HONG KONG DRUG LICENSING

Hong Kong Drug Licence FAQs

Search 500 Hong Kong drug licence FAQs on applications, personnel, premises, quality systems, ongoing regulation, renewals and acquisitions.

Information status: The original FAQ material dates from 2025 and is provided for topic-based reference; it does not represent an individual verification of all 500 FAQs against current rules. For application, fee, renewal, change, product or prescription requirements, please refer to the current official forms and guidance.

Official information from the Drug Office Official information from the Chinese Medicines Board

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Q9 · What is Good Distribution Practice (GDP), and what does it mean for pharmaceutical licence holders?Direct link

Good Distribution Practice (GDP) is a set of quality management standards for the wholesale and distribution of medicines. It aims to ensure that the quality and integrity of medicines are maintained throughout the supply chain, from the manufacturer to the final retail outlet. GDP covers every aspect of medicine distribution, including establishing a quality management system; personnel qualifications and training; premises and equipment requirements, particularly storage conditions such as temperature and humidity control; order processing; receipt; storage; picking; dispatch; handling returns; and monitoring transport. For holders of a “wholesale dealer licence” in Hong Kong, compliance with GDP is not optional but a mandatory legal requirement. The Drug Office, Department of Health, conducts regular inspections of licensed wholesalers against GDP standards. Any serious GDP breach may result in the licence being suspended or revoked. GDP is therefore the fundamental operating standard for every wholesale medicines business.

📘 Regulatory basis

The Drug Office, Department of Health’s Good Distribution Practice for Pharmaceutical Products guideline is the main regulatory reference. It sets out in detail the standards and requirements that wholesalers must meet.

📗 Drew Tang's recommendations

Do not regard GDP as merely a pile of paperwork. It is a scientific management system. Effective implementation of GDP not only ensures compliance but can also improve operational efficiency, reduce errors, safeguard medicine quality and build customer confidence. We recommend that clients incorporate GDP requirements from the outset, beginning with warehouse selection and system development.

📕 Risk notice

The most common GDP oversights are incomplete temperature monitoring records, disorganised storage areas, and improper handling of returned and recalled pharmaceutical products. These details may seem minor, but any one of them could be treated as a major breach during an inspection by the Department of Health.

Q16 · Approximately how much does a pharmaceutical licence cost? Are there also annual maintenance fees?Direct link

Government fees for a Hong Kong pharmaceutical licence are relatively low, but the main costs arise from the upfront investment needed to meet compliance requirements. Taking the most common type, a Wholesale Dealer Licence, as an example, under the Pharmacy and Poisons Regulations the application fee for a first application is HKD 1,030. If the application is approved, the licence issuance fee is HKD 2,150. The licence is usually valid for one year, and the annual renewal fee is HKD 2,150. For a “Listed Seller of Poisons” licence, the application fee is HKD 455, while the licence fee and annual fee are calculated according to the rateable value of the shop. These are government fees only. In practice, the greater costs include leasing and fitting out a warehouse or shop to GDP/GSP standards, establishing a compliant Quality Management System (QMS), salaries for qualified key personnel (such as a responsible person or pharmacist), and any consultancy fees. Total upfront investment should therefore be budgeted in detail according to the scale of the business.

📘 Regulatory basis

Schedule 7 to the Pharmacy and Poisons Regulations sets out in detail the statutory fees for licence applications and renewals. The government fees are reviewed and adjusted periodically by the Government.

📗 Drew Tang's recommendations

When budgeting, do not consider government licence fees alone. Treat compliance investment as part of your fixed operating costs. A sound financial plan can ensure that your business operates sustainably and compliantly after obtaining a licence, avoiding breaches caused by funding problems.

📕 Risk notice

The annual licence fee must be paid on time. If the licence is not renewed by the due date, it will lapse. Any regulated activity carried out while the licence has lapsed constitutes unlicensed business and may have serious consequences. Be sure to set up renewal reminders.

Q23 · What specific physical requirements apply to premises, such as warehouses or shops, when applying for a pharmaceutical licence?Direct link

When applying for a pharmaceutical licence, the premises' physical facilities are a key focus of the Department of Health's assessment and must meet stringent standards to ensure medicine quality and safety. A wholesaler's warehouse must meet GDP requirements, including sufficient space for segregated storage (such as areas for quarantined goods pending examination, released goods, returned goods and recalled goods); smooth, easily cleanable walls, floors and ceilings; equipment for continuous monitoring and recording of temperature and humidity, particularly for medicines requiring cold-chain storage; and a reliable security system to prevent unauthorised access and theft. Retail pharmacies must have a separate dispensing area with sufficient space and work surfaces. Prescription medicines must be kept in an area inaccessible to the public, preferably in locked cabinets or drawers. A suitable refrigerator must be provided for medicines requiring refrigerated storage, and a security system must also be installed. All premises must be kept clean and tidy, with appropriate pest control measures.

📘 Regulatory basis

The Good Distribution Practice (GDP) for Pharmaceutical Products, the Code of Practice for Authorised Sellers of Poisons and other guidance documents set out detailed requirements for the physical conditions and facilities of different types of licensed premises.

📗 Drew Tang's recommendations

Before renovation, be sure to submit detailed plans to a professional adviser for review. Details such as air-conditioning outlet positions, the layout of temperature and humidity probes, and the height of dispensing counters may affect the inspection outcome. Planning in advance can help avoid costly rework.

📕 Risk notice

Non-compliant premises infrastructure is a common reason for delays or failure in licence applications. Temperature and humidity control is particularly important: if the system is unstable or records are incomplete, it is highly unlikely to pass inspection. This is one of the areas of greatest concern to the regulatory authorities.

Q36 · If I only want to centralise medicine procurement for my own chain of clinics, do I need to apply for a wholesale dealer licence?Direct link

This is a crucial structural issue. Under Hong Kong’s Companies Ordinance and the Department of Health’s licensing requirements, any entity carrying on business in Hong Kong must be registered for Business Registration in Hong Kong. For a pharmaceutical licence application, the applicant must be a Hong Kong-incorporated limited company or a non-Hong Kong company registered with the Companies Registry (that is, one with a Hong Kong branch). It is not possible to apply for a Hong Kong pharmaceutical licence directly in the name of an overseas company, such as a US or European corporate entity. The standard first step is therefore for your overseas parent company to establish a wholly owned subsidiary in Hong Kong. This Hong Kong subsidiary will be the legal entity applying for the licence, responsible for leasing premises and employing staff, and ultimately holding and operating the licence.

📘 Regulatory basis

The key issue here is the interpretation of “wholesale” under the Pharmacy and Poisons Ordinance. Department of Health guidance documents and past enforcement cases indicate that centralised procurement and distribution for independent downstream corporate entities is generally regarded as wholesale activity.

📗 Drew Tang's recommendations

For healthcare groups with multiple clinics or retail outlets, we recommend a comprehensive review of the compliance structure. In some cases, adjusting the company’s legal structure or procurement process can identify the most efficient medicine supply model while remaining compliant. We can assist with this type of structural planning.

📕 Risk notice

Using “group purchasing” as a pretext for unlicensed wholesale is a key area of regulatory concern. If it is found to constitute illegal wholesale, not only may the entity responsible for purchasing be prosecuted, but all the group’s clinics receiving the medicines may also be implicated for purchasing from an unlicensed supplier.

Q45 · What rules apply in Hong Kong to medicines dispensed following telemedicine consultations?Direct link

With the rise of remote consultations, the related issue of dispensing medicines has also attracted considerable attention. Hong Kong law and professional codes emphasise that standards of healthcare and medicines safety must not be lowered, regardless of the consultation format. According to the guidance of the Medical Council of Hong Kong, if a doctor considers it necessary to issue a prescription after a remote consultation, the doctor must ensure that the prescription is appropriate and supported by sufficient clinical grounds. Dispensing must still comply with the Pharmacy and Poisons Ordinance. This means that prescription medicines must be dispensed at a registered pharmacy by a pharmacist or under a pharmacist’s supervision. Doctors may send prescriptions securely by electronic means to the pharmacy designated by the patient, or the clinic may arrange delivery of the medicines to the patient. During delivery, the safety, integrity and privacy of the medicines must be ensured, and there must be a mechanism for verifying the recipient’s identity. The entire process must be clearly documented and traceable.

📘 Regulatory basis

The Hong Kong Medical Council’s Ethical Guidelines on Practice of Telemedicine and relevant announcements by the Pharmacy and Poisons Board provide a framework for dispensing medicines following remote consultations. The core requirement remains compliance with the Pharmacy and Poisons Ordinance provisions on the sale of prescription medicines.

📗 Drew Tang's recommendations

For platforms or clinics providing telemedicine consultations, establishing a compliant, closed-loop medicine delivery arrangement is key to success. We recommend working with a licensed pharmacy or pharmaceutical wholesaler to jointly design a “last-mile” delivery process consistent with the principles of GDP and GSP.

