1. Hong Kong Pharmaceutical Wholesaler License (medicine brand)core legal access conditions
Business premises restrictions
The business premises of the applicant company must be located in a commercial building or industrial building。Located underground(G/F)、Within retail premises、Premises operating within a secretarial or accounting firm，Generally will not be considered。Sharing premises with another wholesaler requires submission of sufficient written explanation and approval by the committee。
Core staffing
A responsible person must be appointed who has passed the “fit and proper” review and interview，Possess sufficient knowledge of pharmaceutical trade。If you intend to deal in psychotropic substances or Part I dangerous drugs，It is mandatory to hire a Hong Kong registered pharmacist to be solely responsible for related transactions。
Warehousing Facility Compliance
The premises shall be provided with a lockable、Independent storage facilities with appropriate temperature and humidity。Part I dangerous drugs must be equipped with double-locked special containers。Cold chain products must pass temperature mapping、Door opening/power outage test and backup power supply verification，and install a temperature alarm system。
2. Hong Kong Pharmaceutical Wholesaler License (medicine brand)Details of statutory fees
| License/Permit Category | statutory fees(Hong Kong dollar) | Remark |
|---|---|---|
| Drug wholesaler license (WDL) | 625Yuan | Pay after approval |
| Antibiotic license | 450Yuan | Pay when submitting application，No refund |
| Wholesale dealer license to supply dangerous drugs | 860Yuan | Pay after approval |
3. Hong Kong Pharmaceutical Wholesaler License (medicine brand)application process
Preparatory stage
Establishing a Hong Kong Limited Company，Rent a compliant warehouse for industrial use，Signature required by registered pharmacist(If applicable)，Develop standard operating procedures for drug storage and traceability(SOP)。
Submit application
Through the Department of Health Drug Office electronic system(PRS 2.0)Or submit the complete application form in person、document、Plans and SOPs。
Site inspection
Pharmacist inspector of the Department of Health inspects the warehouse on site，Check hardware facilities、Temperature and humidity monitoring、quarantine area，and conduct interviews with the person in charge。
committee review
Pharmacy and Poisons(wholesale license)committee meeting，Comprehensive inspection report、Interview performance and criminal record review，make licensing decisions。
Pay and license
After committee approval，Applicant pays statutory license fee，Obtained a formal "Wholesaler License"，Ready to start business。
4. Hong Kong Pharmaceutical Wholesaler License (medicine brand)List of application materials
Statutory application form：Form A (Application for Wholesaler License)
Company registration certificate(CI)and business registration certificate(BR)
Latest Annual Return(NAR1)or incorporation form(NNC1)
Identity documents of all directors/partners and declaration of no criminal record
Declaration of qualifications and proof of work experience of the proposed person in charge
(If applicable) Registration certificate and employment contract of registered pharmacist
Warehouse lease agreement or proof of ownership，and high-precision floor plan signed and stamped
Temperature and humidity measuring instrument calibration certificate，Cold chain verification report (if applicable)
Covers receipt and delivery、temperature control、Full set of standard operating procedures for recalls and other procedures(SOP)
5. Hong Kong Pharmaceutical Wholesaler License (medicine brand)Compliance red lines and risk reminders
⚠️ It is absolutely prohibited to retail pharmaceutical products to the public：Wholesale dealer licenses are only available to other licensed dealers、Wholesale to medical institutions or overseas buyers，Violators commit serious criminal offenses。
⚠️ Unauthorized repackaging or labeling is prohibited：Any unpacking、Any act of changing packaging is considered “manufacturing”，Must apply for a manufacturer license separately and pass GMP certification。
⚠️ The warehouse address must be physically compliant：Purely residential、Pure office building、Secretary's address will not be approved；Shared warehouses must be physically separated and managed independently。
⚠️ Transaction records will be recorded within 72 hours，Keep for at least 2 years：In particular, missing records of dangerous drugs will lead to direct criminal prosecution.，Directors and officers may be imprisoned。
⚠️ It is compulsory to hire a registered pharmacist for psychotropic drugs and dangerous drugs：Cannot be replaced by an ordinary person in charge，and pharmacists must be employed full-time。
6. Hong Kong Huitong applies for Hong Kong pharmaceutical wholesaler license (medicine brand)success stories
Assisted a biologics start-up company to pass warehouse acceptance within 14 days
The customer’s original leased industrial unit did not meet the cold chain storage requirements，The Hong Kong Huitong team intervened in advance，Assist in renovating the warehouse、Complete temperature control mapping and power outage testing，And provide guidance on SOP writing，Finally passed the inspection by the Department of Health in one go，It only takes 45 days from application submission to approval。
Simultaneously obtained the WDL+ antibiotic license for the Hong Kong subsidiary of a European pharmaceutical company
The customer needs to import and wholesale patented antibiotic raw materials in Hong Kong，Hong Kong Huitong plans the dual certificate application path at the stage of registering a Hong Kong company.，Coordinate the appointment of pharmacists and the allocation of hazardous drug warehouses，Successfully obtained both wholesaler license and antibiotics license within 3 months。
7. Hong Kong Huitong - Your exclusive Hong Kong pharmaceutical wholesaler license (medicine brand)Legal advisory team
Chen Dawen
Senior corporate lawyer，Specializing in pharmaceutical regulations，Former Compliance Advisor, Office of Drugs, Department of Health
Li Si
registered pharmacist，Doctor of Pharmacy，Familiar with GDP specifications and cold chain management，10Years of pharmaceutical quality inspection experience
Wang Minde
Compliance Director，Served in the legal department of a multinational pharmaceutical company，Leading more than 50 WDL application projects
8. Hong Kong Pharmaceutical Wholesaler License (medicine brand)Frequently Asked Questions(FAQ)
cannot。According to the Pharmacy and Poisons Ordinance，Applicants must be a limited company registered in Hong Kong or an unlimited company/partnership registered in Hong Kong。Overseas or mainland enterprises must first establish a Hong Kong subsidiary or branch，Or entrust a licensed local pharmaceutical company in Hong Kong to act as a compliance agent。
does not affect。The law does not restrict non-Hong Kong residents from serving as directors of licensed companies，However, all directors must pass the "fit and proper" integrity review，Submit proof of identity and a statement stating that you have no past criminal record related to the pharmacy industry。
Absolutely not。The Department of Health clearly stipulates that only residential、Properties purely for office use will not be approved。The warehouse must be located in an industrial building or logistics center that meets the land use，With independent temperature control、Fire safety and loading and unloading conditions。
It depends on the situation，However, there are strict administrative requirements。If the medicine does not enter Hong Kong customs territory at all (such as being sent directly from overseas to a third party)，In theory, it is possible to apply for exemption from some hardware requirements，But you still need to hold a wholesaler license。Once it involves customs clearance in Hong Kong、Unpack or change the status of goods，must have a physical warehouse approved by the Department of Health。
In principle, it is extremely difficult to obtain approval，Is a high-risk compliance area。The Department of Health requires licensees to have absolute management rights and division of responsibilities over drugs，Sharing open warehouses can lead to batch code confusion。Unless the warehouse is completely physically separated (e.g. separate locked rooms)、independent entrance)，And submit the approved floor plan and management SOP respectively。
uncertain。If you only wholesale conventional pharmaceutical products (poisons other than Part I of the Poison List)，Just appoint a person in charge with more than 1 year of experience in drug handling。But if you deal in Part I Poison、Antibiotics or dangerous drugs，You must hire at least one Hong Kong registered pharmacist full-time for on-site management。
Can't。To ensure the quality of performance of duties，The Department of Health requires key compliance personnel to serve on a licensed premises full-time during the same business hours，Not to concurrently hold other wholesaler or retail pharmacy positions。
Absolutely prohibited。The statutory authority of the wholesaler license is limited to wholesale transactions and import and export.，Can only be sold to other licensed wholesalers、Authorized Seller of Poisons (Pharmacy)、Registered doctor、dentisit、Veterinary and hospital institutions。Retailing to individuals is a criminal offense of unlicensed retailing。
cannot。Every imported pharmaceutical product must first complete drug registration with the Hong Kong Pharmacy and Poisons Board (obtain a registration number starting with HK-)。Importing unregistered pharmaceutical products is a criminal offense，Unless it is for specific patient treatment or re-export with one-time permission from the Department of Health。
No。Repackaging and labeling are legally defined as “manufacturing” activities，Must apply for a separate pharmaceutical product manufacturer license and pass PIC/S GMP certification。Unauthorized operation will result in license revocation and criminal prosecution.。
meeting。Make an appointment for inspection during the license application stage；After the cards are dealt，Inspectors may enter licensed premises at any time without notice，View transaction account、Take inventory and check temperature and humidity records。It is illegal to refuse to cooperate。
According to section 36 of the Pharmacy and Poisons Regulations，All accounts involving the purchase and sale of pharmaceutical products、Receipts and vouchers must be kept for at least 2 years from the transaction date，and the record must contain the batch number，To facilitate drug traceability and recall。
will face serious criminal consequences。Failure to keep or produce records as required is a statutory offense，The Department of Health usually refers directly to the Department of Justice for prosecution。Companies can be fined heavily，The directors and responsible persons involved may be imprisoned，And the license will be revoked immediately。
If the documents submitted by the applicant are 100% complete and the warehouse facilities are fully up to standard，The performance commitment of the Department of Health is to approve and issue the license within 2 months from the date of confirmation of receipt of the complete application.。However, if it involves complex situations or fails the inspection,，The time will be extended accordingly。
need。On the basis of wholesaler license，If dealing in antibiotic substances，An additional antibiotic license must be applied for；If you deal in Part I or Part II dangerous drugs under the Dangerous Drugs Ordinance，An additional license to supply dangerous drugs wholesalers is required，Each has independent costs。
