The “Authorised Person” (AP) system is a key element in ensuring the safety and quality of the medicine supply chain. For a pharmaceutical wholesaler, the AP is a staff member formally authorised in writing by the licensee to oversee and manage all activities relating to the procurement, storage, sale and distribution of medicines. The AP must ensure that all operations comply with the Pharmacy and Poisons Ordinance and Good Distribution Practice (GDP). Core responsibilities include approving and managing suppliers and customers, ensuring that medicines are from lawful sources, overseeing medicine storage conditions, handling customer complaints and medicine recalls, and maintaining complete distribution records. The AP is one of the company’s main contacts for communication with the Drug Office and bears significant responsibility for licence compliance.
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What is the “Authorised Person” (AP) system? What are the AP’s responsibilities in an application for a pharmaceutical wholesaler licence?
A complete explanation of the regulatory basis, Drew Tang’s recommendations and risk alerts. The original material dates from 2025; read it alongside the latest official requirements.
Original guide, 2025 edition: These FAQs are provided for topic-based reference and have not all been individually checked against current rules. Please confirm fees, personnel, renewal, changes and product requirements against the professional in-depth guide for the relevant licence type and the official requirements in force at the time.
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