Chapter 8: Chinese Medicine Licence Types and Key Application Points
Hello, everyone. I am Drew Tang. In Hong Kong, the practice and regulation of Chinese medicine, a treasured part of Chinese heritage passed down over thousands of years, are also subject to a rigorous and comprehensive legal framework. The core of this framework is the Chinese Medicine Ordinance (Cap. 549). Compared with western medicine, Chinese medicine licence categories and application requirements have their own distinctive features, with greater emphasis on practitioners’ professional backgrounds and the authenticity of herbal medicines. Today, I will explain the types of Chinese medicine licences and key application requirements to help you establish your business in this field on a sound footing.
8.1 Licensing framework under the Chinese Medicine Ordinance
Hong Kong's Chinese medicine regulatory system is based primarily on the Chinese Medicine Ordinance (Cap. 549) and is administered by the Chinese Medicine Council of Hong Kong (the “Council”). The Council has a Chinese Medicines Board, which deals specifically with licensing Chinese medicine traders. Routine regulatory, inspection and approval work is carried out by the Chinese Medicine Regulatory Office (CMRO) under the Department of Health. The system as a whole aims to ensure the quality, safety and efficacy of Chinese herbal medicines and proprietary Chinese medicines, and to protect public health.
Unlike Western medicine licences, which are administered by the Pharmacy and Poisons Board (PPB), approval of Chinese medicine licences is centralised under the Chinese Medicines Board. Applicants must submit applications to the Chinese Medicine Regulatory Office and undergo its rigorous assessment of premises, personnel and quality management systems. The Ordinance divides Chinese medicine business activities into four categories, with a separate licence for each: a Chinese herbal medicines retailer licence, a Chinese herbal medicines wholesaler licence, a proprietary Chinese medicine wholesaler licence and a proprietary Chinese medicine manufacturer licence. Each licence has clearly defined eligibility criteria, premises requirements and scope of operation, all of which must be met.
Drew Tang's advice:Many newcomers readily confuse the regulatory bodies for Chinese medicines and Western medicines. Please remember that Chinese medicine businesses fall under the Chinese Medicine Regulatory Office (CMRO), not the Drug Office responsible for Western medicines. From application submission to final assessment, you will deal with CMRO officials. Clarifying this distinction is important. RGYS may assist with document preparation and project coordination within the written scope of services; personnel qualifications, statutory roles and professional judgments are to be verified and assumed by the respective responsible parties, and approval is decided independently by the competent authority.
8.2 Comparison and details of the four types of Chinese medicine licence
Understanding the differences between the four types of licence is crucial, as they directly determine your business model and investment costs. I will explain each one in turn and compare them in a table for easy reference.
Retailer’s licence for Chinese herbal medicines
This is the most common type of Chinese medicine licence, applicable to what are commonly known as “herbal medicine shops” or “ginseng and herbal medicine shops”. The licensee may sell the 31 types of toxic Chinese herbal medicines and 574 types of commonly used Chinese herbal medicines listed in Schedules 1 and 2 to the Chinese Medicine Ordinance directly to end consumers at the registered address. Applications for this licence are subject to strict requirements for shop storage conditions. For example, suitable facilities must be provided to protect against damp, pests and fire, and toxic Chinese herbal medicines must be kept in a separate locked cabinet.
Wholesaler’s licence for Chinese herbal medicines
This licence permits the holder to engage in the wholesale, import and export of Chinese herbal medicines. Unlike retailers, wholesalers transact with other Chinese medicine traders (such as retailers and manufacturers), rather than end consumers. Their business premises are therefore usually warehouses or offices. The CMRO imposes higher requirements on wholesalers in areas such as warehouse management, batch traceability records and import/export documentation to ensure the safety and control of the entire supply chain.
Wholesale Dealer Licence for proprietary Chinese medicines
If you plan to deal in proprietary Chinese medicines that are pre-packaged, with fixed dosages and instructions for use, you need to apply for this licence. The licence holder may wholesale, import and export proprietary Chinese medicines registered with the Chinese Medicine Council of Hong Kong. The key point is that they must be “registered”: all proprietary Chinese medicines sold in Hong Kong must have a Certificate of Registration (HKC-XXXXX). A company's business under this licence is therefore closely linked to the proprietary Chinese medicine registration system.
Manufacturer of proprietary Chinese medicines licence
This is the most difficult and stringent of all Chinese medicine licence applications. It authorises the licensee to manufacture and package proprietary Chinese medicines. Applicants must establish a factory that complies with the Hong Kong Good Manufacturing Practice for Proprietary Chinese Medicines (GMP). A comprehensive and extremely stringent set of standards applies to factory design, equipment qualification, raw material testing, production process controls, finished product release and adverse reaction monitoring. This is also a core element in ensuring the safety and efficacy of proprietary Chinese medicines.
| Licence types | Main business scope | Core regulatory requirements | Key qualification points for nominees/persons-in-charge |
|---|---|---|---|
| Retailer of Chinese herbal medicines | Retail Chinese herbal medicines to the public | The shop meets storage standards, and toxic Chinese herbal medicines are properly safeguarded | The nominee should have completed a recognised Chinese medicine dispensing course or have sufficient experience. |
| Wholesaler of Chinese herbal medicines | Wholesale of Chinese herbal medicines and import/export | Comprehensive storage and batch traceability systems | The nominee should have extensive experience in the identification and management of Chinese herbal medicines. |
| Wholesaler of proprietary Chinese medicines | Wholesale and import/export of registered proprietary Chinese medicines | Ensure that only registered (HKC) proprietary Chinese medicines are sold, and that comprehensive sales records are kept. | The person responsible must have expertise in Chinese medicine and understand the registration regulations for proprietary Chinese medicines. |
| Manufacturer of proprietary Chinese medicines | Manufacture and packaging of proprietary Chinese medicines | Factory premises and production processes must comply with GMP standards | Heads of key functions, including production and quality control, should have relevant qualifications and experience in Chinese medicine, pharmacy or related fields. |
8.3 Special requirements in the application process
The application process for Chinese medicine licences is similar to that for Western medicines, comprising submission of an application, document review, site inspection and final approval. However, there are several specific requirements that applicants should note.
First is the “nominated person” scheme. For licences for the retail and wholesale of Chinese herbal medicines, the applicant must nominate a person with sufficient knowledge and experience in Chinese herbal medicines to supervise the sale or wholesale activities. The qualifications of this nominee are assessed by the Chinese Medicine Regulatory Office. Completion of a dispensing course recognised by the Chinese Medicine Council or possession of relevant academic qualifications will generally be an important advantage. For manufacturers of proprietary Chinese medicines, the requirements for key technical personnel, such as the person in charge of production and the person in charge of quality, are higher. They will generally need a bachelor’s degree or above in Chinese medicine or a related discipline.
“The legislative intent of the Chinese Medicine Ordinance is to put people first. It recognises the complexity of Chinese medicine and its high degree of non-standardisation, and therefore places great importance on practitioners’ professional competence. A qualified nominee or Person-in-Charge is central to your successful licence application and compliant operations.”
Secondly, premises layout and design are a top priority in CMRO inspections. Whether a retail shop or a production facility, areas must be segregated strictly in accordance with regulatory requirements. For example, a retail shop must clearly delineate a storage area for toxic Chinese herbal medicines, a general herbal medicine area, a dispensing area and a sales area. Manufacturers must follow GMP requirements and provide personnel and material flow routes with different cleanliness grades to avoid cross-contamination. I, Drew Tang, have personally assisted clients in drawing and revising premises floor plans in many previous cases. RGYS may assist with document preparation and project coordination within the written scope of services; personnel qualifications, statutory roles and professional judgments are to be verified and assumed by the respective responsible parties, and approval is decided independently by the competent authority. This is one of the core values of our services.
Illustrative Project Scenario (Not a Verified Pharmaceutical Licensing Outcome)I once assisted a client with an application for a Chinese herbal medicines wholesaler licence. The initial warehouse design did not meet CMRO's requirements for first-in, first-out management of herbal medicines. I advised him to renumber the shelving and introduce a simple computerised inventory management system to record clearly the receipt date and batch number of each batch of herbal medicines. During the inspection by CMRO officers, we demonstrated on site how the system effectively prevented herbal medicines from expiring, earning strong recognition from the officers. RGYS may assist with document preparation and project coordination within the written scope of services; personnel qualifications, statutory roles and professional judgements are to be verified and assumed by the respective responsible parties, while approval is determined independently by the competent authority. This example shows that a seemingly minor process improvement may be the key to the success or failure of a licence application.