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.

Q41 · 香港的药牌可以转让或许可给第三方使用吗？独立链接

No. Hong Kong pharmacy and poisons licences are non-transferable. A licence is issued to a specific applicant (an individual or company) and is linked to the specific premises, key personnel and Quality Management System submitted with the application. The regulatory authority’s decision is based on an assessment of the overall compliance capability of that specific applicant. Therefore, if a company holding a pharmaceutical licence is acquired by another company, or a pharmacy business is sold to a new operator, the new owner or operator must submit a completely new licence application to the regulatory authority in its own name. It must demonstrate that it can also meet all statutory requirements. The old licence ceases to be valid when the business changes hands. Similarly, a licence holder must not “licence” or “lend” its licence to a third party to operate a medicines business in the third party’s name; this is a serious violation.

📘 Regulatory basis

The non-transferability of licences is a fundamental principle of Hong Kong’s licensing system, reflected in the Pharmacy and Poisons Ordinance and the terms under which relevant licences are issued. Any change in business ownership is regarded as requiring a new licence assessment.

📗 Drew Tang's recommendations

For any M&A or asset sale involving a licensed business, an application for a new licence must be made a condition precedent to completion. The buyer should conduct thorough compliance due diligence and allow sufficient time (usually several months) to complete the new licence application process.

📕 Risk notice

Any attempt to circumvent the principle that a licence is not transferable by using complex corporate structures or nominee agreements may be detected by the regulator and treated as fraud. If discovered, not only will the new business be unable to operate lawfully, but the individuals and companies involved may also be blacklisted.

Q42 · 如果我的产品是一种中西药复方制剂，它将如何被规管？独立链接

Combination products containing both Western and Chinese medicines are subject to very close scrutiny in Hong Kong and are usually classified and regulated as Western medicines. Under the Pharmacy and Poisons Ordinance, any product containing a Western medicine ingredient listed in the Poisons List is classified as a “pharmaceutical product”, whether or not it also contains Chinese medicine ingredients. Such a product must therefore follow the full Western medicine regulatory pathway: it must be registered with the Pharmacy and Poisons Board (PPB) (and obtain an HK-XXXXX number), and its manufacturer, importer and distributor must hold the relevant Western medicine licences, such as a manufacturer’s licence or wholesaler’s licence. In assessing the product, the regulator will evaluate the safety and quality of both its Western and Chinese medicine ingredients. Claiming that a product is “all natural” or “herbal” when it has been found to contain illegally added Western medicine ingredients is an offence that regulators crack down on severely.

📘 Regulatory basis

The definition of “pharmaceutical product” in section 2 of the Pharmacy and Poisons Ordinance is key. Any product containing a regulated Western medicine ingredient falls within the scope of the Ordinance, regardless of the quantity. This takes precedence over the application of the Chinese Medicine Ordinance.

📗 Drew Tang's recommendations

If you plan to develop or import combination products containing both Western and Chinese medicines, you must consider compliance from the research and development stage. We recommend a comprehensive ingredient analysis and legal assessment to determine the regulatory pathway in Hong Kong and devise a registration and market launch strategy accordingly.

📕 Risk notice

Illegally adding western medicines to unapproved proprietary Chinese medicines or health products (such as “paracetamol” for pain relief, “sibutramine” for weight loss or “sildenafil” for sexual enhancement) is extremely dangerous and a serious offence. It poses a direct threat to consumers’ health and may result in the most severe criminal penalties.

Q43 · 香港的药牌制度对“医疗器械”的规管是怎样的？独立链接

At present, regulation of most “medical devices” in Hong Kong is voluntary, but this is changing. The Medical Device Division (MDD) under the Department of Health has established the Medical Device Administrative Control System (MDACS). Under this system, manufacturers and importers may voluntarily apply to have their medical devices listed to demonstrate that they meet basic safety and performance requirements. Devices are classified into four risk classes (I, II, III and IV). However, if a medical device is used in combination with a pharmaceutical product (for example, a pre-filled medicine syringe or a drug-eluting stent), the “drug-device combination product” will generally be regarded as a pharmaceutical product and subject to mandatory regulation under the Pharmacy and Poisons Ordinance. The Hong Kong Government is planning a comprehensive statutory regulatory framework for medical devices, and it is expected that all medical devices will require mandatory registration before they can be marketed in future.

