When the Pharmacy and Poisons Board (PPB) considers my application, what factors does it primarily take into account?

The Pharmacy and Poisons Board (PPB) is the final approval authority for pharmaceutical licence applications in Hong Kong. After receiving the inspection report and recommendations from Drug Office pharmacist inspectors, the Board will meet to consider your application. Its primary concern is public safety and health. Specifically, the Board will assess several aspects: first, whether the applicant (the company) is a “fit and proper” licence holder, including the company’s background, reputation and any past record of non-compliance. Second, whether the Person-in-Charge (RP) has sufficient knowledge, experience and ability to supervise all activities under the pharmaceutical licence. Third, whether the business premises fully comply with all regulatory requirements and can ensure the safety and quality of medicines. Finally, the Board will review the inspectors’ report, particularly any deficiencies or concerns noted. The licence application will be approved only when the Board is satisfied that the applicant is fully prepared to operate lawfully and compliantly.