📕 Risk notice

Remote consultations must never be used as a shortcut to over-prescribe or bypass the professional role of a pharmacist. Prescribing high-risk medicines without a doctor having sufficient understanding of the patient, or a platform shipping prescription medicines directly from a warehouse to patients without the involvement of a pharmacy and pharmacist, carries substantial legal and safety risks.

Q48 · If I only provide warehousing or logistics services to pharmaceutical manufacturers, do I need to apply for a pharmaceutical licence?Direct link

Yes, it is highly likely to be required. Under Hong Kong's GDP requirements, a third-party logistics provider (3PL) that provides medicine storage and transport services must apply for a Wholesale Dealer Licence if its services form part of the medicine distribution chain. Merely providing a “warehouse” or “delivery vehicle” is not sufficient; you must establish a complete Quality Management System (QMS) that complies with GDP requirements. This includes appointing a qualified responsible person, qualifying your storage facilities and cold-chain vehicles, establishing Standard Operating Procedures (SOPs) for receiving, storage, picking, packing and transport of medicines, and having contingency plans for handling deviations and emergencies. The Department of Health considers the quality and safety of medicines to be critical at every stage of the supply chain. Therefore, even if you do not own the medicines, you assume responsibility for safeguarding their quality if you physically handle and store them, and are subject to regulation.

📘 Regulatory basis

The Department of Health’s Good Distribution Practice (GDP) for Pharmaceutical Products clearly states that it applies to all parties involved in pharmaceutical wholesale and distribution activities, including outsourced service providers. This means that third-party logistics companies also need to be licensed.

📗 Drew Tang's recommendations

For logistics companies, obtaining a pharmaceutical wholesaler licence is an important strategic upgrade that allows entry into a professional service sector with high barriers to entry and high added value. RGYS has extensive experience and can guide logistics companies in establishing GDP-compliant quality systems. 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.

📕 Risk notice

A pharmaceutical manufacturer that outsources storage or logistics to an unlicensed third-party company is committing a serious breach. As a manufacturer, you are responsible for ensuring that all outsourced service providers are properly qualified. A thorough compliance audit is essential before selecting a logistics partner.

Q54 · What specific requirements, such as area and facilities, apply to my warehouse when applying for a wholesale dealer licence?Direct link

The Hong Kong Department of Health has not specified a minimum area for a warehouse used for a “wholesale dealer licence” application. The key requirement is that the warehouse design and facilities must ensure the quality and safety of medicines. Specifically, the warehouse must have sufficient space for orderly storage and operations to avoid mix-ups and cross-contamination. It must also have effective temperature and humidity control and monitoring systems to ensure that storage conditions meet the requirements on medicine labels, particularly for medicines requiring refrigeration. Adequate security measures, such as burglar alarms and access controls, must be in place to prevent unauthorised access. Storage areas must be clearly separated from office, receiving and dispatch areas. Finally, appropriate facilities must be available to handle returned, expired or recalled medicines, with a dedicated quarantine area.

📘 Regulatory basis

The Code of Practice for Licensed Wholesale Dealers sets out detailed requirements for storage management, covering premises, equipment, temperature control, security and hygiene procedures. Department of Health officers will inspect strictly in accordance with this code during on-site audits.

📗 Drew Tang's recommendations

We recommend that clients choose warehouse space that allows flexible zoning. Before fitting out the premises, it is best to submit the design drawings to us or consult the Department of Health directly for preliminary acceptance before proceeding with the works. Start-ups may consider using a qualified third-party logistics (3PL) provider, which can greatly reduce initial capital investment and management complexity.

📕 Risk notice

Inadequate warehouse conditions are one of the most common reasons for an application to be delayed or refused. This is particularly true of temperature and humidity control: if records are incomplete or equipment is unstable, the assessment cannot be passed. After a licence is granted, failure to maintain compliant storage conditions on an ongoing basis may also cause difficulties at renewal.

Q58 · If my business involves both Western medicine and proprietary Chinese medicine wholesaling, do I need to apply for two separate licences?Direct link

Yes, you need to apply for two entirely separate licences. Western medicines and Chinese medicines are governed in Hong Kong by two different legal frameworks and regulatory authorities. Wholesale dealing in western medicines is regulated by the Pharmacy and Poisons Ordinance (Cap. 138), with applications reviewed and regulated by the Drug Office, Department of Health; you need to apply for a “Wholesale Dealer Licence”. Wholesale dealing in proprietary Chinese medicines is regulated by the Chinese Medicine Ordinance (Cap. 549), with the Chinese Medicine Regulatory Office (CMRO) under the Department of Health responsible; you need to apply for a “Wholesale Dealer Licence for Proprietary Chinese Medicines”. The application requirements, assessment criteria and requirements for personnel and facilities differ, and the licences are not interchangeable.

