Regulation of Medical Gases

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The Pharmacy and Poisons Board of Hong Kong (the “Board”) has endorsed regulation of medical gases as pharmaceutical products under the Pharmacy and Poisons Ordinance (the “Ordinance”) (Cap. 138) and will come into effect on 14 June 2026.

When the new regulatory control takes effect, the pharmaceutical products of medical gases have to be registered with the Board before they can be legally sold or supplied in Hong Kong. In addition, traders of the pharmaceutical products must obtain relevant licence(s) from the Board before conducting manufacture, wholesale (including import and export) of pharmaceutical products and retail sale of pharmaceutical products containing poisons.

In this regard, relevant Guidance Notes have been promulgated to facilitate the relevant trade for preparing and seeking licensing of the premises and registration of their products, and are available at the following links:

Guidance Documents:

Guidance Notes on Registration of Medical Gases

Guidance Notes on Manufacture, Wholesale, Storage and Transport of Medical Gases

Guidance on Qualification, Experience and Training Requirements for Authorized Persons and Other Key Personnel of Licensed Manufacturers in Hong Kong

For further information about regulation of medical gases, please visit the website of the Drug Office at
https://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/medical_gases_regulation.html.

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