General Information
Registration of Medical Gases
Clinical Trial of Medical Gases
Import/ Export of Medical Gases
Wholesale Dealing of Medical Gases
Manufacturing of Medical Gases
Reporting Adverse Drug Reaction (ADR)
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General Information |
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Q.1 Which medical gases will be regulated as pharmaceutical products under the Pharmacy and Poisons Ordinance (Cap. 138)?
A.1 The Pharmacy and Poisons Board of Hong Kong has endorsed regulation of medical gases as pharmaceutical products under the Pharmacy and Poisons Ordinance (Cap. 138) (“the Ordinance)”.
The scope of the regulatory control of medical gases covers any gases or mixtures of gases in cylinder that fulfil the definition of pharmaceutical products as stipulated under section 2 of the Pharmacy and Poisons Ordinance (Cap. 138), which may cover medical gases including oxygen, nitrogen, nitrous oxide, nitric oxide, carbon dioxide, helium, medical air and mixture of some of the above gases.
However, there are gases which would not be controlled as pharmaceutical products in Hong Kong which include:-
- Gases that do not achieve their mode of action by pharmacological, immunological or metabolic action in human beings or animals;
- Gases that are produced in situ in healthcare facilities, i.e. manufactured, mixed and handled in hospitals or day procedure centres for their patients’ own use;
- Bulk liquefied gases in tankers or vessels (e.g. Vacuum Insulated Evaporator);
- The equipment attached later to the gas container at the time of use (e.g. pressure regulator and pipe network);
- Gases specified for non-medicinal use such as in laboratories (e.g. for calibration), oxygen mixtures for smoke-helmeted firemen, oxygen mixtures for divers during normal diving and ascent, etc.;
- Oxygen that is produced via generator or concentrator to be used at patient’s bedside; and
- Gases that are used in pulmonary function tests to measure gas transfer in the lung.
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Registration of Medical Gases |
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Q.2 Are medical gas products required to be registered as pharmaceutical products in Hong Kong?
A.2 As stipulated under Regulation 36(1) of the Pharmacy and Poisons Regulations (Cap. 138A), pharmaceutical products must be registered with the Pharmacy and Poisons Board before they can be sold, offered for sale, distributed or possessed for the purposes of sales, distribution or other uses in Hong Kong. Medical gases that are regulated as pharmaceutical products under the Pharmacy and Poisons Ordinance (Cap. 138) are also subject to the regulatory requirements.
Sale of unregistered pharmaceutical products is an offence under the Pharmacy and Poisons Ordinance (Cap. 138). The maximum penalty is a fine at level 6 of Criminal Procedure Ordinance (Cap. 221) ($100,000) and two year’s imprisonment.
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Q.3 How can I apply for registration of a medical gas product as a pharmaceutical product?
A.3 You should submit your new application via the online Pharmaceutical Registration System 2.0 (PRS 2.0) at
https://www.drugoffice.gov.hk/prs2-ext/client_authentication.jsp
together with the application fee.
If the medical gas is manufactured in Hong Kong, the person responsible for obtaining registration of the medical gas should be the licensed manufacturer, or the licensed wholesale dealer contracting with the licensed manufacturer. If the medical gas is manufactured outside Hong Kong, the person responsible for obtaining registration should be the licensed wholesale dealer importing the pharmaceutical product, or the Hong Kong branch, subsidiary, representative, agent or distributor of the overseas of the manufacturer.
When an application is approved, the applicant will receive the Certificate of Drug / Product Registration upon payment of the fee.
A medical gas will only be approved for registration if it meets the criteria of safety, efficacy and quality relevant to it. For the documents required, please refer to the following guidance documents:
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Q.4 What are the labelling requirements of medical gas products for the purpose of registration as pharmaceutical products?
A.4 The labelling requirements of pharmaceutical products are applicable to medical gases that fall into the scope of regulatory control as stated above in A.1. In addition, medical gas should be labelled with ‘For medical use only 只供医疗用途’, and the label shall possess traceability measures. Other labelling requirements related to safety aspects of medical gases as stipulated under other applicable legislations or guidelines shall also be fulfilled.
For details, please refer to the Pharmacy and Poisons Ordinance (Cap.138) and the following guidance documents:
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Q.5 How to determine an expiry date of a medical gas product for the purpose of registration as a pharmaceutical products?