📘 Regulatory basis

The Pharmacy and Poisons Ordinance (Cap. 138) and the Chinese Medicine Ordinance (Cap. 549) are two parallel legal regimes that separately regulate businesses dealing in Western medicines and Chinese medicines. Applicants must meet the requirements of both regimes to lawfully deal in both types of products.

📗 Drew Tang's recommendations

If your warehouse is intended to store both Western medicines and proprietary Chinese medicines, you must establish clearly separated areas to prevent cross-contamination and mix-ups. Applications for the two licences can be made at the same time, but two separate sets of application documents must be prepared. We will assist you in ensuring that the warehouse layout, Quality Management System and staffing arrangements meet the dual review standards of the Drug Office and the Chinese Medicines Regulatory Office.

📕 Risk notice

You absolutely cannot use a Wholesale Dealer Licence to conduct wholesale business in proprietary Chinese medicines, or vice versa. If this commingling of business activities is discovered, severe penalties may follow. In addition, purchase, sales and stock records for the two product categories must be strictly segregated for inspection by the respective regulatory authorities.

Q62 · What licence do I need to wholesale proprietary Chinese medicines, such as branded cold remedy granules and medicated oils?Direct link

If you plan to wholesale proprietary Chinese medicines, that is, purchase registered proprietary Chinese medicines from manufacturers or importers and distribute them to retailers (such as Chinese medicine shops, pharmacies and supermarkets), you must apply to the Chinese Medicines Regulatory Office (CMRO) for a “Wholesale Dealer Licence for Proprietary Chinese Medicines”. To apply for this licence, you need a business address and storage facilities that meet the required standards for storing proprietary Chinese medicines. As with a Western medicine wholesaler, you must establish a complete Quality Management System covering procurement, receipt, storage, distribution and recall procedures, and keep detailed transaction records.

📘 Regulatory basis

Section 129 of the Chinese Medicine Ordinance (Cap. 549) expressly provides that anyone carrying on the business of wholesale of proprietary Chinese medicines must hold a wholesaler licence for proprietary Chinese medicines. The CMRO’s Guide to Good Wholesale Practice for Proprietary Chinese Medicines provides licensees with detailed operational guidance.

📗 Drew Tang's recommendations

As with Western medicine wholesaling, we recommend applying Good Distribution Practice (GDP) principles to warehouse management, even though the requirements under the Chinese medicine legislation are less explicit than those for Western medicine. A well-organised warehouse with clear records not only helps the business pass inspections but also effectively controls risks and improves efficiency in day-to-day operations. We can help you design storage arrangements suited to the characteristics of proprietary Chinese medicines.

📕 Risk notice

As a wholesale dealer in proprietary Chinese medicines, you are responsible for ensuring that all products you handle are registered in Hong Kong and bear a valid registration number (HKC-XXXXX or HKP-XXXXX). Wholesaling unregistered proprietary Chinese medicines is a serious offence. It may result in revocation of the licence and criminal prosecution.

Q63 · Can I apply at the same time for licences as a Chinese herbal medicine wholesaler and a proprietary Chinese medicine wholesaler?Direct link

Yes. If your business covers wholesale of both Chinese herbal medicines (such as crude herbal medicines and prepared slices) and proprietary Chinese medicines (such as capsules, pills and medicinal oils), you may, and must, apply for both a wholesaler’s licence for Chinese herbal medicines and a wholesaler’s licence for proprietary Chinese medicines. Both licences are approved by the Chinese Medicines Regulatory Office (CMRO), but they are different licence categories. You may operate from the same business address and warehouse, but must demonstrate to the CMRO that you can effectively manage the two types of products separately and prevent confusion. Your Quality Management System and record-keeping system must also be able to manage and trace the movement of Chinese herbal medicines and proprietary Chinese medicines separately.

📘 Regulatory basis

The Chinese Medicine Ordinance (Cap. 549) sets out separate licensing requirements for wholesale of Chinese herbal medicines (section 119) and wholesale of proprietary Chinese medicines (section 129). Accordingly, anyone carrying on both businesses must apply for two licences.

