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.

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.

Q81 · 香港法例中的“第一部毒药”和“第二部毒药”究竟如何区分？这对我选择牌照有何影响？独立链接

In Hong Kong, the Pharmacy and Poisons Regulations divide regulated Western medicines (i.e. “poisons”) into two main categories. Part I poisons (Part 1 Poisons) are the most strictly regulated category and generally include all prescription medicines (such as antibiotics and antihypertensive medicines), as well as certain medicines that must be sold under the supervision of a pharmacist (such as cough mixtures containing codeine). These medicines may only be sold by an Authorised Seller of Poisons (ASP) (a pharmacy) with a registered pharmacist on the premises, on a doctor's prescription or under a pharmacist's supervision. Part II poisons (Part 2 Poisons) are less strictly regulated non-prescription medicines, commonly known as “over-the-counter medicines”, such as most cold and flu medicines and pain relief tablets. These medicines may be sold by a pharmacy or by a Listed Seller of Poisons (LSP) (a medicine shop) with only a “qualified person” on the premises. This classification therefore directly determines your choice of retail licence: if you wish to sell Part I poisons, you must operate a pharmacy; if you sell only Part II poisons, a medicine shop is sufficient.

📘 Regulatory basis

Schedules 1 and 3 to the Pharmacy and Poisons Regulations (Cap. 138A) set out detailed lists of Part I and Part II poisons. Schedule 10 prescribes the licence requirements for selling different categories of poisons.

📗 Drew Tang's recommendations

When planning your retail business, first define your product range. If you want to provide a comprehensive range of pharmaceutical services, including dispensing prescriptions, the aim should be to apply for a Pharmacy licence. If you are positioning the business as a community convenience outlet selling commonly used medicines, an LSP licence is a more practical choice. We will develop the most suitable licence application strategy based on your market positioning.

📕 Risk notice

A “medicine shop” must never sell any medicine that is a Part I poison. This is one of the most common breaches. If discovered, the medicines may be confiscated, and the shop may face prosecution and fines or even have its licence revoked. You must have a clear understanding of the legal classification of the medicines you sell.

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.

Q83 · 我持有“药行”牌照，可以售卖那些包装看起来像药品，但声称是“保健食品”的产品吗？独立链接

This is a grey area that requires very careful handling. The key is how the product is classified. If a product, despite having packaging (such as capsules or tablets) and marketing similar to those of medicines, is legally classified as a “food” or “health food” because of its ingredients and claimed effects, you may in theory sell it in a pharmacy because it is not regulated by the Pharmacy and Poisons Ordinance. However, if the product contains controlled Western medicine or Chinese medicine ingredients, or its label or advertising expressly or implicitly claims to treat, diagnose or prevent disease, it is highly likely to be classified by the Department of Health or the Chinese medicine regulatory office as a “pharmaceutical product” or “proprietary Chinese medicine”. In that case, selling it without the relevant licence, such as a Pharmacy licence or a proprietary Chinese medicine retailer licence, would be unlawful.

📘 Regulatory basis

The final status of a product is determined jointly under the Pharmacy and Poisons Ordinance, the Chinese Medicine Ordinance and the Public Health and Municipal Services Ordinance. The Department of Health’s “Guidance Notes on the Differentiation between Pharmaceutical Products and Non-pharmaceutical Products” set out specific criteria.

📗 Drew Tang's recommendations

Before introducing any new “health food” product, we strongly recommend asking the supplier for an official product classification certificate issued by the Hong Kong Department of Health confirming that the product is not classified as a pharmaceutical product. If you do not have this document, you should provide us with the product information so that we can make an enquiry with the Department of Health on your behalf. Do not put a product on sale based solely on the supplier’s assurances.

📕 Risk notice

Selling ‘borderline products’ whose regulatory status has not been determined is one of the greatest risks facing pharmacies. Many overseas health supplements may be regarded in Hong Kong as ‘unregistered medicines’ because of their ingredients or claims. If detected, you may face prosecution; claiming ‘I did not know’ is generally not accepted as a valid defence.

Q84 · 持牌“批发商”的“负责人”（Responsible Person, RP）具体需要承担哪些责任？独立链接

For a licensed medicine wholesaler, the “Responsible Person” (RP) is a key management role. Although its statutory requirements are not as strict as those for a manufacturer's Authorised Person (AP), the responsibilities remain significant. The RP's main duty is to ensure that the company's day-to-day operations, particularly activities relating to medicine quality, fully comply with the Code of Practice for Wholesale Dealers in Medicines and relevant legislation. Specifically, the RP is responsible for managing and overseeing the effective operation of the company's Quality Management System (QMS), including approving and managing Standard Operating Procedures (SOPs), ensuring that all staff receive appropriate training, overseeing the procurement, storage, sale and transport of medicines, handling customer complaints and product recalls, and ensuring that all records are accurate and complete. The RP is the company's main contact with the Department of Health and has primary responsibility for the company's compliance.

📘 Regulatory basis

The Code of Practice for Licensed Wholesale Dealers describes in detail the expectations and responsibilities of management and the “person-in-charge”, emphasising their central role in maintaining the quality of the medicine supply chain.

📗 Drew Tang's recommendations

Although the regulations do not prescribe formal academic qualifications for an RP, we strongly recommend appointing a senior manager with a background in pharmacy or life sciences, or extensive experience in the pharmaceutical industry. A competent RP can not only ensure the company’s compliance but also improve operational efficiency and market reputation by establishing an effective quality system. We can help train your RP to ensure that they fully understand their responsibilities.

📕 Risk notice

The RP cannot be a nominal appointee. During a Drug Office inspection, inspectors will interview the RP directly to assess their understanding and control of the company's quality system. If the RP cannot answer questions or the quality system has serious deficiencies, the Drug Office may consider the company to lack effective management. This may hinder licence renewal or even lead to suspension.

Q85 · 持牌“药房”是否可以提供疫苗接种服务？需要什么额外的批准吗？独立链接

Yes, a licensed pharmacy may provide vaccination services subject to specific conditions. This is an important direction for the development of primary healthcare in Hong Kong. First, the pharmacist providing the service must have completed training on a “vaccination course” recognised by the Department of Health and obtained the relevant qualification. Secondly, the pharmacy must have a separate consultation area or room that meets privacy and hygiene requirements for administering vaccinations. This area must be equipped with appropriate facilities, such as handwashing facilities, first-aid supplies and a vaccine refrigerator that meets the requirements. Before providing the service, the pharmacy must notify the Department of Health of this additional service and may be required to undergo an on-site inspection to ensure that the facilities and procedures meet the standards.

📘 Regulatory basis

Providing vaccination services falls within a pharmacist’s professional autonomy, but the pharmacist must comply with the Hong Kong Society of Pharmacy’s Guidelines on Vaccination by Pharmacists and the relevant administrative directions issued by the Department of Health. The premises facilities must continue to meet the requirements of the Pharmacy and Poisons Regulations.

📗 Drew Tang's recommendations

Introducing vaccination services into a pharmacy can effectively increase customer footfall and enhance its professional image. We recommend contacting us at the planning stage. We can provide consultation-area design proposals that meet Department of Health requirements and assist your pharmacists in enrolling in recognised training courses. It is also essential to establish comprehensive procedures for appointments, informed consent and vaccination records.

📕 Risk notice

Vaccines are biological products and have very stringent storage and handling requirements (that is, “cold chain management”). Vaccine refrigerators must be dedicated and subject to continuous temperature monitoring and recording. Any break in the cold chain may render vaccines ineffective. In addition, there must be an emergency plan and medicines to deal with rare allergic reactions, such as anaphylaxis; otherwise, the consequences of an incident could be serious.

Q86 · 什么是“指定患者药品使用计划”（Named Patient Program）？持牌批发商如何参与？独立链接

The Named Patient Program (NPP), sometimes also known as “compassionate use”, is a special medicine supply mechanism. It allows a registered doctor in Hong Kong to apply to use, for a specific patient under their care, a medicine that is not yet registered in Hong Kong but is already marketed in another country and has significant therapeutic benefits. Licensed wholesalers play a key role in importing and distributing the medicine. The usual process is as follows: a doctor submits an application to the Department of Health for a patient. After approval, the doctor engages a licensed wholesaler to use the one-off special permit to import a specified quantity of the unregistered medicine from overseas and supply it directly to the doctor for treating that named patient.