A.5 The expiry date of medical gas products should be based on data of the stability studies performed in appropriate storage conditions.
For those very stable gases with long history of use and packing and use in the container concerned, justification shall be provided to support the proposed shelf-life and storage condition in case no stability study data could be provided.
For details, please refer to the Pharmacy and Poisons Ordinance (Cap.138) and the following guidance documents:
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Q.6 If I have applied for product registration for the medical gas and obtained the Certificate of Drug/ Product Registration, is it exempted from complying to other legislations?
A.6
Medical gas is also regulated under other legislations in Hong Kong. The registration of medical gases under the Pharmacy and Poisons Ordinance will not exempt the product from complying with other statutory regulations and relevant guidelines. Applicants should observe and follow all the relevant statutory requirements stipulated under the related ordinances, which include but not limited to:
- Boilers and Pressure Vessels Ordinance (Cap. 56);
- Factories and Industrial Undertakings Ordinance (Cap. 59);
- Fire Services Ordinance (Cap. 95);
- Dangerous Goods Ordinance (Cap. 295);
- Electricity Ordinance (Cap. 406); and
- Occupational Safety and Health Ordinance (Cap. 509).
Traders should seek legal advice on the legality of their business. For the contents of the relevant legislation, please refer to the website of Hong Kong e-Legislation at
https://www.elegislation.gov.hk.
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Clinical Trial of Medical Gases |
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Import/ Export of Medical Gases |
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Q.8 What is the procedure of importing / exporting a medical gas pharmaceutical product?
A.8
Under the Import and Export Ordinance (Cap. 60), all imports or exports of pharmaceutical products must be covered by import/export licences. Medical gases that are regulated as pharmaceutical products under the Pharmacy and Poisons Ordinance (Cap. 138) are also subject to the control under relevant regulations.
You are required to obtain the appropriate trader licenses in order to handle different categories of medical gas pharmaceutical products. (Please refer to the FAQ on Licensing). For every single importation / exportation, you need to apply for an Import Licence (Form 3) / Export Licence (Form 6) from Drug Information and Import/Export Control Division of Department of Health. For details, please refer to the guidelines and forms on “Import and Export” which is available at the webpage of our office:
http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/useful_guidelines_forms.html
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Wholesale Dealing of Medical Gases |
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Q.9 Where and how can I apply for the Wholesale Dealer Licence for handling medical gases by way of wholesale dealing?
A.9
Company wishes to apply for a licence to deal in any medical gases that are pharmaceutical products by way of wholesale dealing should refer to the “Guidance Notes on Application of Wholesale Dealer Licence” for the application procedures. You may fill in the relevant application forms and provide all the supporting documents as listed in the checklists for application. For application guidelines and forms, please refer to the website below:
https://www.ppbhk.org.hk/eng/wholesale_dealer_licence/index.html
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Q.10 If I am a wholesaler involved in the storage and distribution of medical gases, is there any guidelines available and how can I know more about the legal requirement of handling of medical gases?
A.10
In general, wholesalers that are involved in the storage and distribution of medical gases that are pharmaceutical products should document, implement and maintain a comprehensively designed and clearly defined quality management system related to the operation, handling, storage, supply, record keeping and other requirements as set out in the “Code of Practice for Holder of Wholesale Dealer Licence” (“COP”) and “Guidance Notes on Manufacture, Wholesale, Storage and Transport of Medical Gases”. You may download the documents via the following websites:
https://www.ppbhk.org.hk/eng/code_of_conduct_practice/index_3.html
https://www.ppbhk.org.hk/eng/files/Guidance_Notes_on_MWST_of_Medical_Gases_eng.pdf
Also, the regulation of pharmaceutical products is mainly governed under the below legislations which you may also need to be aware of:
- Pharmacy and Poisons Ordinance (Cap. 138)
- Antibiotics Ordinance (Cap.137)
- Dangerous Drugs Ordinance (Cap. 134)
- Undesirable Medical Advertisements Ordinance (Cap. 231)
- Public Health and Municipal Services Ordinance (Cap. 132)
- Import and Export Ordinance (Cap. 60)
The printed versions of these Laws of Hong Kong can be purchased from the Publications Sales Unit of Information Services Department (Tel.: 2537 1910) or from the Government Bookstore (www.bookstore.gov.hk). For the contents of the relevant legislation, please refer to the website of Bilingual Laws Information System of Department of Justice below:
https://www.elegislation.gov.hk/index/chapternumber?p0=1&TYPE=1&TYPE=2&TYPE=3&_lang=en
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Q.11 Can I apply for a Wholesales Dealer Licence with a residential premise?
A.11
No, only companies occupying commercial or industrial buildings would be considered. Also, the building must be of permanent construction with postal and physical address. The premises shall also be in such conditions that are suitable for the business to be carried out and fully satisfy, inter alia, the fire prevention and floor loading requirements. Requirements on premises as stipulated under other applicable legislations or guidelines should also be observed and followed.
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Q.12 I also conduct business with non-medical gases, can I store all the gases in the same premises?
A.12
Cylinders for medical gases should be stored in a separate area from non-medical gases and there should be no exchange of cylinders between these areas. Also, there should be sufficient space and capacity for orderly storage of cylinders to avoid the risk of mix-up. Premises should be designated to provide separate marked areas for different gases and clear identification and segregation of cylinders. For example, "Quarantine", "Released" or “Rejected”, etc.
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Q.13 Can I hire a van to deliver medical gases?
A.13
No, medical gases shall be transported in accordance with the conditions stated on the labels, handled in such a manner so that they are delivered in a clean and safe state by trained porters. All cylinders shall be restrained and secured during transport, wherever possible be transported upright for reasons of safety and by the trained porters especially for heavy cylinders. Requirements on vehicles or vessels for the transport of medical gases as stipulated under applicable guidelines or legislations e.g. Dangerous Goods Ordinance should be observed and followed.
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Manufacturing of Medical Gases |
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Q.14 My company manufactures gases. Do I need to apply for a licence for manufacturer under the Pharmacy and Poisons Regulations (Cap. 138A)?
A.14
A company dealing with the manufacturing of any medical gases or mixtures of medical gases in cylinders that fulfil the definition of pharmaceutical products should apply for a Licence for Manufacturer under the Pharmacy and Poisons Regulations (Cap. 138A). You may refer to Q&A 1 regarding the scope of medical gases under regulatory control as pharmaceutical products.
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Q.15 What shall I do if I intend to apply for the licence to manufacture medical gases?
A.15
A company who is interested to apply for a licence to manufacture pharmaceutical products, including medical gases, may express their intent in writing and submit a related project proposal and relevant supporting information to the Manufacturers Regulatory Unit of the Drug Office, Department of Health, at Room 3817, 38/F, Revenue Tower, 5 Gloucester Road, Wan Chai, Hong Kong (Tel: 2961 8028, Fax: 3904 1225).
Meeting(s) with the applicant may be held, and the company is expected to present specific information about the quality management policies and activities of the site, the production and/or quality control of pharmaceutical manufacturing operations carried out therein, and any closely integrated operations at adjacent and nearby buildings.
Personnel of a manufacturer of medical gases must have the necessary qualifications and practical experience to carry out their responsibilities, and manufacturers are responsible for providing training for all personnel whose activities could affect the quality of the product. The company should therefore also prepare and provide personal particulars, qualification and working experience of the key personnel, including the Authorized Person responsible for product release, the head of production and the head of quality control to the Drug Office for consideration. Please refer to Q&A 18 for details. Upon completion of commissioning and qualification of the site and implementation of quality management system according to the requirements in the GMP Guide issued by the Board, the company may wish to apply for a licence to manufacture medical gases.
Interested company should refer to the "Guidance on Application for Licence for Manufacturer of Pharmaceutical Products"
(https://www.ppbhk.org.hk/eng/files/Guidance_on_Application_for_ML_EN.pdf) for the application procedures and details.
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Q.16 What are the requirements that a licensed manufacturer of medical gases should comply with?
A.16
Licensed manufacturer of medical gases should ensure all manufacturing processes and activities conducted on the premises are carried out in a manner compliant with the conditions specified on the manufacturer licence and the requirements laid down in the Pharmacy and Poisons Regulations (Cap. 138A), the GMP Guides issued by the Pharmacy and Poisons Board, the applicable Code of Practice as well as other legislations in Hong Kong relevant to pharmaceutical products, which include but are not limited to: (i) Import and Export Ordinance (Cap. 60); (ii) Public Health and Municipal Services Ordinance (Cap. 132); (iii) Undesirable Medical Advertisements Ordinance (Cap. 231); and (iv) Trade Descriptions Ordinance (Cap. 362).