📗 Drew Tang's recommendations

When submitting the application, we can prepare an integrated application plan that clearly shows the CMRO how you will meet the compliance requirements for both licences within a unified management framework. For example, clearly marking the dedicated storage areas for Chinese herbal medicines and proprietary Chinese medicines, as well as quarantine and returned goods areas, on the warehouse layout plan will create a professional and thorough impression on the reviewing officer.

📕 Risk notice

In daily operations, the inventory and records for the two product categories must be strictly separated. For example, batch management and traceability requirements for Chinese herbal medicines may differ from those for proprietary Chinese medicines. Disorganised records will not only cause difficulties during routine inspections; if a product quality issue requires a recall, they may also prevent you from quickly and accurately identifying the affected products, leading to greater losses.

Q65 · If I only package or label medicines, do I still need a manufacturer's licence?Direct link

Yes, this is absolutely required. Under Hong Kong law, the definition of “manufacture” of pharmaceutical products is broad. It includes not only the process of synthesising or mixing raw materials into a finished dosage form, but also all forms of packaging, repackaging, labelling and relabelling. Even if you only subdivide unpackaged finished medicines (such as bulk tablets) or add localised Chinese labels to already packaged medicines, these activities are considered part of “manufacture”. You must therefore apply for and hold a valid Manufacturer of Pharmaceutical Products Licence, and your premises and processes must fully comply with GMP standards.

📘 Regulatory basis

The definition of “manufacture” in the Pharmacy and Poisons Ordinance (Cap. 138) covers all processes that alter, package or label medicines. The Department of Health’s GMP guidelines also expressly state that activities such as secondary packaging constitute regulated manufacturing activities.

📗 Drew Tang's recommendations

For many small and medium-sized importers, establishing a fully GMP-compliant packing area to meet local labelling requirements is very costly. A more cost-effective compliant solution is to outsource packing to a local third-party contract packager holding a Manufacturer of Pharmaceutical Products licence. We can recommend and audit qualified partners and assist with drafting a compliant quality agreement.

📕 Risk notice

Repackaging or relabelling medicines at any premises without a Manufacturer of Pharmaceutical Products licence, such as an ordinary office or warehouse, is unlawful manufacturing. The Department of Health has zero tolerance for such unlawful activities. If discovered, it will immediately take enforcement action, seize all related products and prosecute.

Q69 · If my company's address or person in charge changes, do I need to notify the Department of Health?Direct link

Yes, you must notify the relevant authority immediately. You are legally responsible for notifying the relevant licensing authority (the Drug Office, Department of Health, or the Chinese Medicine Regulatory Office) in writing within the specified period, usually within 28 days of the change, of any change to key information recorded on the licence. This includes, but is not limited to, the company name, business address, warehouse address, changes of directors or partners, and changes to key personnel (such as the supervising pharmacist at a pharmacy, the qualified person at a Chinese medicine shop, or the Authorised Person at a wholesaler or manufacturer). A change of address in particular usually requires a fresh review and an on-site inspection by the Department of Health. Approval can be granted only after the new address has been confirmed as meeting all regulatory requirements.

📘 Regulatory basis

Both the Pharmacy and Poisons Regulations and the Chinese Medicines Regulations contain provisions on notifying changes to licence-holder information. Failure to notify on time is itself a breach and may result in a fine.

📗 Drew Tang's recommendations

Before planning any major change, particularly a change of address, please consult us. We will explain the application process, documents and possible review time required for the change, helping you plan a smooth transition and avoid disruption to operations caused by administrative approval processes. We can also help you identify and assess the qualifications of successors when key personnel change.

📕 Risk notice

After moving to a new address, you must not conduct any regulated pharmaceutical business there until formal approval has been obtained from the Department of Health. This would be regarded as operating from unapproved premises and would amount to operating without a licence. Following a change of Person-in-Charge, the new Person-in-Charge must assume all legal responsibilities, so ensure that the handover is clear.

Q76 · If my business involves dangerous drugs, what specific security requirements apply to their storage?Direct link

Yes, storing “Dangerous Drugs”, such as morphine and fentanyl, which are strictly controlled narcotic and psychotropic medicines, requires security standards far higher than those for ordinary medicines. First, all Dangerous Drugs must be kept in a fixed safe or vault made of strong metal or other heavy-duty material. The safe must be firmly secured to the building structure (for example, bolted to a concrete floor or wall) to prevent it from being removed in its entirety. Secondly, access to the storage location must be strictly controlled, with only a very small number of authorised personnel having access to the keys or combination. In addition, in many cases the Department of Health will require a separate 24-hour CCTV system to provide comprehensive coverage of the safe area.