📘 Regulatory basis

Section 36 of the Pharmacy and Poisons Regulations allows medicines to be exempted from registration requirements in certain circumstances, and NPP is based on this provision. The process requires close coordination between doctors, wholesale dealers and the Department of Health, together with stringent documentation requirements.

📗 Drew Tang's recommendations

For wholesalers, participating in NPP projects is not merely a business activity but also an opportunity to demonstrate professional competence and social responsibility. To operate NPP successfully, RGYS may assist with organising roles, qualification evidence and responsibility arrangements within the written scope; candidate suitability, appointment and actual attendance in the role must still be verified by the applicant and legally qualified personnel. No provision of personnel or certification is promised. We will assist you in establishing SOPs specifically for handling NPP orders, ensuring accuracy at every stage from application and import to delivery.

📕 Risk notice

Medicines supplied under the NPP are not locally registered, so the chain of ownership and responsibility for their use must be very clear. The medicines may and must be supplied directly only to the applying doctor; they must never be diverted for another use or sold to anyone else. Any discrepancy in quantity or incorrect distribution will be treated as a serious breach and undermine the foundation of trust in the entire special approval mechanism.

Q87 · 对于“配方颗粒中药”的监管，与传统中药饮片有何不同？我需要什么牌照来经营？独立链接

Formula granules for Chinese medicine (commonly known as ‘Chinese medicine granules’) are standardised granules made by extracting, concentrating and drying traditional Chinese herbal medicines and decoction pieces using modern technology. In Hong Kong, they are treated as a special form of Chinese medicine and are regulated between traditional Chinese herbal medicines and proprietary Chinese medicines. To trade in these products, you need a wholesaler’s and/or retailer’s licence for Chinese herbal medicines. However, because their production involves complex extraction and formulation processes, the Chinese Medicine Council of Hong Kong applies higher quality standards. Suppliers must be able to provide detailed quality documentation demonstrating that their granules meet Hong Kong standards for identification, content, pesticide residues, heavy metals and other aspects.

📘 Regulatory basis

At present, Chinese medicine granules are mainly regulated by reference to the provisions for Chinese herbal medicines under the Chinese Medicine Ordinance. The Chinese Medicine Council of Hong Kong has also issued the Hong Kong Chinese Materia Medica Standards and specific quality guidance for granules as important technical references for market regulation.

📗 Drew Tang's recommendations

If you plan to deal in Chinese medicine granules, choosing a reliable, compliant supplier is key to success. You must require the supplier to provide a Certificate of Analysis (COA) for every batch and ensure that it meets Hong Kong standards. Before signing a contract with a supplier, we recommend that you ask us to review its full set of qualifications and quality documents to avoid introducing non-compliant products.

📕 Risk notice

The quality of formula granules on the market varies. If the granule products you sell are found to contain insufficient active ingredients or excessive contaminants, you as the seller will bear direct legal responsibility. This may not only damage your reputation but also affect your Chinese medicine licence.

Q88 · 如果我的公司只是更改了名称，但股东、董事、地址和业务范围都完全没变，牌照需要重新申请吗？独立链接

You do not need to reapply for the entire licence, but you must complete a very important change notification procedure. When your company name changes (usually after the name-change procedure has been completed at the Companies Registry), you must formally notify the relevant licensing authority in writing within the period prescribed by law (usually 28 days). You will need to submit copies of the new Certificate of Incorporation (CI) and Business Registration certificate (BR), together with an explanatory letter. After verifying the documents, the licensing authority will issue an original licence bearing the new company name to replace the old licence. This process is usually straightforward and does not involve an on-site inspection, but you must initiate it yourself.