📘 Regulatory basis

At present, the main basis is the administrative guidance issued by the Department of Health’s Medical Device Division: the Medical Device Administrative Control System. The Pharmacy and Poisons Ordinance applies to drug-device combination products. Mandatory legislation is currently being developed.

📗 Drew Tang's recommendations

For medical device manufacturers and distributors, we strongly recommend participating in the current voluntary listing scheme as early as possible. This not only demonstrates your commitment to product quality to customers and the public, but also prepares you for the future introduction of mandatory regulations and gives you a head start.

📕 Risk notice

Do not assume that all medical devices are unregulated. Regulatory requirements may already be very stringent for high-risk devices, implantable devices or devices used in combination with medicines. Detailed classification and regulatory assessment are essential before introducing any new device.

Q44 · 如果我持有的药牌即将到期，续牌的流程是怎样的？独立链接

Renewal of a pharmaceutical licence is an important procedure that must be completed on time to ensure the lawful continuity of your business. Usually, the Drug Office, Department of Health will mail the renewal application form to the registered address on its records about two to three months before your licence expires. You need to complete the form, update basic company information (such as any changes to directors or the Person-in-Charge), and return it by post or submit it in person to the Drug Office before the licence expires, together with a cheque for the specified renewal fee. The Department will review the application. For higher-risk licences, such as wholesaler or manufacturer licences, it may arrange a re-inspection before deciding on renewal. If all documents are complete, the fee has been paid and the company has a good compliance record, renewal will usually proceed smoothly. The new licence will be mailed to you.

📘 Regulatory basis

The validity period and renewal requirements for licences are expressly set out in the Pharmacy and Poisons Regulations. Renewal fees are listed in Schedule 7 to the Regulations.

📗 Drew Tang's recommendations

Be sure to keep the correspondence address registered with the Department of Health up to date so that you do not miss a renewal notice. We recommend setting up an internal licence management calendar and starting renewal preparations at least three months in advance. Do not leave it until the last minute.

📕 Risk notice

Failure to submit a renewal application or pay the fees on time will cause the licence to expire automatically on its expiry date. Any regulated activity carried out after the licence expires constitutes the serious offence of unlicensed operation. Even a delay of only a few days may require a completely new application, making the process much more complicated.

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

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

📘 Regulatory basis

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

📗 Drew Tang's recommendations

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

📕 Risk notice

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

Q46 · 什么是“药物回收”（Drug Recall）？在什么情况下会发生？独立链接

A medicine recall is an action to retrieve one or more batches of medicines already distributed on the market. It is an important measure to protect the public from medicines that may pose a risk. A recall may be initiated voluntarily by a manufacturer or distributor, or carried out compulsorily at the request of the Department of Health. Recalls may be triggered by various reasons, most commonly quality issues (such as incorrect ingredient content, impurities or packaging errors), safety issues (such as unexpected serious adverse reactions) or compliance issues (such as incorrect label information or use of unapproved raw materials). Recalls are classified by risk level, from the most urgent Class I recall, requiring retrieval to the patient level, to Class III, requiring retrieval only at the wholesale and retail levels. Licensed wholesalers and manufacturers must establish an effective recall procedure to ensure that, when needed, the distribution of affected medicines can be traced quickly and accurately and downstream customers notified.

📘 Regulatory basis

Both the Good Distribution Practice (GDP) for Pharmaceutical Products and the Good Manufacturing Practice (GMP) for Medicinal Products require licensees to establish written recall procedures and conduct mock recalls regularly to test their effectiveness.

📗 Drew Tang's recommendations

An effective batch tracking system is key to a successful recall. We recommend that clients’ inventory management systems record every goods receipt and dispatch by batch number. The ability to generate an accurate distribution list quickly during a recall is an important measure of your management capability in the regulator’s eyes.

