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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Q401 · 我的西药批发商牌照即将到期，具体的续期流程是怎样的？独立链接

An application to renew a Wholesale Dealer Licence should be submitted within the 3 months before the licence expires, but no later than the expiry date. You must submit the designated renewal application form to the Drug Office, Department of Health, together with relevant documents, such as a copy of the company’s Business Registration Certificate, the company’s annual return and payment of the renewal fee. The Drug Office will review your application and may arrange an on-site inspection to ensure that your business operations, premises and facilities, and Quality Management System still meet licensing requirements. The renewal process usually takes several weeks. We recommend preparing early to avoid disruption to your business if the licence expires.

📘 Regulatory basis

Under section 18 of the Pharmacy and Poisons Regulations (Cap. 138A), licence holders must apply for renewal in the prescribed manner before the licence expires.

📗 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. Experience tells us that all documents must be prepared in advance, particularly records of updates to the quality management system (QMS). The Drug Office has extremely stringent requirements for document completeness and compliance, and any omission may delay approval.

📕 Risk notice

If your licence is not successfully renewed before its expiry date, it will lapse. Continuing to operate a wholesale business in Western medicines will constitute unlicensed operation, which is a criminal offence and may result in a substantial fine or even imprisonment.

Q402 · 如果错过了续期申请的截止日期，还有补救措施吗？独立链接

If you miss the deadline for submitting a renewal application before the licence expires, the licence will automatically expire. There is no statutory grace period or remedial period. You must immediately stop all relevant licensed activities. The only option is to submit a completely new licence application, not a renewal application. This means going through the entire application process again, including submitting all initial application documents and undergoing rigorous review and an on-site inspection. This is not only time-consuming and demanding, but your business will also come to a complete standstill until a new licence is granted, causing substantial commercial losses.

📘 Regulatory basis

The Pharmacy and Poisons Ordinance (Cap. 138) clearly requires businesses to be licensed. A licence becomes invalid as soon as it expires, and there is no statutory remedy.

📗 Drew Tang's recommendations

To avoid this situation, we strongly recommend setting multiple reminders and starting renewal preparations 4-5 months before expiry. Rengangyongsheng (Hong Kong) Limited can provide licence management services and proactively follow up on your renewal to help ensure nothing is overlooked.

📕 Risk notice

Continuing business after a licence has lapsed is regarded as unlicensed business. Under Cap. 138, upon conviction, the maximum penalty is a fine of HKD 100,000 and imprisonment for 2 years. Do not take the risk.

Q403 · 我计划将药房搬迁到新的地址，需要办理哪些变更手续？独立链接

The premises of a pharmacy (Authorised Seller of Poisons) are one of the core elements of the licence, and any relocation must be approved in advance by the Pharmacy and Poisons Board (PPB). You must submit an application to change the licensed premises and provide detailed plans of the new premises and a tenancy agreement or proof of ownership. The Department of Health will send officers to conduct a thorough on-site inspection of the new premises to check whether the layout, security facilities, storage conditions (such as temperature control) and dispensing area meet the requirements of the Code of Practice for Authorised Sellers of Poisons. You may operate at the new address only after the inspection has been passed and formal approval granted.

📘 Regulatory basis

Under the Pharmacy and Poisons Regulations (Cap. 138A), changing licensed premises is a major licence variation and requires an application and approval in advance.

📗 Drew Tang's recommendations

Before signing a new lease, it is best to have an adviser from Rengangyongsheng (Hong Kong) Limited or yourself conduct a preliminary assessment of the proposed site against the Code of Practice. We have seen too many clients suffer significant financial losses after their applications were refused because of unsuitable premises, such as insufficient floor area or poor ventilation.

📕 Risk notice

Relocating and operating without prior approval amounts to conducting business at unauthorised premises. Your licence may be suspended or revoked. This may also constitute unlicensed operation and lead to criminal prosecution.

Q404 · 我们公司的“获授权人”（Authorized Person, AP）即将离职，如何办理负责人变更？独立链接

The “Authorised Person” is a key position at a licensed manufacturer, and any change must be notified to the Drug Office, Department of Health immediately. Under the requirements, you must notify the Drug Office in writing within 7 days after the change takes effect. You must also nominate a new, suitably qualified AP and submit their detailed CV, academic qualifications and proof of professional qualifications for the Drug Office’s approval. The newly nominated AP must have the pharmacist qualifications and relevant industry experience required by law. Until approval is granted, the former AP remains legally responsible for the relevant matters.

📘 Regulatory basis

The Pharmacy and Poisons (Manufacturers and Wholesale Dealers) Regulations set out clear requirements for the qualifications of an “Authorised Person” and the procedure for changes, ensuring the continued monitoring of the quality of pharmaceutical products.

📗 Drew Tang's recommendations

Finding a suitable AP is the key to a successful change. RGYS may assist with clarifying roles, evidence of qualifications and responsibility arrangements within the written scope; the suitability, appointment and actual presence at work of candidates remain subject to verification by the applicant and legally qualified personnel, and no provision or certification of personnel is promised. RGYS may assist with clarifying roles, evidence of qualifications and responsibility arrangements within the written scope; the suitability, appointment and actual presence at work of candidates remain subject to verification by the applicant and legally qualified personnel, and no provision or certification of personnel is promised. We will also guide you in preparing a complete set of submission documents. RGYS may assist with document preparation and project coordination within the written scope of services; personnel qualifications, statutory roles and professional judgements are to be verified and assumed by the respective responsible parties, while approval is determined independently by the competent authority.

📕 Risk notice

Failure to notify the authorities promptly or continuing production without a qualified AP is a serious breach. This may result in suspension or revocation of your Manufacturer of Pharmaceutical Products licence and may affect the company’s GMP certification status.

Q405 · 我的中成药批发商牌照持牌公司发生了股权变更，是否需要向中医药管理委员会（CMRO）申报？独立链接

Yes, this is absolutely required. Whenever the directors or shareholding structure of a licensed company wholesaling proprietary Chinese medicines changes, you must notify the Chinese Medicines Board under the Chinese Medicine Council of Hong Kong in writing within 28 days of the change. You must submit details of the change, including identity documents for the new and former directors/shareholders and changes in shareholding percentages. Although a shareholding change does not necessarily require prior approval, notification after the event is mandatory. The Chinese Medicines Board will assess whether the change affects the company's effective control and management to ensure that it continues to meet the licensing requirements.

📘 Regulatory basis

Under the subsidiary legislation of the Chinese Medicine Ordinance (Cap. 549), licence holders are responsible for notifying the regulatory body of any significant change in the company’s control.

📗 Drew Tang's recommendations

We recommend seeking professional advice before any shareholding change transaction. We can help assess whether the background of a new shareholder may raise regulatory concerns and ensure that all notification documents are accurate, avoiding unnecessary scrutiny arising from improper notification.

📕 Risk notice

If you fail to report on time or provide false information, the Chinese Medicines Council has the authority to take disciplinary action against your licence, including issuing a warning letter, suspending the licence or, in extreme cases, revoking it.

Q406 · 如果被发现无牌经营药房，会面临什么样的具体处罚？独立链接

In Hong Kong, operating a pharmacy without a licence (that is, selling Part I poisons without a licence) is an extremely serious offence. Under the Pharmacy and Poisons Ordinance, any unauthorised person who sells or possesses Part I poisons commits an offence. On summary conviction, the maximum penalty is a fine of HKD 100,000 and imprisonment for 2 years. In addition, enforcement officers of the Drug Office, Department of Health have the power to enter and search any premises suspected of unlicensed operation and seize all relevant medicines and documents as evidence. In sentencing, the court will consider not only fines and imprisonment but may also order forfeiture of all poisons seized.

📘 Regulatory basis

Section 28 of the Pharmacy and Poisons Ordinance (Cap. 138) expressly sets out the offences and penalties for the unlawful sale and possession of poisons.

📗 Drew Tang's recommendations

Do not take any chances. The regulator has a zero-tolerance policy towards unlicensed operations and often takes joint enforcement action with the police. If you intend to engage in retail sales of medicines, you must first apply for a Pharmacy licence through a professional organisation such as Rengangyongsheng (Hong Kong) Limited.

📕 Risk notice

In addition to statutory fines and imprisonment, a record of unlicensed operation will seriously affect your and your associated companies’ future applications for any type of licence in Hong Kong. It is a lasting “blemish”, and its commercial consequences go far beyond the fine itself.

Q407 · 作为持牌中药材零售商，哪些行为会被视为违规？独立链接

Common violations by licensed retailers of Chinese herbal medicines mainly fall into several categories. First, “adulteration or substitution”, meaning that the Chinese herbal medicines sold do not match the varieties indicated on the labels, or that other substances have been added. Second, non-compliant labelling, such as failing to state the name, origin, batch number or expiry date of the Chinese herbal medicines as required. Third, improper storage, with inadequate storage conditions to prevent deterioration, mould or contamination. Fourth, failing to record purchaser details as required when selling toxic Chinese herbal medicines listed in Schedule 1 or Schedule 2. Finally, operating beyond the scope of the licence, such as also selling proprietary Chinese medicines, is a violation.

📘 Regulatory basis

The Chinese Medicine Ordinance (Cap. 549) and its subsidiary legislation, particularly the Chinese Medicines Regulation, set out in detail the requirements for the retail of Chinese herbal medicines, labelling and storage.

📗 Drew Tang's recommendations

We recommend that clients establish a strict internal control system, including supplier audits, quality inspection of incoming goods (SOP), and clear labelling and stock management systems. Regular staff training is also essential to ensure that everyone understands the legal requirements.

📕 Risk notice

Any breach may result in disciplinary action by the Chinese Medicine Council. Serious breaches affecting public health, particularly the sale of adulterated or poisonous herbal medicines, may not only put the licence at risk of revocation but may also lead to criminal prosecution.

Q408 · 如果我的药房因违规行为被提交到药剂业及毒药管理局（PPB）的纪律委员会，可能会有什么处分？独立链接

If your pharmacy is referred to the PPB’s Disciplinary Committee on suspicion of breaching the Pharmacy and Poisons Ordinance or a relevant code of practice, the Committee may impose various sanctions after completing a hearing and finding the allegations substantiated. These sanctions include issuing a written warning to the licence holder; ordering the licence holder to rectify the breach within a specified period; ordering suspension of the licence for a period, such as 14 days or longer; and, in the most serious cases, ordering revocation of your licence. The Disciplinary Committee may also order the licence holder to pay the costs relating to the disciplinary proceedings.

📘 Regulatory basis

Section 9 of the Pharmacy and Poisons Ordinance (Cap. 138) confers disciplinary powers on the Pharmacy and Poisons Board.

📗 Drew Tang's recommendations

If you receive notice of a disciplinary hearing, do not take it lightly. You should immediately seek professional legal and compliance advice. Rengangyongsheng (Hong Kong) Limited can help you review the case, prepare your defence materials and simulate the hearing, with a view to minimising potential penalties.

📕 Risk notice

Disciplinary decisions are generally published in the Government Gazette, making your breach a matter of public record and seriously damaging the company’s reputation and business standing. Suspension or revocation of a licence directly disrupts business operations.

Q409 · 在什么情况下，违规经营药品会从行政处罚上升到刑事检控？独立链接

Whether a breach in the course of dealing in medicines will lead to criminal prosecution depends mainly on its nature and seriousness. Serious offences involving public health and safety, or conduct with an obvious fraudulent intent, are highly likely to result in criminal prosecution. Examples include operating any type of medicine business without a licence; selling or possessing unregistered pharmaceutical products (“counterfeit medicines”); selling proprietary Chinese medicines containing undeclared Western medicine ingredients; illegally selling antibiotics or dangerous drugs; and adulterating medicines with harmful substances. Such cases are usually investigated jointly by the Department of Health and the Commercial Crime Bureau of the Hong Kong Police Force, with the Department of Justice deciding whether to prosecute.