📘 Regulatory basis

Both the Pharmacy and Poisons Regulations and the Chinese Medicines Regulations contain provisions requiring licence holders to notify the licensing authority promptly of any change to information on a licence, including the company name.

📗 Drew Tang's recommendations

To ensure a seamless transition, we recommend contacting us as soon as you receive the new CI and BR from the Companies Registry. We will prepare the complete set of notification documents and submit them to the Department of Health on your behalf. We will also remind you to update the company name on all business-related documents, such as invoices, delivery notes and bank accounts, to maintain consistency in the company’s operations.

📕 Risk notice

Failure to notify the authorities promptly of a company name change may seem minor, but it is a procedural breach that may result in a fine. More importantly, if the name on your licence does not match your Business Registration name, you may encounter unnecessary difficulties and delays with import/export customs declarations, banking transactions or contracts with business partners.

Q89 · 作为一家持牌“制造商”，我可以将一部分生产工序（如质量检验）外包给另一家持牌机构吗？独立链接

Yes. This is very common in the pharmaceutical industry and is known as “contract manufacturing” or “contract analysis”. As a licensed manufacturer, you may outsource one or more steps in the manufacturing process, such as raw material testing, intermediate product manufacturing, finished product testing, stability studies or packaging, to another organisation that also holds a valid manufacturer’s licence and has the relevant GMP capability (the “contract acceptor”). However, as the party that places the product on the market (the “contract giver”), you remain fully responsible for the final quality of the product.

📘 Regulatory basis

Chapter 7 of the GMP Guide, “Contract Manufacture and Analysis”, sets out the responsibilities and obligations of both parties to a contract in detail. The key document is a comprehensive “Quality Agreement”, which must clearly define each party's specific responsibilities for production and quality control.

📗 Drew Tang's recommendations

Before selecting a contract partner, you must conduct rigorous qualification checks to ensure that they can meet your quality and regulatory requirements. It is essential to draft a robust quality agreement setting out in detail all relevant matters, including how materials will be transferred, how records will be handed over, what the inspection criteria are and how deviations will be handled. We can assist you with supplier audits and drafting quality agreements.

📕 Risk notice

Outsourcing does not mean outsourcing responsibility. If your contract laboratory issues an incorrect test report that results in a batch of non-conforming products being released to the market, you, as the commissioning party and final AP, may bear primary legal responsibility. You must therefore retain the right to supervise and audit the contractor.

Q90 · 什么是“临床试验证明书”？它是一种独立的牌照吗？我需要它来做什么？独立链接

A Certificate for Clinical Trial / Medicinal Test is not a “business licence” like a wholesale dealer or manufacturer licence. It is an “approval for a project” relating to a specific clinical research project. When a sponsor (usually a pharmaceutical company) plans to conduct a clinical trial in Hong Kong involving an unregistered medicine, or to study a new indication for a registered medicine, it must submit detailed study protocols, investigator information, technical documents on the medicine and other materials to the Department of Health to apply for this certificate. Only after the certificate has been obtained may investigators (doctors) lawfully administer the investigational medicine to trial participants, with exemption from the relevant drug registration and import and export licensing requirements.

📘 Regulatory basis

Section 36B of the Pharmacy and Poisons Regulations authorises the Director of Health, subject to conditions for protecting public health and promoting medical research, to issue a certificate for a clinical trial or test on a medicine, exempting the medicine concerned from registration requirements.

📗 Drew Tang's recommendations

Applying for a clinical trial certificate is a highly specialised process requiring close collaboration between pharmaceutical, medical and regulatory affairs professionals. If you are a sponsor, we can help prepare the complete application dossier, coordinate with the research centre (hospital) and Principal Investigator (PI), and represent you in communications with the Department of Health and the hospital ethics committee (IRB/REC), to help the study obtain approval and commence as soon as possible.

📕 Risk notice

Clinical trials are subject to extremely strict regulation. Labelling, packaging, storage, distribution and recovery of investigational medicines must comply with Good Clinical Practice (GCP). Any deviation from the study protocol must be documented, and significant deviations may even require resubmission. Failure to comply with GCP may result in trial data being deemed invalid and may even endanger the safety of participants.

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