DH reminds trade that medical gases will be regulated as pharmaceutical products starting from June 14

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     The Department of Health (DH) today (April 14) reminded the trade that medical gases will be regulated as pharmaceutical products two months from now (starting from June 14). By that time, any company involved in the manufacture, wholesale or retail sales of medical gases must obtain the relevant drug dealer's licence(s) in accordance with the Pharmacy and Poisons Ordinance (Cap. 138) (the Ordinance), so that they can operate the businesses lawfully. In addition, medical gases must first be registered with the Pharmacy and Poisons Board of Hong Kong (the Board) before they can be legally sold in Hong Kong, to ensure that the products meet the required standards of safety, efficacy and quality.

     The Board decided on June 14, 2024, that medical gases should be regulated as pharmaceutical products under 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 to the trade for obtaining the relevant licences and registering their related products.

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

     Since 2024, the DH has maintained ongoing communication with the trade and stakeholders regarding the new regulatory arrangements, including sending letters to notify them and remind them to make early preparations. The DH will further enhance its communication efforts before the new regulatory arrangements take effect to help the trade understand the relevant requirements. Medical gases will soon be regulated as pharmaceutical products. For details on applying for the relevant licence(s) 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 and a list of registered medical gases can be found on the DH's Drug Office website.

Ends/Tuesday, April 14, 2026
Issued at HKT 19:25

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