The license for traditional Chinese medicine in Hong Kong is not just "a piece of paper". In today's increasingly crowded cross-border medical industry sector, it serves as both a "passport" for entering the Hong Kong market and a "platform" for mainland Chinese traditional Chinese medicine enterprises to go international.

According to the latest data released by the Hong Kong Government Statistics Department, in 2024, the total value of Hong Kong's traditional Chinese medicine exports reached 2.88 billion Hong Kong dollars, with over 70% of the sales going to the mainland.

However, many pharmaceutical companies registered Hong Kong companies and found buyers, but the subsequent work could not be advanced. The problem often lies in the fact that the enterprises do not have the license for wholesale distribution of traditional Chinese medicines, which prevents them from applying for import licenses and starting product registration - and unregistered traditional Chinese medicines (without HKC numbers) are legally not allowed to be imported or sold.

Please note: Obtaining a wholesale license does not mean you can immediately start selling medicines. This license only addresses the business qualification of the enterprise. Each traditional Chinese medicine product still needs to be independently registered by the licensed company (obtaining the HKC number) before it can be marketed.

First, obtain the license, then complete the product registration (obtain the HKC number).

So, how is this license application done? What are the conditions? What's the process? How much does it cost? What policy benefits will there be in 2026? This article will use 7 sections to help you understand the entire process from "zero" to "getting the license" at one go.

1. Why the Hong Kong Traditional Chinese Medicine License?

When choosing the "pharmaceutical license" sector, many business owners will hesitate between the traditional Chinese medicine license and the Western medicine license. To put it simply: The traditional Chinese medicine license is currently the most cost-effective and preferred path for the majority of mainland enterprises to enter the Hong Kong pharmaceutical market.

// Why is it recommended to choose it?

The biggest drawback of the Western medicine brand lies in "people" - to obtain the license for drug wholesale business, one must have a full-time registered pharmacist on the team. This is also a scarce resource in Hong Kong, and the recruitment process is lengthy and costly.

The licensing requirements for traditional Chinese medicine products are relatively flexible in terms of the qualifications of the responsible personnel, and the overall cost of compliance matching is also controllable. The application process for traditional Chinese medicine licenses is shorter, the personnel threshold is lower, and the start-up costs are more manageable. This better meets the demands of small and medium-sized enterprises in the mainland for "quick compliance and getting started quickly".

2. Who needs to apply for a wholesale license for traditional Chinese medicines?

According to Section 135 of Chapter 549 of the Hong Kong Laws, all traditional Chinese medicine dealers engaged in the following businesses must apply to the Hong Kong Traditional Chinese Medicine Regulatory Committee for a wholesale license for traditional Chinese medicines:

• Wholesale of traditional Chinese medicines - Bulk distribution of traditional Chinese medicines
• Import and export of traditional Chinese medicines - The first step of entering and leaving the Hong Kong customs
• Supply of traditional Chinese medicines - Supply to pharmacies, clinics, and medical institutions

In addition, Section 119 of the regulation clearly stipulates that no one is allowed to sell, import or possess unregistered traditional Chinese medicines (with HKC registration number). Offenders may be fined up to 100,000 Hong Kong dollars and imprisoned for up to two years.

If you plan to sell Hong Kong-registered traditional Chinese medicines online (such as on Amazon, Tmall International, JD Health, etc.), it also falls under the category of wholesale and requires obtaining a license first. If you only engage in the retail of registered traditional Chinese medicines (and the products come from licensed wholesalers), then you do not need to apply for a separate wholesaler license - provided that you do not involve any import, export or bulk distribution activities. However, most cross-border businesses (wholesale, import, export, platform distribution) are within the scope of this license, so in practice, it is basically a necessary certificate for all trading parties.

3. Core application conditions - Venue + Personnel + System

The Traditional Chinese Medicine Regulatory Office of the Department of Health is the actual processing agency for the licensing of Chinese patent medicines in Hong Kong. All applications will go through multiple stages such as material review, on-site inspection, and group approval. The license is issued by the Traditional Chinese Medicine Section of the Department of Health, and after issuance, it will continue to be included in the daily compliance management of the Department of Health.

