Q272 · As a licensed pharmaceutical company, are…

Q272 · Category F: Fees, Budget and Financial Planning (Q251-Q300)

As a limited company registered in Hong Kong, you must first comply with the basic requirements of the Companies Ordinance: appoint a Hong Kong practising accountant each year to audit the company's financial statements, and submit the audit report and profits tax return to the Inland Revenue Department. Although there are no additional statutory format requirements for the routine financial reporting of pharmaceutical licence holders, in practice and during regulatory inspections your financial records must clearly support your compliance. For example, your purchasing records must trace each batch of medicines to its lawful source and cost; sales records must be clear; and stocktake records must reconcile with the inventory value in your financial statements.

📘 Regulatory basis

The Companies Ordinance (Cap. 622) requires companies to keep accounting records and conduct an annual audit. The Department of Health also has the right to inspect records relating to medicine traceability during Good Distribution Practice (GDP) inspections, including financial documents for purchases and sales.

📗 Drew Tang's recommendations

We strongly recommend using professional accounting software and setting up dedicated accounts to record costs and income directly related to the pharmaceutical business. For example, record “medicine purchasing costs”, “losses from scrapped medicines” and “licence-related expenses” separately. This not only facilitates internal management, but also provides clear and compelling evidence in response to regulatory enquiries or tax audits.

📕 Risk notice

Disorganised financial records pose a serious compliance risk. If your financial statements cannot be reconciled with your medicine Stock Movement Record, the regulatory authority may suspect illegal procurement or sales. This could lead to a reassessment of your licence eligibility.

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang

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.

As a licensed pharmaceutical company, are there any special requirements for financial reporting?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang