DH Reminds Trade that Medical Gases will be Regulated as Pharmaceutical Products Starting from June 14

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

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 hasmaintained 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.

The Department of Health (DH), Photo source: HKSAR Government Press Releases

Applications invited for flag days in 2027-28

Charitable organisations wishing to hold flag days between April 2027 and March 2028 are invited to apply to the Social Welfare Department (SWD) from today (April 15) to May 14.

To enable more organisations to solicit donations through flag sales, 27 flag days in 2027-28 will be assigned as regional flag days so that three organisations can sell flags concurrently on those days, one each on Hong Kong Island, in Kowloon and in the New Territories. There will be 28 territory-wide flag days to be held in the year.

An SWD spokesman said today that applicant organisations must be bona fide non-profit-making organisations exempt from tax under Section 88 of the Inland Revenue Ordinance (Cap. 112) and, after the recognition of tax exemption, have organised charitable activities in each of the past three years. Applicant organisations should refer to the eligibility criteria as detailed in the Explanatory Notes for Application for Flag Days in 2027-28.

"Flag day applications will be considered by the Lotteries Fund Advisory Committee according to factors including the organisation's integrity and management capability; the nature, value and standard of its existing services; its financial need; and its ability to organise a flag day, etc", the spokesman said.

The application form and the Explanatory Notes for Application for Flag Days in 2027-28 can be downloaded from the SWD’s website at www.swd.gov.hk/en/ngo/controlofc/flagdays/index.html or obtained from the Lotteries Fund Projects Section of the SWD at Rooms 3601-02, 36/F, Dah Sing Financial Centre, 248 Queen's Road East, Wan Chai, Hong Kong, from today to 6pm on May 14. Applications for flag days in 2027-28 can also be submitted online. Please refer to the SWD's website for application details.

The completed application form together with the required documents should reach the department at the above address by 6pm on May 14. Late applications will not be considered.

"Applicant organisations will be informed of the result around October this year," the spokesman added.

Enquiries can be made by telephone to 2832 4318 or 28324301; by fax to 2838 0441; or by email to flagday@swd.gov.hk.

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