Chapter 10: Applicant Eligibility and Responsible Person (RP) Requirements
Hello, those wishing to conduct pharmaceutical business in Hong Kong. I am Drew Tang from Rengangyongsheng (Hong Kong) Limited. In previous chapters, we explored the types of pharmaceutical licences in Hong Kong and the application overview. Today, I will analyse an essential part of the application process in detail: applicant eligibility and Responsible Person (RP) requirements. This is a key consideration in the Drug Office’s assessment and directly affects the compliant operation of your future business. Many applicants take the wrong path because they do not fully understand these requirements, so please read this chapter carefully.
10.1 Basic eligibility requirements for applicants
First, let us discuss the basic requirements that the applicant entity must meet. The Department of Health requires every application for a pharmaceutical licence to be made in the name of a Hong Kong legal entity. This means that individuals cannot apply in their own names; you must first incorporate a Hong Kong limited company and ensure that it is in good standing.
Specifically, your company needs to meet the following two requirements:
- Valid Hong Kong Certificate of Incorporation (CI): You need to apply to the Companies Registry to incorporate a local limited company. The company's Memorandum and Articles of Association should clearly include relevant business activities such as the wholesale, retail or manufacture of pharmaceutical products, dangerous drugs and antibiotics.
- Valid Business Registration Certificate (BR): After the company is incorporated, it must register with the Business Registration Office under the Inland Revenue Department in accordance with the Business Registration Ordinance (Cap. 310) and obtain a valid Business Registration Certificate. A copy of the BR is one of the required documents for a licence application.
Drew Tang’s reminder: the importance of the company structure
I advise clients to plan their shareholding structure and board membership at the outset of setting up the company. Although the regulations do not restrict the nationality of shareholders or directors, a clear, stable and professional company structure will create a good first impression on the Pharmacy and Poisons Board (PPB). If the structure is overly complex or changes frequently during the application process, this may attract unnecessary scrutiny from the regulator.
10.2 Core responsibilities and legal status of the Responsible Person (RP)
The Responsible Person (RP) is central to the entire licence application and subsequent operations. Under the Pharmacy and Poisons Regulations (Cap. 138A), the RP is an individual designated by the licence holder to actively supervise all transactions involving pharmaceutical products. This is not a nominal position; the RP has substantive legal liability and day-to-day management responsibilities.
The RP's core responsibilities include, but are not limited to:
- Compliance oversight: Ensure that all the company's pharmaceutical activities, from procurement, storage and sales to record-keeping, fully comply with relevant Hong Kong legislation, such as the Pharmacy and Poisons Ordinance (Cap. 138) and the Antibiotics Ordinance (Cap. 137).
- Quality assurance: Establish and maintain an effective Quality Management System (QMS) to ensure the quality, safety and efficacy of pharmaceutical products. This includes handling product complaints, conducting product recalls and managing suppliers.
- Staff training: Supervise and train all employees who handle pharmaceutical products to ensure that they understand and comply with the relevant procedures and legal requirements.
- Official communications: As the company's main technical contact, liaise with the Drug Office, Department of Health, and respond to routine enquiries and on-site inspections.
The Pharmacy and Poisons Regulations expressly provide that the RP must “provide adequate supervision”. In practice, this means that if the company commits a breach, the RP may also be held legally liable alongside the company. The consequences could range from a fine to criminal prosecution. It is therefore essential to choose a qualified and diligent RP.
10.3 Detailed qualification requirements for the RP for different licence types
The Drug Office, Department of Health sets different qualification requirements for RPs according to the type of licence. These are based mainly on the risk levels and professional knowledge required by different business models. In general, a qualified RP must be a “fit and proper person”, meaning that they must have good character and integrity and meet specific education and experience requirements.
During the licence application process, the RP will usually need to attend an interview with the Pharmacy and Poisons Board (PPB) in person. At the interview, Board members will examine the RP’s understanding of the relevant legislation, familiarity with business operating procedures and ability to handle emergencies such as product recalls in depth. The RP must therefore have a thorough and comprehensive understanding of the business, not merely theoretical knowledge.
Illustrative project scenario (not a verified pharmaceutical licensing outcome)
I once assisted a client with an application for a wholesale dealer licence. Although his nominated RP did not have a pharmacist background, he had more than 10 years of procurement and quality management experience in the relevant industry and had studied Hong Kong's pharmaceutical regulations in depth. With our assistance, he prepared thoroughly for the interview and clearly explained how he would establish the company's SOP and QMS. 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. 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.
The following table compares the core RP qualification requirements for different licence types to help you assess and prepare more clearly.
| Licence types | Qualification requirements | Work experience requirements | Other key requirements |
|---|---|---|---|
| Wholesale Dealer Licence (Wholesaler Licence) |
Usually a degree in pharmacy, pharmacology, biomedical science or a related scientific discipline. If the person does not have a relevant degree, they must demonstrate an equivalent level of knowledge. | Must have at least 2 years of full-time practical experience in pharmaceutical product wholesaling or manufacturing in Hong Kong. The relevance and quality of the experience are key to the approval decision. | Must be a director or employee of the company in Hong Kong; must ordinarily reside in Hong Kong and be able to perform regulatory duties effectively; and must pass a PPB interview. |
| Manufacturer of Pharmaceutical Products Licence (Pharmaceutical Manufacturer Licence) |
Usually a registered pharmacist or a person with a relevant higher degree in pharmacy, chemistry, microbiology or a related field. | Extensive practical experience in production and quality control at a licensed pharmaceutical factory is required; the specific number of years depends on the scope of the person’s responsibilities. | In-depth understanding and practical experience of GMP (Good Manufacturing Practice); must be a Hong Kong-based employee; must pass a PPB interview. |
| Authorised Seller of Poisons (ASP) (Pharmacy) Licence (Authorised Seller of Poisons - Pharmacy) |
Must be a pharmacist registered in Hong Kong under the Pharmacy and Poisons Ordinance. | There is no express statutory retention period, but you must be able to manage the pharmacy’s day-to-day operations and supervise the sale of Part I poisons. | The RP must personally and continuously supervise the business at the registered address; the RP's name will be displayed prominently in the pharmacy. |
| Listed Seller of Poisons (LSP) Licence (Listed Seller of Poisons) |
No specific degree is required, but the person must demonstrate completion of a PPB-recognised training course. | There is no specific minimum period of experience, but the person must be familiar with the nature of the Part II poisons sold and the relevant legal requirements. | The RP must be the proprietor, a partner or a company director; they must pass the PPB's suitability assessment. This usually applies to shops selling medicated oils, ointments and similar products labelled “For use by medical practitioners only”. |
Risk alert: integrity requirements and background checks
Please note that applicants and all key personnel, including directors and the RP, must meet the fit and proper requirements. If false information is found to have been provided during the application process, or if there is a relevant criminal record, particularly for offences involving dishonesty, fraud or pharmacy, the application is almost certain to be rejected. The Department of Health may conduct background checks, so do not take any chances.