Medical gases to be regulated as pharmaceutical products starting from June 14
The Department of Health (DH) today (June 12) reminded the trade that medical gases will be regulated as pharmaceutical productsstarting 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 questionson the regulation of medical gases, relevant licences and application details.
The Department of Health, Photo source: reference image
CHP investigates case of influenza A (H9) infection
The Centre for Health Protection (CHP) of the Department of Health (DH) is today (June 12) investigating a case of human infection with influenza A (H9) in collaboration with relevant departments. The patient is a two-year-old boy. His condition has remained mild and he is currently in stable condition. The CHP will send a letter to all doctors in Hong Kong to update them on the latest developments regarding avian influenza A and to urge them to remain vigilant and report any suspected cases.
Case information
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The boy lives in Sha Tin District. He developed a fever and mild diarrhoea on June 9. On the following day (June 10), he was brought to Prince of Wales Hospital and was admitted for treatment. His clinical specimen tested positive for the influenza A (H9) virus by the Public Health Laboratory Services Branch (PHLSB) of the CHP. The subtyping result is pending. His clinical diagnosis was novel influenza. He is currently in stable condition and has been admitted to an isolation ward at Princess Margaret Hospital for treatment.
The CHP's preliminary investigation revealed that the patient had no travel history during the incubation period. The case has been classified as a locally acquired case. The patient does not attend school or receive daycare services. He is primarily cared for by his family members and spends most of his time at home or nearby. His household does not keep poultry. According to information provided by his family members, he has neither consumed undercooked poultry nor come into contact with any patients. In early June, one of his family members took him to Wo Che Market on two occasions. During these visits, the patient stayed at a fresh provision shop in the market that sells live chickens to watch the poultry and touched the surroundings of the fresh provision shop. The CHP conducted an investigation with the Food and Environmental Hygiene Department (FEHD) and collected environmental samples from the shop concerned. The shop staff remained asymptomatic. The patient has six household contacts and they remain asymptomatic so far. The CHP has provided them with preventive medication and put them under medical surveillance.
The CHP is continuing to investigate the source of infection of the case and is conducting whole genome sequencing of the virus sample. The CHP will also report the case to the World Health Organization (WHO).
Humans are primarily infected with the influenza A virus through direct contact with infected poultry or through indirect contact with environments contaminated by their droppings. The CHP's epidemiological investigation indicated that the patient had visited a location where live poultry was sold. It cannot be ruled out that the patient was infected through indirect contact with a contaminated environment at the wet market. As young children have weaker immune systems and are incapable of maintaining good hand hygiene, the CHP advised parents to avoid taking young children to places where live poultry is sold. Transporting poultry may contaminate the ground and the surrounding environment. As young children are shorter in height and easy to be in contact with the surrounding environment, they are at greater risk of coming into contact with poultry droppings or contaminated areas.
In the past ten years, the WHO has received reports of a total of over 160 cases of human infection with influenza A (H9) worldwide. To date, most case of human infection with influenza A (H9) have presented with only mild clinical illness. According to the WHO's risk assessment, the influenza A (H9) virus has not acquired the ability for sustained human-to-human transmissions.
Government's comprehensive follow-up actions
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Novel influenza A infection, including influenza A (H9), is a notifiable infectious disease in Hong Kong. Compared to other highly pathogenic avian influenza strains such as H5N1 and H7N9, influenza A (H9) is a low-pathogenic avian influenza strain that causes milder illness. Excluding the aforementioned case, 10 cases of influenza A (H9N2) have been reported since 1999, including four locally acquired cases and six imported cases. No deaths have been recorded so far. In response to the latest local case, the CHP will issue a letter to all doctors in Hong Kong, reminding them of the latest situation of influenza A (H9), and urging them to remain vigilant and report any suspected cases.
Sporadic cases of human infection with avian influenza occur from time to time internationally. Although the current risk of an outbreak is low, the Hong Kong Special Administrative Region Government has consistently implemented preventive measures, including a disease surveillance system, the implementation of livestock control measures at farms, markets and ports, in order to prevent avian influenza.
The PHLSB of the CHP comprises laboratories with high biosafety standards, capable of conducting, testing for high-risk pathogens, and which also possess sufficient testing and genetic analysis capabilities and facilities. Hong Kong currently has sufficient reserve of antiviral medications.
Preventive measures to be taken by the public
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Humans are primarily infected with the avian influenza A virus through contact with infected birds, poultry or other animals (whether alive or dead), or through surfaces or environments contaminated with saliva, mucous and animal faeces (such as wet markets and live poultry markets). The virus has very low transmissibility among humans. People who have close contact with live poultry are more susceptible to contracting avian influenza. The elderly, children and people with chronic illnesses have a higher risk of developing complications such as bronchitis and pneumonia, if infected. Members of the public should remain vigilant and take the following measures to prevent avian influenza:
Avoid contact with poultry, birds or their droppings. If contact has been made, thoroughly wash hands with soap and water;
Poultry and eggs should be thoroughly cooked before eating;
Perform hand hygiene at all times, especially before touching the mouth, nose or eyes; after contact with animals or their living environments; after touching public installations such as handrails or doorknobs; or when hands are contaminated with respiratory secretions, such as after coughing or sneezing;
Cover the mouth and nose with tissue paper when sneezing or coughing. Dispose of soiled tissues into a lidded rubbish bin, then wash hands thoroughly;
When having respiratory symptoms, wear a surgical mask, do not go to work or school, avoid crowded places and seek medical advice promptly;
Avoid crowded public places or areas with poorly ventilated; high-risk individuals may consider putting on a surgical mask when staying in such places; and
Travellers returning to Hong Kong from areas affected by avian influenza outbreaks should consult doctors promptly if they have flu-like symptoms, and inform the doctor of the recent travel history and wear a surgical mask to help prevent spreading of the disease.
The public may visit the CHP's webpages for more information: Avian Influenza Webpage, Avian Influenza Report, Avian influenza statistics and affected areas around the world, Facebook page and Youtube channel.
CHP investigates case of influenza A (H9) infection Source: HKSAR Government Press Releases