top of page

Setting Up of Wholesale Medicines Company

Updated: Dec 23, 2023

Setting Up of Wholesale Medicines Company

Wholesale Dealer Licence Required for Poisons and Pharmaceutical Products

  • Companies engaging in wholesale dealing of poisons or pharmaceutical products must obtain a Wholesale Dealer Licence.

Products to Handle

  • Pharmaceutical Products

  • Advanced Therapy Products

  • Medical Devices

  • Industrial Chemicals

  • Hair Dyes

Key Definitions:

  • Poison: A substance (or preparation containing it) listed in the Poisons List under the Pharmacy and Poisons Ordinance (PPO) (Cap. 138).

  • Pharmaceutical product: A substance or combination of substances defined in Section 2 of the PPO as:

  • Having properties for treating or preventing disease in humans or animals.

  • Used or administered to humans or animals to:

  • Restore, correct, or modify physiological functions.

  • Make a medical diagnosis.

  • Includes advanced therapy products.

Relevant Legislation:

  • Pharmacy and Poisons Ordinance (PPO), Cap. 138

  • Section 2 of the PPO (definition of "pharmaceutical product")

Setting up a wholesale medicines company in Hong Kong involves several legal and regulatory steps to ensure compliance with the Pharmacy and Poisons Ordinance (Cap. 138). Here's a comprehensive guide to navigate the process:

1. Business Registration:

  • Company Incorporation: Register your company with the Companies Registry. You can choose a sole proprietorship, partnership, or limited liability company structure.

  • Business Registration Certificate: Obtain a Business Registration Certificate from the Inland Revenue Department for tax purposes.

2. Wholesale Dealer Licence:

  • Application: Apply for a Wholesale Dealer Licence (WDL) from the Drug Office of the Department of Health. The WDL authorizes you to wholesale pharmaceutical products in Hong Kong.

  • Person in Charge (PIC): Appoint a Person in Charge (PIC) responsible for overseeing the WDL compliance. The PIC must have relevant qualifications and experience in pharmaceutical wholesale.

  • Premises: Secure suitable premises that meet the Drug Office's storage and security requirements for medicines.

  • Secure and climate-controlled storage: Adequate lockable facilities with appropriate temperature and humidity are mandatory within the premises. If not available, a written explanation and details of an alternative secure, controlled storage facility at another location, including routine maintenance and monitoring plans, must be provided. The Committee will consider these applications on a case-by-case basis.

  • Documentation: Provide necessary documents, including business plans, financial statements, floor plans, and qualifications of the PIC.

Demonstrations of relevant work experience: Provide official certifications and/or testimonials from previous employers that showcase your skills and accomplishments in areas related to this position.

If your storage facilities are located off-site, please provide one of the following documents as proof of access and control:

  1. Branch Business Registration Certificate: Show a copy of your company's Business Registration Certificate for the other premises where the storage facilities are located. (Imagine a document displaying your company name, business registration number, and the address of the off-site storage facility.)

  2. Tenancy Agreement: If you lease the storage space, provide a copy of your Tenancy Agreement outlining the terms of your occupancy at the other location. (Picture a document specifying your company as the tenant, the owner of the off-site premises as the landlord, and the agreed-upon usage rights for the storage facility.)

  3. Logistics Services Agreement: In case you utilize a third-party logistics provider for off-site storage, submit a copy of your Logistics Services Agreement demonstrating the contractually agreed upon use of the storage space. (Think of a document detailing the services provided by the logistics company, including secure storage for your poisons and pharmaceutical products.)

Required Floor Plans:

  1. Overall Floor Plan: Show the entire floor where your business operates, including the location of the premises within the floor.

  2. Premises Layout: Provide a detailed plan of your business premises, highlighting areas like storage, dispensing, and administration.

Storage Facilities:

  1. On-site Storage Layout: If your storage facilities are located within the premises, provide a dedicated plan showing their layout and location within your overall layout.

  2. Off-site Storage Layout (if applicable): If your storage is at another location, submit a plan of the entire floor and a detailed layout of the storage facilities, similar to on-site requirements.

Additional Information for Cold Storage:

  • If your storage involves a cold room, pharmaceutical refrigerator, or freezer, please submit trading documents for the relevant cold chain products. This helps us verify proper temperature control for sensitive items.

For each storage facility you use for poisons or pharmaceutical products, provide the following documentation:

1. Accurate Temperature and Humidity Monitoring:

  • Calibration Certificates:

  • calibration certificate

  • Submit calibration certificates for all hygrothermometers, issued by the manufacturer or an accredited laboratory (HOKLAS, CNAS, or MRA partners).

  • Uniformity Assessment and Daily Monitoring:

  • temperature and humidity monitoring device

  • Conduct a temperature and humidity uniformity assessment, explaining the rationale for chosen monitoring locations.

  • Maintain daily records of temperature and humidity at designated locations, starting after the assessment.

2. Clean and Pest-Free Environment:

  • Cleaning Procedures and Records:

  • cleaning checklist

  • Establish clear cleaning procedures, specifying items and frequency.

  • Keep accurate records of cleaning activities.

  • Pest Control Procedures and Records:

  • pest control log

  • Implement pest control procedures, detailing methods and frequency.

  • Maintain records of pest control activities.

Demonstrate Your Business Scope:

  • Provide documents showcasing your offer for sale and purchase of poisons/pharmaceutical products.

Choose Your Category:

(a) Import/Export Only:

  • Importing: Submit price quotations or proforma invoices from overseas suppliers, along with relevant product information. Think of photos showing the product packaging with details like ingredients, dosage, and storage conditions.

  • Exporting: Prove your overseas buyer's legitimacy. Provide their enquiry with your price quotations and documentation showing their legal authorization to handle the products.

(b) Local Distribution Involved:

  • Product Certificate Holder: If you hold a product certificate for a pharmaceutical product, show a copy of the certificate and relevant product information (again, imagine photos of the packaging with details).

  • No Product Certificate: If you don't hold a certificate, submit a copy of the product's registration certificate, alongside an agency agreement/appointment letter from the certificate holder and product information like the photos mentioned before.

  • Non-Pharmaceutical Products: If you deal in non-pharmaceutical products, provide an agency agreement/appointment letter from your supplier, along with product information, including photos of the packaging and details like ingredients and storage conditions.

Following a premises inspection by a pharmacist inspector and an interview with the applicant's designated responsible person(s), the Wholesale Dealer Licence Committee will consider the application. The Committee's decision will be guided by (but not limited to) the inspection results, which assess the suitability of the premises, and the interview results, which evaluate the fit and knowledge of the person(s) responsible for managing poisons and pharmaceuticals.

3. Additional Permits (if applicable):

  • Antibiotics Permit: If you intend to wholesale antibiotics, you need a separate Antibiotics Permit from the Drug Office.

  • Dangerous Drugs Permit: For dealing with dangerous drugs, a Dangerous Drugs Permit is required.

4. Good Wholesale Practice (GWP):

  • Implement Good Wholesale Practice (GWP) guidelines to ensure proper storage, handling, and distribution of medicines. This includes maintaining temperature and humidity control, segregation of different drug categories, and proper record-keeping.

5. Qualified Personnel:

  • Employ qualified personnel such as registered pharmacists and pharmacy technicians to handle and manage medicines according to regulations.

6. Ongoing Compliance:

  • Regularly update the Drug Office of any changes in your business, such as PIC, premises, or scope of business.

  • Be prepared for inspections by the Drug Office to ensure compliance with GWP and licensing conditions.

Processing Time

Expect a processing time of around 2 months for the WDL application, provided all required documents are submitted and adequate storage facilities are demonstrated.

Prescribed Fee

Wholesale Dealer Licence: HK$625

Additional Resources:

Compliance with regulations is crucial to avoid penalties and ensure the safe and ethical operation of your wholesale medicines company.

Seeking Professional Help

Consulting with Bestar accountant can be extremely helpful when setting up your wholesale medicines company. We can guide you through the legal and regulatory complexities, ensuring you comply with all necessary requirements.

Bestar has a team of experienced accountants who are well-versed in the pharmaceutical industry in Hong Kong. We can provide you with a range of services, including:

  • Business registration: Helping you register your company and obtain the necessary licenses and permits.

  • Taxation advice: Advising you on the tax implications of your business and helping you comply with Hong Kong tax regulations.

  • Financial planning and budgeting: Assisting you with financial planning and budgeting to ensure your business is viable.

  • Accounting and bookkeeping: Maintaining your accounting records and preparing financial statements.

  • Regulatory compliance: Advising you on and helping you comply with all relevant pharmaceutical regulations in Hong Kong.

Consulting with Bestar professional can save you time, money, and stress in the long run. We can help you avoid costly mistakes and ensure that your business is compliant with all the necessary regulations.

Here are some of the benefits of consulting with Bestar professional accountant when setting up a wholesale medicines company in Hong Kong:

  • Access to expertise: Bestar accountants have a deep understanding of the legal and regulatory landscape in Hong Kong, as well as the specific requirements for the pharmaceutical industry.

  • Save time and money: Bestar accountants can handle all the paperwork and filings for you, freeing you up to focus on running your business.

  • Peace of mind: Knowing that your business is compliant with all the necessary regulations can give you peace of mind and allow you to focus on growing your business.

If you are considering setting up a wholesale medicines company in Hong Kong, contact Bestar professional accountant. We can help you navigate the process smoothly and ensure that your business is a success.

13 views0 comments


bottom of page