📘 Regulatory basis

The Dangerous Drugs Ordinance (Cap. 134) and its regulations contain extremely detailed and stringent requirements for the custody, records and disposal of dangerous drugs. When considering an application for a “Dangerous Drugs Licence”, the Department of Health conducts a very thorough on-site assessment of the applicant’s security measures.

📗 Drew Tang's recommendations

When designing a warehouse or Pharmacy layout, if you plan to handle dangerous drugs, you must allocate a corner or room that meets security requirements. We can advise on safe specifications that meet Department of Health standards and guide you in setting up procedures such as a dual-person, dual-lock system and stock movement registers to establish a robust security system.

📕 Risk notice

Any loss of dangerous drugs or inability to account for their whereabouts is an extremely serious incident and must be reported immediately to the Department of Health and the police. Even the loss of a single tablet may trigger a criminal investigation. If dangerous drugs are not properly safeguarded and are stolen or misused, the licence holder may face the most severe legal sanctions.

Q82 · As a licensed wholesaler, can I set up a small laboratory in my warehouse to conduct quality sampling tests on medicines?Direct link

You may set up a laboratory, but doing so is not straightforward. If the results of tests conducted by the laboratory will be used to decide whether a batch of medicines may be released for sale, the laboratory itself must be treated as part of the medicine manufacturing process and must comply with GMP standards. Your company may also need to apply for an additional Manufacturer of Pharmaceutical Products licence, at least for the testing activities. If the laboratory is used only for internal monitoring, preliminary screening or non-decisive testing (such as checking the appearance of packaging), and is not used as the formal basis for quality release, operations may be more flexible. Even so, you must ensure that laboratory operations do not cause contamination or mix-ups involving stored medicines, and that clear procedures are included in your Quality Management System (QMS).

📘 Regulatory basis

Under GMP guidelines, any activity that tests medicine quality and is used as a basis for release is “quality control” and constitutes a regulated manufacturing activity. A wholesaler’s responsibility is to ensure quality during “distribution”, not quality control during “manufacture”.

📗 Drew Tang's recommendations

For most wholesalers, a more practical and compliant approach is to outsource medicine quality testing to a third-party contract laboratory holding a Manufacturer of Pharmaceutical Products licence and having GMP qualifications. This provides legally valid test reports without the substantial cost and complexity of establishing and maintaining a GMP laboratory. We can recommend qualified local contract laboratories.

📕 Risk notice

Do not conduct formal release testing of medicines in an in-house laboratory that does not meet GMP standards. The test results are legally invalid and the regulator may regard the testing as illegal manufacture. If the original manufacturer's medicines have a quality problem, your own test report will provide no legal protection.

Q92 · I am a logistics company providing warehousing and transport services to a licensed pharmaceutical wholesaler. Does my company need a pharmaceutical licence?Direct link

Generally, if your logistics company (a third-party logistics provider, or 3PL) only provides warehouse space and transport vehicles, while ownership of the medicines and ultimate responsibility for quality management remain with your client—the licensed medicines wholesaler—your logistics company does not itself need to apply for a wholesale licence. However, your facilities and services must meet the wholesaler’s compliance requirements and be subject to its supervision and audit. This means that your warehouse must comply with GDP principles, such as temperature and humidity control and monitoring, good security and clearly defined zones. You must operate strictly in accordance with the Quality Agreement signed with your client.

📘 Regulatory basis

The Code of Practice for Licensed Wholesale Dealers allows licensees to outsource some of their functions, such as storage and transportation. However, the code expressly states that the licensee (your client) remains ultimately responsible for the quality and safety of the medicines and is responsible for ensuring that its subcontractor (you) is qualified.

📗 Drew Tang's recommendations

As a 3PL company seeking to enter pharmaceutical logistics, we strongly recommend proactively designing and managing your warehouse in accordance with GDP standards. Independent GDP certification, for example from an organisation such as SGS, can significantly enhance your appeal and credibility among pharmaceutical clients. We can provide GDP compliance consultancy and certification preparation services to help you develop this specialist market.

📕 Risk notice

If an operational error in your storage or transport processes, such as a cold-chain interruption, damage to or loss of goods, causes a medicine quality issue, your customer (the licensed wholesaler) may pursue substantial financial and legal claims against you under your contract, even if you are unlicensed. Professional SOPs and staff training are therefore essential.

