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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Q441 · 我的西药批发商牌照续期申请被拒绝了，主要可能是什么原因？独立链接

Refusal of a renewal application is uncommon but has serious consequences, and usually stems from fundamental compliance issues. The most common reasons include serious breaches during the previous licence period, such as repeated warnings or disciplinary action; major deficiencies identified during the renewal inspection that were not corrected promptly, particularly in the Quality Management System (QMS), medicine traceability or storage conditions; the company or one of its key personnel being convicted of a criminal offence, leading the regulator to consider it no longer a ‘fit and proper’ licence holder; or failure to provide key documents required for the renewal review, such as a valid Business Registration Certificate or SOP documents meeting GDP requirements.

📘 Regulatory basis

When assessing renewal applications, the regulatory authority comprehensively evaluates the licence holder’s compliance throughout the licence period to determine whether it remains suitable to hold the licence.

📗 Drew Tang's recommendations

The best way to avoid renewal refusal is to maintain ongoing compliance in day-to-day operations. Our annual compliance consultancy service for clients is intended to keep their operations inspection-ready through regular reviews and follow-up, and to eliminate renewal risks at source.

📕 Risk notice

If a renewal application is refused, it is equivalent to revocation of the licence and your business must cease immediately. This is not only a major commercial setback; it also means that the compliance credibility you have built up is gone.

Q442 · 如果我怀疑有其他公司在进行无牌经营，应该向哪个部门举报？独立链接

If you suspect that any individual or company is conducting unlicensed pharmaceutical activities in Hong Kong (including manufacture, wholesale, retail, import or export), you should report it to the Drug Office, Department of Health, through its medicine complaint hotline. You can call the hotline or submit a complaint by email, fax or post. When reporting, provide specific information wherever possible, such as the name and address of the company suspected of operating without a licence, the specific activities, when they occurred, and any evidence you can gather (such as photographs, receipts or screenshots of webpages). The Department of Health will handle all complaints confidentially and investigate based on the information you provide.

📘 Regulatory basis

The Drug Office, Department of Health is the principal enforcement department responsible for administering the Pharmacy and Poisons Ordinance and other relevant legislation. Its duties include investigating and combating unlicensed medicine activities.

📗 Drew Tang's recommendations

Reporting illegal activities is an important part of maintaining order in the industry and protecting public health. As a responsible member of the industry, reporting such activities helps combat wrongdoing, promote fair competition and protect the interests of legitimate businesses.

📕 Risk notice

Unlicensed activities pose a direct threat to public health because the source, quality, storage and efficacy of these medicines cannot be assured. Do not dismiss the importance of reporting such activity; your report could prevent a serious public health incident.

Q443 · 我是否可以在同一个持牌处所内，同时经营西药批发和中成药批发业务？独立链接

Yes, but you must apply for and hold two different licences for the premises: a Wholesale Dealer Licence issued by the Department of Health and a wholesaler’s licence for proprietary Chinese medicines issued by the Chinese Medicine Council of Hong Kong. In addition, you must establish clearly segregated physical areas within the premises for storing Western medicines and proprietary Chinese medicines separately, to prevent cross-contamination and confusion. Two separate Quality Management Systems and record-keeping systems are also essential, each meeting the GDP requirements for Western medicines and the relevant requirements for proprietary Chinese medicines. During inspections, the regulatory authorities will independently inspect each area and system.

📘 Regulatory basis

Western medicines and proprietary Chinese medicines are regulated under different legislation and by different regulatory authorities. They therefore require separate licences and compliance systems, even when operated at the same physical address.

📗 Drew Tang's recommendations

RGYS may assist with document preparation and project coordination within the written scope of services; the respective responsible parties must verify personnel qualifications and statutory roles and take responsibility for professional judgements, while approval is determined independently by the competent authority. The key is careful planning at an early stage to ensure that the warehouse layout, workflows and document systems are clearly separated and independently compliant from the outset, avoiding confusion in subsequent operations.

