pCM Wholesaler Licensing (1C) & Compliance

Assessment of 1C should start with the products and transaction chain, not the company name, warehouse name or a customer's informal description. List each SKU, ownership of the goods, source, destination and whether the company manufactures the products itself before deciding whether 1C is sufficient.

In law, “wholesale of proprietary Chinese medicines” means acquiring or importing proprietary Chinese medicines and then selling them to a manufacturer of proprietary Chinese medicines, or to a person who, in the course of their business or activities, will resell, supply or arrange to supply them to a third party. A 1C wholesaler licence is generally required for this type of wholesale activity in Hong Kong. Sales to end consumers, dispensing Chinese herbal medicines at premises, wholesale of Chinese herbal medicines and manufacture of proprietary Chinese medicines in Hong Kong should not be subsumed under the 1C licence; each must be assessed according to the actual activity.

Retailers of Chinese herbal medicines (1A), wholesalers of Chinese herbal medicines (1B), wholesalers of proprietary Chinese medicines (1C) and manufacturers of proprietary Chinese medicines (1D) are four separate categories. In particular, activities involving scheduled Chinese herbal medicines, toxic Chinese herbal medicines or materials habitually used as Chinese medicines by the Chinese are not automatically covered merely because the business also holds a 1C licence. If the business intends to deal in both Chinese herbal medicines and proprietary Chinese medicines, the relevant licences and storage arrangements should be established for each activity.

There is a narrow but important statutory boundary for manufacturers of proprietary Chinese medicines: a manufacturer may wholesale its own registered proprietary Chinese medicines without obtaining a separate 1C licence; however, a 1C licence is still required to wholesale proprietary Chinese medicines that it did not manufacture. Drew Tang recommends recording “own manufacture / purchased from others”, “manufactured in Hong Kong / manufactured overseas” and “for end consumers / for onward supply” in the master SKU list, to avoid mistakenly extending the manufacturing exemption to third-party products when the product range expands.

Ordinary Chinese herbal medicines, proprietary Chinese medicines and plant, animal or mineral materials habitually used as Chinese medicines are generally regulated under the Cap. 549 regime and should not be described broadly as western medicine licence business under Cap. 138. If an individual product contains western medicine ingredients or involves other specially controlled materials, review the applicable regulatory regime separately before marketing, purchasing or trading it.

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A 1C licence is a regulatory authorisation linked to the applicant, the premises specified in the licence and the information declared. It is not an asset that can circulate freely independently of the operating entity. The entity's information should remain consistent across the application, renewal and any transaction.

Section 135 of the Chinese Medicine Ordinance starts from the premise that “any person” may apply. The official checklist specifies separate information requirements for limited companies, sole proprietorships and partnerships. A limited company is therefore a common commercial choice, but is not the only legally permitted form of applicant for 1C. Prepare the relevant information for the structure actually selected; do not describe a sole proprietorship or partnership as a limited-company application simply to fit a template.

For an applicant that is a limited company, the checklist specifies copies of the Certificate of Incorporation and the list of directors. Regardless of the entity structure, the applicant must list the sole proprietor, partners or directors and key personnel, and submit a simple plan of the business premises. The company name, Business Registration, list of directors, authorised signatory arrangements and information in the application form should be consistent to reduce the risk of further requests and discrepancies at renewal.

For changes to shareholding, control or directors, the verified rules specifically for Chinese medicines traders do not give a uniform conclusion that a change of shareholding is automatically approved or automatically invalidates the licence. The official renewal notes expressly state that where licence information differs from the Chinese Medicines Board's records, for example following a change of company director or Person-in-Charge, the Board should be notified as soon as possible and the change reflected in the renewal checklist. Drew Tang recommends preparing a regulatory impact table before signing a transaction, assessing in turn whether the licensed entity, directors, key personnel, actual activities, premises, product registrations or import/export accounts will change.

Buyers should therefore not check only the share-transfer documents filed with the Companies Registry. Even if the company entity remains unchanged, relocating the warehouse, changing the people who actually manage the business, introducing purchased products or changing the trading model may also trigger separate licensing, product or trade compliance work.

Staffing arrangements for an ordinary 1C licence should be based on the actual responsibilities for purchasing, receipt, storage, dispatch and traceability, rather than borrowing job titles from manufacturing or western medicine regimes.

The official 1C checklist requires the applicant to declare the sole proprietor, partners or directors and key personnel. Key personnel expressly include management, as well as those responsible for purchasing, receipt, storage and dispatch of proprietary Chinese medicines. The Practice Guidelines for Wholesalers of Proprietary Chinese Medicines further state that staff should know the names, specifications, expiry dates, storage instructions and methods of use of the products handled, and have knowledge of warehouse management, including receipt, storage and dispatch.