📕 Risk notice

Delaying the reporting of a quality issue requiring recall, or acting slowly and failing to provide transparent information during a recall, will seriously undermine the trust of regulators and the public. The ability to handle a recall is a litmus test of whether a pharmaceutical company is responsible.

Q47 · 香港对传统草本药物（Traditional Herbal Medicines）的规管是怎样的？独立链接

Hong Kong's regulation of traditional herbal medicines depends mainly on their source and category. If a herbal medicine falls within the categories of “Chinese herbal medicine” or “proprietary Chinese medicine”, it is subject to comprehensive regulation under the Chinese Medicine Ordinance (Cap. 549). The trader must apply for a Chinese medicine trader licence, and the product (if it is a proprietary Chinese medicine) must also be registered. However, the legal status of “traditional herbal medicines” outside the Chinese medicine system (for example, Western herbal remedies such as St John's wort and echinacea) is less clear. They are generally regulated as ordinary foods or health products, provided they contain no Western medicine ingredients controlled under the Pharmacy and Poisons Ordinance and their claims do not relate to the treatment or prevention of disease. The Department of Health nevertheless monitors these products closely and may investigate if they are found to contain harmful substances or make false medical claims.

📘 Regulatory basis

The Chinese Medicine Ordinance is the principal legislation regulating Chinese medicines. For herbal medicines that are not Chinese medicines, the key considerations are whether they fall within the definition of “pharmaceutical product” under the Pharmacy and Poisons Ordinance, or the food safety provisions of the Public Health and Municipal Services Ordinance.

📗 Drew Tang's recommendations

For companies dealing in various herbal products, it is crucial to clearly determine the legal status of each product. We recommend creating a product file documenting its source, ingredients, traditional uses and all marketing materials, and conducting a compliance risk assessment for each product.

📕 Risk notice

“Natural” does not mean “risk-free”. Many natural herbs contain chemical constituents that are pharmacologically active or even toxic. Selling products containing harmful herbal ingredients as food, or illegally adding Western medicines to herbal products, may result in serious legal consequences.

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

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

📘 Regulatory basis

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

📗 Drew Tang's recommendations

For logistics companies, obtaining a pharmaceutical wholesaler licence is an important strategic upgrade that allows entry into a professional service sector with high barriers to entry and high added value. RGYS has extensive experience and can guide logistics companies in establishing GDP-compliant quality systems. RGYS may assist with document preparation and project coordination within the written scope of services; personnel qualifications, statutory roles and professional judgments are to be verified and assumed by the respective responsible parties, and approval is decided independently by the competent authority.

📕 Risk notice

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

Q49 · 香港的药剂制品注册，是否接受中国内地药监局（NMPA）的审批结果？独立链接

At present, Hong Kong’s pharmaceutical product registration system simplifies procedures mainly by recognising approval decisions made by the regulatory authorities of certain designated “reference countries”. These include the United States, the United Kingdom, EU Member States, Australia, Canada and Japan. If a medicine has obtained marketing authorisation from at least two authorities in these countries, its application for registration in Hong Kong may benefit from a degree of simplification. However, to date, China’s National Medical Products Administration (NMPA) has not been formally designated as a “reference authority” for Hong Kong medicine registration. This means that even if a medicine has been approved by the NMPA for marketing in mainland China, a full set of technical documents must still be submitted for a comprehensive assessment by the Department of Health when applying for registration in Hong Kong; the simplified procedure is not available. However, as integration within the Greater Bay Area deepens, communication and mutual recognition between the regulatory authorities on both sides are strengthening, and policy may develop in future.

📘 Regulatory basis

The annex to the Department of Health’s Guidelines on Registration of Pharmaceutical Products/Substances lists in detail the “reference countries” accepted for the simplified registration procedure.

📗 Drew Tang's recommendations

For pharmaceutical companies seeking to bring high-quality medicines already marketed in Mainland China to Hong Kong, although the simplified route is unavailable, a well-prepared, high-quality registration dossier remains key to success. We can help you organise, translate and supplement NMPA submission materials in accordance with Hong Kong requirements to meet local assessment standards.

