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HONG KONG DRUG LICENSING

How should access by personnel to medicine storage areas be effectively controlled?

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

Q181 · Category D: Premises and Storage Requirements (Q151-Q200)
Access control in medicine storage areas is essential to safeguard medicines and prevent unauthorised access. An effective access control system should combine physical barriers with procedural controls. Physically, all entrances to storage areas should be locked and access restricted to authorised personnel. An electronic access control system (such as card or fingerprint access) is recommended instead of traditional keys. Electronic systems can assign different access permissions to each employee and generate detailed entry and exit records. Procedurally, a written Access Control Procedure must specify which roles have access and under what circumstances they may enter. Visitors, maintenance personnel and contractors, as well as other unauthorised persons, must be accompanied at all times by an authorised employee, and their identity, reason for visit, and entry and exit times must be recorded in a Visitor Register.

📘 Regulatory basis

Good Distribution Practice (GDP) requires that “unauthorised personnel must not enter storage areas”. Licence holders must therefore establish and implement effective security and access controls to protect stored medicines.

📗 Drew Tang's recommendations

We recommend that clients issue identification cards to all employees entering the storage area and require them to wear them while on duty. This helps identify authorised personnel. For special circumstances such as maintenance, issue time-limited temporary access cards and retrieve them immediately after the work is completed. Regularly reviewing access records for unusual entry or exit activity is an important part of proactive security management.

📕 Risk notice

A warehouse with no access controls and unrestricted entry is wholly non-compliant. This not only increases the risk of medicines being stolen, but also fails to prevent potential malicious damage or contamination. If a Department of Health inspection finds that anyone can freely enter and leave your pharmaceutical warehouse, your security management will be rated very poorly and your licence application will face significant difficulties.

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