Chapter 11: Pharmacist Registration and the Authorised Person System
Hello, industry colleagues. I am Drew Tang from Rengangyongsheng (Hong Kong) Limited. To ensure the safety, efficacy and quality of medicines in Hong Kong, the most important element, beyond a comprehensive licensing framework, is “people”. Professional pharmacists and Authorised Persons (APs) safeguard the entire pharmaceutical supply chain. In this chapter, I will explain the registration requirements for pharmacists in Hong Kong, the routes to registration for pharmacy professionals with different backgrounds, and the Authorised Person system, which is crucial to pharmaceutical manufacturing and wholesale. This will help you understand the central value of these professional roles in compliant operations.
Statutory requirements and routes for pharmacist registration
In Hong Kong, the registration, practice and disciplinary regulation of pharmacists are administered by the Pharmacy and Poisons Board of Hong Kong under the Pharmacy and Poisons Ordinance (Cap. 138). The Ordinance clearly provides that anyone practising as a pharmacist in Hong Kong must first register with the Board and obtain a valid practising certificate. This is fundamental to protecting public health and ensuring that pharmacy services meet the statutory professional standards.
There are two main routes to becoming a registered pharmacist in Hong Kong. The first is for graduates with a Bachelor’s degree in pharmacy from a local Hong Kong university, who must complete one year of practical training. The second is for pharmacists who graduated overseas, who must pass the registration examination held by the Board and meet specific practical training requirements. Whichever route is taken, the aim is to ensure that applicants have the knowledge, skills and professional conduct needed to practise independently and safely as pharmacists in Hong Kong.
Key legislative basis
Under section 7 of the Pharmacy and Poisons Ordinance (Cap. 138), the Pharmacy and Poisons Board is responsible for keeping a register of registered pharmacists. Only persons whose names appear on the register are entitled to practise as pharmacists in Hong Kong. This provision establishes the mandatory and authoritative nature of pharmacist registration in law.
Internships for local graduates and examinations for non-local graduates
For graduates of pharmacy programmes at the University of Hong Kong and the Chinese University of Hong Kong, the path to registration begins with 52 weeks of full-time practical training. This training must take place at an institution recognised by the Board, such as a pharmacy department under the Hospital Authority or Department of Health, a university pharmacy practice unit, a licensed pharmaceutical product manufacturer or wholesaler, or a community pharmacy. During the training period, under the guidance of experienced pharmacists, trainees apply theoretical knowledge in practical settings and learn a full range of practical skills, including dispensing, patient counselling, medicine procurement and inventory management, and pharmacovigilance.
Applicants holding a non-local pharmacy degree face a higher hurdle: the registration examination of the Pharmacy and Poisons Board of Hong Kong. The examination is held once a year and consists of written and oral examinations. The written examination covers three subjects: “Hong Kong Pharmacy Legislation”, “Pharmacy Practice” and “Pharmacology”. After passing the written examination, applicants must also take a comprehensive oral examination. The examination is intended to assess whether applicants have a sufficient understanding of Hong Kong’s legal framework, practice environment and standards for the use of medicines. After the examination, the Board may also require applicants to complete a period of practical training, the duration of which may vary according to their individual experience, to ensure that they can integrate successfully into the local healthcare system.
Comparison of pharmacist registration routes
| Item | Local pharmacy graduates | Non-local pharmacy graduates |
|---|---|---|
| Academic qualifications | Bachelor’s degree in pharmacy from the University of Hong Kong or The Chinese University of Hong Kong | A pharmacy degree from a non-local university recognised by the Board (usually a course of 3 years or more) |
| Key requirements | Complete one year of local internship training | Pass the registration examination (written and oral) organised by the Council |
| Internship / training | Must complete a 52-week full-time internship at a recognised institution. | After passing the examination, the person may need to complete a specified period of internship, depending on their individual circumstances. |
| Key areas of assessment | Developing practical skills and professional conduct | Knowledge of Hong Kong law, professional practice standards and pharmacology |
Registration requirements and duties of an Authorised Person (AP)
In pharmaceutical manufacturing and wholesale, the Authorised Person (AP) is a crucial role. Under the Pharmacy and Poisons Regulations (Cap. 138A), a company holding a Manufacturer of Pharmaceutical Products Licence or a wholesaler licence must appoint at least one AP. The AP bears ultimate personal responsibility for ensuring that all pharmaceutical products handled by the company meet local legal standards for quality, safety and efficacy. The AP can be regarded as the core and driving force of the pharmaceutical quality management system.
To qualify as an AP, an applicant must be a registered pharmacist in Hong Kong and have sufficient experience in the relevant field. An AP for a pharmaceutical manufacturer is generally required to have at least 2 years’ relevant work experience, such as in quality assurance or production at a licensed manufacturer. The AP’s duties are extensive and include, but are not limited to, reviewing and approving production processes; ensuring that raw materials and finished products meet specifications; handling product quality complaints and deviation investigations; overseeing product recall procedures; and, most importantly, signing batch release documents before each batch of products is placed on the market, confirming that it complies with all statutory requirements. This signature represents a solemn commitment to public medication safety.
Drew Tang's tip: An Authorised Person (AP) bears personal responsibility, not company responsibility. This means that if a serious quality issue arises with a medicine, the AP may face the corresponding legal consequences. Therefore, the appointment of an AP must be approached with great care, ensuring that the person has a high level of professional competence, integrity and responsibility. When assisting clients with licence applications, Rengangyongsheng (Hong Kong) Limited places particular emphasis on the importance of the AP role and can help clients find and assess suitable candidates.
Continuing Professional Education (CPE) requirements
Medical and pharmaceutical knowledge is constantly evolving. To ensure that pharmacists’ professional standards keep pace, the Pharmacy and Poisons Board (PPB) operates a mandatory Continuing Professional Education (CPE) programme. All registered pharmacists wishing to renew their practising certificates must complete a specified number of CPE credits within the designated period. The current requirement is at least 45 CPE credits in each 3-year cycle.
CPE credits can be earned in various ways, such as attending academic conferences, professional seminars or workshops, completing online courses, publishing articles in academic journals, or participating in teaching activities. The Board provides guidance on which activities are acceptable and the credits that may be earned. This system is not only essential to maintaining individual professional competence, but also an important way for the pharmaceutical profession as a whole to demonstrate its professional commitment and determination to improve. For a professional pharmacist, lifelong learning is not merely a requirement, but a responsibility.