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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Thematic illustration for pharmaceutical licensing business queries and document organisation services — Discuss actual operating questions one-to-one to clarify the next decision.

Q61 · 我想开一家专门卖中药材的店铺，是申请中药材零售商牌照就可以了吗？独立链接

Yes, if you plan to open a retail shop in Hong Kong selling Chinese herbal medicines listed in Schedule 2 to the Chinese Medicine Ordinance (Cap. 549), you need to apply to the Chinese Medicine Regulatory Office (CMRO) for a retail licence for Chinese herbal medicines. This licence permits you to sell these traditional herbs to end consumers. In your application, you must demonstrate that your shop meets hygiene, storage and safety standards, and that you or your staff have sufficient knowledge of Chinese herbal medicines to provide customers with appropriate guidance. The shop must also have compliant measuring instruments, such as a traditional Chinese balance.

📘 Regulatory basis

Section 113 of the Chinese Medicine Ordinance (Cap. 549) provides that any person carrying on the business of retail of Chinese herbal medicines in Hong Kong must hold a valid retailer licence for Chinese herbal medicines. The relevant Chinese Medicines Regulation sets out specific requirements for premises, personnel and operations.

📗 Drew Tang's recommendations

Before applying for a licence, ensure that you have clearly classified and managed the Chinese herbal medicines you sell. Chinese herbal medicines listed in Schedule 1, in particular, are more toxic and subject to stricter storage and sales requirements. They must be kept separately in locked cabinets and their sale must be supervised by a Chinese medicine practitioner or Chinese medicine pharmacist. We can help you establish a comprehensive herbal medicine management process that meets the audit standards of the Chinese Medicines Regulatory Office (CMRO).

📕 Risk notice

Do not sell unregistered proprietary Chinese medicines in your shop. A Chinese herbal medicine retailer licence does not cover retail sales of proprietary Chinese medicines. In addition, the sales record requirements for toxic herbal medicines in Schedule 1 must be strictly observed; otherwise, serious legal consequences may follow if a problem arises.

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.

Q64 · 我想在香港生产一款保健品，它含有一些草本成分，我需要申请药物制造商牌照还是中成药制造商牌照？独立链接

This is a very good question and reflects forward-thinking about business development. In Hong Kong, pharmaceutical products and medical devices are governed by two separate regulatory systems. Pharmaceutical products are regulated by the Drug Office, Department of Health, and the PPB, and you need to apply for the various pharmaceutical licences discussed above. Medical devices are regulated by the Medical Device Division (MDD) under the Department of Health. Hong Kong currently operates a voluntary listing system for medical devices, known as the Medical Device Administrative Control System (MDACS). Although listing is voluntary, most importers and distributors apply to list their medical devices to demonstrate product safety and efficacy and to supply public organisations such as the Hospital Authority. You must therefore submit a separate application to the MDD and demonstrate that your company meets the requirements of the Code of Practice for Medical Device Importers and Distributors under the Medical Device Administrative Control System, including having a Quality Management System (such as ISO 13485). The two application processes run in parallel and do not affect each other, but you must meet two different sets of regulations and standards.

📘 Regulatory basis

The main basis for determining product classification is the definitions of “proprietary Chinese medicine” and “food” in the Chinese Medicine Ordinance (Cap. 549) and the Public Health and Municipal Services Ordinance (Cap. 132). A product's ingredients, dosage form, label and promotional claims are all key factors in the assessment.

📗 Drew Tang's recommendations

We strongly recommend consulting us during the product development stage. You can provide the product formulation, draft label design and marketing materials, and we will conduct a professional product classification assessment. We can also make a formal enquiry to the Department of Health or the Chinese Medicine Regulatory Office on your behalf to obtain a clear official determination. This can help you avoid the substantial compliance risks of discovering that the product has been classified incorrectly only after investing heavily in building a factory.

📕 Risk notice

Manufacturing and selling a regulated “proprietary Chinese medicine” as “food” is a serious offence. If substantiated, the product may have to be withdrawn, and the company and persons responsible may face prosecution. This practice of “passing off a medicine as food” is a target of strict regulatory enforcement.

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.

Q66 · 我持有批发商牌照，可以从海外直接进口药物到香港吗？独立链接

Holding a Wholesale Dealer Licence is necessary to conduct wholesale drug business in Hong Kong, but it does not in itself entitle you to import drugs directly from overseas. To bring pharmaceutical products into Hong Kong from outside Hong Kong, you must also apply to the Department of Health and the Trade and Industry Department for an “Import Licence” for each consignment of imported goods. When applying for an Import Licence, you will need to provide detailed information about the goods, including the drug name, quantity, batch number, manufacturer details and your Wholesale Dealer Licence number. Your goods can clear customs smoothly on arrival at the Hong Kong border only after the Import Licence has been approved.