📕 Risk notice

If Western medicines and proprietary Chinese medicines are treated as one in management, for example by sharing stock areas or combining records, this will constitute a serious non-compliance in the assessment of both licences and may put both licences at risk.

Q444 · 什么是“药物回收”？如果我的产品需要回收，我应该怎么做？独立链接

A medicine recall is the withdrawal from the supply chain of one or more batches of medicines distributed on the market, usually because a quality, safety or efficacy issue has been identified or suspected. If, as a licence holder, you are instructed by the Department of Health or decide yourself to initiate a recall, you must immediately implement a pre-established recall procedure. This includes immediately stopping the distribution of affected batches; notifying all downstream customers who received them, such as pharmacies and hospitals; arranging for the medicines to be returned by customers; segregating the returned medicines and keeping records; and submitting a detailed recall report to the Department of Health.

📘 Regulatory basis

The Good Distribution Practice (GDP) for Wholesale Dealers in Medicines requires all licensees to establish an effective Standard Operating Procedure (SOP) for medicine recalls.

📗 Drew Tang's recommendations

Effective recall capability depends on accurate day-to-day batch management and distribution records. We recommend that clients conduct mock recalls regularly to test and optimise their traceability systems and communication processes, ensuring they can respond quickly and effectively when an actual recall occurs.

📕 Risk notice

Failure to carry out an effective recall is an extremely serious breach because it directly affects the ability to control public health risks. This will not only invite severe disciplinary action but also completely destroy the market’s confidence in your products and brand.

Q445 · 我更改了公司的商业登记地址，这会影响我的药品牌照吗？独立链接

This depends on which address you are changing. If only the company’s registered office address or business correspondence address changes, while the licensed premises used to store pharmaceutical products remain unchanged, this is an administrative change of particulars. You must notify the regulatory authorities in writing to update their records, but this will not usually affect the validity of the licence. The key point is that you must never store pharmaceutical products at a new business registration address that has not been approved under the licence. A pharmaceutical licence is strictly tied to the premises used for storing pharmaceutical products.

📘 Regulatory basis

A licence primarily regulates medicine-related activities at specific premises. A company’s administrative address and the address of its licensed premises are two different concepts.

📗 Drew Tang's recommendations

To avoid confusion, we recommend that clients clearly distinguish between the “company registered address” and the “licensed premises address” in all correspondence with the regulatory authority. Any change involving licensed premises must follow the formal licence variation application process.

📕 Risk notice

The greatest risk is mistakenly moving medicines to a new Business Registration address for storage. This would constitute storing medicines at an unapproved location, a serious breach that may result in suspension or revocation of the licence.

Q446 · 卫生署督察在没有事先通知的情况下进行突击视察，这合法吗？独立链接

Yes, this is entirely lawful. In fact, unannounced inspections are a commonly used and important regulatory tool. The law gives Department of Health inspectors the power to enter licensed premises at any “reasonable time” for inspection, usually during normal business hours, without prior notice. The purpose of unannounced inspections is to observe the licence holder's real, day-to-day operations and ensure ongoing compliance with the regulations and codes of practice, rather than allowing them to make a “show” solely to prepare for a scheduled inspection.

📘 Regulatory basis

The powers of entry and inspection conferred by section 26 of the Pharmacy and Poisons Ordinance (Cap. 138) are not subject to a requirement for prior notice.

📗 Drew Tang's recommendations

The only way to deal with unannounced inspections is to make compliance part of your everyday routine. The compliance systems we design for clients aim to keep the company “inspection-ready” at all times. All documents, records and operating procedures should be well organised and readily available for inspection.

📕 Risk notice

If you refuse entry to an inspector conducting a surprise inspection, or attempt to conceal or destroy documents, this will be regarded as obstruction of enforcement. This is itself a criminal offence, and the consequences may be more serious than any breach discovered during the inspection.

