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How does Hong Kong’s pharmaceutical licensing system treat “physician samples”?

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

Q37 · Category A: Licensing system and regulatory fundamentals (Q1–Q50)
“Doctor’s samples” are small quantities of medicines supplied free of charge by pharmaceutical companies to doctors for clinical evaluation or to let patients try. In Hong Kong, the distribution and possession of doctor’s samples are also strictly regulated. First, all doctor’s samples must themselves be pharmaceutical products registered in Hong Kong (with an HK-XXXXX number). Secondly, the packaging and labelling must clearly state “Doctor’s Sample”, “Free Sample” or “Not for Sale” to prevent improper sale. When distributing doctor’s samples, a pharmaceutical company (as a wholesale dealer licence holder) must keep detailed records, including the name and clinic address of the doctor receiving the samples, the sample name, quantity and batch number. These records must also be kept for at least two years. Doctors receiving and storing these samples should ensure that they are kept safe and properly stored, just as they would for ordinary medicines. They may provide them only to their own patients free of charge and must never sell them.

📘 Regulatory basis

The labelling and record-keeping requirements under the Pharmacy and Poisons Regulations also apply to doctors’ samples. The Code of Professional Conduct for the Guidance of Registered Medical Practitioners issued by the Medical Council of Hong Kong also provides ethical guidance on how doctors should handle medicine samples.

📗 Drew Tang's recommendations

For pharmaceutical manufacturers, it is important to establish an independent, rigorous system for managing and distributing doctors’ samples. This system should be separate from the commercial sales system but follow equally stringent GDP principles to ensure that the movement of every sample pack is clear and traceable.

📕 Risk notice

Selling doctors' samples is a serious breach. Both pharmaceutical-company sales representatives and doctors receiving samples may face disciplinary action or even criminal prosecution. Samples with improper labels may also be regarded as non-compliant pharmaceutical products.

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