Compare Hong Kong wholesale and proprietary Chinese medicine licensing routes, including regulators, personnel, premises and ongoing obligations.
For comparison: This table compares the Wholesale Dealer Licence (WDL) with the wholesaler licence in proprietary Chinese medicines (1C). They fall under different legislation and regulatory systems. Wholesale of Chinese herbal medicines is a separate licence category, and the 1C rules in this table do not apply. An operating licence is also distinct from product registration or a permit for a specific import or export consignment. All changes and renewals are subject to the current official forms, guidance and case-specific requirements.
This table focuses on wholesale of Western medicines and proprietary Chinese medicines. For a comparison of business arrangements, application preparation, maintenance and changes for ASP pharmacies and LSP drugstores as well, see the comprehensive professional guide.
| Comparison item | Wholesale Dealer Licence (WDL) | Wholesaler Licence in Proprietary Chinese Medicines (1C) |
|---|---|---|
| Regulation and legislation | Pharmacy and Poisons (Wholesale Licences) Committee under the Pharmacy and Poisons Board of Hong Kong; the Drug Office, Department of Health / Wholesale Dealers Regulatory Unit is responsible for related administration, inspections and regulation. Cap. 138 / Cap. 138A | The Chinese Medicines Board under the Chinese Medicine Council of Hong Kong makes licensing decisions. The Chinese Medicines Regulatory Office of the Drug Office handles receipt of applications, forms, premises inspections and licence administration, and provides import and export licence services for Chinese medicines. Cap. 549 / Cap. 549F |
| Applicable activities | A WDL applies to wholesale trading in poisons and/or pharmaceutical products in Hong Kong. Check antibiotics, dangerous drugs, product registration and the import or export licence required for each consignment separately; a WDL does not automatically replace them. | 1C applies where proprietary Chinese medicines are acquired or imported and then sold to manufacturers, or to persons who acquire the products for resale, supply or arranging their supply to third parties. It is not a licence for wholesale or retail dispensing of Chinese herbal medicines, or for the manufacture of proprietary Chinese medicines. |
| Applicant entity and eligibility | The current checklist covers limited companies, sole proprietorships and partnerships. There is no official conclusion setting a uniform minimum capital, minimum area or requirement that the business must be a limited company. | Section 135 of the Chinese Medicine Ordinance starts from an application by “any person”. The official checklist sets out separate requirements for limited companies, sole proprietorships and partnerships. A limited company is common, but is not the only legally permitted form. |
| Key personnel and professional qualifications | An approved PIC is required; where pharmaceutical products are traded, the PIC is also the GDP RP. A registered pharmacist is a specific requirement for transactions involving listed psychotropic substances and certain dangerous drugs, not a general requirement for every WDL. A manufacturer’s AP is not the same as a WDL PIC/RP. | 1C applications must declare the proprietor/partners/directors and key staff. Key staff include management and people responsible for procurement, receipt, storage and dispatch. The verified 1C materials do not list a universal requirement for an AP, nominee or registered pharmacist. |
| Premises and storage | The premises and storage facilities must be lockable, suitable for the products’ storage conditions and approved. Changes to the address, an additional warehouse, storage layout or facilities must follow the information-change and approval process. | The application premises must be hygienic, have adequate space and suitable storage facilities. Warehouse capacity should be commensurate with the volume of proprietary Chinese medicines stored, with arrangements to prevent insects, rodents, damp and mould. The Department of Health will inspect the application premises. |
| Capital and budget | The authorities have not specified a fixed minimum capital. Budget separately for government fees, premises and equipment, GDP validation/calibration, outsourcing and professional services. | The verified 1C legislation, application manual and checklist do not specify a uniform minimum floor area or registered/paid-up capital amount. The focus is whether the applicant entity, premises and proposed scale of operations are commensurate. |
| Official Target and Service Estimate | The official two-month service target applies only to applications with complete documentation and adequate, satisfactory storage facilities; it is not a guarantee of processing within two working months, unconditional approval or a project timetable with a fixed start date. | The Department of Health will issue an acknowledgement letter and application number within 30 days of receiving an application. It will then arrange an inspection of the premises and refer the application to the Chinese Medicines Board for consideration. A new licence is statutorily valid for 2 years. Drew Tang’s team may use 3 to 4 months or more as a non-guaranteed project estimate for document preparation, submission, inspection and coordination of supplementary information; this is not a government commitment. |
| Product registration | A wholesale licence does not replace pharmaceutical product registration. Specific controlled products and import/export arrangements must be checked separately. | Product registration for proprietary Chinese medicines is separate from the business licence. A wholesaler licence in proprietary Chinese medicines does not automatically confer permission for retail or wholesale of Chinese herbal medicines or for manufacture. |
| New licence validity and renewal | A wholesale dealer licence is an annual licence. A renewal / payment notice is usually issued about one to two months before expiry. Refer to the expiry date on the certificate and the requirements in force at the time; the deadlines for different western medicine licences should not be treated as identical. | A new 1C licence for wholesale of proprietary Chinese medicines is valid for two years. A renewal may be granted for two years or for a shorter period considered appropriate by the Chinese Medicines Board. Official renewal guidance requires applications to be made at least six months before expiry. |
| Fees and government charges | Service quotations, operating budgets and government fees are separate items. Government charges are subject to the current official forms, website and regulatory requirements, and are not included in consultancy service fees. | |
| Changes to directors, personnel and premises | After a change of sole proprietor, partner or director, the Board should be notified in writing within one month. Changes to the PIC, deputy PIC and person in charge of dangerous drugs require prior application. Changes to premises address, warehouse or storage arrangements must also follow the applicable change application process and comply with the licence requirements. | An application to change the address of 1C premises should be made in advance as early as possible, and no later than the third day after the change takes effect. Business must not be conducted at the new address before approval is granted. If the address has changed without approval, the licence may become invalid one month after the date of the change. Changes to directors and other particulars should be handled promptly in accordance with official procedures. Before a share transaction, check the entity, directors, key personnel, premises and control arrangements individually. |
| Ongoing maintenance | A WDL is an annual licence. Changes to directors/owners/partners must be notified in writing within one month; changes to the PIC/DPIC/dangerous-drug PIC and to the address/warehouse/storage arrangements are handled through different procedures requiring prior application and approval. | Licence holders must maintain suitable premises, controls over unexpired and traceable products, and complaint and recall systems. Transaction documents must be kept at the premises to which the licence relates for at least 2 years after the transaction date. Apply for renewal no less than 6 months before expiry. |
Drug Office, Department of Health Chinese Medicine Council of Hong Kong / Chinese Medicines Board
Business Manager Tang Shangyong (Drew Tang) will review your products, operating model, licence type and preparation requirements with you one-to-one. The precise service scope is confirmed in writing; pharmaceutical duties are carried out by legally qualified personnel, and approvals are determined by the competent authorities.