The first three are the most likely to cause delays, and they are also the parts where we invest the most effort in our代办 work.

01. Company Requirements

Applicants must be a limited company registered in Hong Kong and must provide：

• Business Registration Certificate (BR)
• Company Registration Certificate (CI)
• A fixed business location
• A copy of the Annual Return (NAR1) or the Company's Incorporation Form (NNC1)

This is why Hong Kong secretarial companies often help clients complete company registration first， and then simultaneously proceed with the application for the license - the two are complementary projects， and doing them separately will consume more time.

Many clients ask， "Can I apply for the license without a Hong Kong company first?" The answer is no. One must register a Hong Kong company， obtain the BR and CI， and then submit the license application in the name of the company.

02. Venue Requirements - ⏳ The most likely to cause delays

The Department of Traditional Chinese Medicine of the Health Bureau will send personnel for a pre-license inspection. The venue must meet the following conditions：

• Location： Must be in a commercial or industrial building， and must not be located at a residential address or the office of a secretarial service company.
• Zone Division： Must be divided into three areas： drug storage area， receiving area， and shipping area. They must not be mixed with the人流 area.
• Equipment： Must be equipped with temperature and humidity monitoring equipment， pest control facilities， anti-theft systems， and cleaning and safety signs.
• Storage： Drugs must not be mixed with food or cosmetics. There must be a dedicated storage rack for drugs, and for temperature-sensitive drugs, a refrigerator or low-temperature equipment must be provided.
• Area: Generally, it is recommended to be 150-500 square feet, depending on the business scale and inventory.
• Administrative On-site Presence: On working days， there must be administrative staff on-site to handle Health Bureau inspections and letter receiving and dispatching.

Many applications are rejected or postponed. In the end， the reasons are usually that the location is a residential building， the temperature and humidity are uncontrollable， the zoning is chaotic， and the hardware does not meet the standards. When the Health Bureau conducts a pre-license inspection， if such problems are found， they usually return the application and require rectification， resulting in an extended overall application cycle. Therefore， finding a professional agency to conduct a compliance assessment of the venue in advance can significantly increase the application success rate.

03. Responsible Person (RP)

Applicants must appoint a responsible person to supervise the drug entry and exit records， manage drug storage， monitor temperature and humidity， and ensure compliance with legal regulations. The basic qualifications of the RP are as follows：

• Hong Kong-registered pharmacist
• Professional degree from a recognized Hong Kong institution + more than 1 year of important supply chain experience
• Hong Kong-registered/registered Traditional Chinese Medicine doctor

One major advantage of the Traditional Chinese Medicine license over the Western medicine license is that Western medicine wholesalers must have a full-time registered pharmacist and strictly implement the "one license， one person" system， and cannot hold a part-time position； while the RP qualification requirements for Traditional Chinese Medicine licenses are relatively flexible， and professionals with relevant academic degrees or experience in the pharmaceutical supply chain can be appointed， which has significantly better human resource costs and management flexibility. For mainland clients without an existing RP， we can assist in connecting.

04. Internal Enterprise System Documents

The Health Bureau requires enterprises to establish a complete quality management system (QMS)， including：

• Standard Operating Procedures (SOP)
• Record Retention System
• Complaint Handling Mechanism
• Product Recall Procedure
• Internal Audit System

These system documents are also important review contents during the inspection.

05. Import and Export Licenses

This is a part that many applicants easily overlook but is extremely important.

In addition to obtaining the license, when importing or exporting traditional Chinese medicines, one must also apply in advance for the relevant import license or export license in accordance with the "Import and Export (General) Regulations" (Chapter 60A) of Hong Kong. According to the clear warning from the Office for the Regulation of Traditional Chinese Medicine of the Department of Health: Importing or exporting related traditional Chinese medicines without obtaining the import license and export license may violate the "Import and Export (General) Regulations". If convicted, the maximum penalty could be a fine of HK$500,000 and imprisonment for 2 years.

