Chapter 12: Premises Requirements and Warehouse Planning
Hello to everyone aspiring to engage in the pharmaceutical business in Hong Kong! I am Drew Tang. RGYS may assist with document preparation and project coordination within the written scope of services; personnel qualifications, statutory roles and professional judgements are to be verified and assumed by the respective responsible parties, while approval is determined independently by the competent authority. RGYS may assist with document preparation and project coordination within the written scope of services; personnel qualifications, statutory roles and professional judgements are to be verified and assumed by the respective responsible parties, while approval is determined independently by the competent authority. The Department of Health's Drug Office scrutinises premises extremely strictly, and overlooking any detail may delay an application or even cause it to fail. In this chapter, I will explain in detail the specific requirements for premises and warehouse planning for pharmaceutical operations in Hong Kong, particularly for wholesale dealer licences, helping you take the right approach from the outset.
12.1 Site selection and basic layout of wholesale premises
First, choosing suitable premises is crucial. Under the Department of Health’s Good Distribution Practice for Pharmaceutical Products and Substances, a pharmaceutical wholesaler’s premises must be in a commercial or industrial building and must not be a residential unit. This is to ensure professional and safe business operations and avoid affecting residents.
The independence of the premises is another focus of the assessment. Your pharmaceutical business area must be physically separated from other businesses (even other businesses operated by your own company), with a separate entrance and storage space. Although the legislation does not specify a minimum floor area, based on our experience, a fully functional wholesaler’s premises—including an office, warehouse, receiving area and dispatch area—needs a usable floor area of at least 80–100 square metres (about 800–1,000 square feet) to meet basic operational needs and support future development.
Core principle underpinning the Pharmacy and Poisons Ordinance (Cap. 138): to ensure the safety, efficacy and quality of medicines. Compliant premises are the first physical safeguard for achieving this objective. Drug Office inspectors begin with the premises layout plan and carefully check that each facility meets the requirements, ensuring that medicines remain under control throughout the distribution chain.
12.2 Detailed management of pharmaceutical storage areas
Storage area planning is central to premises design. A compliant medicine warehouse must have clearly defined zones to prevent cross-contamination and mix-ups. Basic zones should include: a receiving area, a quarantine area, an approved storage area, a rejected area, a returned goods area and a dispatch area. Each area should be clearly labelled, with material movement procedures strictly followed.
Temperature and humidity control is the lifeline of medicine storage. The premises must be equipped with a system that continuously monitors and records temperature and humidity. Unless the medicine label specifies otherwise, the storage temperature is generally required to be kept below 25°C, with relative humidity maintained below 65%. Medicines requiring refrigeration (such as vaccines and some biologics) must be stored in dedicated refrigerators or cold rooms, with the temperature kept stable between 2°C and 8°C. All temperature-control equipment must be calibrated regularly, and complete records must be retained for inspection.
Risk alert: lapses in cold-chain management
Cold-chain medicine management is a major focus of inspections. Any temperature excursion may result in an entire batch of medicines being destroyed, causing substantial financial losses. We have had clients whose medicines, worth hundreds of thousands, had to be destroyed because a refrigerated cabinet lost power overnight and the failure was not detected in time. A 24-hour temperature monitoring system with remote alarms is therefore an essential investment.
12.3 Facility, equipment and environmental security standards
In addition to the core storage areas, the premises’ ancillary facilities are equally important. A comprehensive pest and rodent control and cleaning programme must be established and implemented. This involves more than simple cleaning: regular professional pest control services are required, and all service reports must be retained. The entire premises, particularly the storage areas, must be kept clean and tidy, with no standing water or accumulated clutter.
A security system is another line of defence for medicine safety. The premises should have a reliable intruder alarm system, with access control for all entrances and exits. In particular, for businesses handling dangerous drugs listed under the Dangerous Drugs Ordinance (Cap. 134), the Drug Office will require a higher level of security, such as a 24-hour CCTV system connected to a security company and dangerous drugs kept in a robust, locked safe.
Drew Tang’s advice: best practices beyond the minimum requirements
When planning your security system, I recommend that you go beyond merely meeting the minimum requirements. Consider installing an electronic access control system that records the entry and exit times of all personnel. This not only enhances security but also provides valuable data to support your medicine traceability management. Install high-definition cameras in key areas, such as the goods-receiving area and controlled medicines storage area, to deter potential theft and provide evidence for investigations if an incident occurs.
Comparison of premises area and facility requirements for different licence types
| Licence types | Recommended minimum practical area | Key facility requirements |
|---|---|---|
| Wholesale Dealer Licence | 80–100 square metres | Separate office and warehouse, temperature and humidity monitoring system, clearly defined storage zones (quarantined, released, non-conforming, etc.) and a compliant security system. |
| Authorised Seller of Poisons (ASP) (Pharmacy) | 40–60 square metres | A separate dispensary, medicine storage cabinets, refrigeration equipment, a dangerous drugs safe and a patient consultation area that meets privacy requirements. |
| Listed Seller of Poisons (LSP) (medicine shop) | 20–30 square metres | Medicines must be stored in an area that customers cannot access directly, in locked storage cabinets, with basic anti-theft measures in place. |
In short, compliant premises are the “hardware” of your business and your first calling card for demonstrating professional competence and a sense of responsibility to the regulator. Before leasing and fitting out premises, I strongly recommend discussing your floor plans in depth with professional consultants such as ourselves. We can help you avoid many common mistakes. RGYS may assist with document preparation and project coordination within the written scope of services; personnel qualifications, statutory roles and professional judgments are to be verified and assumed by the respective responsible parties, and approval is decided independently by the competent authority.