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.

Q421 · 如果我的持牌公司被裁定触犯刑事罪行，牌照会受到什么影响？独立链接

If a company holding a pharmaceutical licence is convicted by a court of a criminal offence relating to medicines, public health or commercial integrity, this poses a serious threat to its licence. Even if the offence does not directly breach the Pharmacy and Poisons Ordinance, after learning of the conviction the regulator (such as the PPB or CMRO) will reassess whether the company remains a “fit and proper” licence holder. The regulator has the power to convene a disciplinary hearing and, having regard to the nature and seriousness of the offence, decide whether action against the licence is warranted, including suspension or revocation.

📘 Regulatory basis

A licence holder must be an “appropriate and qualified” entity; this is an implicit basic requirement of all licensing regimes. A criminal conviction record is a key factor in assessing this qualification.

📗 Drew Tang's recommendations

A company’s legal compliance obligations are comprehensive. We recommend that clients comply not only with regulations governing the pharmaceutical industry, but also with all business laws, including those on anti-bribery and anti-money laundering. Any criminal record may become a “ticking time bomb” for the licence.

📕 Risk notice

Do not assume that only breaches of medicines legislation can affect your licence. Any criminal conviction indicating a lack of integrity on the part of company management may cause the regulatory authority to lose confidence in you and jeopardise your licence eligibility.

Q422 · 我持有西药批发商牌照，可以偶尔向最终消费者少量销售药品吗？独立链接

Absolutely not. The type of licence strictly defines the scope of your business. A Wholesale Dealer Licence authorises you to supply medicines to specified parties, such as other licensed wholesalers, licensed manufacturers, registered pharmacies, hospitals and registered doctors. It is, by nature, a B2B (business-to-business) activity. You must not sell medicines directly to end consumers, regardless of the quantity. Direct sales of regulated medicines to the public are the exclusive right of an Authorised Seller of Poisons (ASP) (pharmacy) or a Listed Seller of Poisons (LSP).

📘 Regulatory basis

The Pharmacy and Poisons Regulations (Cap. 138A) clearly define the scope of authorisation for different licence types. Operating outside that scope is an explicit breach.

📗 Drew Tang's recommendations

Please provide rigorous training to your sales team to ensure they clearly understand the types and qualifications of customers. Establishing a customer qualification review procedure to verify a customer's licence or registration status before opening an account is an effective way to prevent non-compliant sales.

📕 Risk notice

Selling medicines to the public as a wholesaler not only breaches your licence conditions and may result in disciplinary action, but may also be regarded in law as unlicensed retailing, exposing you to the risk of criminal prosecution.

Q423 · 在香港为药品做广告有哪些规定？什么情况会构成违规？独立链接

Pharmaceutical advertising in Hong Kong is subject to strict legal controls, primarily under the Undesirable Medical Advertisements Ordinance. First, advertisements to the public for medicines claiming to treat or prevent diseases or conditions listed in Schedule 1 to that Ordinance, such as cancer and diabetes, are prohibited. Second, advertisements that may lead or induce someone to use a medicine to terminate a pregnancy are prohibited. In addition, pharmaceutical advertisements must not contain false, exaggerated or misleading information. This covers advertisements in traditional media as well as on the internet and social media platforms.

📘 Regulatory basis

The Undesirable Medical Advertisements Ordinance (Cap. 231) is the principal legislation regulating medicine advertising. It aims to protect the public from being misled by improper medical advertising.

📗 Drew Tang's recommendations

Before planning any medicine promotion, we strongly recommend having the advertising copy reviewed for compliance by a professional consultant. Claims about efficacy in particular must be supported by sufficient scientific evidence and must not breach statutory restrictions.

📕 Risk notice

Publishing unlawful medicine advertisements is a criminal offence. Upon conviction, a first-time offender may be fined up to HK$50,000 and imprisoned for 6 months. This causes not only financial loss but also serious damage to brand reputation.

Q424 · 我是一家列载毒药销售商，我的“负责人”要休长假，需要做什么安排？独立链接

A Listed Seller of Poisons (commonly known as a “drug store”) must have a “Responsible Person” to supervise the sale of Part II poisons. If this person is to take a long holiday, you must make appropriate arrangements. First, you need to nominate one or more “Deputy Responsible Persons”. A deputy must also be approved by the Pharmacy and Poisons Board and meet certain qualification and experience requirements. You should submit an application for the deputy to the Drug Office in advance. During the Responsible Person’s absence, you must ensure that an approved Responsible Person or Deputy Responsible Person is on duty throughout every day’s business hours.

📘 Regulatory basis

The Code of Practice for Listed Sellers of Poisons requires a Responsible Person or an approved deputy to be present during business hours to supervise operations.

📗 Drew Tang's recommendations

We recommend that clients do not wait until a Person-in-Charge is about to take leave before rushing to apply. It is preferable to develop and seek approval for one or two alternate Persons-in-Charge as part of routine operations, to cover unexpected staff absences and ensure business compliance and continuity.

📕 Risk notice

If business continues and Part II poisons are sold without the Person-in-Charge or an approved alternate Person-in-Charge on duty, this will be regarded as a serious breach if discovered by a Department of Health inspector. It may result in disciplinary action or even suspension of the licence.

Q425 · 如果我的公司被另一家公司收购，我的药品牌照会自动转移给收购方吗？独立链接

No. A pharmaceutical licence is not transferable. A licence is granted to the legal entity that made the original application (that is, your company). If your company is acquired, there are usually two scenarios. The first is a share acquisition: the purchaser buys shares in your company, which remains the same legal entity, although its shareholders change. In this case, the licence remains with your company, but you must notify the regulatory authority of changes to directors and shareholders as required. The second is an asset acquisition: the purchaser buys only the business assets (such as stock and equipment) and operates through its own company. In this case, the purchaser must apply for an entirely new licence in the name of its own company.

📘 Regulatory basis

Both the Pharmacy and Poisons Ordinance and the Chinese Medicine Ordinance establish the principle that licences are non-transferable. A licence is tied to a specific licensee and licensed premises.

📗 Drew Tang's recommendations

Licence issues must be a central consideration in any M&A transaction. Rengangyongsheng (Hong Kong) Limited has provided compliance due diligence and post-transaction integration advice for numerous M&A cases, helping to ensure a smooth transition or reapplication for the licence.

📕 Risk notice

It is a major misconception to think that a licence can be “bought and sold” along with a business. If the acquiring company takes over operations without first obtaining a new licence, it will be operating without a licence, with very serious consequences.

Q426 · 作为持牌西药批发商，我需要保存哪些交易记录？需要保存多久？独立链接

Under the Good Distribution Practice (GDP) requirements for wholesale dealers in medicines, you must keep detailed records of the receipt and supply of all medicines to ensure complete traceability. Records should include, at a minimum: the name of the medicine, dosage form, strength, batch number, expiry date, transaction date, name and address of the supplier or recipient, and quantity involved. All records must be properly kept and made available for inspection by Department of Health inspectors at any time. The law requires these records to be retained for at least two years from the transaction date.

📘 Regulatory basis

The Pharmacy and Poisons (Manufacturers and Wholesale Dealers) Regulations and GDP guidelines set out clear statutory requirements on the types of records to be kept and their retention periods.

📗 Drew Tang's recommendations

We strongly recommend that clients use an electronic inventory and sales management system (ERP). This not only efficiently and accurately generates and retains all statutory records, but also enables you to quickly identify affected batches and customers when a medicine needs to be recalled, greatly enhancing your responsiveness.

📕 Risk notice

Incomplete or inaccurate record-keeping is one of the most common breaches identified during Department of Health inspections. This may lead not only to a warning or disciplinary action, but, more importantly, leave you unable to trace the distribution of products effectively in the event of a medicine safety incident, exposing you to substantial legal and compensation risks.

Q427 · 我的药房出售了一款伪冒药物，但这是从一家持牌批发商那里进的货。我需要承担责任吗？独立链接

Yes, you remain responsible. Everyone holding a licence at each stage of the medicine supply chain is responsible for ensuring that the medicines they deal in are genuine. As a retailer, you are responsible for sourcing medicines from reputable and reliable suppliers. Although your supplier is a licensed wholesaler, this does not completely exempt you from responsibility. If you purchase goods at prices far below market rates or obtain medicines through unusual channels, the regulatory authority may consider that you “ought to have known or suspected” that there was a problem with their source. Selling counterfeit medicines is a strict liability offence, and it is often difficult to rely on a defence of lack of knowledge.

📘 Regulatory basis

The Trade Descriptions Ordinance (Cap. 362) prohibits the sale of goods bearing a forged trade mark. The Pharmacy and Poisons Ordinance prohibits the sale of unregistered pharmaceutical products.

📗 Drew Tang's recommendations

It is essential to establish a rigorous supplier qualification and management system. Work only with reputable wholesalers or agents authorised by the original manufacturers. Inspect every incoming batch and check the packaging, labels and batch numbers. Never buy through questionable channels just to save money.

📕 Risk notice

Selling counterfeit medicines is a serious criminal offence. Your pharmacy licence may be revoked, and the person-in-charge may also face imprisonment. Although wholesalers may be held liable, you, as the last safeguard at the retail stage, are also responsible.

Q428 · 药剂业及毒药管理局的“纪律委员会”是一个什么样的机构？由谁组成？独立链接

The Disciplinary Committee is a statutory body established under the Pharmacy and Poisons Ordinance to hear cases concerning professional misconduct or breaches by licence holders or registered pharmacists. It is not a standing committee; when a case requires an inquiry, the chairperson of the Pharmacy and Poisons Board (PPB) appoints members from among the Board’s members. Under the law, the Disciplinary Committee must comprise at least three members, and its chairperson must be the chairperson of the PPB or another member appointed by the chairperson. Its members usually include pharmacists, doctors and government representatives, helping to ensure that decisions are professional and impartial.

📘 Regulatory basis

Section 9 of the Pharmacy and Poisons Ordinance (Cap. 138) authorises the PPB to establish a disciplinary committee and sets out its composition and powers.

📗 Drew Tang's recommendations

A disciplinary hearing is a very serious quasi-judicial process. If you receive a hearing notice, you must treat it seriously. Understanding the committee’s composition can help you understand its concerns. Your statement and submissions should focus on professional standards, operating procedures and the public interest, rather than solely on commercial considerations.

📕 Risk notice

Do not underestimate the powers of the Disciplinary Committee. It may suspend or permanently revoke your licence or registration. Giving false testimony or misleading the Committee at a hearing is itself serious misconduct that may aggravate the penalty.

Q429 · 有刑事案底的人，可以担任持有药品牌照的公司的董事吗？独立链接

This depends on the circumstances. When assessing a licence application or renewal, the regulator will assess whether all the company’s directors are “fit and proper persons”. If a director’s criminal record involves dishonesty, fraud, or offences related to medicines or public safety, the regulator is highly likely to consider that director not to be a “fit and proper person”. This may directly result in a new licence application being refused or cause problems with renewal of an existing licence. The impact may be smaller if the record relates to a minor offence unrelated to the company’s business or integrity, such as a minor traffic offence.

📘 Regulatory basis

The “Fit and Proper Person” principle is a cornerstone of regulation for all financial and professional licences in Hong Kong, and the medicines sector is no exception.

📗 Drew Tang's recommendations

It is essential to conduct background checks before appointing new directors or bringing in new shareholders. We recommend that clients include a clause in the company’s articles of association requiring directors to declare any criminal convictions. If in doubt, it is best to seek the regulatory authorities’ views anonymously in advance.

📕 Risk notice

Attempting to conceal a director's criminal record is extremely unwise. The regulatory authority conducts background checks during its review. If inaccurate declarations are discovered, the application will not only be refused but may also seriously affect the company's future integrity record.

Q430 · 监管机构如何处理关于持牌药房或批发商的匿名投诉？独立链接

The Drug Office, Department of Health and the Chinese Medicine Council of Hong Kong both have channels for handling public complaints and accept anonymous complaints. After receiving a complaint, whether anonymous or identified, the regulatory authority conducts an initial assessment. If the complaint is specific and clear and concerns conduct that may breach relevant legislation or a code of practice, the authority will usually open a case and investigate. The investigation may include unannounced inspections of the licensed premises concerned, examination of relevant records and interviews with relevant personnel. Although anonymous complaints do not allow investigators to obtain further information from the complainant, they are still taken seriously.

📘 Regulatory basis

Handling public complaints is part of a regulatory agency’s duty to protect public health. Risk assessment of all information received is part of its standard procedures.

📗 Drew Tang's recommendations

Do not assume that nobody knows what you are doing. Your employees, customers and even competitors may make a complaint. The only way to respond is to operate compliantly at all times, ensuring that every part of your business can withstand scrutiny.

📕 Risk notice

Anonymous complaints are one important source of information that helps regulators identify possible non-compliance. Do not assume that a breach will go undetected simply because it is concealed. A single unannounced inspection may expose all non-compliant practices.

Q431 · 如果我的药房在续期视察中被发现有不符合项，会发生什么？独立链接

If a Department of Health inspector finds during a renewal inspection that your pharmacy does not comply with the Code of Practice for Authorised Sellers of Poisons, the subsequent process will depend on the seriousness of the non-compliance. For minor shortcomings, such as incomplete records or a small number of items being stored incorrectly, the inspector will usually issue an oral or written warning and require you to make corrections within a specified period. However, if a serious breach is found, such as storage conditions that fall significantly short of requirements, poor management of prescription medicines or a safety hazard, the Drug Office may suspend processing of your renewal application until you have completed all necessary corrective actions and passed a follow-up inspection. In the worst case, if the breach is extremely serious, disciplinary proceedings may be initiated.

📘 Regulatory basis

Renewal is conditional on the licence holder continuing to meet all legislative and Code of Practice requirements. Inspections are the statutory means by which regulators verify this.

📗 Drew Tang's recommendations

We recommend that clients conduct a comprehensive internal self-inspection before submitting a renewal application. RGYS can provide mock inspection services to identify potential issues in advance from the regulator's perspective and guide you in implementing corrective measures. 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.

📕 Risk notice

Do not wait until an inspection to discover problems. If your renewal application is delayed because serious non-compliances have not been corrected promptly, your business will have to suspend operations once the existing licence expires, resulting in direct financial losses.

Q432 · 牌照的“暂停”（Suspension）和“撤销”（Revocation/Cancellation）有何区别？独立链接

“Suspension” and “revocation” are disciplinary measures of different severity. “Suspension” temporarily suspends your licence for a specified period, such as 14 or 30 days, during which you may not carry out any licensed activities. After the suspension period, the licence may be reinstated if specific conditions are met. “Revocation” is the most severe measure: your licence is permanently cancelled and your licensed status terminated. Once your licence is revoked, you lose the right to conduct the relevant business at those premises. This is generally imposed for very serious breaches or where the licence holder is found no longer to be a “Fit and Proper Person”.

📘 Regulatory basis

Both the Pharmacy and Poisons Ordinance (Cap. 138) and the Chinese Medicine Ordinance (Cap. 549) confer disciplinary powers on regulators to suspend or revoke licences.

📗 Drew Tang's recommendations

Any breach that results in a licence suspension should be treated as a final warning. You must immediately undertake thorough internal reform and process redesign, and demonstrate your determination and ability to return to compliance to the regulator, to avoid moving towards revocation.

📕 Risk notice

Revocation of a licence is tantamount to an almost irreversible commercial death sentence. The relevant records are kept permanently. Not only does the current business come to an end, but the future industry reputations of the company and its key persons are also severely damaged, making it extremely difficult to re-establish themselves in the same field.

Q433 · 如果我的药品牌照曾被撤销，我或我的公司将来还能重新申请吗？独立链接

Technically, the law does not expressly prohibit an individual or company whose licence has been revoked from submitting a new application at some point in the future. In practice, however, this is extremely difficult. When you submit a new application, the regulatory authority will inevitably review your past record. You must provide highly persuasive evidence that the root causes of the licence revocation have been fully addressed, that you and your company have changed fundamentally, and that you are now a ‘fit and proper’ applicant. Rebuilding credibility takes a long time, and you will need to demonstrate a completely new and robust compliance management system.

📘 Regulatory basis

When assessing new applications, the regulatory authority closely scrutinises the applicant’s past record, including that of its directors and key management personnel, as part of its gatekeeping responsibilities.

📗 Drew Tang's recommendations

Rather than hoping to reapply after “turning over a new leaf”, make every effort to prevent your licence from being revoked in the first place. Compliance is an ongoing investment, not a cost that can be remedied after the event. Prevention is better than cure.

📕 Risk notice

The likelihood of success on reapplication is extremely low. The regulator will take a very cautious, even sceptical, approach. The effort required and the standards you must meet will be far higher than for a first-time applicant. Do not take the law lightly.

Q434 · 持牌人的纪律处分记录会向公众披露吗？独立链接

Yes, this will usually happen. Under the relevant ordinances, after making a disciplinary decision, the Pharmacy and Poisons Board and the Chinese Medicine Council of Hong Kong may publish the outcome (including the licence holder's name/company name, a summary of the misconduct and the specific penalty) in the Government Gazette. In serious cases involving the public interest, the regulatory authority may also issue a press release to inform the public. This means that records of serious disciplinary action are public information and may be consulted by anyone, significantly increasing the reputational cost of non-compliance.

📘 Regulatory basis

Section 9A and other provisions of the Pharmacy and Poisons Ordinance (Cap. 138) authorise the regulator to publish disciplinary committee orders to enhance transparency and alert the public.

📗 Drew Tang's recommendations

In today's digital age, negative public records can spread faster and more widely than one might imagine. A good compliance reputation is one of a company's most important intangible assets. The compliance systems we help clients establish are intended to reduce this reputational risk to zero.

📕 Risk notice

Once publicly named, you may not only lose existing customers but also seriously damage your relationships with suppliers, banks and other business partners. The resulting loss of business reputation often has a deeper and more lasting impact than the fine itself.

Q435 · 我的公司从独资经营转为有限公司，原来的药品牌照还能继续用吗？独立链接

No. A licence is granted to a specific legal entity. When your business changes from a sole proprietorship to a limited company, a new and separate legal entity is created in law. Therefore, you cannot directly “continue” or “transfer” the licence held by the sole proprietorship for use by the new limited company. The new limited company must submit a completely new licence application to the regulatory authority in its own name and go through the full approval process, including submitting all documents and undergoing an on-site inspection.

📘 Regulatory basis

The principle that a licence is strictly tied to the licensed legal entity is fundamental to all licensing systems. A change of legal entity is equivalent to a change of licence holder.

📗 Drew Tang's recommendations

Before proceeding with a corporate restructuring, a new licence application must be treated as a key element of the timetable and budget. We recommend starting the application for the new licence immediately after the limited company is incorporated, to minimise any gap in operations during the handover.

📕 Risk notice

Starting a medicines business in the name of a limited company without first obtaining a new licence will be regarded as operating without a licence. This is a very serious mistake: do not confuse an individual sole proprietor with a limited company as a separate legal entity.

Q436 · 在药房营业时间内，如果没有注册药剂师当值，会有什么后果？独立链接

A registered pharmacist (RP) must be physically present on duty at a pharmacy (Authorised Seller of Poisons) at all times during its business hours. This is a mandatory legal requirement. If no RP is present during business hours, the pharmacy must not sell any medicines required to be sold under supervision (that is, Part I and Part III poisons). If a Department of Health inspector finds a “ghost pharmacy” (a pharmacy operating without a pharmacist on duty), this will constitute a serious breach. The licence holder and/or company directors may be held responsible and are very likely to face disciplinary proceedings, which may result in a warning, suspension or revocation of the licence.

📘 Regulatory basis

The Pharmacy and Poisons Regulations (Cap. 138A) expressly provide that medicines for sale under supervision must be sold under the supervision of a registered pharmacist.

📗 Drew Tang's recommendations

Appropriate pharmacist rostering and a backup plan are vital to pharmacy operations. We recommend that clients establish working relationships with several pharmacists, both full-time and part-time, to ensure regulatory requirements can be met in all circumstances and to avoid being forced into non-compliance or closure because of staff shortages.

📕 Risk notice

“Snakehead pharmacies” are a target of strict enforcement by regulators because they directly endanger public medicine safety. If a business is classified as a “snakehead pharmacy”, it will generally face very severe penalties. Do not take any chances.

Q437 · 我是否可以将药品存放在持牌地址以外的地方，例如迷你仓？独立链接

Absolutely not. Under Hong Kong law, all regulated medicines, whether Western medicines or proprietary Chinese medicines, must be stored at licensed premises specified on the licence and approved by the regulatory authority. The facilities at these premises, including temperature and humidity controls, security systems and fire prevention measures, are subject to rigorous scrutiny to ensure the quality and safety of the medicines. Unapproved external storage locations, such as offices, homes or mini-storage units, do not meet statutory storage requirements. Storing medicines at these locations is a serious breach.

📘 Regulatory basis

Both the Good Distribution Practice (GDP) for Wholesale Dealers in Medicines and guidance such as the GMP for proprietary Chinese medicines strictly require medicines to be stored at qualified premises.

📗 Drew Tang's recommendations

If your licensed warehouse does not have sufficient capacity, the only lawful solution is to apply to expand the area of the existing licensed premises or apply for a new, suitably qualified licensed warehouse. Rengangyongsheng (Hong Kong) Limited can assist you in finding suitable storage space and completing the licence application or change procedure.

📕 Risk notice

Storing medicines at an unapproved location not only puts their quality at risk; more seriously, if this is discovered, the regulatory authorities may consider that you are attempting to conceal or distribute medicines of unknown origin, triggering a serious loss of trust and disciplinary action.

Q438 · 如果我不再想经营药品业务，如何合法地注销我的药品牌照？独立链接

If you decide to cease your pharmaceutical business, you should proactively apply to the relevant regulatory authority (the Drug Office, Department of Health, or the Chinese Medicine Council of Hong Kong) to cancel your licence. You need to submit written notice clearly stating the date on which you intend to cease operations. Before ceasing operations, you must deal properly with all remaining medicine stock. This usually means lawfully selling or transferring the stock to another licensed wholesaler or manufacturer, or arranging for a qualified chemical waste contractor to destroy it. You must retain all relevant records of how the stock was dealt with. After completing all stock clearance procedures, return the original licence to the regulatory authority.

📘 Regulatory basis

Although no legislation prescribes a mandatory cancellation procedure, proactively and orderly winding down a licensed business is responsible practice and helps ensure that all regulated materials are handled properly.

📗 Drew Tang's recommendations

A clean and orderly exit is equally important. We recommend that clients draw up a detailed cessation plan covering inventory handling, staff arrangements, customer notifications and communications with the regulator. This can help preserve your and your company’s good reputation should you wish to re-enter the market in future.

📕 Risk notice

Do not simply close the doors and walk away. If you still hold a valid licence, in theory you remain legally responsible as the licence holder. Failure to deal properly with the remaining medicine stock may give rise to unforeseen legal risks in future.

Q439 · 针对中成药的监管，和西药相比，在违规处罚方面有什么主要不同？独立链接

Although proprietary Chinese medicines and Western medicines are regulated by different bodies (the Chinese Medicine Council of Hong Kong and the Pharmacy and Poisons Board), their regulatory philosophies and penalty principles are similar, with the protection of public health as the primary objective. The main differences lie in the specific legal bases and certain types of non-compliance unique to each. For example, regulation of proprietary Chinese medicines focuses particularly on quality standards for “heavy metals and toxic elements”, “pesticide residues” and “microbial limits”. Breaches of these standards are serious forms of non-compliance specific to proprietary Chinese medicines. Proprietary Chinese medicines are also subject to the issue of “unregistered proprietary Chinese medicines”, similar to “unregistered pharmaceutical products” in the case of Western medicines. In general, penalties for serious offences such as unlicensed operations and the sale of counterfeit or substandard products are severe for both, including substantial fines and imprisonment.

📘 Regulatory basis

The Chinese Medicine Ordinance (Cap. 549) is the main legal framework for regulating proprietary Chinese medicines, while Western medicines are primarily regulated under the Pharmacy and Poisons Ordinance (Cap. 138).

📗 Drew Tang's recommendations

Whether you deal in Chinese or Western medicines, the core principles of compliance are the same: ensure that products are safe, effective and of controlled quality, and that their sources and destinations are clear and traceable. Our compliance consultancy is tailored to each client's specific business type.

📕 Risk notice

Do not assume that Chinese medicines are subject to more lenient regulation than Western medicines. In recent years, Hong Kong has continued to tighten safety standards and enforcement for proprietary Chinese medicines, particularly in tackling products containing undeclared Western medicine ingredients or excessive levels of heavy metals.

Q440 · 作为公司董事，在牌照违规事件中，我个人需要承担法律责任吗？独立链接

Yes, company directors may well incur personal legal liability. Under the Pharmacy and Poisons Ordinance, the Chinese Medicine Ordinance and other relevant legislation, if a company's offence is proved to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of, a director, manager or other senior officer of the company, that person as well as the company is guilty of the offence. This means that, in addition to the company facing a fine or licence sanctions, the relevant management personnel may also be prosecuted and face personal penalties, including a fine or imprisonment. A defence that they “did not know” or “had authorised a subordinate to handle it” will generally not be sufficient to avoid liability.

📘 Regulatory basis

Several laws relating to public safety contain “directors’ liability” provisions designed to look beyond the corporate veil and hold decision-makers personally responsible.

📗 Drew Tang's recommendations

As a director, you have ultimate oversight responsibility for the company's compliant operation. We strongly recommend that the company takes out directors' and officers' liability insurance (D&O Insurance) and establishes clear internal compliance reporting lines to ensure that the board is promptly informed of and oversees compliance risks.

📕 Risk notice

The company’s licence is one of your core responsibilities as a director. Licence breaches may not only harm the company’s business, but may also result in a criminal record for you personally. This is a significant risk that all company managers must remain alert to.

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