Q447 · 我的药房因为违规被命令暂停牌照14天，期间我能做什么和不能做什么？独立链接

During the 14-day suspension of your licence, your Pharmacy has the same legal status as an unlicensed pharmacy. You must not carry out any activity requiring a licence, including selling any Part I, Part II or Part III poisons; displaying any products containing controlled drug ingredients; or using any title with the meaning of ‘Pharmacy’, ‘dispensary’ or similar. You may clean the shop, take stock, handle administrative work or train staff, but all commercial activities related to the sale of medicines must cease completely.

📘 Regulatory basis

Suspension of a licence means the temporary suspension of licensed status, and all privileges and authorisations based on that licence are temporarily invalid.

📗 Drew Tang's recommendations

We recommend that clients use this period for thorough internal reflection and remediation. Organise all staff to study the relevant regulations, review and revise all work procedures (SOPs), and document all corrective measures in writing, so that you can demonstrate your commitment to improvement and the results achieved to regulators after the suspension period ends.

📕 Risk notice

If you are found secretly continuing to sell medicines during the suspension period, this will be regarded as operating without a licence and will compound the existing disciplinary action. It will almost certainly result in your licence being revoked immediately after the suspension period ends.

Q448 · 我如何知道哪些中药材是附表1或附表2所列的毒性中药材？独立链接

The most authoritative way to identify the toxic Chinese herbal medicines listed in Schedules 1 and 2 to the Chinese Medicine Ordinance (Cap. 549) is to consult the text of the Ordinance. Schedule 1 lists 31 “highly toxic” Chinese herbal medicines, such as nux vomica and Sichuan aconite, while Schedule 2 lists 579 “toxic” Chinese herbal medicines, such as aconite and pinellia. The official website of the Chinese Medicine Council of Hong Kong will generally also make these lists available for public reference. As a practitioner, you are responsible for familiarising yourself with them. When purchasing and selling these herbal medicines, you must manage them with particular care, for example by storing them separately and clearly labelling them. When selling Schedule 1 herbal medicines, you must also record purchaser details as required.

📘 Regulatory basis

Schedules 1 and 2 of the Chinese Medicine Ordinance (Cap. 549) provide the legal basis for distinguishing and regulating toxic Chinese herbal medicines.

📗 Drew Tang's recommendations

We recommend that clients print out these two schedules and display them in the purchasing and sales departments, and provide dedicated training to relevant staff to ensure they can accurately identify these herbal medicines. These medicines should also be specially flagged in your computerised inventory system as a warning.

📕 Risk notice

Improper handling or sale of these toxic Chinese herbal medicines, such as confusing them with ordinary herbal medicines or failing to sell them in accordance with requirements, is a very serious violation. If this causes poisoning or harm to a patient’s health, you may face serious criminal prosecution and substantial civil liability.

Q449 · 在进行股权变更时，新股东的国籍或居住地会影响牌照吗？独立链接

In Hong Kong, there are no explicit legal restrictions on the nationality or place of residence of shareholders in a company holding a pharmaceutical licence. As an international business centre, Hong Kong welcomes investors from around the world. However, when a shareholding change is notified, the regulatory authorities will still assess whether new major shareholders, particularly those able to exercise controlling influence over the company, are fit and proper. If a new shareholder is from a country or region subject to sanctions by an international organisation such as the United Nations, or has a poor international commercial or legal record, this may raise concerns and lead to more in-depth scrutiny by the regulatory authorities.

📘 Regulatory basis

Although there are no nationality restrictions, the suitability of persons assessment principles apply universally to anyone with control over a licensed company, regardless of nationality.

📗 Drew Tang's recommendations

When introducing non-local shareholders, particularly those from regions whose financial regulatory systems differ significantly from Hong Kong’s, we recommend conducting more thorough due diligence. Preparing a clear explanation of the new shareholder’s background and source of funds can help address any concerns the regulatory authorities may have.

📕 Risk notice

If the introduction of new shareholders leads the regulator to suspect that the company may be used for money laundering or other illegal activities, or that actual control of the company’s business has become opaque, the regulator may take action against the licence on public interest grounds, even if there is no express legal prohibition.