📕 Risk notice

Do not assume that a medicine approved in the Mainland can readily be marketed in Hong Kong. The review standards and areas of focus may differ between the two jurisdictions. A detailed gap analysis is essential before starting a Hong Kong registration project.

Q50 · 香港药牌制度的未来发展趋势是怎样的？独立链接

Hong Kong’s pharmaceutical licensing system is moving towards greater scientific rigour, international alignment and comprehensive coverage. Key future trends include the following. First, risk-based regulation will be further strengthened, with regulatory resources increasingly focused on high-risk products and activities. Second, alignment with international standards will deepen. For example, internationally accepted standards will be adopted comprehensively in areas such as medical devices and clinical trials. Third, the application and regulation of new technologies will become a focus. Regulatory frameworks for advanced therapy products (ATPs), such as cell and gene therapies, are being developed, while clearer guidance is also expected on telemedicine and the use of artificial intelligence in the pharmaceutical sector. Fourth, regulatory coordination and interoperability for medicines and medical devices within the Greater Bay Area will remain a long-term trend, with policies facilitating access for Hong Kong and Macao residents potentially being expanded. For the industry, this means the need for continuous learning and ongoing improvements in compliance to adapt to an increasingly stringent and complex regulatory environment, while also creating opportunities to access broader markets.

📘 Regulatory basis

Government policy addresses, Legislative Council discussion papers, and the strategic plans of the Department of Health and the Hospital Authority all reveal the direction of future pharmaceutical regulatory policy.

📗 Drew Tang's recommendations

As an industry participant, you should embrace change proactively and with a forward-looking attitude. Investing in a Quality Management System, staff training and new technologies is not only about meeting immediate compliance requirements, but also about maintaining a leading position in future competition. Rengangyongsheng (Hong Kong) Limited will work with you to anticipate opportunities and shape the future.

📕 Risk notice

Clinging to old practices and ideas while ignoring developments in regulations and technology is one of the greatest risks to a business. In the rapidly changing pharmaceutical and healthcare sector, businesses that fail to keep pace will ultimately be left behind by the market and regulations.

Q51 · 我想在香港开一家药房，专门销售处方药和监督售卖药物，应该申请哪种牌照？独立链接

If you plan to operate a retail pharmacy in Hong Kong that dispenses prescriptions and sells various Western medicines (including prescription medicines, medicines for sale under supervision and over-the-counter medicines), you must apply for an Authorised Seller of Poisons licence, commonly known as a “pharmacy licence” or “pharmacist licence”. This is the only licence under Hong Kong law that permits retail sale of all categories of pharmaceutical products (Part I and Part II poisons). The key requirement is that you employ a registered pharmacist to manage and supervise the shop full-time during business hours. The shop layout, facilities, security system and medicine storage conditions must also meet the stringent standards set by the Pharmacy and Poisons Board (PPB) to ensure the safety and quality of medicines.

📘 Regulatory basis

Under section 17 of the Pharmacy and Poisons Ordinance (Cap. 138), only an Authorised Seller of Poisons may retail poisons at its registered address. The Pharmacy and Poisons Regulations also set out in detail the registration standards for pharmacies, management requirements and the duties of pharmacists.

📗 Drew Tang's recommendations

At the site-selection stage, you should consider whether the premises meet the Department of Health’s requirements for setting up a pharmacy, such as the shop area and the provision of dispensing and storage areas. We recommend that you engage us to carry out a preliminary assessment of the proposed address before signing a lease. This can help avoid unnecessary financial losses if the application is refused because the premises do not meet the requirements.

📕 Risk notice

Do not sell prescription medicines or operate under the name “pharmacy” without first obtaining a Pharmacy / Authorised Seller of Poisons (ASP) licence. This is a criminal offence and, upon conviction, may result in a substantial fine and imprisonment. A pharmacy must also not sell regulated medicines unless a pharmacist is present to supervise.

