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.

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.

Q91 · 如果我只想销售急救箱（First-aid Kit），里面包含一些消毒药水和绷带，我需要申请药物牌照吗？独立链接

This depends on the specific contents of the first-aid kit. If it contains only non-medicated items, such as bandages, gauze, adhesive tape and scissors, as well as disinfectants that are not classified as “pharmaceutical products” (for example, low-concentration chlorhexidine or cetrimide disinfectant), a pharmaceutical licence is generally not required to sell the kit. However, if it contains any item classified as a Part I or Part II poison, such as an antibiotic ointment, a strong painkiller or a disinfectant at a specified concentration, the whole kit will be regarded as a combined medicinal pack and its sale will be regulated under the Pharmacy and Poisons Ordinance. You will need to hold at least a Listed Seller of Poisons (LSP) licence to sell it.

📘 Regulatory basis

The regulatory status of a product is determined by each of its ingredients. The Department of Health’s “Guidance Notes on the Differentiation between Pharmaceutical Products and Non-pharmaceutical Products” may be used to determine whether disinfectants or ointments in a first-aid kit are regulated pharmaceutical products.

📗 Drew Tang's recommendations

Before designing or purchasing first-aid kit products, we strongly recommend submitting the complete ingredient list to us for review. We can assess the regulatory classification of each ingredient to ensure that your product range complies with the regulations and avoid the unauthorised sale of controlled medicines. For corporate clients, we can also customise fully compliant first-aid kits for offices or factories.

📕 Risk notice

Do not underestimate the regulation of first-aid supplies. Some disinfectants or burn creams that appear commonplace may contain ingredients classified as “poisons” in Hong Kong. Selling first-aid kits containing such ingredients without a licence amounts to unlicensed sale of medicines and is a serious offence.

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.

Q93 · 如果我申请的牌照被拒绝，我有什么权利？可以上诉吗？独立链接

Yes, if your application for a pharmaceutical licence is refused by the Pharmacy and Poisons Board (PPB) or the Chinese Medicine Council of Hong Kong (CMCC), you have a right of appeal. When the licensing authority refuses an application, it will usually notify you in writing and state the reasons for refusal. After receiving the refusal notice, you may appeal to an independent appeal board within the specified period (for example, 28 days). The appeal board's members are usually appointed by the Government and include professionals from the legal, medical, pharmaceutical and other fields. They will reconsider your application and whether the licensing authority's decision was reasonable.

📘 Regulatory basis

Both the Pharmacy and Poisons Ordinance and the Chinese Medicine Ordinance provide appeal mechanisms to ensure the fairness and transparency of administrative decisions and safeguard applicants’ procedural rights. The ordinances set out the appeal procedures and time limits in detail.

📗 Drew Tang's recommendations

After receiving a refusal letter, the first priority is to analyse the reasons for refusal calmly. In many cases, a refusal results from incomplete documents or a misunderstanding of certain requirements. Before deciding whether to appeal, we recommend assessing with us whether the issue can be resolved by providing supplementary information or communicating further with the licensing authority. If an appeal is indeed necessary, we will help prepare strong appeal submissions and evidence to demonstrate to the Board that your application meets all statutory requirements.

📕 Risk notice

An appeal is a serious, time-consuming and costly legal process. Without adequate grounds and evidence, a blind appeal is unlikely to succeed. More importantly, if any concealment or misrepresentation is discovered during the appeal, it will cause lasting damage to your credibility and affect any future related licence applications.

Q94 · 在香港，个人是否可以从海外邮购自用的药物？这和商业进口有何区别？独立链接

Yes, Hong Kong residents may, subject to certain conditions, order by post from overseas or carry into Hong Kong reasonable quantities of medicines for their personal use without applying for an import licence. This is the “personal baggage exemption”. The key requirements are “reasonable quantities” and “personal use”. “Reasonable quantities” is usually understood to mean enough for one course of treatment or use over a few months; Customs officers determine the specific quantity at their discretion. “Personal use” means that the medicines must not be resold or distributed to others. This exemption is fundamentally different from commercial importation, which is for sale or distribution in Hong Kong, must be carried out by a licensed company and requires an official import/export licence for each consignment.

