When applying for a Wholesale Dealer Licence, what are the quantified qualification and experience requirements for the RP?

The regulatory authority’s requirements for the qualifications of a ‘Responsible Person’ (RP) combine principle-based assessment with flexibility. There is no absolute quantitative standard; each case is assessed individually. PPB guidance states that an RP should have appropriate qualifications and experience. In practice, a Hong Kong registered pharmacist is the ideal candidate, as their qualifications are almost certain to be recognised. If the candidate is not a pharmacist, they will need to demonstrate sufficient relevant experience and knowledge of the pharmaceutical industry. This generally means: 1) a degree in a relevant subject, such as pharmacy, pharmacology or biochemistry; 2) several years’ work experience in pharmaceutical wholesale, manufacturing or quality management, particularly in a management role; and 3) familiarity with Hong Kong pharmaceutical regulations and GSDP (Good Storage and Distribution Practice). When applying, you will need to submit the RP’s detailed CV, academic qualifications and evidence of previous employment for the Department of Health to assess.