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

What specific standards does the Department of Health require for records of medicine receipts and supplies, and how long must they be kept?

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

Q353 · Category H: Licensed operations and routine regulatory oversight (Q351–Q400)
Records of medicine receipts and issues are central to the medicine traceability system and a key focus of regulatory inspections. Under the requirements, records of all receipts and issues of Part I poisons and dangerous drugs in Schedules 1 and 3 must be detailed and accurate. The specific standards are as follows: for purchases (receipts), records must include the purchase date, medicine name, dosage form, strength, quantity, and supplier’s name and address. For sales (issues), records must include the sale date, medicine name, dosage form, strength, quantity, and purchaser’s name and address. Each transaction should be supported by a corresponding invoice or document. All records must be maintained legibly and indelibly, whether in paper ledgers or an electronic system. They must be entered as soon as possible after each transaction and retained for at least two years from the date of the last entry.

📘 Regulatory basis

The Pharmacy and Poisons Regulations (Cap. 138A) set out clear requirements for the sale of poisons and record-keeping. Section 28 specifies in detail the information that must be included in a Poisons Register. The Code of Practice for Wholesale Dealers in Poisons also provides detailed guidance on this.

📗 Drew Tang's recommendations

We strongly recommend that clients use an electronic inventory management system that complies with Good Distribution Practice (GDP). This helps ensure the accuracy and integrity of records and enables reports to be generated quickly when needed, greatly simplifying traceability and stocktaking. When selecting a system, ensure that it has access controls and tamper-proof functions to meet regulatory requirements. Rengangyongsheng (Hong Kong) Limited can recommend a suitable system and help you implement it.

📕 Risk notice

Inaccurate or incomplete receipt and dispatch records are among the most common breaches by wholesalers. This not only affects pharmaceutical traceability, but may also prevent you from establishing the extent of your responsibility if a pharmaceutical safety issue arises. If seriously inaccurate records are identified during an inspection, this may be grounds for revoking the licence.

Back to Category H: Licensed Operations and Routine Oversight (Q351-Q400) Search more questions

YOUR NEXT STEP

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.

Book a Project Assessment ↗