Q135 · When applying for a pharmaceutical licence, do I need to submit all employees' personal information for background checks?Direct link

No. Regulatory background checks are targeted and focus mainly on people with key responsibilities for the company’s operations and compliance. You do not need to submit details of every employee. Those generally required to provide detailed personal information and undergo a “fit and proper person” assessment include: 1) all company directors; 2) the company’s ultimate beneficial owner (UBO); 3) nominated key personnel, such as the RP for a wholesaler or manufacturer, an Authorised Person (AP) and the person in charge of quality control; and 4) the pharmacist-in-charge of a pharmacy. Personal details of non-key staff, such as warehouse operators, sales representatives and general clerical staff, do not need to be submitted to the regulatory authority at the licence application stage.

📘 Regulatory basis

The PPB's assessment of whether a person is “fit and proper” mainly applies to individuals able to control or influence the licensed business. The scope of review is intended to cover the company's “directing mind and will”.

📗 Drew Tang's recommendations

We recommend that clients establish a clear organisational chart identifying which key positions must be declared to regulators. We will provide a detailed checklist to guide you in preparing the required personal information forms (Form 11) and supporting documents for these key personnel, ensuring that the application materials are accurate and complete.

📕 Risk notice

Although ordinary employees do not need to be declared, the licence holder is responsible for ensuring that all employees are of good character and have received appropriate training. If deliberate misconduct by an ordinary employee, such as stealing medicines, results in a breach during day-to-day operations, the company may still be held responsible for inadequate management.

Q152 · What are the key principles for planning a medicine warehouse layout to meet Department of Health requirements?Direct link

The layout of a medicine warehouse is key to ensuring medicine quality and safety. It must follow the principles of clear workflow, physical segregation and prevention of cross-contamination. First, clearly defined functional areas must be established, including receiving, quarantined goods pending examination, released goods, non-conforming goods (including returned, recalled, expired or damaged medicines) and dispatch areas. There should be clear physical boundaries between areas, for example, walls, partitions or clearly marked floor areas. Second, the layout should ensure a one-way workflow from receiving to dispatch, without crossing paths, to avoid confusion between medicines that have passed examination and those pending examination or deemed non-conforming. In addition, dedicated storage areas meeting the relevant requirements must be provided for medicines with special storage conditions (such as refrigeration, protection from light or controlled poisons).

📘 Regulatory basis

Good Distribution Practice (GDP) expressly requires the design and layout of premises to minimise the risk of errors and allow effective cleaning and maintenance. It particularly emphasises the separation of receiving, storage and dispatch areas, and the need for dedicated areas for special materials.

📗 Drew Tang's recommendations

When planning the layout, consider using a racking system instead of storing goods on the floor. This makes effective use of vertical space and better supports the ‘first expiry, first out’ (FEFO) / ‘first in, first out’ (FIFO) inventory management principles. In the warehouses we help clients design, each rack and storage location is usually coded and integrated with the warehouse management system (WMS), enabling precise location and traceability. This creates a highly professional impression when Drug Office officers inspect the premises.

📕 Risk notice

A confusing layout is one of the common reasons for a licence application to fail. If the quarantine area is not physically segregated from the released goods area, or returned medicines are left near released goods, this will be regarded as a serious breach. Such confusion may result in non-conforming medicines being dispatched in error, leading to a serious public health incident and exposing the company to the risk of licence revocation and legal proceedings.

Q153 · What specific technical requirements apply to temperature and humidity control systems for medicines requiring temperature-controlled storage?Direct link

For medicines requiring constant-temperature storage (usually in the range of 15-25°C), the temperature and humidity control system is a core facility for ensuring medicine stability. The technical requirements mainly include the following. First, a commercial-grade air-conditioning system capable of covering the entire storage area and operating continuously must be installed. Second, calibrated temperature and humidity loggers must be installed at multiple representative locations in the warehouse for uninterrupted 24/7 monitoring. These locations should include the centre and corners of the warehouse, and areas near doors, windows or heat sources. Third, the system must have high- and low-temperature alarms that immediately notify designated personnel by audible and visual alerts, text message or email when temperature or humidity falls outside the preset range. Finally, all temperature and humidity data must be fully recorded and retained for at least one year after the medicines’ expiry dates, so that the Department of Health can inspect them at any time.

📘 Regulatory basis

The Good Distribution Practice (GDP) requirements under the Pharmacy and Poisons Ordinance require storage conditions to be controlled and monitored. Medicines requiring storage at a specific temperature should be monitored continuously using appropriate equipment (such as temperature and humidity data loggers), and relevant records must be kept. Equipment calibration is also mandatory.

