DH reminds trade that sales of medical gases require registration from June 14, 2026

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     The Department of Health (DH) today (December 30) reminded the trade that, starting from June 14, 2026, medical gases will be regulated as pharmaceutical products. Medical gases, classified as pharmaceutical products, must be registered with the Pharmacy and Poisons Board of Hong Kong 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). To avoid contravening the Ordinance, suppliers who have not yet applied for a relevant licence and/or registration of pharmaceutical products should take immediate action before the regulation officially takes effect.

     The Board decided on June 14, 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 DH today issued a reminder to the trade and notified other stakeholders about the aforesaid regulation. For details on applying for the relevant licences and product registration, please visit the Board's website or the website of the Drug Office of the DH. Information on the regulation of medical gases can be found on the DH's Drug Office website.

     According to the Ordinance, illegal possession or sale of unregistered pharmaceutical products or prescription drugs, and manufacture or wholesale of pharmaceutical products without relevant licences, are criminal offences. The maximum penalty for each offence is a fine of $100,000 and two years' imprisonment upon conviction.

Ends/Tuesday, December 30, 2025
Issued at HKT 16:00

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