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What should we do if our licensed premises need to be relocated or undergo major refurbishment?

A complete explanation of the regulatory basis, Drew Tang’s recommendations and risk alerts. The original material dates from 2025; read it alongside the latest official requirements.

Original guide, 2025 edition: These FAQs are provided for topic-based reference and have not all been individually checked against current rules. Please confirm fees, personnel, renewal, changes and product requirements against the professional in-depth guide for the relevant licence type and the official requirements in force at the time.

Drug Office, Department of Health Chinese Medicines Board

Q361 · Category H: Licensed operations and routine regulatory oversight (Q351–Q400)
The address and layout of licensed premises are key considerations in the licensing assessment, and any changes must be approved in advance by the Department of Health. If you plan to relocate or carry out major renovations to the existing premises (for example, changing the structure of a storage area or increasing or reducing the floor area), you must submit a written application to the Drug Office, Department of Health in advance. The application should include detailed plans of the new premises, renovation plans and the reasons for the changes. The Department of Health will assess whether the new premises or layout continues to meet the licensing conditions, particularly the requirements for drug storage and security. You must not handle any drugs at the new or renovated premises before formal approval has been obtained from the Department of Health. After approval, the Department of Health will generally arrange an on-site inspection to confirm that everything complies with the plans and requirements before updating your licence details.

📘 Regulatory basis

Under the Code of Practice for Wholesale Dealers in Drugs, licence holders must ensure that their premises continue to meet the licensing requirements. Any major change to the premises may affect compliance and therefore requires prior notification and regulatory approval.

📗 Drew Tang's recommendations

We strongly recommend speaking to a professional consultant such as Rengangyongsheng (Hong Kong) Limited before signing a new lease or finalising a renovation plan. We can help you assess whether a new site or design meets GDP/GMP requirements and prepare the full set of documents for submission to the Department of Health, avoiding wasted investment and application delays caused by an unsuitable location or design. Planning ahead is key.

📕 Risk notice

Relocating without prior approval or changing the layout of the premises is a serious breach. If the Department of Health discovers this, it will immediately require you to stop all pharmaceutical handling activities at the premises concerned until approval has been obtained. This means your business will be completely interrupted. In the worst case, the Department of Health may consider that you have disregarded regulatory oversight and take disciplinary action, such as revoking your licence.

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