📗 Drew Tang's recommendations

We strongly recommend that clients invest in an automated, cloud-based temperature and humidity monitoring system. Such systems not only provide real-time data and remote alerts, but can also automatically generate reports that meet regulatory requirements, greatly reducing the burden and risk of errors associated with manual record-keeping. When selecting equipment, be sure to obtain and check the supplier's Calibration Certificate, and establish an annual calibration plan.

📕 Risk notice

Installing a household air conditioner alone is wholly inadequate. Department of Health officers will carefully examine the continuity and completeness of temperature and humidity records and whether probe placement is appropriate. Any interruption in records, missing data or unrepresentative probe locations may result in an unsatisfactory inspection. Uncontrolled temperature and humidity may cause pharmaceutical products to degrade and lose efficacy, resulting in a serious quality issue.

Q154 · How should a medicine warehouse be effectively divided into zones, such as areas for quarantined goods pending examination, released goods and returned goods?Direct link

Effective zoning is fundamental to preventing medicine mix-ups and cross-contamination. First, each functional area must be clearly physically separated. Separate rooms or solid walls are ideal; if this is not possible, sturdy partitions, barriers or cage trolleys must be used to create clear separation. Second, every area must have prominent, firmly affixed signs naming the area in both Chinese and English, such as “待验区/Quarantine Area”, “合格品区/Approved Stock Area” and “不合格品区/Rejected Stock Area”. Third, the movement of materials between areas must be strictly controlled by procedures. For example, all newly received medicines must first be placed in the quarantine area. They may only be moved to the released goods area after inspection by the quality control department and issue of release authorisation. Any returned, recalled or damaged medicines must be isolated immediately in the non-conforming goods area pending further action.

📘 Regulatory basis

Good Distribution Practice (GDP) is explicit about functional segregation. It states that “physically separated areas or areas separated by other effective means should be provided for the storage of medicines pending examination, non-conforming medicines, returned medicines or recalled medicines” to prevent them from entering saleable stock without authorisation.

📗 Drew Tang's recommendations

We recommend that clients use different-coloured paint or tape on the floor to mark the boundaries of each area. This is a low-cost and highly visible way to reinforce zoning controls. For example, use yellow for the quarantine area, green for released goods, and red for non-conforming goods. This visual management approach can effectively reduce operator errors and is well regarded by Department of Health officials.

📕 Risk notice

A single line of adhesive tape or a verbal instruction is far from sufficient to define a segregated area. The Department of Health requires “effective segregation”. If products with different statuses are found stored in the same area or are not clearly labelled during an inspection, this will be treated as a serious deficiency. This may not only result in the licence application failing, but also require the relevant operations to cease immediately until the deficiency is rectified.

Q156 · What measures must a warehouse implement to protect medicines from pests and rodents?Direct link

Pest control in a medicine warehouse is an ongoing, systematic activity aimed at prevention, not just extermination. First, the building structure of the premises must be intact, with no holes or gaps through which pests can enter. Doors and windows should close tightly, and drainage outlets should have mesh covers to prevent rodents from entering. Second, the environment must be kept clean and hygienic. There must be no standing water, rubbish or food debris in or around the warehouse, to eliminate sources that attract pests. Third, an integrated pest management plan should be established, usually in partnership with a professional pest control service provider. The plan should include regular inspections, installation and maintenance of pest control devices (such as glue boards, traps and fly killers), and detailed records of all activity. Any insecticides or rodenticides used must be approved products that pose no contamination risk to medicines, and must not be sprayed directly in medicine storage areas.

📘 Regulatory basis

Good Distribution Practice (GDP) requires premises to be kept clean and measures to be taken to prevent the entry and breeding of insects, rodents and other pests. A written pest control procedure must be in place and relevant records kept.

📗 Drew Tang's recommendations

We recommend that clients enter into an annual service contract with a reputable specialist pest control company. As well as carrying out regular inspections and treatments, it will provide a detailed pest control file, including service reports, a floor plan (showing the locations of all monitoring points), and safety data sheets (MSDS) for the chemicals used. This file is one of the documents that the Department of Health will check during an inspection and can clearly demonstrate your attention to pest control and professional management standards.

📕 Risk notice

Finding live pests or rodents, droppings or gnaw marks in a warehouse is a very serious deficiency. It directly demonstrates that pest control measures are ineffective and that medicines face a direct risk of contamination. In addition, indiscriminate use of highly toxic or odorous pesticides may chemically contaminate medicines and is equally unacceptable. Failure to have a contract with a professional company and retain complete records will be regarded as management negligence.

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