Medical gases to be regulated as pharmaceutical products starting from June 14

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     The Department of Health (DH) today (June 12) reminded the trade that medical gases will be regulated as pharmaceutical products starting from Sunday (June 14). All companies involved in the manufacture, wholesale or retail sale of medical gases must obtain the relevant drug dealer's licence(s) in accordance with the Pharmacy and Poisons Ordinance (Cap. 138) in order to operate lawfully. In addition, medical gases must be registered with the Pharmacy and Poisons Board of Hong Kong before they can be legally sold in Hong Kong, ensuring that the products meet the required standards of safety, efficacy and quality.

     Any person who illegally possesses or sells pharmaceutical products or prescription drugs that are not registered under the Ordinance, or who operates the manufacture or wholesale of pharmaceutical products without the relevant licence, commits a criminal offence. The maximum penalty for each offence is a fine of $100,000 and two years' imprisonment upon conviction.

     Drug retailers that only engage in the retail sale of medical gases that are not specified in the Poisons List under the Ordinance (such as medical oxygen), are not required to hold a retail licence.

     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.

     Since 2024, the DH has maintained ongoing communication with the trade and stakeholders regarding the new regulatory arrangements, including sending letters to medical gas and pharmaceutical traders, healthcare professional organisations, healthcare facilities and other relevant stakeholders, reminding them to make early preparations. In addition, the DH has provided the pharmaceutical industry with guidelines to help them understand and comply with the relevant statutory requirements.

     A list of local licensed traders dealing with medical gases and a list of medical gases registered as pharmaceutical products have been uploaded to the DH's Drug Office website. The DH reminded the industry to purchase relevant pharmaceutical products from licensed dealers in future in order to safeguard product quality and public safety.

     Members of the public can visit the DH's website for more information and frequently asked questions on the regulation of medical gases, relevant licences and application details.

Ends/Friday, June 12, 2026
Issued at HKT 11:30

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