📘 Regulatory basis

The Import and Export (General) Regulations under the Import and Export Ordinance (Cap. 60) classify pharmaceutical products and medicines as controlled articles whose import and export require a licence issued by the Director-General of Trade and Industry. The Department of Health reviews whether these applications meet the requirements of medicines regulation.

📗 Drew Tang's recommendations

We recommend that you familiarise yourself with the entire import licence application process before signing contracts with overseas suppliers and arranging shipment. Rengangyongsheng (Hong Kong) Limited provides comprehensive import and export licence application services. We can submit applications quickly and accurately through the Trade and Industry Department’s electronic system and liaise with the Department of Health to help ensure that your goods clear customs on time, avoiding unnecessary storage charges and delays.

📕 Risk notice

Bringing medicines into Hong Kong without a valid import licence is smuggling. The Customs and Excise Department conducts very strict checks for such conduct. If discovered, the goods will be detained and the persons concerned may face criminal prosecution. Even licensed wholesalers must strictly comply with the “one consignment, one licence” requirement.

Q67 · 如果我只是在香港“转口”药物，货物不进入香港市场销售，是否也需要申请牌照？独立链接

Yes, even if medicines are only trans-shipped through Hong Kong—that is, transported from one country to Hong Kong and then onward to another country, without entering the local Hong Kong market for distribution—you must still comply with Hong Kong's medicines control regulations. First, the Hong Kong company handling these medicines must hold a Wholesale Dealer Licence, because “possession for sale” of these medicines (even if the sale is to an overseas customer) falls within the scope of regulation. Secondly, you must apply for both an “import licence” and an “export licence” for the consignment. In the applications, you must clearly state that the goods are for trans-shipment and provide evidence of the final destination. The entire process must be carried out under Customs supervision to ensure that the goods do not enter the local market.

📘 Regulatory basis

The Pharmacy and Poisons Ordinance (Cap. 138) and the Import and Export Ordinance (Cap. 60) also apply to the re-export of medicines. The Department of Health and Customs have specific regulatory procedures to ensure that Hong Kong’s status as a free port is not used for illegal trade in medicines.

📗 Drew Tang's recommendations

Hong Kong can serve as a hub for pharmaceutical product re-exports, offering efficient logistics and financial services. To ensure a smooth re-export process, the key is to prepare flawless documentation. We can help you establish operating procedures specifically for re-export business, including how to make the correct declarations to the Department of Health and the Trade and Industry Department, and how to coordinate with logistics companies to ensure goods are transferred seamlessly under regulatory control.

📕 Risk notice

The regulation of drug transhipment is also stringent. Document discrepancies, quantity mismatches or attempts to divert some of the goods unlawfully into the local market during operations will all be treated as serious non-compliance. This could not only cause the transaction in question to fail, but also affect your Wholesale Dealer Licence and future eligibility to apply for import and export licences.

Q68 · 各种牌照的有效期是多久？续期时需要注意什么？独立链接

In Hong Kong, most pharmaceutical licences issued by the Department of Health, including wholesale dealer licences, Authorised Seller of Poisons (pharmacy) licences and Listed Seller of Poisons (dispensary) licences, are usually valid for one year. You must apply for renewal before the licence expires to ensure business continuity. Renewal is not automatic: the Department of Health will reassess your compliance. It may ask you to submit up-to-date documents and may even conduct a site inspection to confirm that your operations have remained compliant with all regulatory requirements over the past year. For manufacturer licences, renewal is usually accompanied by a comprehensive GMP reassessment audit.

📘 Regulatory basis

The validity periods and renewal requirements for the various licences are expressly set out in the Pharmacy and Poisons Regulations (Cap. 138A) and the Chinese Medicine Regulation. If a licence is not renewed by its expiry date, it will automatically lapse, and continuing to operate will amount to unlicensed operation.

📗 Drew Tang's recommendations

We provide licence management services to all clients, proactively reminding you three months before your licence expires and assisting with preparation of the documents required for renewal. Before renewal, we will conduct an internal mock assessment for you, checking for issues in recordkeeping, personnel qualifications, facility maintenance and other areas so that they can be rectified in advance. 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

Do not wait until the last minute to submit a renewal application. If processing is delayed because information is incomplete or an on-site inspection is required, there may be a gap in your licence coverage, forcing your business to suspend operations. In addition, any record of non-compliance during the past year may adversely affect renewal.

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.

Q70 · 对于初创企业，您建议先申请哪种牌照作为起点？独立链接

For start-ups, the best licence to start with depends entirely on your business model and financial resources. If your team has retail experience and relatively limited funds, you could consider starting with a Listed Seller of Poisons (LSP) licence (drug store). This model requires less investment and has lower operating costs, focusing on commonly used over-the-counter medicines for which demand is stable. If your strengths are in distribution channels and supply chain management and you aspire to B2B business, applying for a wholesale licence is a good starting point. You could focus on a particular field, such as dermatology medicines or health supplements, and build your distribution network. A Pharmacy / Authorised Seller of Poisons (ASP) licence and a Manufacturer of Pharmaceutical Products licence usually require substantial investment in professional staff and capital, so they are generally not recommended as a first step for a start-up unless you already have a strong team of pharmacists or substantial financial backing.

📘 Regulatory basis

The application thresholds for different licences are clearly set out in the Pharmacy and Poisons Ordinance and its subsidiary regulations. For example, a pharmacy licence requires pharmacist supervision, while a manufacturer’s licence must meet GMP standards; these are mandatory requirements.

📗 Drew Tang's recommendations

We recommend that you have an in-depth discussion about your business plan with us before making a decision. Based on your background, resources and market objectives, we will analyse the pros and cons, investment budget and payback period of different licence models to help you choose the path best suited to your development. Sometimes, it is wiser to start with a smaller licence, operate steadily and expand the scope of your business gradually.

📕 Risk notice

Choosing the wrong starting point can lead to misallocated resources and substantial opportunity costs. For example, applying for a Wholesale Dealer Licence without a stable network of upstream suppliers and downstream customers may result in considerable pressure from inventory and funding requirements. Conversely, underestimating the complexity and ongoing investment needed to open a compliant pharmacy may cause the project to be abandoned part-way through.

Q71 · 我持有“列载毒药销售商牌照”（药行），可以通过网站或社交媒体向香港本地顾客销售非处方药吗？独立链接

Hong Kong law currently imposes very strict controls on the sale of medicines over the internet. Even if you hold a Listed Seller of Poisons licence and sell only non-prescription medicines (Part II poisons), you cannot freely sell directly through a website, app or social media platform. Medicines must be sold at your registered physical shop address under the supervision of a “qualified person”. Although you may display products and publish information online, the final transaction and delivery—particularly steps involving confirmation of the customer’s needs and provision of usage advice—must take place at the licensed premises. Any form of distance selling may be considered non-compliant.

📘 Regulatory basis

The core principle of the Pharmacy and Poisons Ordinance is to ensure that medicines are used safely under professional guidance. The current regulatory framework is based on the regulation of physical shops and does not provide a clear lawful route for remote sales, including online sales. The Department of Health takes a conservative and cautious approach to this.

📗 Drew Tang's recommendations

We recommend that clients adopt an “online customer acquisition, offline sales” (O2O) model. You can create a comprehensive product catalogue and provide health information on your website, while setting the purchase button to “collect in store” or “enquire in store”. This lets you benefit from the promotional advantages of the internet while avoiding the risk of breaching regulations. We can help you design compliant website features and user journeys.

📕 Risk notice

Do not attempt any “grey-area” online sales model, such as private transactions through instant messaging apps. The Drug Office is stepping up online surveillance. If clear evidence of online sales is found, disciplinary action may be taken against your licence, including a warning, a fine or even revocation.

Q72 · 在申请流程上，“批发商牌照”和“制造商牌照”最关键的区别是什么？独立链接

The most important differences between the application processes for a “wholesale dealer licence” and a “manufacturer licence” lie in the core assessment criteria and level of complexity. For a wholesale dealer licence, the focus is whether your Quality Management System (QMS) and storage facilities comply with Good Distribution Practice (GDP) principles, ensuring that the quality of medicines is not affected during storage and transport. The standards for a manufacturer licence are much more stringent: the core issue is whether your entire production facility and operating procedures fully comply with Good Manufacturing Practice (GMP). A GMP assessment is comprehensive, covering everything from the factory’s air purification and water treatment systems, to the qualification of production equipment and cleaning procedures, and the quality testing and release procedures for every batch. Every detail must be documented and strictly implemented.

📘 Regulatory basis

A wholesaler’s licence is assessed against the Code of Practice for Wholesale Dealers, while a manufacturer’s licence is assessed against the Hong Kong Good Manufacturing Practice (GMP) Guide for Pharmaceutical Products, which is aligned with international standards. GMP requirements are far more complex and extensive than GDP requirements.

📗 Drew Tang's recommendations

You can think of it this way: a wholesaler’s licence ensures that you “manage” medicines properly, while a manufacturer’s licence ensures that you can “make” them properly. GMP certification is a systems project involving multiple disciplines, including architecture, engineering, chemistry and microbiology. If you plan to establish a plant, you must engage a GMP consultant on the first day of the project; otherwise, subsequent remedial costs could be astronomical.

📕 Risk notice

Many applicants underestimate the complexity of GMP, believing that good equipment alone is enough. However, the core of GMP is the ‘software’—the documentation system, validation records and staff training. Without a rigorous, traceable documentation system, even the best facilities and equipment will not pass a GMP audit.

Q73 · 我持有“批发商牌照”，是否可以把药品卖给任何人？客户方面有什么限制？独立链接

Absolutely not. Holding a “wholesaler’s licence” does not mean that you can sell medicines to anyone. Your customer base is strictly restricted by law. You may sell pharmaceutical products only to the following eligible customers: 1. Other licensed wholesalers; 2. Licensed manufacturers; 3. Authorised Sellers of Poisons (ASPs) (pharmacies); 4. Listed Sellers of Poisons (LSPs) (medicine shops, but only for the sale of Part II poisons); 5. Doctors, dentists or veterinary surgeons registered in Hong Kong, for their professional use; and 6. Specified hospitals, clinics, academic institutions or government departments. You must not sell any medicines, directly or indirectly, to end consumers, that is, members of the public.

📘 Regulatory basis

Section 27 of the Pharmacy and Poisons Ordinance (Cap. 138) expressly specifies the persons to whom a wholesale dealer may lawfully supply medicines. Supplying medicines to any person or entity outside this scope is unlawful.

📗 Drew Tang's recommendations

We recommend that you establish a strict Know Your Customer (KYC) process. Before trading with a new customer, obtain and verify a copy of their valid licence or permit. For individual customers such as doctors or veterinarians, verify their registration status as well. We will provide standard customer file management templates to ensure that every sale is supported by records and complies with regulations.

📕 Risk notice

Selling pharmaceutical products to unqualified customers is one of the most serious breaches by a wholesaler; this is known as “diversion”. If discovered by the Department of Health, it may result in substantial fines, and your Wholesale Dealer Licence is highly likely to be suspended or revoked because this undermines the security of the entire pharmaceutical supply chain.

Q74 · 在“药行”工作的“合资格人士”需要接受什么样的培训？培训内容是什么？独立链接

The current LSP application documents and code of practice do not require every person in charge of the business to complete a recognised pharmacy course or hold a uniform pharmacy qualification. The generic “qualified-person training” condition in the old text should not be carried forward; the actual fitness of personnel, business scope, role responsibilities and current official requirements must be checked.

📘 Regulatory basis

The current LSP application form, checklist and code of practice do not require every person in charge of the business to have completed a recognized pharmacy course or hold a uniform pharmacy qualification; the original draft's description of “training for qualified persons” as a general statutory requirement for medicine companies should not be carried forward. Persons in charge, proprietors/partners/directors and employees should be declared as required by the current forms, and personnel suitability, drug classification, purchasing, storage and actual management must remain verifiable. Current LSP Application Form and Guidance

📗 Drew Tang's recommendations

Drew Tang recommends first determining whether LSP status is applicable based on the actual SKUs and business model, then developing role responsibilities, training and operational records covering classification of Part 2 poisons and non-poison products, checks of suppliers and product registration, original packaging and expiry dates, retention of transaction documents, recalls and handling of irregularities. Training forms part of practical competence and operational preparation and should not be presented on one's own initiative as having received official recognition under a uniform course scheme.

📕 Risk notice

An LSP's person in charge must not be equated with an ASP registered pharmacist, a manufacturer's AP or a WDL GDP responsible person, and nominal appointments or false qualifications must not substitute for actual management. LSPs must not possess or sell Part 1 poisons, antibiotics or dangerous drugs, and must not imply ASP status through the use of pharmacy designations, the ℞ symbol or promotional claims of pharmacist supervision.

Q75 · 香港的药房可以凭海外医生开具的处方配药吗？独立链接

This is a common question about choosing premises. The answer is: it is theoretically possible, but very stringent conditions must be met in practice. The Drug Office, Department of Health, requires areas used to store pharmaceutical products to be physically separated, secure and dedicated to that purpose. This means that you cannot simply set aside a corner of an open-plan office for storing pharmaceutical products. You must establish a separate, access-controlled room or warehouse area, with walls, ceiling and floor that meet the requirements. More importantly, the entire premises, including office and storage areas, must be suitable for commercial use, and the building’s Deed of Mutual Covenant (DMC) must not prohibit the storage of pharmaceutical products. You must also ensure that the storage area has effective, independent temperature and humidity control, fire protection and security systems. Therefore, although a combined office-and-warehouse model is possible, the renovation and compliance costs may be substantial.

📘 Regulatory basis

The Pharmacy and Poisons Regulations define “prescription” clearly and require it to be issued for a particular patient by a “registered medical practitioner”, “registered dentist” or “registered veterinary surgeon”. “Registered” here means registered with the relevant professional board in Hong Kong.

📗 Drew Tang's recommendations

The correct approach is to advise patients with overseas prescriptions to consult a registered doctor in Hong Kong. Patients may show the Hong Kong doctor their overseas medical records and prescription for reference. The Hong Kong doctor can then exercise their professional judgement and issue a new, valid local prescription. The patient can obtain the medicine from a pharmacy using this new prescription. This is the only compliant way to protect patients’ safety in the use of medicines.

📕 Risk notice

If a pharmacy pharmacist dispenses medicines against an overseas prescription for convenience or commercial gain, and this is discovered, it will be treated as the sale of prescription medicines without a prescription. This is a very serious case of professional misconduct and an offence. Not only may the pharmacy’s licence be affected; the pharmacist on duty may also have their personal registration revoked.

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.

Q77 · 批发兽药和批发人类使用的药物，在牌照申请上有什么不同？独立链接

In Hong Kong, whether you wholesale medicines for human use or veterinary drugs, you need to apply for a wholesale dealer licence issued by the Department of Health. The licence application process and the basic requirements for storage and the QMS are the same. However, the key difference is that you must demonstrate your ability to handle the specific requirements of veterinary drugs. For example, your staff need basic knowledge of veterinary medicines and must be able to understand the information on their labels. Your records system must be able to trace whether medicines were sold to veterinary clinics or ordinary pharmacies. In addition, if the veterinary drugs you wholesale contain antibiotics or certain controlled ingredients, you must also apply for additional permits, such as an antibiotic permit.

📘 Regulatory basis

The Pharmacy and Poisons Ordinance (Cap. 138) covers both human medicines and veterinary medicines. Wholesale dealing in veterinary medicines is therefore also regulated by the Ordinance. Veterinary surgeons’ prescribing rights and use of medicines are also subject to the Veterinary Surgeons Registration Ordinance (Cap. 529).

📗 Drew Tang's recommendations

If you plan to deal exclusively or mainly in veterinary medicine wholesale, we recommend making this clear in your application documents and highlighting your expertise in the veterinary field. For example, you could appoint someone with a veterinary background or relevant experience as your person responsible for quality, and establish sales and support procedures specifically for veterinary clients. This can help demonstrate your expertise to the Department of Health and expedite the approval process.

📕 Risk notice

Although they fall under the same licence, human medicines and veterinary medicines must never be confused in the supply chain. Selling veterinary medicines to human healthcare providers in error, or incorrectly recommending human medicines for animals, may create serious health risks and legal liabilities. Your inventory and sales records must clearly distinguish between these two product categories.

Q78 · 在一家持牌的药品“制造商”中，“获授权人”（Authorised Person, AP）扮演什么角色？独立链接

The “Authorised Person” (AP) is a critical statutory position at a pharmaceutical manufacturer and the final safeguard for medicine quality. Under GMP requirements, every batch of medicine manufactured must undergo a final review and be signed off for release by an AP before it can be sold. The AP must independently review all relevant records for the batch, including manufacturing records, environmental monitoring data and quality control laboratory test reports, to confirm that the entire manufacturing and testing process complies with GMP requirements and product registration standards. The batch may only be lawfully placed on the market after the AP has confirmed that everything is in order and signed off. The AP must have professional qualifications in pharmacy or a related scientific field, as well as substantial pharmaceutical manufacturing experience.

