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

找到 50 条结果，第 1／3 页。每页显示 20 条；无需启用 JavaScript。

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

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.

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

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

📘 Regulatory basis

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

📗 Drew Tang's recommendations

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

📕 Risk notice

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

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

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

📘 Regulatory basis

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

📗 Drew Tang's recommendations

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

📕 Risk notice

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

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

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

📘 Regulatory basis

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

📗 Drew Tang's recommendations

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

📕 Risk notice

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

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

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

📘 Regulatory basis

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

📗 Drew Tang's recommendations

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

📕 Risk notice

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

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

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

📘 Regulatory basis

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

📗 Drew Tang's recommendations

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

📕 Risk notice

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

Q66 · 我持有批发商牌照，可以从海外直接进口药物到香港吗？独立链接

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

📘 Regulatory basis

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

📗 Drew Tang's recommendations

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

📕 Risk notice

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

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

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

📘 Regulatory basis

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

📗 Drew Tang's recommendations

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

📕 Risk notice

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

Q68 · 各种牌照的有效期是多久？续期时需要注意什么？独立链接

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

📘 Regulatory basis

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

📗 Drew Tang's recommendations

We provide licence management services to all clients, proactively reminding you three months before your licence expires and assisting with preparation of the documents required for renewal. Before renewal, we will conduct an internal mock assessment for you, checking for issues in recordkeeping, personnel qualifications, facility maintenance and other areas so that they can be rectified in advance. RGYS may assist with document preparation and project coordination within the written scope of services; personnel qualifications, statutory roles and professional judgments are to be verified and assumed by the respective responsible parties, and approval is decided independently by the competent authority.

📕 Risk notice

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

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

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

📘 Regulatory basis

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

📗 Drew Tang's recommendations

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

📕 Risk notice

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

Q70 · 对于初创企业，您建议先申请哪种牌照作为起点？独立链接

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

📘 Regulatory basis

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

📗 Drew Tang's recommendations

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

📕 Risk notice

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

Hong Kong Drug Licence FAQs

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang