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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Q21 · What is the process for registering a new medicine for sale in Hong Kong (commonly known as obtaining a “drug certificate”)?Direct link
Before any pharmaceutical product can be sold in Hong Kong, it must first be registered with the Pharmacy and Poisons Board (PPB) and issued a Hong Kong registration number (HK-XXXXX). This is a rigorous process. First, the applicant must submit a complete set of technical documents to the Drug Office, Department of Health, to demonstrate the medicine’s safety, efficacy and quality. These documents typically include pharmacological and toxicological study data, clinical trial data, the manufacturing process, quality control standards and stability test data. For medicines already registered in certain designated countries, such as the United States, the United Kingdom and EU Member States, applicants may use a simplified procedure and submit proof of registration in those countries. The Drug Office’s assessors will conduct an initial review and may request further information. Once the review is complete, the application will be submitted to the Registration Committee under the PPB for final consideration. If approved by the Committee, the medicine will be formally registered and a registration certificate issued.
Q22 · What is pharmacovigilance, and what responsibilities do pharmaceutical licence holders in Hong Kong have in this area?Direct link
“Pharmacovigilance” is a scientific system for monitoring, assessing, understanding and preventing adverse drug reactions (ADRs) and other medicine-related problems. Its aim is to monitor the safety of medicines continuously and ensure that their benefits outweigh their risks. Under Hong Kong’s laws and guidelines, holders of certificates of drug registration and licensed manufacturers and wholesalers are responsible for establishing and maintaining an effective pharmacovigilance system. This includes appointing a qualified drug safety officer; establishing a systematic process for collecting, recording and assessing local and global ADR reports; reporting all serious ADRs occurring in Hong Kong to the Drug Office, Department of Health, as required; and preparing and submitting Periodic Safety Update Reports (PSURs) regularly. These responsibilities ensure that medicines continue to be monitored after they are placed on the market, allowing timely action to be taken if new safety risks are identified.
Q23 · What specific physical requirements apply to premises, such as warehouses or shops, when applying for a pharmaceutical licence?Direct link
When applying for a pharmaceutical licence, the premises' physical facilities are a key focus of the Department of Health's assessment and must meet stringent standards to ensure medicine quality and safety. A wholesaler's warehouse must meet GDP requirements, including sufficient space for segregated storage (such as areas for quarantined goods pending examination, released goods, returned goods and recalled goods); smooth, easily cleanable walls, floors and ceilings; equipment for continuous monitoring and recording of temperature and humidity, particularly for medicines requiring cold-chain storage; and a reliable security system to prevent unauthorised access and theft. Retail pharmacies must have a separate dispensing area with sufficient space and work surfaces. Prescription medicines must be kept in an area inaccessible to the public, preferably in locked cabinets or drawers. A suitable refrigerator must be provided for medicines requiring refrigerated storage, and a security system must also be installed. All premises must be kept clean and tidy, with appropriate pest control measures.
Q24 · If my pharmaceutical licence application is refused by the Pharmacy and Poisons Board (PPB), do I have any right of appeal?Direct link
Yes, if you are dissatisfied with a decision of the Pharmacy and Poisons Board (PPB), such as refusing your licence application or deciding to suspend or revoke your existing licence, the law gives you a right of appeal. Under the Pharmacy and Poisons Ordinance, you may appeal to an independent appeal tribunal. The tribunal is chaired by a judge and includes members from the legal and medical professions. You must submit a notice of appeal within the specified period, usually 28 days after receiving the PPB's written decision. The appeal tribunal will rehear the entire case. You may submit evidence, call witnesses and make submissions. The tribunal may uphold, overturn or vary the PPB's original decision. Its decision is final. This appeal mechanism ensures that the PPB's powers are subject to checks and balances and safeguards procedural fairness for applicants and licence holders.
Q25 · What routine inspections does the Department of Health conduct after a pharmaceutical licence is granted, and how often?Direct link
Obtaining a pharmaceutical licence is the beginning, not the end, of compliant business operations. The Drug Office, Department of Health conducts routine inspections of all licensed premises to ensure that licence holders continue to comply with relevant laws and codes of practice. Inspection frequency depends on the licence type and risk level. Higher-risk licence holders, such as medicine manufacturers and wholesalers, are generally inspected more frequently; for example, a comprehensive GDP or GMP re-inspection may take place every 1 to 2 years. Routine inspections of retail pharmacies and dispensaries may be less frequent, but the Department of Health also conducts unannounced ‘mystery shopper’-style inspections to check for breaches such as the illegal sale of prescription medicines. During inspections, officers will examine your premises, records (such as purchasing, sales and temperature records), staff qualifications and operating procedures. After the inspection, you will receive a report identifying any deficiencies and requiring you to correct them within a specified period.
Q26 · What is a Clinical Trial Certificate (CTC), and how is it related to product registration?Direct link
A Certificate for Clinical Trial (CTC) is a necessary authorisation for conducting clinical trials of medicines. In Hong Kong, any trial involving humans (patients or healthy volunteers) and intended to study the effects or reactions of a pharmaceutical product must first be applied for and obtain a CTC from the Department of Health. A CTC application requires detailed trial protocols, the Investigator’s Brochure, approval documents from the ethics committee, quality data for the investigational medicines and other materials. A CTC and drug registration are two different but related concepts. Clinical trials are usually conducted before drug registration to collect data on the safety and efficacy of the medicine in humans. These data are among the core technical documents required for a subsequent drug registration application (HK-XXXXX). In short, a CTC is an authorisation sought for “research”, while drug registration is sought for “sale”. Clinical trials conducted in Hong Kong must comply with the internationally recognised Good Clinical Practice (GCP) standard.
Q27 · What are the differences and connections between the Dangerous Drugs Ordinance (Cap. 134) and the Pharmacy and Poisons Ordinance?Direct link
These two Ordinances are complementary parts of Hong Kong’s pharmaceutical control system, but they regulate different subjects and serve different purposes. The Pharmacy and Poisons Ordinance (Cap. 138) provides a broad framework for regulating the quality, safety and distribution of all “pharmaceutical products” to protect public health. It establishes the pharmaceutical licensing and product registration systems. The Dangerous Drugs Ordinance (Cap. 134), by contrast, is a more specifically targeted criminal law aimed at combating the illegal trafficking, manufacture and abuse of dangerous drugs. “Dangerous drugs” controlled under it are substances with a high potential for addiction and abuse, such as morphine, cocaine and ketamine (“K”). Many dangerous drugs are also legitimate medicines for medical use, such as morphine for pain relief, and are then subject to both Ordinances. For example, a company wishing to deal lawfully in morphine needs a wholesaler licence under Cap. 138 and a separate dangerous drugs licence from the Department of Health under Cap. 134; its storage and record-keeping must also comply with more stringent requirements.
Q28 · For importing and exporting medicines, do I need to apply for an import or export licence for each consignment in addition to holding a wholesale dealer licence?Direct link
Yes, this is required in the vast majority of cases. A Wholesale Dealer Licence establishes your eligibility to conduct medicine import and export business, but for each individual consignment you must also apply to the Department of Health for the relevant import/export licence under the Import and Export Ordinance (Cap. 60). An import licence must be applied for and approved before the goods arrive in Hong Kong; an export licence must also be obtained before the goods leave Hong Kong. You will need to provide detailed information about the goods, including the medicine name, quantity, dosage form, manufacturer, batch number and details of the importing and exporting companies. By approving import/export licences for each consignment, the Department of Health monitors medicines entering and leaving Hong Kong in real time, tracks their movement and prevents unregistered or non-compliant medicines from entering the market. Small quantities of medicines for use as samples or in clinical trials may be exempt from registration requirements, but an import/export licence is usually still required.
Q29 · If a company holding a pharmaceutical licence undergoes a shareholding change or director change, must it notify the Department of Health?Direct link
Yes, it must be notified. A pharmaceutical licence is issued to a specific corporate entity, and the regulatory authority pays close attention to the individuals who control and manage that entity. Any change that may affect the company's control or management must therefore be notified to the Drug Office, Department of Health, in a timely manner. For a “Wholesale Dealer Licence” or a manufacturer's licence, if the company's directors change or there is a significant change in its shareholding structure (for example, a change of controlling shareholder), the licence holder is responsible for notifying the Drug Office in writing within a reasonable time after the change. For a licence as an “Authorised Seller of Poisons (ASP)” (pharmacy), the licence is linked to a specific “Authorised Person” (usually the company itself) and the pharmacist responsible for management, so any change of director should be reported immediately. In addition, if a pharmacy business is transferred to another company, the new operator must apply for a new licence because licences are not transferable.
Q30 · How does Hong Kong law define and regulate cosmeceuticals?Direct link
As with “health supplements”, “cosmeceutical” is not a legally defined category under Hong Kong law. Whether a product is treated as a “cosmetic” or a “pharmaceutical product” depends entirely on its ingredients and claimed effects. Under the Consumer Goods Safety Ordinance (Cap. 456), cosmetics are subject to its general safety requirements. However, if a “cosmeceutical” contains any Western medicine ingredient controlled under the Pharmacy and Poisons Ordinance (for example, certain antibiotics used to treat acne, hydroquinone used for skin whitening, or steroids), or is promoted as being able to treat or prevent a skin disease (such as eczema or psoriasis), it will be classified immediately as a “pharmaceutical product”. Once classified as a pharmaceutical product, it must comply with the full range of pharmaceutical regulatory requirements: the product must be registered (obtaining an HK-XXXXX number), and the seller must hold a pharmaceutical licence. As a result, many products sold overseas as “cosmeceuticals” may be regarded as medicines in Hong Kong and cannot be sold in ordinary cosmetics shops or department stores.
Q31 · As a pharmaceutical licence holder, what are the specific record-keeping requirements for medicine procurement and sales?Direct link
Yes. Keeping detailed and accurate purchase and sales records is a basic legal responsibility of a licence holder and a core requirement of GDP and GSP. These records form the basis of medicine traceability. For wholesalers, each purchase record should include the supplier's name and address, the medicine name, dosage form, strength, quantity, batch number, and manufacturing/expiry dates. Each sales record should include the customer's name and address, details of the medicine and the dispatch date. For retail pharmacies, in addition to purchase records, records of sales of all prescription medicines must be kept, including the prescription date, patient's name, prescribing doctor's name, medicine name and quantity, and the name of the pharmacist responsible for dispensing. All these records must be properly maintained in written or electronic form for at least two years from the date of the transaction. They must be available for inspection at all times, and Department of Health inspectors are entitled to examine them during inspections.
Q32 · What is the correct procedure for handling expired or damaged medicines? Can they simply be discarded?Direct link
Absolutely not. Expired or damaged medicines must be handled according to a strict procedure to prevent them from accidentally re-entering the market or polluting the environment. The correct procedure is as follows: first, immediately segregate all expired, damaged or returned medicines from normal stock and place them in a clearly labelled, secure “non-conforming goods area”. Next, prepare a detailed inventory of the medicines awaiting destruction, recording their names, quantities, batch numbers and other information. The licensee must then engage a professional company holding a “chemical waste collection / disposal licence” issued by the Environmental Protection Department to handle the medicines. A representative of the licensee must supervise the destruction and obtain a certificate of destruction. All destruction-related records, including the inventory and certificate of destruction, must be properly retained for at least two years, just like purchase and sales records, for inspection by the Department of Health.
Q33 · Are online pharmacies permitted in Hong Kong, and what regulations apply?Direct link
Hong Kong’s current legal framework is based on physical premises and does not establish a dedicated licence category for purely “online pharmacies”. The core legal requirement is that controlled medicines, particularly prescription medicines and medicines subject to sale supervision, must be sold and dispensed at a registered physical pharmacy by a registered pharmacist or under their supervision. Accordingly, a lawful “online pharmacy” business must be supported by a physical pharmacy holding an Authorised Seller of Poisons Licence. Customers may place orders and upload prescriptions online, but the final prescription check, dispensing and distribution must be carried out by a pharmacist at the physical pharmacy. Delivery of medicines must also comply with GDP requirements to ensure quality and safety during transport. Any platform claiming to sell prescription medicines purely online without a physical pharmacy is unlawful in Hong Kong.
Q34 · If I only conduct entrepôt trade in medicines, with the goods not entering Hong Kong's customs territory, do I still have to comply with Hong Kong's pharmaceutical licensing regulations?Direct link
This question concerns the meaning of “re-export” trade. If a consignment of pharmaceutical products is shipped from Country A to Country C and merely transits through a Hong Kong port or airport, remaining in a bonded area without being cleared into Hong Kong, it is generally regarded as “goods in transit” and may not require a Hong Kong import/export licence. However, if your company is established in Hong Kong and conducts the commercial transaction in the name of the Hong Kong company—for example, purchasing from a supplier in Country A and reselling to a customer in Country C—your company may be required to hold a wholesaler licence because it is engaging in the “wholesale” of pharmaceutical products, even if the goods do not enter Hong Kong. The Department of Health’s position is that if the transaction (that is, the transfer of ownership) takes place at the level of the Hong Kong company, this constitutes a regulated activity. This is a complex legal grey area and must be analysed on a case-by-case basis according to the specific business model.
Q35 · How are pharmacists registered and regulated in Hong Kong, and what is their professional role?Direct link
Pharmacists in Hong Kong are subject to a strict professional registration system administered by the Pharmacy and Poisons Board (PPB). To become a registered pharmacist, an applicant must complete a PPB-recognised bachelor’s degree or higher qualification in pharmacy (currently offered by the University of Hong Kong and The Chinese University of Hong Kong), complete one year of practical training and pass the registration examination conducted by the PPB. Pharmacists who graduated overseas must undergo an assessment of their qualifications and pass a professional qualification examination. Once registered, pharmacists’ names are entered in a public register. Their professional role is to act as the final safeguard in the use of medicines. Their duties include checking the legality and appropriateness of doctors’ prescriptions, dispensing medicines accurately, advising and counselling patients on medicine use, managing pharmacy stock and supervising the sale of medicines. They are essential to ensuring that medicines used by the public are safe, effective and economical.
Q36 · If I only want to centralise medicine procurement for my own chain of clinics, do I need to apply for a wholesale dealer licence?Direct link
This is a crucial structural issue. Under Hong Kong’s Companies Ordinance and the Department of Health’s licensing requirements, any entity carrying on business in Hong Kong must be registered for Business Registration in Hong Kong. For a pharmaceutical licence application, the applicant must be a Hong Kong-incorporated limited company or a non-Hong Kong company registered with the Companies Registry (that is, one with a Hong Kong branch). It is not possible to apply for a Hong Kong pharmaceutical licence directly in the name of an overseas company, such as a US or European corporate entity. The standard first step is therefore for your overseas parent company to establish a wholly owned subsidiary in Hong Kong. This Hong Kong subsidiary will be the legal entity applying for the licence, responsible for leasing premises and employing staff, and ultimately holding and operating the licence.
Q37 · How does Hong Kong's pharmaceutical licensing system treat physician samples?Direct link
“Doctor’s samples” are small quantities of medicines supplied free of charge by pharmaceutical companies to doctors for clinical evaluation or to let patients try. In Hong Kong, the distribution and possession of doctor’s samples are also strictly regulated. First, all doctor’s samples must themselves be pharmaceutical products registered in Hong Kong (with an HK-XXXXX number). Secondly, the packaging and labelling must clearly state “Doctor’s Sample”, “Free Sample” or “Not for Sale” to prevent improper sale. When distributing doctor’s samples, a pharmaceutical company (as a wholesale dealer licence holder) must keep detailed records, including the name and clinic address of the doctor receiving the samples, the sample name, quantity and batch number. These records must also be kept for at least two years. Doctors receiving and storing these samples should ensure that they are kept safe and properly stored, just as they would for ordinary medicines. They may provide them only to their own patients free of charge and must never sell them.
Q38 · How should I respond if an incident occurs during the transport of medicines, such as a break in temperature control?Direct link
An incident such as a break in temperature control during transport is a serious quality event, and the deviation handling procedure must be initiated immediately. First, transport personnel should immediately report the situation to the dispatching party’s (licensed wholesaler’s) quality management department and Person-in-Charge. Second, on receipt of the goods, if the recipient finds abnormal temperature-control records or suspects that medicine quality has been compromised, they have the right and responsibility to refuse the batch or immediately segregate it in an area for quarantined goods pending examination. The dispatching party must conduct a risk assessment of the affected medicines. The assessment should consider factors such as the medicine’s stability data and the extent and duration of the temperature deviation to determine whether its quality remains acceptable. If it cannot be demonstrated that quality has not been affected, or the assessment finds the batch non-conforming, the batch must be treated as non-conforming goods and handled under the destruction procedure described above; it must never be released to the market. The entire incident response, from discovery to final disposition, must be documented in detail.
Q39 · Does Hong Kong's pharmaceutical licensing system apply to veterinary medicines?Direct link
Yes, Hong Kong's pharmaceutical licensing system also applies to veterinary medicines, although the regulatory framework differs slightly from that for medicines for human use. Under the Pharmacy and Poisons Ordinance, veterinary medicines containing scheduled poisons are also regarded as “pharmaceutical products”, and their manufacture, wholesale and retail require the relevant licences. For example, a company wholesaling veterinary medicines must hold a Wholesale Dealer Licence. At retail level, however, registered veterinarians are also entitled to certain exemptions when dispensing medicines to animals under their care. Hong Kong currently has no separate veterinary medicine registration system. However, under the Public Health (Animals and Birds) (Chemical Residues) Regulation, certain medicines used in food-producing animals are strictly regulated. Overall, veterinary medicines are regulated jointly by the Department of Health and the Agriculture, Fisheries and Conservation Department, but core licensing remains within the framework of the Pharmacy and Poisons Ordinance.
Q40 · Do I need to engage a lawyer during the pharmaceutical licence application process?Direct link
Although the law does not require you to engage a lawyer to apply for a pharmaceutical licence, engaging a professional consultant is strongly recommended. The application process involves complex legislation, technical standards and administrative procedures. A good consultancy team will generally comprise experts with legal backgrounds, pharmaceutical knowledge and extensive industry experience. Their role is similar to that of lawyers, but more specialised. They can help you interpret complex regulatory requirements, assess whether your business model complies, guide you in preparing a complete set of application documents, help you design and fit out compliant premises, and provide professional support in communications with the regulator and during inspections. Compared with a general law firm, a consultancy such as Rengangyongsheng (Hong Kong) Limited, which specialises in pharmaceutical compliance, has a deeper understanding of the Department of Health’s procedures, technical standards and areas of focus. This can substantially improve your chances of success and save valuable time and money.