Furthermore, if the product contains ingredients of endangered species (such as musk, bear bile, etc.), it is necessary to undergo a compliance screening by the Agriculture, Fisheries and Conservation Department in advance - the Health Department has imposed regulations on "Chinese patent medicines containing ingredients of endangered species", and details can be found in the "Protecting Endangered Species - Traditional Chinese Medicine" booklet of the Agriculture, Fisheries and Conservation Department. The Health Department takes a strict "red line" attitude towards such ingredients, and once detected, it may directly refuse to accept or even involve criminal liability. It is recommended to conduct a comprehensive check of the ingredients during the selection stage, as this is a frequently overlooked but extremely important step.

4. What documents are required for the application? | Official List

According to the Application Form for Traditional Chinese Medicine Wholesalers (Form 1C), the applicant needs to submit the following documents:

• Company documents:

Copy of business registration certificate

Copy of company registration certificate

Copy of the list of directors (if NAR1 or NNC1 form is used)

List of sole proprietors, partners or directors and key staff (including names in both Chinese and English, ID numbers, positions)

• Site documents: Floor plan of the business premises
• Application form: Completed Application Form for Traditional Chinese Medicine Wholesalers (Form 1C) + Verification Form 2C

⚠ Material Notes: The applicant must fill in all the contents in the application form (including Chinese and English addresses) and provide true and accurate data. If incomplete core materials are provided, the application may be directly rejected; incorrect, missing or unclearly expressed materials may also affect the progress of the application. It is recommended to have professional institutions review the documents one by one before formal submission to ensure completeness and accuracy of the files.

5. Application Process and Official Time Limits | Completing Each Step

According to the service commitment of the Traditional Chinese Medicine Regulatory Office of the Health Department, after receiving the completed application form and all relevant documents, an on-site inspection before licensing will be arranged within two weeks; after the applicant pays the required fees as per the regulations, the license will be issued within 20 working days. The following are the detailed steps:

Weeks 1-2: Application Preparation (Suggested to reserve 1-6 weeks)

Complete the registration of a Hong Kong company; lease a compliant business site; appoint a responsible person (RP); prepare SOP system documents; prepare floor plans and other materials (avoid using industrial building partitions, cold storage partitions). Prepare site zoning, install temperature and humidity monitoring, and rectify rat-proof and theft-prevention equipment, etc.

Weeks 2-3: Submission of Application

Submit the completed application form (Form 1C) and all required documents, and can also submit a verification form to expedite the initial review.

Weeks 4-8: Receipt Confirmation (Within 30 days)

The Health Department issues a receipt letter, containing the application number. According to the official E-form system regulations, the Traditional Chinese Medicine Regulatory Office of the Health Department will issue a receipt letter within 30 days after receiving the application form.

Weeks 6-10: On-site Inspection Before Licensing (Within 2 weeks after all materials are complete)

The Health Department sends personnel to the business site for on-site inspection, focusing on checking site zoning, temperature and humidity records, storage environment, SOP system and personnel processes.

Weeks 8-12: Approval (Usually 1-2 weeks)

The Health Department completes the review, and the Traditional Chinese Medicine group reviews the entire application.

Weeks 10-14: Payment and License Issuance (Within 20 working days after payment)

The Health Department will issue a "General Payment Slip", and after the applicant pays the fee, the license will be officially issued.

Important reminder: Applicants must keep a copy of the completed application form and all submitted materials as a reference when checking the progress. It is recommended that the total preparation period be 3-4 months.

6. Fee Explanation and License Renewal Management

Initial application fee: Refer to the "General Payment Slip" issued by the Hong Kong Department of Health.

Annual renewal fee: HK$1,050. It is recommended to include this expense in your budget in advance.

License validity period: The validity period will be indicated on the license. Generally, it is no more than two years. (Approved by the Chinese Medicine Group. The initial period may be 1 year, 1.5 years or 2 years.)

Renewal requirements: According to Sections 116 and 136 of the "Traditional Chinese Medicine Ordinance", licensed wholesale distributors of Chinese patent medicines must apply for renewal to the Chinese Medicine Group at least 6 months before the expiration date. The new license will be delivered by mail after the application is approved.

⚠ Special Note: Failure to complete the renewal process on time may result in the license being suspended. You will need to go through the entire application process again.

Appeal rights: If the renewal application is rejected, the applicant can submit a review to the Chinese Medicine Group within 14 days after receiving the notice, or appeal to the Court of First Instance within one month.

