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.
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.
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.
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.
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.
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.
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.
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.
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.
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.