Q52 · “药房”和“药行”有什么区别？我申请了“列载毒药销售商”牌照后，可以称自己的店为“药行”吗？独立链接

In Hong Kong, “pharmacy” and “dispensary” are concepts that are strictly distinguished by law. A shop holding an “Authorised Seller of Poisons Licence” and staffed by a registered pharmacist may lawfully use the terms “pharmacy”, “pharmacist” or “Dispensary”. A shop holding a “Listed Seller of Poisons Licence” is commonly referred to as a “dispensary”. Such shops may sell only Part II poisons (commonly known as non-prescription or over-the-counter medicines), such as cold and flu medicines and painkillers. They do not need to have a pharmacist on the premises, but a “qualified person” who has received specific training must be present. Therefore, after obtaining a “Listed Seller of Poisons Licence”, you may refer to your shop as a dispensary, but you must not use the term “pharmacy”.

📘 Regulatory basis

The Pharmacy and Poisons Ordinance (Cap. 138) clearly defines the rights and restrictions of holders of different licences. The use of shop names is strictly regulated to prevent misleading the public. Improper use of titles such as “pharmacy” may contravene the relevant legislation.

📗 Drew Tang's recommendations

When naming your shop and marketing your business, you must strictly comply with the legal definitions. If your target customers are mainly buying everyday proprietary Chinese medicines, applying for an LSP licence is a more economical and efficient option. We can help you arrange training and assessment for a Competent Person to ensure that licensing requirements are met.

📕 Risk notice

Passing off a “medicine shop” as a “pharmacy” is seriously misleading. It may result in prosecution and fines by the Department of Health, as well as seriously damage your business reputation. If consumers discover that you are illegally selling prescription medicines or misrepresenting your professional standing, you may lose customers permanently.

Q53 · 如果我只打算批发成药，不直接零售给市民，需要申请什么牌照？独立链接

If you plan to wholesale pharmaceutical products in Hong Kong, you must apply for a Wholesale Dealer Licence, whether or not the medicines are proprietary preparations (non-prescription medicines). This licence allows you to sell pharmaceutical products to other licensed wholesalers, licensed manufacturers, Authorised Sellers of Poisons (pharmacies), Listed Sellers of Poisons (drugstores), registered doctors, dentists and veterinary surgeons, as well as specified institutions such as hospitals and clinics. This licence does not allow you to retail any medicines directly to the general public. To apply, you need a business office address and storage facilities that meet the required standards, and must establish a comprehensive system for recording medicine procurement, storage, sales and recalls.

📘 Regulatory basis

Under the Pharmacy and Poisons Ordinance (Cap. 138), any business activity involving the sale of pharmaceutical products, other than retail sale, requires a valid wholesaler’s licence. The Code of Practice for Wholesale Dealers in Drugs published by the Department of Health provides licence holders with detailed operational guidance.

📗 Drew Tang's recommendations

Before applying, we strongly recommend establishing a Quality Management System (QMS) that complies with Good Distribution Practice (GDP). Although this is not currently mandatory in Hong Kong, GDP certification can greatly enhance your competitiveness and reputation in the industry, and is also a regulatory trend. We can provide comprehensive GDP compliance advice and document preparation services.

📕 Risk notice

Wholesale dealing in medicines without a licence is a serious offence. In addition, licensed wholesalers must rigorously check their customers' qualifications to ensure that medicines are supplied only to eligible organisations or individuals. If you sell medicines to unlicensed operators or members of the public, your licence may be suspended or even revoked.

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

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

📘 Regulatory basis

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

📗 Drew Tang's recommendations

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

📕 Risk notice

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

Q55 · 我想在香港生产药物，例如片剂或胶囊，需要申请哪种牌照？对厂房有何规定？独立链接

If you plan to carry out any pharmaceutical product manufacturing activities in Hong Kong, including manufacture, packaging or labelling, you must apply for a Manufacturer of Pharmaceutical Products Licence (Manufacturer Licence). This is the most stringent and complex of all pharmaceutical licence applications. Your manufacturing premises must strictly comply with Good Manufacturing Practice (GMP) requirements. GMP is an internationally recognised set of mandatory standards for the pharmaceutical industry, covering the entire process from facility design, equipment validation, raw material procurement, production process control, quality testing, to finished product release and distribution. The premises must have separate production areas, storage areas and quality control laboratories, and be equipped with key facilities such as an advanced heating, ventilation and air-conditioning system (HVAC) and a purified water system.