📘 Regulatory basis

Under the Import and Export Ordinance (Cap. 60), a reasonable quantity of pharmaceutical products or medicines contained in a person’s personal baggage and for their personal use may be exempt from the import licensing requirement. However, stricter restrictions may apply to dangerous drugs or antibiotics.

📗 Drew Tang's recommendations

If you genuinely need to carry or order personal medicines by post, we recommend also keeping your doctor's prescription or medical records as evidence for Customs, if asked, that the medicines are required for your personal treatment and that the quantity is reasonable. Do not attempt to use this exemption to bring or send large quantities of medicines into Hong Kong in multiple batches with the intention of selling them. Such conduct can easily be detected and treated as smuggling.

📕 Risk notice

The “personal-use exemption” is a measure to facilitate the public, but it is easily abused. Customs has strong monitoring capabilities to detect the smuggling of medicines through repeated small consignments. If the activity is determined to be commercial rather than for personal use, all medicines will be confiscated and the people involved will face criminal prosecution, with very serious consequences.

Q95 · 我看到有些便利店或超市也在卖一些药，他们持有的是什么牌照？独立链接

The ‘medicines’ you see in convenience stores or supermarkets are generally not ‘poisons’ as defined under the Pharmacy and Poisons Ordinance (that is, Part I and Part II poisons). In law, these products are known as ‘non-pharmaceutical products’ or medicines that are exempt because they pose very low risks. Examples include certain throat lozenges, medicated shampoos and topical disinfectants at very low concentrations. Their sale does not require a pharmacy or medicine shop licence. In addition, the law provides for a very short Exempted Medicines List. Aspirin, for example, may be sold in any retail shop when sold in specified packaging and dosage. These large chains can therefore lawfully sell these particular goods, which are not subject to medicine licensing controls, under their ordinary retail licences.

📘 Regulatory basis

Schedule 2 to the Pharmacy and Poisons Regulations lists “exempted poisons”. In addition, the final classification of a product depends on the Department of Health’s determination of its ingredients and claims. Products that do not contain any controlled “poison” ingredients are not regulated by these Regulations.

📗 Drew Tang's recommendations

This situation demonstrates the importance of “product classification”. Where a product can be sold depends entirely on its legal classification. For pharmaceutical manufacturers or brand owners, if the product can legally be classified as a “non-pharmaceutical product” or an “exempt drug” through changes to its formulation or the management of its claims, this can greatly broaden its distribution channels and open up the wider fast-moving consumer goods market. We can provide advice on regulatory strategy in this area.

📕 Risk notice

As a retailer, even a large supermarket, you must ensure that the “health products” you sell are not in fact regulated pharmaceutical products. If a supplier has misclassified a product or a product is found to contain undeclared medicinal ingredients, the retailer may also be held legally liable. Supplier checks and requests for evidence of compliance are therefore very important.

Q96 · 如果我计划收购一家已经持有药物牌照的公司，我需要注意什么？牌照会自动转移给我吗？独立链接

Acquiring an already licensed company is an effective way to enter the market quickly, but the process requires great care. A pharmaceutical licence is granted to a specific company to operate at a specific address; it does not “automatically” transfer or remain valid when the company’s shares change hands. If the company’s ownership (shareholders) or control (directors) changes materially, you must formally notify the licensing authority. The authority will reassess the background and capabilities of the new shareholders and management to decide whether the licence may remain valid under the new ownership. This process may involve submitting extensive documentation and even undergoing a further on-site inspection.

📘 Regulatory basis

Although there is no such thing as a “licence transfer”, the Pharmacy and Poisons Regulations require changes of company directors or partners to be declared. The regulator is entitled to reassess the suitability of the licence in light of the new persons in control.

📗 Drew Tang's recommendations

Before signing any acquisition agreement, we strongly recommend commissioning us to conduct comprehensive compliance due diligence on the target company. We will thoroughly review its licence history, inspection reports, QMS documents, inventory and sales records to identify any potential undisclosed compliance risks or legacy issues. This can help you avoid discovering only after the acquisition that you have taken over a ‘mess’.