Regarding agency fees: The above are the official fees directly collected by the government department. They do not include the agency service fees of professional institutions. Our agency fees are customized based on the specific needs of the client (such as whether company registration, site rectification, RP recommendation, etc. are required). The specific quotations can be consulted with our professional advisors. The advantage of choosing our agency service is: One-stop solution for core issues, avoiding repeated expenditures due to incomplete materials or non-compliant sites, and allowing clients to avoid detours.

7. Major Positive Development in 2026: Grading and Diversion Mechanism

This is the policy that has the greatest impact and the most significant effect on Chinese patent medicine enterprises entering the Hong Kong market in recent years.

On November 20, 2025, the Hong Kong Health Department officially announced: Starting from January 1, 2026, a "graded and diverted review and approval arrangement for the registration applications of Chinese patent medicines" will be piloted for a period of two years. The specific mechanism is as follows:

• New drugs: 120 working days (meeting the characteristics such as "new active ingredients" or "new dosage forms/new uses")
• Designated priority products: 150 working days (up to 2 products per year can take the accelerated channel)
• General applications: Over 250 working days (existing level, no change in time)

A spokesperson from the Health Department clearly stated: "As long as you hold the wholesale or manufacturing license of Chinese patent medicines issued by the Chinese Medicine Management Committee under the Hong Kong government, you can select the appropriate Chinese patent medicine products through the graded and diverted mechanism to accelerate their entry into the Hong Kong market."

It should be noted that: The benefit of the graded and diverted mechanism is in the drug product registration process (obtaining the HKC number), not in the company's license application itself. However, for licensed enterprises, this is an important strategic window period - the earlier you obtain the license, the earlier you can enjoy the acceleration benefits of product registration.

What can we do for you? | Full-process handling, from zero to obtaining the license

As a dedicated Hong Kong licensed secretary agency, we collaborate closely with Hong Kong licensed certification institutions and can connect you with the entire process of applying for a Chinese medicine wholesale distributor license and the resources for registering Chinese medicine products.

Our services include:

✅ Company registration preparation: Assist in completing the registration of a Hong Kong limited company and lay the foundation for the application for a drug license at the same time

✅ Comprehensive pre-evaluation of the venue: Assess in advance whether the alternative business premises meet the standards of the Department of Health

✅ Recommendation of RP managers: Assist in recommending qualified license-holders or professionals

✅ Documents + application forms: Provide a complete set of SOP/QMS document templates

✅ Filling out application forms: Assist in filling out Form 1C, organizing company documents, floor plans and other attachments

✅ Electronic submission: Submit through official emails or online channels to ensure the application is delivered immediately

✅ Full-process follow-up: Tracking of material review submission, notification of receipt, inspection guidance, supplementary responses

✅ Product registration: Submit product registration applications on behalf of the licensed company

✅ Company maintenance one-stop service: One-stop services including company account opening, annual review, audit, and tax filing

We assist throughout every step from company registration, venue selection for business operations, to the final inspection by the Department of Health, striving to pass the approval in one go.

With the opening of the 2026 classification and diversion mechanism window and the increasingly in-depth cooperation of traditional Chinese medicine in the Guangdong-Hong Kong-Macao Greater Bay Area, the value of a wholesale license for Chinese patent medicines is being redefined.

It is not only an operating qualification that complies with Hong Kong laws, but also the starting point for introducing your products into the Chinese patent medicine distribution market. Instead of missing the window period by waiting passively, it is better to complete the Hong Kong compliance layout in one step with professional assistance.

Declaration: The policy information and image sections of this article are sourced from publicly available online materials. The copyright of the images of related brands, products, and institutions belongs to their respective rights holders. If there is any improper use, please contact us and we will handle it promptly. This article is merely for industry information sharing and does not constitute any legal advice or commercial commitment. The specific requirements, procedures, and fees for applying for a Chinese medicine license in Hong Kong are subject to the latest official announcements by the Hong Kong Department of Health's Traditional Chinese Medicine Regulatory Office. If you have any questions, it is recommended to consult professional legal experts or relevant departments of the Hong Kong government.

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