Q318 · What should I do if I find…

Q318 · Category G: Quality management and compliance systems (Q301–Q350)

Discovery of suspected counterfeit medicines is an emergency requiring immediate and decisive action. Your SOP must include a clear emergency procedure. First, immediately segregate all medicines suspected of being counterfeit from stock and place them in a secure, clearly marked quarantine area to prevent further distribution. Second, notify management immediately and report the matter without delay to the Drug Office, Department of Health, Hong Kong. At the same time, check your procurement records to identify the source of the suspect medicines and notify your supplier. You must fully cooperate with the Department of Health’s investigation and provide all relevant documents and information. Do not dispose of the suspect medicines in any way until you have received clear instructions from the Department of Health.

📘 Regulatory basis

The Good Distribution Practice (GDP) for Medicinal Products sets out clear requirements on this. Licensees must have procedures for responding when falsified medicines are found or suspected to have entered the legitimate supply chain. The key requirements are: isolate, report and cooperate. The Trade Descriptions Ordinance (Cap. 362) also prohibits the sale of goods bearing forged trade marks.

📗 Drew Tang's recommendations

Prevention is the best strategy. Establish a rigorous supplier qualification procedure and purchase medicines only through reputable, authorised channels; this is the first and most important line of defence against counterfeit medicines entering the supply chain. Train your staff to recognise signs of suspicious medicines, such as unusual packaging, incorrect labelling or inconsistent batch numbers. Stay vigilant and never buy stock from unknown sources just because it is cheap.

📕 Risk notice

Selling or possessing counterfeit medicines is a serious criminal offence. Upon conviction, the company may face a substantial fine, and the persons responsible may also be sentenced to imprisonment. Failing to report the matter despite knowing about it, or attempting to cover it up, will only make the legal consequences more serious. In cases involving counterfeit medicines, transparent communication and prompt cooperation with the regulator are the only appropriate course of action.

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.

What should I do if I find “falsified/counterfeit medicines” in my stock or receive a customer report about them?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang