Q404 · Our company’s Authorised Person (AP) is…

Q404 · Category I: Renewals, changes and penalties for non-compliance (Q401–Q450)

The “Authorised Person” is a key position at a licensed manufacturer, and any change must be notified to the Drug Office, Department of Health immediately. Under the requirements, you must notify the Drug Office in writing within 7 days after the change takes effect. You must also nominate a new, suitably qualified AP and submit their detailed CV, academic qualifications and proof of professional qualifications for the Drug Office’s approval. The newly nominated AP must have the pharmacist qualifications and relevant industry experience required by law. Until approval is granted, the former AP remains legally responsible for the relevant matters.

📘 Regulatory basis

The Pharmacy and Poisons (Manufacturers and Wholesale Dealers) Regulations set out clear requirements for the qualifications of an “Authorised Person” and the procedure for changes, ensuring the continued monitoring of the quality of pharmaceutical products.

📗 Drew Tang's recommendations

Finding a suitable AP is the key to a successful change. RGYS may assist with clarifying roles, evidence of qualifications and responsibility arrangements within the written scope; the suitability, appointment and actual presence at work of candidates remain subject to verification by the applicant and legally qualified personnel, and no provision or certification of personnel is promised. RGYS may assist with clarifying roles, evidence of qualifications and responsibility arrangements within the written scope; the suitability, appointment and actual presence at work of candidates remain subject to verification by the applicant and legally qualified personnel, and no provision or certification of personnel is promised. We will also guide you in preparing a complete set of submission documents. 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.

📕 Risk notice

Failure to notify the authorities promptly or continuing production without a qualified AP is a serious breach. This may result in suspension or revocation of your Manufacturer of Pharmaceutical Products licence and may affect the company’s GMP certification status.

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang

Business Manager Tang Shangyong (Drew Tang) will review your products, operating model, licence type and preparation requirements with you one-to-one. The precise service scope is confirmed in writing; pharmaceutical duties are carried out by legally qualified personnel, and approvals are determined by the competent authorities.

Our company’s Authorised Person (AP) is about to leave. How do we handle the change of Person-in-Charge?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang