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As a wholesale dealer, how should I conduct qualification checks on my customers, such as pharmacies and clinics, to ensure lawful sales?

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.

Drug Office, Department of Health Chinese Medicines Board

Q313 · Category G: Quality management and compliance systems (Q301–Q350)
Under GDP requirements, medicine wholesalers are responsible for ensuring that their products are sold only to entities or individuals with the legal qualifications and authorisation to procure and sell medicines. This is a key “gatekeeper” duty intended to prevent medicines from entering illegal channels. Your customer qualification procedure must be clearly set out in an SOP. Before supplying a new customer for the first time, you must obtain and verify its Business Registration (BR) certificate and relevant licences for dealing in medicines (such as an Authorised Seller of Poisons licence for a pharmacy or a doctor’s practising licence). You must retain copies of these documents and recheck them periodically (for example, annually) to ensure that the qualifications remain valid. For every sales order, you should verify that the recipient is an approved customer.

📘 Regulatory basis

The Good Distribution Practice (GDP) for Medicinal Products expressly requires wholesalers to take measures to ensure that medicines are supplied to entities with appropriate authorisation. In addition, the Pharmacy and Poisons Ordinance (Cap. 138) imposes strict legal restrictions on supplying certain medicines to unauthorised persons.

📗 Drew Tang's recommendations

We recommend that you establish a “qualified customer master data” file, flagging customers’ qualification status and expiry dates in your ERP or sales system. This enables systematic automated checks at the order placement stage. For medicines with a risk of misuse, pay particular attention to unusual order frequency or quantities. Communicate clearly with your sales team that verifying customer qualifications is their primary responsibility, not merely meeting sales targets.

📕 Risk notice

Selling pharmaceutical products to unqualified individuals or companies is an extremely serious offence. It not only breaches GDP but may also constitute a criminal offence, resulting in a heavy fine for the company and a risk of imprisonment for the person responsible. Regulators adopt a zero-tolerance approach to such conduct. An inadequate customer qualification system is effectively an open invitation to illegal pharmaceutical trading.

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