Reminder: Registration is required prior to the Sale of Medical Gases Starting From 14 June 2026

The Drug Office of the Department of Health would like to remind you that starting from 14 June 2026, medical gases will be regulated as pharmaceutical products.  From that time, medical gases, classified as pharmaceutical products, must be registered with the Pharmacy and Poisons Board of Hong Kong (the Board) before they can be legally sold in Hong Kong.  In addition, traders involved in the manufacture, wholesale, or retail of medical gases must obtain relevant drug dealer’s licence(s) in accordance with the Pharmacy and Poisons Ordinance (Cap. 138) (the Ordinance).

The Board had decided in June 2024 that medical gases should be regulated as pharmaceutical products under the regulatory framework of the Ordinance.  In addition, pharmaceutical products containing nitrous oxide (laughing gas) and nitric oxide should be regulated as prescription drugs.  A two-year preparation period has been provided for the trade to apply for relevant licences and registration of their products.

The scope of the regulatory control of medical gases covers any gases or mixtures of gases in cylinders that fulfil definition of pharmaceutical product as stipulated under section 2 of the Ordinance, which may cover medical gases such as oxygen, nitrogen, nitrous oxide (laughing gas), nitric oxide, carbon dioxide, helium, medical air and mixture of some of the above gases.

In this connection, a press release and a letter to trade have been issued.

For relevant information on the regulation of medical gases, please visit the website of the Drug Office of the Department of Health (www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/medical_gases_regulation.html).