📘 Regulatory basis

The Pharmacy and Poisons Ordinance (Cap. 138) requires manufacturers to hold a licence. Specific production standards are prescribed in the Hong Kong Good Manufacturing Practice (GMP) Guide for Pharmaceutical Products issued by the Pharmacy and Poisons Board (PPB), which is aligned with international standards such as PIC/S GMP.

📗 Drew Tang's recommendations

Establishing a pharmaceutical factory that complies with GMP is a major investment requiring a long lead time and a high level of technical expertise. We strongly recommend engaging a professional GMP consultancy team at the outset of the project. Rengangyongsheng (Hong Kong) Limited can provide one-stop project management and compliance services, from site selection, concept design and detailed engineering design to equipment procurement, validation and final GMP audit.

📕 Risk notice

Any lapse at any stage of GMP may cause the entire project to fail. For example, an unsuitable factory layout may create an irreversible risk of cross-contamination, while incomplete validation documents make it impossible to demonstrate that the manufacturing process is stable and reliable. Manufacturing without a Manufacturer of Pharmaceutical Products licence will attract the most severe legal penalties.

Q56 · “抗生素许可证”和“危险药物许可证”是独立的牌照吗？还是在申请其他牌照时一并申请？独立链接

An “Antibiotics Permit” and a “Dangerous Drugs Licence” are not standalone basic licences; they are special permits additional to a “Wholesale Dealer Licence” or a “Manufacturer’s Licence”. If your business involves the wholesale, import, export or manufacture of antibiotics or dangerous drugs (such as controlled psychotropic drugs or potent painkillers), you must first hold the relevant basic licence and then separately apply to the Department of Health for these special permits. Applicants must demonstrate that they have higher-level security measures and stricter record-tracking systems to prevent these strictly controlled medicines from being abused or entering illegal channels.

📘 Regulatory basis

The Antibiotics Ordinance (Cap. 137) and Dangerous Drugs Ordinance (Cap. 134) impose strict requirements on the import, export, manufacture, wholesale and supply of these two categories of medicines respectively. Applicants must demonstrate that their business operations fully comply with the additional requirements of both Ordinances.

📗 Drew Tang's recommendations

When applying for the basic licence, you should clearly inform us whether you plan to handle these two categories of controlled drugs. We can pursue applications for these special permits alongside the basic licence application, and plan compliant security facilities for you (such as reinforced safes and independent surveillance systems) and detailed ledger recordkeeping procedures. 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

The consequences of illegally handling antibiotics or dangerous drugs are extremely serious. In particular, records for dangerous drugs must account precisely for every tablet and every millilitre; any loss or discrepancy may trigger a criminal investigation. Failure to safeguard these drugs, resulting in their diversion to the black market, could cause enormous harm to society, and licence holders may incur serious legal liability.

Q57 · 我计划进口并批发一种在香港尚未注册的药剂制品，需要办理哪些额外手续？独立链接

In Hong Kong, all pharmaceutical products must be registered with the Pharmacy and Poisons Board (PPB) and obtain a Hong Kong registration number (HK-XXXXX) before they may be sold on the market. If you plan to import and wholesale a medicine that is not yet registered in Hong Kong, you must first act as the product’s local agent and submit a “pharmaceutical product registration application” to the Drug Office, Department of Health. This is a complex process requiring extensive technical documentation, including chemistry, manufacturing and controls (CMC) information, preclinical and clinical study data, and stability study reports, to demonstrate the medicine’s safety, efficacy and quality. You may lawfully import and sell the product only after obtaining a Certificate of Drug Registration and using it together with your wholesale dealer licence.

📘 Regulatory basis

Section 36 of the Pharmacy and Poisons Regulations (Cap. 138A) provides that all pharmaceutical products sold in Hong Kong must be registered unless exempted. The documents and procedures required for registration are explained in detail in the Department of Health’s Guidance Notes on Registration of Pharmaceutical Products.