📕 Risk notice

The greatest risk is “hidden liabilities”. If the target company committed serious breaches before the acquisition that have not been discovered, you, as the new owner, may face the corresponding legal consequences if they come to light after you take over, including fines or even revocation of the licence. Due diligence is the only way to mitigate this risk.

Q97 · 中成药的“注册”和西药的“注册”是一回事吗？流程和要求有何不同？独立链接

Registration of proprietary Chinese medicines and Western medicines is intended to ensure that medicines sold in Hong Kong are safe, effective and of controlled quality. However, these are two separate, parallel systems administered by different departments, with significant differences in their procedures and requirements. Registration of Western medicines is handled by the Drug Office, Department of Health, and requires submission of a complete dossier in the internationally used Common Technical Document (CTD) format, including detailed pharmacological, toxicological and clinical study data. Registration of proprietary Chinese medicines is handled by the Chinese Medicine Regulatory Office (CMRO), with requirements that focus more on demonstrating the product’s history of use, supporting literature, and quality control of raw materials and finished products. Although safety data, such as tests for heavy metals and pesticide residues, must also be submitted, the requirements and methods for demonstrating clinical efficacy differ significantly from those for Western medicines, with greater acceptance of traditional use data and documentary evidence.

📘 Regulatory basis

Western medicine registration is governed by the Pharmacy and Poisons Regulations, while proprietary Chinese medicine registration is governed by the Chinese Medicines Regulations under the Chinese Medicine Ordinance. The CMRO has published the Manual on Application for Registration of Proprietary Chinese Medicines, which sets out the specific application requirements in detail.

📗 Drew Tang's recommendations

For companies seeking to register their products in Hong Kong, the first step is to clarify the product’s status. If your product is a proprietary Chinese medicine, documents must be prepared under the CMRO route. Our expert team is familiar with both registration systems and can tailor the most efficient registration strategy to your product, whether that means preparing CTD documents for western medicines or compiling historical literature and quality standards for proprietary Chinese medicines.

📕 Risk notice

It will not work to prepare for proprietary Chinese medicine registration using the approach for Western medicine registration, or vice versa. For example, attempting to submit a complete Phase III Western clinical trial report to the CMRO as a substitute for evidence of traditional use may be considered inapplicable. Failing to understand the fundamental differences between the two systems is a major cause of registration applications being delayed or rejected.

Q98 · 如果我只是想开一家网店，专门从海外代购药品给香港客户，我需要牌照吗？独立链接

Yes, you absolutely need a licence, and under the current regulations this business model is almost impossible to operate lawfully. First, your personal shopping service—where you take orders and payment from customers and then purchase and deliver medicines for them—constitutes “sale”, so you need the relevant retail licence (a pharmacy or dispensary). Secondly, purchasing medicines from overseas for customers constitutes “import”, which requires an import licence for each consignment and, in turn, a Wholesale Dealer Licence. More importantly, as noted above, Hong Kong does not permit the sale of regulated medicines solely online. A purely online medicine personal-shopping platform would therefore breach several requirements, including those relating to unlicensed sales, unlicensed imports and unlawful online sales, and would be strictly illegal.

📘 Regulatory basis

Your business model breaches both the licensing requirements for the sale and possession of medicines under the Pharmacy and Poisons Ordinance and the licensing requirements for importing medicines under the Import and Export Ordinance. This is a typical case involving multiple offences.

📗 Drew Tang's recommendations

We never recommend that anyone try this business model. If you are interested in cross-border pharmaceutical e-commerce, the lawful route is much more complex. It may involve establishing a fully compliant physical pharmacy and licensed wholesale business in Hong Kong, and reaching customers through an O2O model (online display, offline transactions). We would be pleased to discuss these lawful and sustainable business models with you.

📕 Risk notice

Operating a website for the illegal procurement of medicines is a key enforcement target for the Department of Health and the Customs and Excise Department. As transaction records are online, evidence is easy to obtain. If the offence is established, operators may face very severe criminal prosecution. In addition, the overseas medicines you procure may be of unknown origin and unassured quality. If they cause harm to consumers’ health, you may face unlimited civil liability for damages.

Q99 · 在选择牌照类型时，我应该主要考虑哪些因素？独立链接

This is a strategic decision, and you should consider the following key factors together. First, **product range**: what medicines do you want to sell? This is the most fundamental question. If you want to handle prescription medicines, a “Pharmacy licence” is the only option. If you will handle non-prescription medicines only, a “medicine shop licence” is more suitable. Second, **target customers**: will your customers be members of the public (B2C) or other organisations (B2B)? The former requires a retail licence, while the latter requires a wholesaler licence. Third, **capital investment**: investment varies greatly between licence types. A Manufacturer of Pharmaceutical Products licence requires investment of tens of millions or even over a hundred million; a Pharmacy licence requires the employment of a highly paid pharmacist and the payment of costly shop rent, while the initial investment for a medicine shop or wholesaler is relatively low. Fourth, **team expertise**: does your team include a pharmacist, GMP expert or experienced supply chain manager? Your team composition should match the type of licence you choose.

📘 Regulatory basis

Hong Kong’s pharmaceutical licence framework is clearly structured, with different licences corresponding to different scopes of business activity. Your business plan must first align with the licensing framework established under the Pharmacy and Poisons Ordinance and the Chinese Medicine Ordinance.

📗 Drew Tang's recommendations

We recommend that you consider these factors as a matrix. During our initial consultation, we will guide you through this process and, based on your answers, outline the 1–2 licence options most suitable for you, with a detailed analysis of the advantages, disadvantages, costs and timelines of each, helping you make the most informed business decision.

📕 Risk notice

The main pitfalls are having ambition without the means or “mixing things up”. For example, starting a Manufacturer project hastily without sufficient capital and professional staff may result in an abandoned project. Alternatively, operating a retail business using the mindset of a wholesale dealer will prevent you from reaching end customers. A clear understanding of your own position and the regulations is the first step to success.

Q100 · 获得牌照后，是否就一劳永逸了？我还需要持续做什么？独立链接

Obtaining a licence is only the beginning of compliant business operations; it does not mean you can take things for granted. Holding a licence means that you undertake to comply with all relevant laws, regulations and codes of practice on an ongoing, day-to-day basis. You will need to carry out substantial ongoing compliance work, including: 1. **Record-keeping**: You must maintain complete, accurate and traceable records of every stage of medicine procurement, storage, sale and distribution, and retain them for the specified period. 2. **Staff training**: You must ensure that all employees involved in handling medicines receive initial and ongoing training appropriate to their duties. 3. **Facility maintenance**: You must maintain your premises and equipment regularly, particularly temperature and humidity control systems and security systems, to ensure they continue to operate effectively. 4. **Self-review**: You should conduct internal audits or self-inspections regularly to identify and correct potential compliance issues proactively. 5. **Inspections**: You must be ready at all times for routine or unannounced inspections by the Department of Health and cooperate fully.

📘 Regulatory basis

All relevant codes of practice, such as the Code of Practice for Wholesale Dealers in Pharmaceutical Products and the Code of Practice for Pharmacy, emphasise the importance of ‘ongoing compliance’. Whether a renewal application is approved depends directly on your compliance record over the preceding year.

📗 Drew Tang's recommendations

We view compliance as a dynamic, lifecycle-based management process. We provide clients with annual compliance consultancy services, not merely to help you obtain a licence, but more importantly to help you maintain a high level of compliance after the licence is granted through regular compliance reviews, staff training and regulatory updates. This allows you to focus on business development with confidence, without being distracted by complex compliance matters.

📕 Risk notice

“Focusing on applications and neglecting maintenance” is a common mistake among licence holders. They assume that obtaining a licence is the end of the matter and relax their day-to-day management. However, oversight by the Department of Health is ongoing. One unsatisfactory inspection could result in additional licence conditions, suspension or even revocation, undoing all your previous investment.

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