Hong Kong Pharmaceutical Wholesaler License (WDL) Application Guide

Applicants must submit business with a valid Hong Kong business registration, The official list separately lists limited companies, Documents required for sole proprietorship and partnership. Can overseas or mainland enterprises use registered non-Hong Kong companies?, Branch or local entity application, Should be registered as business, Company information and actual business structure confirmed with the Drug Office.

does not affect. The law does not restrict non-Hong Kong residents from serving as directors of licensed companies, However, all directors must pass the "fit and proper" integrity review, Submit proof of identity and a statement stating that you have no past criminal record related to the pharmacy industry.

Official guidance will consider commercial premises or industrial buildings; Ground floor or retail premises are generally not considered, Premises within secretarial or accounting services companies will not be considered. Specific use, Storage facilities and management arrangements still need to be inspected, Not all office buildings are prohibited.

Whether WDL and Hong Kong storage facilities are required depends on whether the entity is engaged in the wholesale business of poisons or pharmaceutical products in Hong Kong, cargo logistics, Contracts and control arrangements. Complete overseas transactions cannot be concluded solely based on the “re-export” label; Off-site storage must be explained in writing and approved by the committee on a case-by-case basis.

Sharing locations or simply storing in other locations is not automatically prohibited, But the reason must be explained, management rights, isolation, Locked, monitor, Maintenance and SOP, Determined by the committee on a case-by-case basis. Specific physical separation and access requirements are subject to inspection and written conditions.

Generally, WDL must be approved by the committee, Suitable person responsible for poisons and pharmaceutical products with sufficient knowledge of the pharmaceutical trade. When dealing with psychotropic or first dangerous drugs, Registered pharmacists are required to handle all relevant transactions; Antibiotic licensing itself cannot be generalized to require full-time pharmacists.

Persons who are already a responsible person of another WDL licensee will generally not be considered, However, the committee will review it on a case-by-case basis. Whether a pharmacist or other key personnel can serve multiple premises depends on the role, Business hours, transaction processing, Confirmation of license conditions and actual ability to perform duties, It cannot be summarized as a blanket prohibition.

A wholesaler's license by itself does not confer full authority to retail poisons or operate a dispensary. Should be classified by drugs, Check the laws and required authorizations for supply objects and sales methods.; Not because you hold a wholesaler's license, retail all medicines directly to the public.

No. Every imported pharmaceutical product must first complete drug registration with the Hong Kong Pharmacy and Poisons Board (obtain a registration number starting with HK-). Importing unregistered pharmaceutical products is a criminal offense, Unless it is for specific patient treatment or re-export with one-time permission from the Department of Health.

repackage, Whether labeling or changing packaging constitutes manufacturing and whether a manufacturer's license is required, GMP or product registration changes, Depends on actual process and product. Check with the drug office before proceeding, Any labeling activity should not be regarded as manufacturing.

During the application stage, pharmacists will inspect the premises; Must continue to comply with regulations after licensing, Licensing conditions and codes of practice, and cooperate with inspections and documentation requirements conducted in accordance with the law.. Check whether advance notification and scope of authority are implemented in accordance with laws and individual cases.

According to section 36 of the Pharmacy and Poisons Regulations, All accounts involving the purchase and sale of pharmaceutical products, Receipts and vouchers must be kept for at least 2 years from the transaction date, and the record must contain the batch number, To facilitate drug traceability and recall.

Failure to maintain or produce records as required may constitute a violation, and may lead to an investigation, warn, Changes to license conditions, pause, withdraw or prosecute. The actual consequences are determined by the committee, Department of Health and Courts by Record Type, products, Severity and evidence determine, Immediate revocation cannot be predicted.

The current performance pledge of the Department of Health is: When the applicant submits all required documentation and demonstrates that the storage facilities are adequate and satisfactory, Process and approve applications within two months. Starting after receipt of confirmation of complete application; information requests, Inspections or complex matters will affect time, This is not an unconditional licensing guarantee.

Handling antibiotics requires an antibiotic license outside the WDL; Handling Part 1 Dangerous Drugs requires applying for a Wholesale Dealer’s License to Supply Dangerous Drugs, If only Part 2 preparations in Part 1 of the Schedule are processed, then apply for the corresponding Part II license. Applicable scope and fees are confirmed by product and submission guidelines.

No. Entity Wholesale License, Drug registration and specific import authorization are separate matters, Products and uses should be checked item by item; Obtaining a wholesale license does not mean that you can freely import all brands.

Acceptance of application does not equal issuance of license. You should first confirm which activities require authorization, and whether the applicable formal or provisional license has been obtained; fit-out, Training and equipment testing should be distinguished from external business.

Can refer toHong Kong Pharmaceutical Wholesaler License (medicine brand)Supervision and application information from competent authorities, Check corresponding systems and processing information.

First check whether the license is issued to an individual, Company, Place or designated business. New business entities or persons in charge should not directly use old documents, Applicable changes should be made, Transfer or New Application Process.

put new location, facility, Compare service content and responsible personnel with approved documents item by item. The original license does not necessarily cover the new venue or activity, Applicable approvals and relevant departmental procedures should be completed first.

Competent authorities may require additional clarifications, Modify plans or make rectifications. It is recommended to check the address before submitting, floor plan, equipment, people and real business, and keep version records of modifications, Reduce round-trip replacement parts.