📘 Regulatory basis

The Hong Kong Good Manufacturing Practice (GMP) Guide for Pharmaceutical Products sets out clear and stringent requirements for the duties, qualifications and independence of an “Authorised Person”. The appointment of an AP requires approval from the Department of Health. This concept derives from EU GMP regulations and is an internationally recognised practice.

📗 Drew Tang's recommendations

The AP bears substantial personal and legal responsibility for the quality of pharmaceutical products. The person selected for this position must therefore be a highly respected expert within the company, with outstanding professional competence and the courage to uphold principles. For small and medium-sized pharmaceutical manufacturers, finding and hiring a qualified and experienced AP may be a major challenge. RGYS may assist with clarifying roles, evidence of qualifications and responsibility arrangements within the written scope; the suitability, appointment and actual presence at work of candidates remain subject to verification by the applicant and legally qualified personnel, and no provision or certification of personnel is promised. RGYS may assist with clarifying roles, evidence of qualifications and responsibility arrangements within the written scope; the suitability, appointment and actual presence at work of candidates remain subject to verification by the applicant and legally qualified personnel, and no provision or certification of personnel is promised.

📕 Risk notice

The AP's decisions are independent and must not be subject to pressure from production or commercial interests. If the AP considers the quality of a batch questionable, they have the right (and responsibility) to refuse its release, even if this causes the company substantial commercial loss. Management pressuring the AP to release non-conforming products constitutes a serious breach of GMP and may result in the manufacturer's licence being revoked.

Q79 · 我可以在香港的商场里设置一个临时摊位或流动车来售卖药油或药膏吗？独立链接

No. Hong Kong medicine sale licences, whether a “pharmacy” licence or a “medicine shop” licence, are linked to a fixed, registered business address. The law requires all regulated medicine sales to take place at licensed premises inspected and approved by the Department of Health. This means that you cannot sell any products classified as “pharmaceutical products” at temporary, unregistered locations, such as a short-term stall in a shopping centre atrium, a trade fair booth or a mobile vehicle, even if the products are non-prescription medicines such as medicated oils or ointments. Such conduct would be regarded as unlicensed sale from unapproved premises.

📘 Regulatory basis

The Pharmacy and Poisons Ordinance provides that a licence authorises operations at a “specified address”. Conducting sales activities anywhere other than the registered address exceeds the scope of the licence and constitutes an offence.

📗 Drew Tang's recommendations

If you wish to use footfall in a shopping centre for promotion, you can adopt a display-only, no-sales approach. You can display product samples at your stand, distribute promotional leaflets, provide advice and direct interested customers to a nearby licensed physical shop to make their purchases. This achieves your promotional aims while avoiding legal risks. We can help you liaise with the shopping centre and the Department of Health before the event to ensure your promotional activities comply with requirements.

📕 Risk notice

Do not take chances and assume that the Department of Health and Customs and Excise Department will not inspect trade fairs and exhibitions. If actual medicine sales are found at a temporary stall, enforcement officers will stop them immediately and may seize all products and prosecute the relevant companies and individuals.

Q80 · 香港的药房在调配处方药后，药品的标签上必须包含哪些信息？独立链接

When a pharmacist at a pharmacy dispenses medicine to a patient in accordance with a doctor’s prescription, the immediate container holding the medicine (such as a medicine bag or bottle) must bear a label that complies with the law. This is known as a “dispensing label”. Under the regulations, the label must clearly display the following key information: 1. the patient’s full name; 2. the pharmacy’s name and address; 3. the dispensing date; 4. the name of the medicine; 5. clear directions for use, such as “Take one capsule three times daily after meals”; 6. any specific warning statements required by law, such as “This medicine may cause drowsiness. If affected, do not drive or operate machinery”. This information is intended to ensure that patients can use prescription medicines safely and correctly.

📘 Regulatory basis

Section 10 of the Pharmacy and Poisons Regulations sets out detailed statutory requirements for the contents of dispensing labels. It is unlawful for any medicine dispensed by a pharmacy to be supplied without a compliant label.

📗 Drew Tang's recommendations

We recommend that all pharmacies use a professional pharmacy management computer system. These systems usually include compliant label-printing functionality that automatically generates labels containing all required statutory information based on the prescription details entered, and can add the required warnings automatically for different medicines. This not only improves efficiency but also greatly reduces the risk of errors from manual operations.

📕 Risk notice

Incorrect label information may lead to serious medication safety incidents. For example, an incorrect patient name or dosage instructions may have fatal consequences. The pharmacist bears ultimate professional responsibility for the accuracy of labels. Compliance of dispensing labels is also a routine focus during inspections by the Department of Health.

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