Hong Kong Drug Licence Applications and Acquisitions · RGYS|Global Licensing and Compliance Service Provider
Hong Kong pharmaceutical compliance · applications / acquisitions / ongoing maintenance Independent Third-Party Service Provider
HONG KONG DRUG LICENSING

Once I have obtained a licence, is everything taken care of? What do I still need to do on an ongoing basis?

A complete explanation of the regulatory basis, Drew Tang’s recommendations and risk alerts. The original material dates from 2025; read it alongside the latest official requirements.

Original guide, 2025 edition: These FAQs are provided for topic-based reference and have not all been individually checked against current rules. Please confirm fees, personnel, renewal, changes and product requirements against the professional in-depth guide for the relevant licence type and the official requirements in force at the time.

Drug Office, Department of Health Chinese Medicines Board

Q100 · Category B: Licence types and scope of application (Q51–Q100)
Obtaining a licence is only the beginning of compliant business operations; it does not mean you can take things for granted. Holding a licence means that you undertake to comply with all relevant laws, regulations and codes of practice on an ongoing, day-to-day basis. You will need to carry out substantial ongoing compliance work, including: 1. **Record-keeping**: You must maintain complete, accurate and traceable records of every stage of medicine procurement, storage, sale and distribution, and retain them for the specified period. 2. **Staff training**: You must ensure that all employees involved in handling medicines receive initial and ongoing training appropriate to their duties. 3. **Facility maintenance**: You must maintain your premises and equipment regularly, particularly temperature and humidity control systems and security systems, to ensure they continue to operate effectively. 4. **Self-review**: You should conduct internal audits or self-inspections regularly to identify and correct potential compliance issues proactively. 5. **Inspections**: You must be ready at all times for routine or unannounced inspections by the Department of Health and cooperate fully.

📘 Regulatory basis

All relevant codes of practice, such as the Code of Practice for Wholesale Dealers in Pharmaceutical Products and the Code of Practice for Pharmacy, emphasise the importance of ‘ongoing compliance’. Whether a renewal application is approved depends directly on your compliance record over the preceding year.

📗 Drew Tang's recommendations

We view compliance as a dynamic, lifecycle-based management process. We provide clients with annual compliance consultancy services, not merely to help you obtain a licence, but more importantly to help you maintain a high level of compliance after the licence is granted through regular compliance reviews, staff training and regulatory updates. This allows you to focus on business development with confidence, without being distracted by complex compliance matters.

📕 Risk notice

“Focusing on applications and neglecting maintenance” is a common mistake among licence holders. They assume that obtaining a licence is the end of the matter and relax their day-to-day management. However, oversight by the Department of Health is ongoing. One unsatisfactory inspection could result in additional licence conditions, suspension or even revocation, undoing all your previous investment.

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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.

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