exemptions.
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On January 15, 2025, the Pharmacy and Poisons (Amendment) (No. 5) Regulation 2024 (the ‘Regulation’) passed in the Legislative Council (LegCo), introducing amendments to the Pharmacy and Poisons Regulations (Cap. 138A). These amendments are designed to strengthen the regulatory framework concerning new drug substances and substances related to nicotine, alongside a refinement of existing tobacco exemptions.
Specifically, the Regulation adds nineteen new drug substances to Schedules 1, 3, and 10, with a comprehensive listing provided in Annex B. This inclusion subjects these substances to the controls outlined within those respective schedules.
The Regulation also revises the sales control of substances chemically related to nicotine. The previous exemption for nicotine contained in chewing gum, lozenges, and patches has been revoked, and replaced with a broader regulatory framework encompassing nicotine itself and substances sharing the chemical structure of 3-(1-methylpyrrolidin-2-yl)pyridine. This change aims to provide more stringent oversight of nicotine-containing products.
Finally, the scope of ‘Tobacco’ exemptions has been narrowed through a specific definition within Schedule 2, Group II, clarifying that ‘Tobacco’ refers to ‘Tobacco in any conventional smoking product’. This legislative clarification ensures that other smoking products containing tobacco are regulated under the poisons provisions of the Pharmacy and Poisons Regulations (Cap. 138A).
The Regulation will come into operation on December 13, 2024.
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