Q450 · 为了防范合规风险，我应该多久对我的员工进行一次合规培训？独立链接

Compliance training should not be a one-off activity, but an ongoing process. We strongly recommend establishing a systematic training programme. First, all new employees should receive comprehensive basic compliance training on joining. Second, all staff should receive comprehensive refresher training at least once a year to reinforce their knowledge and update it. In addition, focused training should be arranged promptly whenever new regulations or company SOPs are introduced or changed. Employees in key roles, such as procurement, quality control and sales, need more frequent and role-specific advanced training. Detailed records of all training should be kept, including the date, content, participants and assessment results.

📘 Regulatory basis

Quality management systems such as Good Distribution Practice (GDP) and GMP expressly require personnel to receive adequate and ongoing training to perform their duties competently.

📗 Drew Tang's recommendations

Treat training as an investment, not a cost. Well-trained staff are your first and most important line of defence against compliance risks. Rengangyongsheng (Hong Kong) Limited can provide clients with tailored annual training plans and course materials.

📕 Risk notice

If a company cannot provide adequate staff training records when a breach occurs, the regulator and the court may well conclude that the company has been systematically negligent in discharging its supervisory and management responsibilities, thereby increasing the penalty imposed on the company.

Q451 · 内地生产的药品如何申请香港药牌进行贴牌销售（OEM/ODM）？独立链接

For medicines manufactured in Mainland China and intended for private-label sale (OEM/ODM) in Hong Kong, first ensure that the manufacturer holds valid GMP certification and meets the relevant requirements for medicine registration under the Pharmacy and Poisons Ordinance (Cap. 138). Applicants must provide detailed product information, including manufacturing processes, quality control, test reports and stability data. The Hong Kong licence holder is also jointly liable for product quality and must ensure that imported medicines meet Hong Kong standards. A complete set of registration documents must be submitted, and the applicant must cooperate with the Drug Office’s review and on-site inspection.

📘 Regulatory basis

Sections 16 and 18 of the Pharmacy and Poisons Ordinance (Cap.138), Guidance on Drug Registration (issued by the Drug Office)

📗 Drew Tang's recommendations

We recommend thoroughly assessing the qualifications and production processes of mainland manufacturers before applying, and ensuring that all documents are complete and meet Hong Kong standards to avoid approval delays due to insufficient documentation.

📕 Risk notice

Products that are unregistered or do not meet the standards must not be imported or sold. Breaches may result in fines, licence revocation or criminal liability.

Q452 · 跨境委托生产药品时，香港持牌人需要承担哪些法律责任？独立链接

Under a cross-border contract manufacturing arrangement, the Hong Kong licence holder bears ultimate responsibility for the quality, safety and compliance of the medicines it sells. The licence holder must ensure that the contract manufacturer complies with the relevant GMP standards and maintain complete production and testing records. Under the Pharmacy and Poisons Ordinance (Cap. 138), the licence holder is legally liable for any incident resulting from a medicine quality issue, including administrative penalties and civil compensation. The licence holder should therefore rigorously audit the supply chain and ensure that every step complies with regulatory requirements.

📘 Regulatory basis

Section 19 of the Pharmacy and Poisons Ordinance (Cap.138), Chapter 4 of the PPB Code of Practice

📗 Drew Tang's recommendations

We recommend that Hong Kong licence holders enter into clear contracts with contract manufacturers, specifying quality standards and the allocation of responsibilities, and establish regular audit and spot-check mechanisms.

📕 Risk notice

If the audit obligations are not fulfilled or a quality incident occurs, the licence holder may face the risk of licence revocation and legal proceedings.

