Q10 · How does Hong Kong’s pharmaceutical licensing…

Q10 · Category A: Pharmaceutical licensing regimes and regulatory fundamentals (Q1–Q50)

In Hong Kong, “parallel-imported” or “grey-market” medicines refer to genuine medicines purchased from overseas markets by importers who are not authorised by the original manufacturer and imported into Hong Kong for sale. Parallel-imported medicines are legal under Hong Kong law if two core conditions are met. First, the medicine must already be registered in Hong Kong, that is, it must have a Hong Kong registration number (HK-XXXXX). Unregistered medicines may not be sold in Hong Kong, regardless of whether they are legal overseas. Second, the company importing and selling the medicine must hold a valid wholesale dealer licence and/or the relevant retail licence. The labelling of parallel-imported medicines must comply with Hong Kong legal requirements, for example by including the Hong Kong registration number and importer’s name. Although parallel importation is legal, the regulatory authorities strictly regulate these products to ensure that their quality has not been affected during transport and storage and that their source is traceable.

📘 Regulatory basis

Section 36(1) of the Pharmacy and Poisons Regulations provides that a pharmaceutical product must be registered before it can be sold. The Import and Export Ordinance (Cap. 60) also contains specific provisions governing the import and export of pharmaceutical products. The legality of parallel imports depends on compliance with these regulations.

📗 Drew Tang's recommendations

For parallel import operations, the key is to establish a robust supply chain management and quality assurance system. You must be able to demonstrate to the Department of Health that your parallel-imported products are of equivalent quality to authorised products. This includes rigorous supplier qualification checks, comprehensive temperature-control records during transport and a clear batch traceability system.

📕 Risk notice

The greatest risk of parallel importation is the reliability of the product source. If an imported medicine is found to be counterfeit or deteriorates during transport because of improper storage, the importer will bear full legal responsibility, with very serious consequences. Intellectual property disputes with the original manufacturer may also pose a potential commercial risk.

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.

How does Hong Kong’s pharmaceutical licensing regime deal with parallel imports (grey-market goods)?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang