Q56 · Are “antibiotics licences” and “dangerous…

Q56 · Category B: Licence types and scope of application (Q51-Q100)

An “Antibiotics Permit” and a “Dangerous Drugs Licence” are not standalone basic licences; they are special permits additional to a “Wholesale Dealer Licence” or a “Manufacturer’s Licence”. If your business involves the wholesale, import, export or manufacture of antibiotics or dangerous drugs (such as controlled psychotropic drugs or potent painkillers), you must first hold the relevant basic licence and then separately apply to the Department of Health for these special permits. Applicants must demonstrate that they have higher-level security measures and stricter record-tracking systems to prevent these strictly controlled medicines from being abused or entering illegal channels.

📘 Regulatory basis

The Antibiotics Ordinance (Cap. 137) and Dangerous Drugs Ordinance (Cap. 134) impose strict requirements on the import, export, manufacture, wholesale and supply of these two categories of medicines respectively. Applicants must demonstrate that their business operations fully comply with the additional requirements of both Ordinances.

📗 Drew Tang's recommendations

When applying for the basic licence, you should clearly inform us whether you plan to handle these two categories of controlled drugs. We can pursue applications for these special permits alongside the basic licence application, and plan compliant security facilities for you (such as reinforced safes and independent surveillance systems) and detailed ledger recordkeeping procedures. RGYS may assist with document preparation and project coordination within the written scope of services; personnel qualifications, statutory roles and professional judgments are to be verified and assumed by the respective responsible parties, and approval is decided independently by the competent authority.

📕 Risk notice

The consequences of illegally handling antibiotics or dangerous drugs are extremely serious. In particular, records for dangerous drugs must account precisely for every tablet and every millilitre; any loss or discrepancy may trigger a criminal investigation. Failure to safeguard these drugs, resulting in their diversion to the black market, could cause enormous harm to society, and licence holders may incur serious legal liability.

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.

Are “antibiotics licences” and “dangerous drugs licences” separate licences, or are they applied for together when applying for other licences?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang