HONG KONG DRUG LICENSING
Hong Kong Drug Licence FAQs
Search 500 Hong Kong drug licence FAQs on applications, personnel, premises, quality systems, ongoing regulation, renewals and acquisitions.
Information status: The original FAQ material dates from 2025 and is provided for topic-based reference; it does not represent an individual verification of all 500 FAQs against current rules. For application, fee, renewal, change, product or prescription requirements, please refer to the current official forms and guidance.
Official information from the Drug Office Official information from the Chinese Medicines Board
找到 500 条结果，第 15／25 页。每页显示 20 条；无需启用 JavaScript。
Q281 · 如果我的公司是初创企业，香港政府有没有提供针对药品行业的财务资助或贷款计划？独立链接
To support local SMEs and the development of innovation and technology, the Hong Kong Government has established various funding schemes, some of which may be relevant indirectly to the pharmaceutical sector. For example, the SME Financing Guarantee Scheme (SFGS) may help you obtain a higher loan amount from a commercial bank. If your business involves innovative technology, such as a new medicine delivery system or the use of artificial intelligence for quality control, you could consider applying for a project under the Innovation and Technology Fund (ITF). However, it should be made clear that Hong Kong currently has no direct financial subsidy specifically for ‘setting up a pharmacy or pharmaceutical wholesaler’. These schemes are generally open to a wide range of applicants, and you will need to frame your business as a project that meets the relevant eligibility criteria.
Q282 · 在做财务预测时，我应该如何设定一个实际的药品销售毛利率？独立链接
Setting a realistic gross profit margin for medicine sales is central to financial forecasting. This rate varies widely in the pharmaceutical sector, depending on your business type and product mix. Wholesalers or pharmacies dealing in patented and branded medicines may achieve higher margins of 15% to 30% because of brand premiums. Margins may be lower, at 5% to 15%, for generic medicines or ordinary health products in highly competitive markets. Margins may be higher for proprietary Chinese medicines, particularly products with exclusive formulations. A practical approach is to review the financial performance of comparable competitors in the market (if they are listed companies) and set a rate based on this together with your procurement costs and pricing strategy.
Q283 · 我的药房需要安装一套POS和库存管理系统，这部分的预算应该怎么规划？独立链接
When budgeting for a pharmacy point-of-sale (POS) and inventory management system, several aspects need to be considered: 1. “Software licence fees”: these may be paid as an annual subscription (SaaS model) or as a one-off purchase. For a small or medium-sized pharmacy, the annual subscription may range from several thousand to 20,000 HKD. 2. “Hardware costs”: including cash registers, barcode scanners, receipt printers, and computers and servers for back-office management. This may require a one-off investment of 10,000 to 50,000 HKD. 3. “Implementation and training fees”: the software supplier may charge an initial fee for system installation, data import and staff training. 4. “Ongoing maintenance fees”: under a perpetual licence model, an annual maintenance fee of 15-20% of the total software price is usually payable for technical support and software updates.
Q284 · 如果我的药品批发业务需要冷链运输（Cold Chain Logistics），这会增加多少成本？独立链接
Cold-chain transport is the most costly part of pharmaceutical logistics and can significantly increase your operating expenses. The additional costs are mainly as follows: 1. “Specialist transport vehicles”: you will need dedicated vehicles fitted with refrigeration units and temperature and humidity data loggers. Their purchase and maintenance costs are far higher than those of ordinary lorries. 2. “Validation and calibration”: refrigerated vehicles and cold-chain facilities in warehouses require regular temperature mapping and equipment calibration. 3. “Packaging materials”: validated shippers and coolants must be used; these are consumables. 4. “Higher transport charges”: if you outsource to a third-party logistics company, cold-chain services typically cost 50% to 200% more than ordinary freight transport.
Q285 · 我是否需要为我的药品业务购买商业保险？主要应覆盖哪些方面？独立链接
Yes, purchasing comprehensive commercial insurance for your medicine business is an essential risk-management measure. You should focus on the following types of insurance: 1. “Public Liability Insurance”, which provides cover for compensation claims for third-party personal injury or property damage arising from your business activities (for example, a customer slipping in your shop). 2. “Product Liability Insurance”, which is of central importance and covers compensation claims for injury to users caused by defects in products you sell. 3. “Property All Risks Insurance”, which covers your assets, such as your shop, warehouse, equipment and inventory, against losses caused by events such as fire, theft and flooding. 4. “Employees' Compensation Insurance”, which is compulsory by law and is commonly known as employees' compensation insurance.
Q286 · 如果我的业务失败，需要清盘关闭公司，这过程会产生哪些费用？独立链接
If the business unfortunately fails and the company has to be wound up, the process itself will also incur a range of costs. The main costs include: 1. “Liquidator’s fees”: you will need to appoint a practising accountant or lawyer as liquidator to handle all the company’s outstanding affairs, and their professional service fees will be a major expense. 2. “Asset disposal costs”: appraisals and commissions may be incurred when liquidating stock and selling assets such as shelving and equipment. 3. “Severance payments”: under the Employment Ordinance, you will need to pay severance pay or long service payments to eligible employees. 4. “Government fees”: fees for filing various documents with the Companies Registry. 5. “Legal and accounting fees”: professional fees for handling debts, tax clearance and other matters. The process may take several months, and costs may reach tens of thousands to hundreds of thousands of Hong Kong dollars.
Q287 · 在财务上，如何区分“资本开支”（CAPEX）和“运营开支”（OPEX）？这对我的税务有何影响？独立链接
In financial and tax planning, it is crucial to distinguish correctly between “capital expenditure” (Capital Expenditure, CAPEX) and “operating expenditure” (Operating Expenditure, OPEX). CAPEX refers to long-term investments to acquire or improve fixed assets, such as purchasing property, carrying out major renovations or buying expensive production equipment. These expenses cannot be deducted in full in the year incurred; instead, they are deducted over the asset's useful life through annual “depreciation” or “allowances”. OPEX refers to expenses incurred to maintain day-to-day operations, such as staff salaries, rent, utilities and medicine purchasing costs. These expenses can be deducted in full from assessable profits in the year of assessment in which they are incurred.
Q288 · 我计划同时经营西药批发和中成药批发，是否需要为这两个业务设立独立的财务账目？独立链接
Although the law does not require separate legal entities or bank accounts for different business lines within the same company, from a management and compliance perspective we strongly recommend setting up separate “cost centres” or “profit centres” in your accounting system for wholesale of western medicines and wholesale of proprietary Chinese medicines. This means you should be able to track and distinguish clearly the sales revenue, procurement costs, inventory value and related operating expenses for each. This gives you a more detailed management perspective and allows you to assess the profitability of each business area accurately.
Q289 · 药品库存是我的重要资产，在财务上应该如何进行估值？这对我的财务报表有何影响？独立链接
Medicine inventory is usually classified as “inventory” in the financial statements and is an important current asset. Under Hong Kong accounting standards, inventory should be valued at the lower of cost and net realisable value. “Cost” usually refers to your purchase cost and may be calculated using the first-in, first-out (FIFO) or weighted average cost method. “Net realisable value” is the estimated selling price less the related costs of sale. If, for reasons such as medicines nearing expiry or falling market prices, net realisable value falls below your purchase cost, you must make an inventory write-down provision and recognise the loss in the current income statement, thereby reducing your reported profit and asset value.
Q290 · 作为公司董事，我是否需要为公司的债务承担个人责任？在财务上如何规避这种风险？独立链接
In Hong Kong, the main advantage of operating as a “limited company” is the shareholders’ “limited liability”. In ordinary circumstances, as a company director or shareholder, you are not personally liable for repayment of the company’s debts. The company’s creditors can claim only against the company itself, and your loss is limited to the share capital you have invested. However, this protection is not absolute. If you are required to provide a “personal guarantee” when applying for a bank loan or other credit for the company, the bank will be entitled to claim the debt from you personally if the company is unable to repay it.
Q291 · 在进行财务规划时，我应该如何考虑“通货膨胀”对长期运营成本的影响？独立链接
When undertaking long-term financial planning (for example, over 3 to 5 years), you must consider the impact of inflation; otherwise, your budget will soon become disconnected from reality. Inflation pushes up operating costs across the board, including staff salaries (employees will seek increases to offset the rising cost of living), rent (landlords may raise it on renewal), utility bills and the cost of some locally sourced materials. A simple and effective approach is to set a reasonable annual growth rate for operating expenses in your financial forecast for each future year, for example, by reference to Hong Kong’s average inflation rate over the past few years (usually around 2–3%), and increase the figures accordingly.
Q292 · 如果我的药品业务涉及跨境电商，其收款和结汇过程会产生哪些额外费用？独立链接
Selling medicines overseas through cross-border e-commerce platforms involves a range of additional payment collection and foreign exchange conversion costs not found in traditional trade. These costs mainly include: 1. ‘Payment gateway fees’: international payment services such as Stripe and PayPal charge a percentage of the transaction amount (typically around 2.9% plus a fixed fee). 2. ‘Platform commission’: if you sell through a third-party e-commerce platform such as Amazon or Tmall Global, the platform takes 5% to 15% of sales as commission. 3. ‘Currency conversion fees’: banks or payment platforms charge a conversion spread or fee when converting foreign currency sales proceeds into Hong Kong dollars. 4. ‘Withdrawal fees’: a fixed fee may apply when withdrawing funds from a payment platform account to your Hong Kong bank account.
Q293 · 我应该如何设定我的药品零售价格？是成本加成法定价好，还是参考市场定价好？独立链接
Setting retail prices for medicines is a complex decision that involves balancing multiple factors; there is no single “best” method. Common strategies include: 1. Cost-plus pricing, which adds a fixed gross margin to your purchase cost. This approach is simple and straightforward, and ensures each transaction makes a profit, but may not maximise profits. 2. Market-oriented pricing, which takes as a reference the prices charged by your main competitors for the same medicine. This approach ensures that your prices are competitive, but if your costs are higher than theirs, it may result in slim margins or even losses. A mature pricing strategy generally combines the two approaches and adjusts prices according to different product characteristics, such as exclusivity and brand recognition.
Q294 · 我的公司需要进行年度审计，聘请会计师事务所的费用大概是多少？独立链接
In Hong Kong, the fees charged by a practising accountancy firm for a company’s annual audit mainly depend on the scale of its business and the complexity of its transactions. For a small or medium-sized pharmaceutical wholesaler or retailer with annual turnover of several million Hong Kong dollars and a simple business model, the annual audit fee is usually between HK$8,000 and HK$20,000. If your company is larger, with annual turnover reaching tens of millions of Hong Kong dollars, or engages in complex international trade or transactions in multiple currencies, the audit fee may rise to tens of thousands or even more than HK$100,000. The fee usually also includes preparing and submitting your profits tax return.
Q295 · 在财务上，我应该如何规划和管理公司的现金流？为什么它比利润更重要？独立链接
Cash flow planning and management are the lifeblood of a business and are even more important than profit. A company can make no profit in the short term, but without cash for even one day it may fail. Effective cash flow management includes: 1. Preparing a cash flow forecast to estimate monthly cash inflows (such as sales receipts) and outflows (such as rent, salaries and payments for goods) over the next 6 to 12 months, so that future funding gaps can be anticipated. 2. Accelerating collection of receivables to recover payments from customers promptly. 3. Managing payables by making reasonable use of credit terms without damaging supplier relationships. 4. Maintaining a healthy cash reserve by keeping enough cash in the bank to cover 3 to 6 months of operating costs and meet unexpected events.
Q296 · 如果我的药房接受医疗券或保险公司的直接结算，这在财务处理上有什么需要注意的？独立链接
Accepting health vouchers or offering direct settlement with insurance companies can be a good way to attract customers, but particular care is needed in financial administration: 1. “Increased accounts receivable”: unlike cash transactions, you need to submit claims to the government (the health voucher scheme) or insurance companies to receive payment. This process usually takes several weeks or even months and ties up cash flow. 2. “Additional administrative work”: you need dedicated staff to process and reconcile these claims, ensure they are accurate and track payment progress. 3. “Potential bad-debt risk”: some claims may not be recovered if the documents submitted do not meet requirements or there is a dispute over the terms with the insurance company. You should set up a dedicated subsidiary ledger for these receivables in your accounting system.
Q297 · 在香港，药品经营企业处置过期或不合格药品，其相关的财务成本和程序是怎样的？独立链接
In Hong Kong, the disposal of expired or non-conforming medicines is a strictly regulated process that incurs costs. These medicines must be handled as “chemical waste” by a waste collector holding a specific licence issued by the Environmental Protection Department (EPD). The main costs are: 1. “Collection and transport fees”: the waste collector will charge according to the weight or volume of the waste. 2. “Treatment fees”: depending on the chemical properties of the medicines, special methods such as incineration may be required, at a higher cost. 3. “Administrative costs”: staff time is needed to segregate and record the waste and arrange its disposal. In the financial statements, the book value of medicines written off in this way must be fully written off as an operating loss for the current period.
Q298 · 如果我计划未来将公司出售或寻求上市，在财务规划上需要从早期就注意哪些方面？独立链接
If you have a long-term exit plan, such as being acquired or listing through an IPO, you must plan and manage your finances to the highest standards from the first day the company is established. Key points include: 1. “Clear and orderly accounts”: appoint a reputable accounting firm to ensure that every account is clear, compliant and able to withstand the most rigorous due diligence. 2. “Sound internal controls”: establish and enforce strict internal control procedures covering procurement, sales, inventory, financial approvals and all other areas. 3. “Impeccable compliance record”: maintain a clean record in all areas, including tax, employment and pharmaceutical regulation, with no material breaches. 4. “Clear shareholding structure”: avoid complex, opaque shareholding arrangements.
Q299 · 在制定年度预算时，我应该采用“增量预算”还是“零基预算”的方法？独立链接
When preparing an annual budget, you can choose from different approaches. The most common are incremental budgeting and zero-based budgeting. Incremental budgeting makes small adjustments to the previous year’s budget or actual expenditure based on expected changes, such as inflation or business growth. It is simple and quick, and suits established businesses with stable business models and little change in their operating environment. Zero-Based Budgeting (ZBB) requires every department or item of expenditure to start from “zero” in each new budget cycle and justify its necessity and reasonableness again. This approach is more complex and time-consuming, but can effectively prevent waste of resources and is suitable for companies requiring in-depth cost control or business restructuring.
Q300 · 作为药品公司的创始人，我应该给自己发多少薪水？这在财务和税务上有什么讲究？独立链接
As a founder, setting your own salary requires balancing your personal needs, the company's interests and tax implications. The key is reasonableness. For tax purposes, the salary you pay yourself is treated as an operating expense of the company and may be deducted from assessable profits. However, this deduction is conditional on the salary being “reasonable”, having regard to your responsibilities as a company executive, industry salary levels and the company's ability to pay. If the salary is excessive and far above the market rate, the Inland Revenue Department may challenge its reasonableness and treat the excess as a “disguised dividend”, disallowing it as an expense deduction.