Q453 · 内地OEM厂商提供的药品批文能否直接用于香港药牌申请？独立链接

A medicine approval number (approval document) issued to a Mainland OEM manufacturer cannot directly replace a Hong Kong Certificate of Drug/Product Registration. A Hong Kong medicine licence application must include a complete set of registration information in accordance with local regulations, including evidence of quality, safety and efficacy. Although Mainland documents may be used as reference material, the Drug Office, Department of Health must still conduct an independent review and grant approval. Applicants should prepare information that meets Hong Kong standards, including the product insert, GMP certificate and test reports, and ensure compliance with the Pharmacy and Poisons Ordinance (Cap. 138).

📘 Regulatory basis

Section 16 of the Pharmacy and Poisons Ordinance (Cap.138), Guidance on Drug Registration Procedures

📗 Drew Tang's recommendations

We recommend that applicants submit mainland approvals as supporting documents while also preparing the complete registration documents required in Hong Kong, to avoid approval delays due to document discrepancies.

📕 Risk notice

Using approval documents from Mainland China in place of Hong Kong registration documents may result in the application being rejected or create a risk of illegal sales.

Q454 · 跨境委托生产的药品在香港进口时有哪些合规要求？独立链接

When medicines manufactured under cross-border contract manufacturing are imported into Hong Kong, they must comply with the relevant requirements of the Pharmacy and Poisons Ordinance (Cap.138) and the Import and Export Ordinance (Cap.60). The importer must hold a valid pharmaceutical licence and ensure that the imported medicines are registered, and provide complete import declaration documents and test reports. Imported medicines must meet Hong Kong quality standards, and complete import records must be retained for inspection by the Department of Health. In addition, imported medicines may be subject to sampling tests or on-site inspections to ensure their safety and compliance.

📘 Regulatory basis

Section 20 of the Pharmacy and Poisons Ordinance (Cap.138), relevant provisions of the Import and Export Ordinance (Cap.60)

📗 Drew Tang's recommendations

We recommend that importers prepare complete registration and testing documents in advance and cooperate with inspections by Customs and the Drug Office to facilitate customs clearance.

📕 Risk notice

Importing unregistered medicines or medicines with incomplete documentation may result in seizure and may even lead to fines or criminal liability.

Q455 · 香港持牌人如何监管内地OEM厂家的质量管理体系？独立链接

Hong Kong licence holders should establish a comprehensive supply chain management system and regularly audit and assess Mainland OEM manufacturers to ensure that their GMP systems meet international and Hong Kong standards. Licence holders are advised to enter into detailed quality agreements specifying each party’s responsibilities and quality standards, and to require manufacturers to provide batch production records, test reports and adverse event reports. Regular on-site audits and third-party testing are also effective oversight measures to ensure consistent product quality and compliance.

📘 Regulatory basis

Section 19 of the Pharmacy and Poisons Ordinance (Cap.138), GMP guidelines

📗 Drew Tang's recommendations

We recommend that licence holders establish a risk-management mechanism combining document review with on-site assessment to ensure that OEM manufacturers continue to meet regulatory requirements.

📕 Risk notice

Failure to address quality regulation may lead to product quality problems and, in turn, recalls, fines or even licence revocation.

Q456 · 跨境委托生产的药品在标签及说明书上应注意哪些合规事项？独立链接

The labels and package inserts for medicines manufactured under cross-border contract manufacturing must comply with the requirements of Hong Kong’s Pharmacy and Poisons Ordinance (Cap.138), including the registration number, batch number, expiry date, ingredients, directions and dosage, and warning information. Labels should be in Chinese and English to ensure that consumers understand them. The licensee should verify that the label information provided by the OEM manufacturer is accurate and contains no misleading information. All labels and package inserts must be reviewed and approved by the Department of Health before use.

📘 Regulatory basis

Section 17 of the Pharmacy and Poisons Ordinance (Cap.138), drug labelling guidance

📗 Drew Tang's recommendations

We recommend that licence holders review label content rigorously to ensure compliance with local regulations and language requirements and avoid legal risks.

📕 Risk notice

Non-compliant labelling may result in medicines being seized and may even lead to consumer complaints and legal proceedings.

Q457 · 内地OEM生产药品出口香港时，如何确保符合香港GMP标准？独立链接

Medicines manufactured by Mainland OEMs and exported to Hong Kong must be produced in accordance with GMP standards recognised by Hong Kong. The licence holder should confirm that the manufacturer holds a valid GMP certificate and conduct regular audits. We recommend following the Drug Office’s GMP guidelines and requiring the manufacturer to establish a complete Quality Management System, covering raw material procurement, production control, quality testing and product traceability. The licence holder should retain relevant audit records as evidence of compliance and to ensure that medicine quality meets Hong Kong market requirements.

📘 Regulatory basis

Section 19 of the Pharmacy and Poisons Ordinance (Cap.138), Hong Kong Drug Office GMP guidelines

📗 Drew Tang's recommendations

We recommend that licence holders actively participate in GMP audits and establish an information-sharing mechanism with manufacturers to improve compliance transparency.

📕 Risk notice

Failure to meet GMP requirements may lead to product recalls, licence revocation or even criminal penalties.

Q458 · 跨境委托生产的药品如果出现质量问题，香港持牌人应如何应对？独立链接

If a quality issue arises with a medicine manufactured under a cross-border contract manufacturing arrangement, the Hong Kong licence holder should immediately initiate a recall, notify the Department of Health and relevant regulatory departments, and cooperate with the investigation. The licence holder must trace the manufacturing and distribution records for the affected batch, assess the risk and take corresponding corrective measures. At the same time, oversight of the OEM manufacturer should be strengthened, the root cause identified and recurrence prevented. Risk alerts should be issued to consumers promptly to protect public health and the company’s reputation.

📘 Regulatory basis

Section 30 of the Pharmacy and Poisons Ordinance (Cap.138), medicine recall guidance

📗 Drew Tang's recommendations

We recommend that licence holders establish a comprehensive emergency plan for quality incidents to ensure a rapid and appropriate response.

📕 Risk notice

Delays in addressing quality issues may lead to serious legal liability and damage to the brand.

Q459 · 香港药牌申请中，内地OEM生产的药品资料应如何准备？独立链接

When applying for a Hong Kong pharmaceutical licence for medicines manufactured by an OEM in Mainland China, the product information should include detailed product descriptions, manufacturing process flow, GMP certificates, quality control standards, stability data and test reports. All information must meet the Department of Health's requirements and be submitted in Chinese or English. Applicants should ensure that the information is true and accurate, and prepare evidence of the manufacturer's qualifications and contract documents to demonstrate the contract manufacturing relationship. Thorough preparation of the information is key to a successful application.

📘 Regulatory basis

Section 16 of the Pharmacy and Poisons Ordinance (Cap.138), Guidance on Drug Registration

📗 Drew Tang's recommendations

We recommend communicating with the Drug Office in advance to ensure that the format and content of documents meet the latest requirements and improve processing efficiency.

📕 Risk notice

Incomplete or non-compliant information may delay approval or even result in refusal of registration.

Q460 · 跨境委托生产药品的进出口流程中，如何确保合规与效率？独立链接

The import and export process for medicines manufactured under cross-border contract manufacturing involves regulation by several departments. Applicants should ensure that all relevant licences are in place, including Hong Kong pharmaceutical licences and import and export licences. For imports, prepare complete declaration documents in advance and ensure that product registration information, test reports, transport documents and other materials meet the requirements. We recommend establishing an efficient supply chain management system and maintaining good communication with logistics providers, Customs and regulatory authorities, so that inspections and requests for additional information can be handled promptly and customs clearance can be completed both compliantly and efficiently.

📘 Regulatory basis

Pharmacy and Poisons Ordinance (Cap.138), Import and Export Ordinance (Cap.60)

📗 Drew Tang's recommendations

We recommend planning import and export timelines in advance and ensuring that all parties follow compliance procedures rigorously to avoid delays caused by incomplete formalities.

📕 Risk notice

Incomplete procedures or non-compliant operations may result in goods being seized, fines and damage to your reputation.

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