HONG KONG DRUG LICENSING

Hong Kong Drug Licence Overview

Explore five Hong Kong drug licensing routes, including wholesale, pharmacy, listed seller, manufacturing and Chinese medicine trader licences.

The applicable licensing pathway depends on the product category, business activity and actual premises. Western medicines, Chinese medicines, retail, wholesale and manufacturing are not interchangeable authorisations. First confirm the applicable pathway based on your business model.

Thematic illustration for pharmaceutical licence type and business activity assessment services — Choose a licence route based on actual business activities.

01 · Wholesale · Import and export

Wholesale Dealer Licence (WDL)

Wholesale Dealer Licence

Supplying pharmaceutical products to pharmacies, hospitals and other authorised buyers, with a focus on the Person-in-Charge, compliant storage and a fully traceable distribution system.

Cap. 138 / Cap. 138A · The Pharmacy and Poisons (Wholesale Licences) Committee under the Pharmacy and Poisons Board of Hong Kong; the Drug Office, Department of Health / Wholesale Dealers Unit handles the relevant administration, inspections and regulatory oversight.

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02 · Professional pharmacy · Retail

Pharmacy / Authorised Seller of Poisons (ASP)

Authorized Seller of Poisons · ASP

A pharmacy business serving the public, involving registered premises, supervision by a registered pharmacist, and statutory conditions governing the sale of medicines on prescription and under supervision.

Cap. 138 / Cap. 138A · The Pharmacy and Poisons Board of Hong Kong is responsible for statutory decisions; the Drug Office, Department of Health handles receipt of applications, licence monitoring, interviews, inspections and general enquiries.

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03 · Drug store · Part II poisons

Listed Seller of Poisons (LSP) drugstore

Listed Seller of Poisons · LSP

Suitable for retail sale of Part II poisons within the licensed scope. It cannot replace pharmacy authorisation, and Part I poisons may not be sold or restricted pharmacy signage used.

Cap. 138 / Cap. 138A · The Pharmacy and Poisons Board of Hong Kong is responsible for the register and decisions; the Listed Sellers of Poisons Committee under the Board processes applications under regulation 24A of Cap. 138A; the Drug Office, Department of Health handles applications, inspections and monitoring.

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04 · Manufacturing · PIC/S GMP

Manufacturer of Pharmaceutical Products

Covers approved pharmaceutical product manufacturing activities, with a focus on PIC/S GMP, the quality system, premises and equipment, key personnel, and batch release.

Cap. 138 / Cap. 138A · Pharmacy and Poisons Board / Manufacturers Licensing Committee

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05 · Proprietary Chinese medicines · Wholesale

Wholesaler licence in proprietary Chinese medicines

Wholesaler Licence in Proprietary Chinese Medicines

Plan the wholesale business in proprietary Chinese medicines under the separate regime established by Cap. 549. Check the business licence, product registration, labels and package inserts, imports and exports, and batch records separately; a wholesale licence does not replace other licences for Chinese medicine traders.

Cap. 549 / Cap. 549F · The Chinese Medicines Board under the Chinese Medicine Council of Hong Kong makes licensing decisions; the Chinese Medicine Regulatory Office of the Department of Health handles receipt of applications, forms, premises inspections and licence administration, and provides import and export permit services for Chinese medicines.

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SELECT THE RIGHT ROUTE

First distinguish between products, activities and customers

Different regulatory regimes apply to wholesale or retail sale to the public of pharmaceutical products, their manufacture, and the handling of Chinese herbal medicines and proprietary Chinese medicines. Product registration, import and export licences, and requirements for prescription or controlled medicines may also apply separately.

Important reminder: The licence name, whether professional personnel are required, premises conditions and change procedures must all be confirmed against current official requirements and assessed on a case-by-case basis. Before applying, it is advisable to verify the scope of business and product classifications.

Compare the Western medicine and proprietary Chinese medicine pathways

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.