📘 Regulatory basis

The Pharmacy and Poisons Ordinance (Cap. 138), the Chinese Medicine Ordinance (Cap. 549) and the Undesirable Medical Advertisements Ordinance (Cap. 231) all contain provisions on serious offences that may lead to criminal prosecution.

📗 Drew Tang's recommendations

The distinction between an administrative breach and a criminal offence is sometimes blurred. Our principle is to never cross the red lines involving “fake” (unregistered products), “poisons” (dangerous drugs) or “deception” (false claims). Compliant operations are the only safeguard.

📕 Risk notice

The consequences of a criminal conviction go far beyond a fine. The person-in-charge may face imprisonment and acquire a permanent criminal record. The company’s reputation will be completely destroyed, making it virtually impossible to establish itself again in the pharmaceutical industry.

Q410 · 作为药品批发商，我们应如何建立有效的合规风险防范体系？独立链接

Establishing an effective compliance risk-prevention system is fundamental to a pharmaceutical wholesaler's continued operation. First, appoint an independent compliance manager or team to oversee all business activities. Second, develop detailed written Standard Operating Procedures (SOPs) covering the entire process from procurement, receipt and storage to picking, packing and transport, and ensure all staff are trained accordingly. Third, establish a comprehensive record-keeping system so that the movement of every pharmaceutical product is clearly traceable. Fourth, conduct regular internal audits and risk assessments to identify and rectify potential compliance gaps proactively. Finally, work closely with professional consultants such as Rengangyongsheng (Hong Kong) Limited to obtain the latest regulatory updates and compliance guidance.

📘 Regulatory basis

The Department of Health’s Good Distribution Practice (GDP) for Wholesale Dealers in Pharmaceutical Products provides a detailed framework and requirements for establishing a compliant system.

📗 Drew Tang's recommendations

Do not treat compliance as a burden. Instead, view it as an opportunity to improve corporate management and core competitiveness. A robust compliance system can earn the trust of customers and regulatory authorities and safeguard long-term development.

📕 Risk notice

Neglecting to establish a compliance system may result in an unsatisfactory rating during a routine Department of Health inspection, even if no serious non-compliance has occurred, which could affect licence renewal. Remedial action after a problem arises will be much more costly.

Q411 · 申请牌照续期的费用是多少？如果迟交会有罚款吗？独立链接

Renewal fees differ between licence types. For example, the current renewal and issue fee for a Western medicine Wholesale Dealer Licence is HK$2,150, while the renewal fee for a Listed Seller of Poisons is lower. The key point is that the legislation does not provide for “late filing fines”. If you miss the deadline for submitting a renewal application before the licence expires, the consequence is not a fine; the licence simply becomes invalid. This means you must stop business immediately and submit a completely new licence application. The overall process and cost are far greater than those of timely renewal. Renewal must therefore be treated as a top priority.

📘 Regulatory basis

Fees for each licence are prescribed by the relevant subsidiary legislation and may be adjusted from time to time. Mandatory licence renewal deadlines are set out in core legislation such as the Pharmacy and Poisons Regulations.

📗 Drew Tang's recommendations

The fee itself is a minor matter, but the deadlines behind it are critical. Rengangyongsheng’s client management system sends multiple advance renewal reminders to clients who have signed up and helps prepare documents, to avoid the disastrous consequences of business interruption caused by a moment’s oversight.

📕 Risk notice

Do not mistake renewal failure for a fine-related issue. Continuing to operate after a licence has lapsed constitutes the criminal offence of operating without a licence and may lead to prosecution, with serious consequences.

Q412 · 我持有列载毒药销售商牌照，可以授权朋友在他的店里销售第二部毒药吗？独立链接

Absolutely not. Hong Kong pharmaceutical licences are tied to the premises, not the person: a licence is strictly linked to specific approved licensed premises. Your Listed Seller of Poisons (LSP) Licence only authorises you to sell Part II poisons at the address stated on the licence. You cannot in any way “authorise”, “lend” or “transfer” your licence rights to a third party for use at any other location. Selling regulated medicines at an unauthorised location will be regarded as unlicensed sale.

📘 Regulatory basis

The core principle of the Pharmacy and Poisons Ordinance (Cap. 138) is to regulate the sale of medicines at specific premises; the geographical restriction of licences is a fundamental feature.

📗 Drew Tang's recommendations

If you or your friends wish to sell medicines at a new location, the only lawful option is to apply for a new, separate licence for that address. Do not try to take a shortcut: sharing or lending a licence is a serious regulatory breach.

📕 Risk notice

Your friend’s sales activities at their shop would constitute unlicensed business. As the licence holder, you would also be liable for authorising another person to engage in illegal activities. Your licence would very likely be subject to disciplinary action and could even be revoked.

Q413 · 我们持牌公司的注册名称变更了，需要通知药物办公室吗？独立链接

Yes, you must notify the authority. After your company has registered its name change with the Companies Registry in Hong Kong, you should notify the Drug Office, Department of Health (or the Chinese Medicine Council, if applicable) in writing as soon as possible. You will need to provide a copy of the “Certificate of Change of Name” issued by the Companies Registry, together with the updated Business Registration Certificate. The regulatory authority needs to ensure that the legal name of the licensed entity in its records exactly matches the official records. This is essential for the validity of the licence and future renewal applications.

📘 Regulatory basis

Although this is an administrative change, licence holders are obliged to ensure that all information submitted to the regulator is up to date and accurate; this is one of the licence conditions.

📗 Drew Tang's recommendations

This step is simple but easy to forget. We recommend that any change to statutory particulars, such as the company name, address or directors, be included in the company’s standard change management process, with a designated person notifying all relevant regulatory authorities as soon as possible.

📕 Risk notice

Failure to update the company name promptly may result in regulatory correspondence not being delivered or raise questions during renewal review because the information does not match, causing unnecessary delays.

Q414 · 药房的注册药剂师（RP）变更，和药品制造商的“获授权人”（AP）变更，流程上有什么不同？独立链接

Both are changes to key personnel, but the regulatory requirements and procedures differ. A pharmacy’s registered pharmacist (Registered Pharmacist, RP) is a key person responsible for supervising the sale of medicines, and a change must be notified to the Pharmacy and Poisons Board. By contrast, an “Authorised Person” (AP) of a manufacturer or wholesaler is a key quality person responsible for ensuring that the manufacture and batch release of medicines comply with GMP/GDP requirements. A change of AP requires an application to the Drug Office, Department of Health, and approval must be obtained. The scrutiny of qualifications and experience is more rigorous. In brief, a change of AP is an approval process, whereas a change of RP is primarily a prompt notification procedure.

📘 Regulatory basis

The RP requirement stems from the provisions on pharmacy sales in the Pharmacy and Poisons Regulations. The AP requirement stems from the quality management requirements for manufacturing under the Pharmacy and Poisons (Manufacturers and Wholesalers) Regulations.

📗 Drew Tang's recommendations

Whether an RP or AP leaves, a seamless handover must be ensured. In particular, pharmacies are prohibited from selling any medicines for sale under supervision when no RP is on duty. Staff cover must be planned in advance to avoid an interruption to business.

📕 Risk notice

Manufacturing or releasing medicines without a qualified AP is a very serious breach that may directly lead to suspension of the Manufacturer of Pharmaceutical Products licence. Selling medicines subject to pharmacist supervision without an RP may also result in disciplinary action.

Q415 · 我的中成药制造商牌照，如果厂房进行内部装修或改动，是否需要事先批准？独立链接

This depends on the nature and scale of the alterations. If renovation or alteration works affect the production process, clean-area layout, air purification system, storage conditions or any important facilities relevant to the Hong Kong Good Manufacturing Practice for Proprietary Chinese Medicines (GMP), you must submit a change application to the Chinese Medicines Board under the Chinese Medicine Council of Hong Kong and obtain approval before commencing work. You will need to submit detailed plans and an explanation of the changes, explaining their purpose and how compliance with GMP will be maintained afterwards. The Chinese Medicines Board will usually arrange an on-site inspection after the work is completed.

📘 Regulatory basis

The Chinese Medicine Ordinance (Cap. 549) and the GMP guidelines for proprietary Chinese medicines require the premises and facilities of licensed manufacturers to remain compliant with good manufacturing practice.

📗 Drew Tang's recommendations

Before planning any factory alterations, we strongly recommend that you consult a professional adviser. Rengangyongsheng (Hong Kong) Limited can help assess whether the proposed alterations comply with GMP requirements and prepare the application documents for submission to the Chinese Medicines Board, helping you avoid wasting investment on an unsuitable design.

📕 Risk notice

Making major changes without prior approval may be classified as a serious non-compliance at the next routine inspection. This may not only affect your GMP certification status but could also lead to suspension of the Manufacturer of Pharmaceutical Products licence until corrective action has been completed.

Q416 · 卫生署的督察进行例行视察时，他们有哪些法定权力？我应该如何配合？独立链接

Under the law, inspectors of the Drug Office, Department of Health are granted extensive powers to carry out their regulatory duties. When inspecting licensed premises, they may enter at any reasonable time; inspect and search the premises; require the production of and inspect any books, records or documents relating to the business; question any person on the premises; and take samples of any medicine or substance for testing. As a licence holder, you are legally obliged to cooperate with inspectors. You should appoint a senior staff member to accompany them throughout the inspection and promptly and accurately provide the documents and information requested.

📘 Regulatory basis

Section 26 of the Pharmacy and Poisons Ordinance (Cap. 138) confers detailed powers on inspectors to enter, search, take samples and seize documents.

📗 Drew Tang's recommendations

An inspection is not only a check but also an opportunity for communication. We recommend that clients approach inspections with a professional, open and cooperative attitude. Clear document management and record-keeping: 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. Thorough preparation in everyday work naturally allows you to remain composed during inspections.

📕 Risk notice

Any deliberate act that obstructs or hinders an inspector in the performance of their duties, such as refusing to open the door, concealing documents or providing false information, is itself a criminal offence and may, upon conviction, result in a fine and imprisonment.

Q417 · 如果我对药剂业及毒药管理局（PPB）纪律委员会的处分决定不服，可以上诉吗？独立链接

Yes. Hong Kong’s legal system provides a route for judicial review of administrative decisions. If you are a licensee disciplined by a PPB Disciplinary Committee (for example, by suspension or revocation of your licence) and believe that the decision involved an error of law, procedural unfairness or unreasonableness, you have the right to appeal to the Court of First Instance of the High Court of Hong Kong within the specified period. A judge will hear the appeal, which primarily reviews whether the Disciplinary Committee’s decision-making process was lawful and reasonable, rather than rehearing the facts of the case. This is a serious legal procedure and requires sound grounds.

📘 Regulatory basis

Section 10 of the Pharmacy and Poisons Ordinance (Cap. 138) expressly provides for a right of appeal to the High Court.

📗 Drew Tang's recommendations

An appeal is a major decision that requires a substantial investment of time and money. Before commencing appeal proceedings, you should conduct a thorough assessment with your legal adviser, analysing the strengths and weaknesses of the case and the prospects of success. In some cases, accepting the disciplinary outcome and focusing on internal corrective action may be the more practical choice.

📕 Risk notice

An appeal is not guaranteed to succeed. If it is dismissed, you may also have to bear the Government's legal costs. In addition, during the appeal, the Disciplinary Committee's original disciplinary decision will generally remain in effect (unless the court orders otherwise), and your business may remain disrupted.

Q418 · 除了卫生署和中医药管理委员会，还有哪些政府机构可能对我的药品业务进行监管？独立链接

Regulation of the medicine industry involves multiple agencies. In addition to the main regulators, the Drug Office, Department of Health and the Chinese Medicine Council of Hong Kong, you may also deal with other bodies. For example, Hong Kong Customs regulates medicine imports and exports to ensure that all medicines in transit have valid licences and documentation. The Consumer Council has no enforcement powers, but it receives and handles consumer complaints about medicine sales and may publicly name and criticise traders for poor business practices. The Hong Kong Police Force may investigate serious criminal offences, such as selling counterfeit medicines. The Labour Department also oversees occupational safety and health in the workplace, particularly in medicine manufacturing and storage environments.

📘 Regulatory basis

The Import and Export Ordinance (Cap. 60), Trade Descriptions Ordinance (Cap. 362) and various other laws may be relevant to the medicines business.

📗 Drew Tang's recommendations

Compliant business operations require a broad perspective. Our compliance services for clients look beyond pharmaceutical regulations to take account of requirements in areas including customs, consumer protection, advertising and labour safety, helping to build a comprehensive compliance framework.

📕 Risk notice

Do not assume that satisfying the Drug Office is all that matters. An investigation or penalty by any regulatory authority may seriously damage your business’s reputation and operations.

Q419 · 我在社交媒体上看到有人销售声称是“从香港药房正规代购”的处方药，这合法吗？独立链接

This is absolutely illegal. In Hong Kong, all Part I poisons, particularly prescription medicines, must be sold to the patient or their representative in a registered pharmacy by a registered pharmacist or a pharmacist intern under their supervision, on the basis of a valid prescription issued by a registered medical practitioner in Hong Kong. Any sale without a prescription through social media, instant messaging software or a website, or by post or cross-border purchasing, bypasses this fundamental safety control mechanism and is unequivocally illegal. Sellers and organisers will face criminal prosecution.

📘 Regulatory basis

The Pharmacy and Poisons Ordinance (Cap. 138) imposes strict and explicit restrictions on the sale of prescription medicines, prohibiting any form of remote or unsupervised sale.

📗 Drew Tang's recommendations

As a licence holder, you are responsible for ensuring that your employees and business partners understand this legal red line. We recommend repeatedly emphasising in internal training that any employee involved in such grey-market transactions will be dismissed immediately and may be reported to the authorities.

📕 Risk notice

If your pharmacy is found to be the source of this kind of illegal parallel import, you may be held responsible for inadequate supervision even if you claim to have been unaware, and risk having your licence revoked. The Department of Health is stepping up its enforcement against such activities.

Q420 · 我们仓库里有一批过期的药品，应该如何处理？可以直接当垃圾丢弃吗？独立链接

Absolutely not. Expired medicines must not be discarded as ordinary rubbish. They are subject to strict disposal requirements to prevent them from re-entering the market or polluting the environment. As a licensed wholesaler or manufacturer, you must establish a formal medicine destruction procedure. First, isolate the expired medicines and label them clearly. Then engage a qualified chemical waste collector to handle them. Detailed records of the entire destruction process must be kept, including the medicine name, batch number, quantity, destruction date and method. At least two staff members, one of whom should be a manager, must jointly supervise and sign to confirm the process. These records must be available for inspection, and the Department of Health may request them during an inspection.

📘 Regulatory basis

Both the Good Distribution Practice (GDP) for Wholesale Dealers in Medicines and the Waste Disposal (Chemical Waste) (General) Regulation set out clear requirements for handling expired medicines and retaining records.

📗 Drew Tang's recommendations

We recommend that clients include the medicines destruction procedure in the company’s Standard Operating Procedures (SOPs) and review it regularly. It is essential to choose a reputable chemical waste disposal company holding the appropriate licence. Keep all destruction contracts and records for inspection.

📕 Risk notice

Improper handling of expired medicines, such as casually discarding or reselling them, is a serious violation. If discovered, this not only breaches medicines management regulations but may also contravene environmental legislation, resulting in penalties under both. If the medicines ultimately endanger public health, the consequences could be severe.

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