📗 Drew Tang's recommendations

Pharmaceutical product registration is highly specialised and time-consuming, usually requiring 12 to 24 months or even longer. We recommend conducting a comprehensive assessment of the product's market potential and registration feasibility before launching the project. RGYS may assist with organising product documentation and project communications within the written scope; professional pharmaceutical judgments, statutory sign-off and regulatory assessment are the responsibility of legally qualified personnel and competent authorities. We can handle the entire process for you, from document review, translation of materials and communication with overseas manufacturers to submitting the application to the Department of Health.

📕 Risk notice

Dealing in unregistered pharmaceutical products is a serious offence. Even if you hold a Wholesale Dealer Licence, you must not deal in unregistered medicines. In addition, if the registration documents submitted are incomplete or do not meet the requirements, the application will be returned, substantially extending the time to market and increasing commercial costs.

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

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

📘 Regulatory basis

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

📗 Drew Tang's recommendations

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

📕 Risk notice

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

Q59 · 我是一家海外的制药公司，想在香港设立一个办事处负责市场推广，是否需要申请牌照？独立链接

If your Hong Kong office serves only as a centre for liaison, coordination and market information gathering, and is not involved in any commercial transactions involving the actual storage, distribution, sale, import or export of medicines, it will generally not need to apply for any pharmaceutical licence issued by the Department of Health (such as a Wholesale Dealer Licence). However, all your promotional activities must comply with the law, and prescription medicines must not be promoted directly to the public. The actual import and distribution of medicines must be carried out by a local Hong Kong company holding a valid Wholesale Dealer Licence. This licensed wholesaler will act as your local agent and handle all compliance matters relating to the physical movement of medicines.

📘 Regulatory basis

The Pharmacy and Poisons Ordinance (Cap. 138) principally regulates the “sale” and “possession for sale” of pharmaceutical products. If an office’s activities do not constitute either of these, they fall outside the scope of licensing regulation. However, legislation regulating the advertising of medicines still applies.

📗 Drew Tang's recommendations

To ensure that your business model is fully compliant, we recommend a detailed consultation on your business processes. We will help you clearly define the scope of the Hong Kong office’s functions and draft a service agreement with a local licensed wholesaler, setting out each party’s responsibilities and obligations to ensure every link in the commercial chain complies with Hong Kong regulations.

📕 Risk notice

The office must maintain strict boundaries and must never handle any medicine orders or samples privately. Any unauthorised sale or distribution, even on a small scale, if discovered, may be regarded as operating without a licence and seriously damage your company’s reputation in Hong Kong and internationally.

Q60 · 申请“列载毒药销售商牌照”需要具备什么资格的人员？这个人员需要全职吗？独立链接

The key staffing requirement for a “Listed Seller of Poisons” licence (commonly known as a “dispensary licence”) is that the retail business must be continuously and personally supervised by one or more “Competent Persons”. A Competent Person must complete a training course approved by the Pharmacy and Poisons Board (PPB) and pass the relevant assessment, demonstrating sufficient knowledge to advise customers on the safe use of Part II poisons (non-prescription medicines). The law requires at least one Competent Person to be present during the shop's opening hours. Although the law does not expressly require the person to be “full-time”, in practice, covering all opening hours means that the person would need to work full-time or several Competent Persons would need to take turns on duty.

📘 Regulatory basis

Schedule 10 to the Pharmacy and Poisons Regulations (Cap. 138A) sets out in detail the requirements for a “qualified person”, including the content and duration of the training course to be completed. The Code of Practice for Listed Sellers of Poisons issued by the PPB further clarifies their supervisory duties in the shop.

📗 Drew Tang's recommendations

We recommend that the shop owner or key management personnel attend training and obtain the “qualified person” qualification in person. This not only meets regulatory requirements but also gives managers a deeper understanding of medicines and their legal responsibilities. Rengangyongsheng (Hong Kong) Limited can arrange enrolment in a PPB-recognised training course and provide examination preparation support to help you obtain the qualification.

📕 Risk notice

The Department of Health conducts inspections of “drug shops” from time to time to check whether a “qualified person” is present and carrying out their duties. If an inspection finds no “qualified person” on duty, or staff present cannot prove their qualifications, the shop may face a warning, a fine or even temporary suspension of its licence.

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