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Q.17 What are the GMP Guides that a manufacturer of medical gases should pay attention to?
A.17
The two GMP Guides issued by the Pharmacy and Poisons Board should be paid attention to:
(i) The gazetted version of Part I, Part II and Annexes of the “Guide to Good Manufacturing Practice for Medicinal Products” published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S). Specifically, GMP principles for the manufacture of finished pharmaceutical products are provided in Part I; Part II covers GMP for active substances used as starting materials; and the Annexes provide details on specific areas of activity. In the context of medical gases, Annex 6 on “Manufacture of medicinal gases”.
(ii) The “Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products” which sets out the standards and requirements to be followed by Licensed Manufacturers authorized to conduct secondary packaging.
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Q.18 What are the qualification, experience and training (QET) requirements for the key personnel for Manufacturers of medical gases?
A.18
The authorized person (AP) and other key personnel for manufacturer of medical gases must be suitably qualified, experienced and competent for medical gases manufacturing operations in accordance with the “Guidance on Qualification, Experience and Training Requirements for Authorized Persons and Other Key Personnel of Licensed Manufacturers in Hong Kong”
(https://www.ppbhk.org.hk/eng/files/Guidance_on_QET_eng.pdf)
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Q.19 If I am a holder of licence to manufacture medical gases / wholesaler licence under the Pharmacy and Poisons Regulations (Cap. 138A), do I still need to apply licences under other legislations, such as Dangerous Goods Ordinance (Cap. 295)?
A.19
Medical gases or mixture of gases are also regulated under other legislations in Hong Kong. The licensing of manufacturers and wholesalers of medical gases under the Pharmacy and Poisons Regulations (Cap. 138A) does not exempt the manufacturers or wholesalers from complying with other legislations. A licensed manufacturer or wholesaler should observe and follow all the relevant requirements stipulated under the related ordinances, which include but not limited to (i) Boilers and Pressure Vessels Ordinance (Cap. 56); (ii) Factories and Industrial Undertakings Ordinance (Cap. 59); (iii) Fire Services Ordinance (Cap. 95); (iv) Dangerous Goods Ordinance (Cap. 295); (v) Electricity Ordinance (Cap. 406); and (vi) Occupational Safety and Health Ordinance Cap. 509).
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Q.20 Do I need to apply for a Licence for Manufacturer under the Pharmacy and Poisons Regulations (Cap. 138A) for the manufacture of gases that are used as oxygen supply for patient’s bedside use?
A.20
It depends on how the gases are produced. According to the “Guidance Notes on Manufacture, Wholesale, Storage and Transport of Medical Gases”, the regulatory control of medical gases under the Pharmacy and Poisons Regulations (Cap. 138A) does not cover gases that are produced in situ in healthcare facilities, i.e. manufactured, mixed and handled in hospitals or day procedure centres for their patients’ own use; and oxygen that is produced via generator or concentrator to be used at patient’s bedside.
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Q.21 If I am a holder of licence to manufacture medical gases, can the facility also manufacture and store other non-medical gases (e.g. for industrial use)?
A.21
According to Annex 6 of PIC/S GMP Guide, “cylinders and mobile cryogenic vessels should be checked, prepared, filled and stored in a separate area from non-medicinal gases, and there should be no exchange of cylinders/mobile cryogenic vessels between these areas.” However, a licensed manufacturer for medical gases may manufacture and store non-medical gases with medical gases in the same areas, provided those non-medical gases comply with the specifications of medical gases and that the operations are performed according to GMP standards. The relevant evidence and information should be properly recorded and documented.
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Q.22 Can medical gases cylinders be transported in a horizontal manner?
A.22
Manufacturers and wholesalers should ensure detailed procedure in place for the transport of medical gases. In particular, there should be procedure to ensure that all medical gases cylinders shall be restrained and secured during transport, wherever possible be transported upright for reasons of safety and by trained porters especially for heavy cylinders.
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Reporting Adverse Drug Reaction (ADR) |
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Jun 2024 |
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Regulation of Medical Gases
