Chapter 9: Antibiotics Permits and Dangerous Drugs Wholesale Dealer Permits
Hello, industry colleagues! I am Drew Tang from Rengangyongsheng (Hong Kong) Limited. In Hong Kong pharmaceutical wholesaling, in addition to the ordinary Wholesale Dealer Licence, we often encounter two special categories of medicines: antibiotics and dangerous drugs. Both are strictly controlled under Hong Kong law, and specific licences are required to wholesale them. Today, I will discuss the antibiotic licence under the Antibiotics Ordinance (Cap. 137) and the Wholesale Dealer Licence for Dangerous Drugs under the Dangerous Drugs Ordinance (Cap. 134), helping you understand the key requirements and practical aspects of applying.
The Antibiotics Ordinance and its regulatory scope
First, let us look at antibiotics. The Antibiotics Ordinance (Cap. 137) is the principal legislation in Hong Kong controlling the sale, possession and use of antibiotic substances. It was enacted to prevent misuse of antibiotics, slow the development of resistance and protect public health. The Ordinance expressly provides that no person may sell or possess any antibiotic substance for sale without a licence.
The definition of ‘antibiotic substance’ in the Ordinance is very broad, covering all substances that can inhibit or kill micro-organisms, whether naturally occurring or synthetic. This means that any business involving any form of antibiotic preparation, whether injectable, tablet or ointment, must first obtain an antibiotic permit. Notably, the Ordinance regulates not only finished medicines but also active pharmaceutical ingredients (APIs) of antibiotics. Companies importing, exporting or wholesaling antibiotic APIs are therefore also subject to the Ordinance.
Drew Tang's tip: Many clients initially overlook the regulatory requirements for active pharmaceutical ingredients. Be sure to check your product ingredients. If they contain any substances listed in the Schedule to the Antibiotics Ordinance, such as penicillin, tetracycline or cephalosporins, you must apply for the relevant licence. Otherwise, if discovered during an inspection by the Drug Office, Department of Health, you may face severe legal penalties.
Antibiotics licence application requirements and process
To apply for an antibiotic permit, you must first hold a valid Wholesale Dealer Licence. You can think of the antibiotic permit as an “endorsement” to the Wholesale Dealer Licence. The applicant must be a company incorporated in Hong Kong and have a compliant business address and storage warehouse. The Drug Office, Department of Health has strict storage requirements when assessing applications.
The specific application requirements include appointing a qualified “Responsible Person”, who must have relevant pharmaceutical knowledge or work experience; ensuring that the premises where antibiotics are stored are secure and hygienic, and effectively prevent access by unauthorised persons; and establishing a complete system for records of the procurement, storage, sale and distribution of medicines, so that the movement of all antibiotics can be traced. The application process is similar to that for a wholesaler’s licence. Applicants must submit an application form, company documents, details of the Responsible Person and a premises layout plan, among other documents, and pass an on-site inspection by the Department of Health.
Section 3(1) of the Antibiotics Ordinance states: “Except under and in accordance with a licence granted under this Ordinance, no person shall sell or have in his possession for the purpose of sale any antibiotic substance.” This is the legal foundation of antibiotic control, and any attempt to circumvent the licensing requirements is unlawful.
The Dangerous Drugs Ordinance and Wholesale Dealer Licences
Next, let us discuss the more sensitive category of “dangerous drugs”. The Dangerous Drugs Ordinance (Cap. 134) regulates medicines with addictive potential that may be misused, such as morphine, codeine and fentanyl. These medicines have important medical uses, but if diverted into illegal channels they can cause serious social problems. The Government therefore imposes the strictest controls at every stage, including their manufacture, wholesale, retail, import and export.
A business wishing to engage in the wholesale of dangerous drugs must apply for a “Dangerous Drugs Wholesaler Licence”. The application is more challenging, and the regulatory requirements are far more stringent, than for an ordinary wholesaler’s licence or an antibiotics permit. The regulator requires applicants to demonstrate a very high degree of integrity and professional management capability, and imposes exceptionally stringent security requirements for the drugs. For example, safes used to store dangerous drugs must meet specified standards and be connected to an alarm system operated by a security company.
Risk warning: Dangerous drugs are a regulatory red line. Any conduct involving falsified records, illegal sales or security lapses may expose the person in charge to criminal liability. I, Drew Tang, hereby solemnly remind everyone that the highest level of vigilance must be maintained at all times when handling dangerous drugs, and every requirement of the law must be strictly observed. Do not take any chances.
Special requirements for the storage and record-keeping of dangerous drugs
The storage and record-keeping of dangerous drugs are among the regulator’s highest priorities. The law requires all dangerous drugs to be stored in a locked safe or dedicated room constructed of solid materials. Only authorised personnel (usually a registered pharmacist or company officer) may hold the key. A Dangerous Drugs Register must also be maintained in the prescribed format, with detailed records of every receipt and supply of dangerous drugs.
The requirements for this register are very strict. Each entry must be made within 24 hours of the transaction and must not be altered; errors may only be corrected by striking through the entry and signing it. During every unannounced Department of Health inspection, checking that the register matches the actual inventory is a key item. Any discrepancy may be regarded as a serious breach. I handled a case in which a company, due to the Person-in-Charge’s negligence, had a minor discrepancy of a few tablets between the register and the inventory. It was ultimately issued a warning and required to carry out a comprehensive internal review.
Dual licence applications and comparison
In practice, many medicines are antibiotics and may also be classified as dangerous drugs because of their ingredients or potential for misuse. Businesses may therefore need to apply for both an antibiotic permit and a dangerous drugs wholesale licence. In practical terms, I recommend preparing both applications in parallel and communicating with Drug Office officers in advance. This can help coordinate the premises inspection and improve the efficiency of the approval process.
To make the difference between the two clearer, I, Drew Tang (Tang Shangyong), have prepared the following comparison table:
| Item | Antibiotics licence | Dangerous Drugs Wholesale Dealer Licence |
|---|---|---|
| Main regulatory legislation | Antibiotics Ordinance (Cap. 137) | Dangerous Drugs Ordinance (Cap. 134) |
| Prerequisite licence requirements | Must hold a valid Wholesale Dealer Licence | Must hold a valid Wholesale Dealer Licence |
| Scope of regulation | Substances capable of inhibiting or killing microorganisms | Psychiatric medicines with addictive properties and a potential for abuse |
| Storage requirements | Safety, hygiene and prevention of unauthorised access | A compliant safe or dedicated room with an alarm system |
| Record-keeping requirements | Complete purchasing, sales and distribution records | A dedicated “Dangerous Drugs Register”, subject to very stringent record-keeping requirements |
| Application difficulty | Intermediate | Very high |
Drew Tang's advice: Although the application requirements for these two types of licence are stringent, the process can be smooth if we prepare fully in advance and plan our premises, personnel and management systems strictly in accordance with the regulatory guidance. The Rengangyongsheng (Hong Kong) Limited team has extensive experience in handling complex applications of this kind and can provide professional support throughout the process, from premises planning and document preparation to communications with government departments, helping you establish your business on a compliant footing. If you have any questions, please feel free to contact me, Drew Tang, and we can discuss the best solution together.