Both are changes to key personnel, but the regulatory requirements and procedures differ. A pharmacy’s registered pharmacist (Registered Pharmacist, RP) is a key person responsible for supervising the sale of medicines, and a change must be notified to the Pharmacy and Poisons Board. By contrast, an “Authorised Person” (AP) of a manufacturer or wholesaler is a key quality person responsible for ensuring that the manufacture and batch release of medicines comply with GMP/GDP requirements. A change of AP requires an application to the Drug Office, Department of Health, and approval must be obtained. The scrutiny of qualifications and experience is more rigorous. In brief, a change of AP is an approval process, whereas a change of RP is primarily a prompt notification procedure.
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How do the procedures differ for changing a pharmacy’s registered pharmacist (RP) and a pharmaceutical manufacturer’s Authorised Person (AP)?
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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