The verified 1C application requirements and checklist do not show that ordinary wholesalers of proprietary Chinese medicines are universally required to appoint a nominee, an AP or a registered pharmacist. A nominee is a specific arrangement found in the retail dispensing of Chinese herbal medicines and the manufacture of proprietary Chinese medicines; AP is a term used in the pharmacy and poisons regime under Cap. 138. Neither should be presented as a statutory threshold for 1C, and Drew Tang should not be described as a registered pharmacist.

This does not mean that staff need no business competence. The Practice Guidelines require staff to ensure that quantities entering and leaving the warehouse are accurate, products remain in good condition and have appropriate labels and package inserts, products are stored under suitable conditions, and premises are kept clean and hygienic. Drew Tang recommends assigning responsibilities across six control points: “product/registration checks, receipt and acceptance, inventory and expiry dates, dispatch review, complaints and recalls, and regulatory liaison”, with designated cover staff and training records.

If the business also carries out 1D manufacture or 1A dispensing, handle the applicable personnel qualifications, nominations and change-notification obligations as separate matters; do not use the 1C key personnel list as a substitute.

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For 1C, a uniform floor-area or capital figure is not a substitute for site suitability. The applicant must ensure that the premises, product quantities, storage conditions and actual operating processes are compatible, and be able to explain this on site.

The direct conditions set out in the 1C application handbook include premises that meet hygiene requirements and have adequate space and sufficient, suitable facilities for storing proprietary Chinese medicines. Examples in the handbook state that warehouse size should be commensurate with the quantity of proprietary Chinese medicines stored, with sufficient storage racks or cabinets and facilities to prevent insects, rats, dampness and mould. The verified materials do not specify a uniform minimum area in square metres, registered capital or paid-up capital for ordinary 1C.

After receiving an application, the Department of Health will arrange for an officer to inspect the applicant's business premises and submit a report to the Chinese Medicines Board for consideration. The address, simple floor plan, storage racks, segregation areas, actual stock levels and description of the proposed business in the application must therefore be consistent. Vacant premises, an office with no corresponding storage arrangements, or a mismatch between the processes shown in the application and those on site will increase the risk of questions and further information requests.

Drew Tang recommends marking the locations for receipt, quarantine/segregation of abnormal goods, released stock, returned-goods segregation, dispatch and document storage on a floor plan, then checking capacity against the packaging dimensions of actual SKUs, peak stock levels and manufacturers' storage instructions. This is practical preparation to make arrangements easier to explain; it does not mean that the authorities prescribe fixed floor areas for each zone.

If the business also holds Chinese herbal medicines, physical segregation of scheduled herbal medicines is a Chinese herbal medicine regulatory matter and should not be replaced by 1C storage arrangements. For mixed operations, also check the licence, area signage and document requirements for each product category.

A complete application is not just a form; it is a set of documents that enables the applicant, key personnel, premises and proposed activities to be checked item by item. Before submission, check every item against the official checklist.

Applications for a wholesaler licence in proprietary Chinese medicines use Form 1C and must be submitted together with the Application for a Wholesaler Licence in Proprietary Chinese Medicines Document Checklist (Checklist 2C) and all documents listed in it. The Department of Health's forms page lists 1C separately from 1A, 1B and 1D, and also provides separate forms for renewal (Form 11) and change of address (Form 12); do not substitute forms for another licence category, outdated scanned copies or a business plan for the specified documents.

Checklist 2C states that a limited company should provide its Certificate of Incorporation and list of directors; sole proprietorships and partnerships should provide the relevant information for their entity structure. All applicants should note the lists of sole proprietors, partners or directors and key personnel, as well as the simple plan of the business premises. The Chinese Medicines Board may request other supporting documents or the originals of the above documents for checking when necessary, so the evidence pack should retain source details, versions and verifiable originals.

Drew Tang recommends preparing a separate “application information matrix”: list the form fields and checklist items on the left, and the evidence document name, issue date, responsible person and corresponding location on site on the right. This allows the same factual record to be used for receipt, further information requests, inspection and renewal, avoiding inconsistencies over the address, director information, stock levels or staff responsibilities.

If the application also involves overseas products under an own brand, product registration, import or re-export, do not assume that including product information in the 1C licence documents meets the separate product or trade requirements. Set up separate product registration and import/export licence files, and cross-check product names, specifications, manufacturers and intended uses.

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The official process includes receipt, acknowledgement, inspection, consideration and payment of the fee followed by issue of the licence. Each stage serves a different purpose; acknowledgement or inspection must not be treated as approval.

After Form 1C, Checklist 2C and all required documents have been submitted, the Department of Health's Chinese Medicine Regulatory Office will issue an acknowledgement letter within 30 days, stating the application number. The application handbook advises applicants to contact the Office if they have not received an acknowledgement letter after 30 days. This 30-day period relates to acknowledgement; it is not a service commitment for granting the licence.

After receiving an application, the Department of Health will arrange for an officer to inspect the applicant's business premises and submit a report to the Chinese Medicines Board for review. If the application is approved, the applicant must pay the required fee as notified before the licence is issued; if it is not approved, the applicant will also be notified. Progress depends on the completeness of the documents, site conditions, quality of responses to further requests and the Chinese Medicines Board's consideration of the case. No service provider should promise approval within two months, guaranteed approval or access to a special fast-track channel.

Drew Tang's team can help coordinate document preparation and submission, a site simulation, an issues list and responses to further requests as a non-guaranteed project estimate of approximately 3 to 4-plus months. This estimate excludes the applicant's document preparation, premises rectification, regulatory consideration and the time required for any uncontrollable exchanges of further information; it should not be conflated with government service targets.

Before inspection, check that the site address matches the application, storage facilities are ready, segregation and returned-goods areas are usable, key personnel can explain the receipt and dispatch processes, and product and document samples are consistent. Responses to further information requests should address each question by reference to evidence and the status on site, rather than offering only general explanations.

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Ongoing compliance for a 1C licence centres on product quality, traceability and recall capability. The official practice guidelines link procurement, receipt, storage, sales, complaints, recalls and transaction documents into a single control chain.

The practice guidelines for wholesalers of proprietary Chinese medicines require that unregistered proprietary Chinese medicines must not be sold in Hong Kong; products of questionable quality or suspected counterfeits should not be handled; and expired proprietary Chinese medicines must not be sold or distributed. Procurement should be from reputable suppliers. On receipt, check the product name, specification, batch number, quantity and expiry date. Returned proprietary Chinese medicines must be kept separately and may only be resold or redistributed after inspection confirms that they are satisfactory.

Storage should follow the manufacturer’s specified storage instructions, and product packaging should provide adequate protection for quality. For sales or distribution, the practice guidelines recommend arranging each product by expiry date; this enables expiry controls, inventory records and dispatch checks to be verified against one another. For re-export goods, the guidelines specifically state that complete records should be properly retained for inspection.

The transaction-document requirements reflected in section 21 of the Chinese Medicine Regulation are enforceable: invoices or other documents for every transaction involving the acquisition, receipt, export, sale or distribution of proprietary Chinese medicines must be kept in an orderly manner at the premises to which the 1C licence relates for at least 2 years from the transaction date. The documents should state the transaction date, product name and quantity, the name and address of the other party, its telephone number and the document reference number. They must remain complete and legible and must not be altered arbitrarily.

Drew Tang recommends conducting a monthly sample “forward and backward traceability” exercise: trace one incoming-goods document to its storage location and all related dispatches, and trace one batch number or complaint back to the supplier and customers. This is a practical internal control method to test whether the business can support statutory recalls and inspections; it does not create a statutory monthly frequency.

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Government fees, licence validity periods, product or trade permit processing times, and service-provider project fees are distinct items. Budgets should list them separately; none should be used as a substitute for another.

The government fees for issuing a wholesaler licence in proprietary Chinese medicines, as listed in the official application handbook and renewal notes, are HK$1,210; the renewal fee is HK$1,050. The official guidance on changing the address of premises specified in a licence lists a fee of HK$805. Fees are governed by the Chinese Medicine (Fees) Regulation. Before submission, check the current electronic legislation, General Demand Note and case-specific notification. These amounts exclude consultancy services, rent, renovation, equipment, testing, transport and product registration costs.

Under section 29 of the Chinese Medicine Regulation, a new 1C licence issued under section 135 is valid for 2 years. A licence renewed under section 136 is valid for 2 years or a shorter period considered appropriate by the Chinese Medicines Board. Do not use the outdated summary “generally not more than two years” in place of the current provision, or mistakenly state that renewal is annual.

The 30-day acknowledgement arrangement is not a licence-issuance timeframe. The general target of 2 working days after receipt of complete information stated in the import and export licence guidance applies only to the relevant import and export licence service; it cannot be extended to 1C approval or product registration timelines. Product registration application information also sets out processing targets by registration category, which should not be applied to 1C.

Drew Tang’s service budget should clearly distinguish government fees, premises and operating costs incurred by the business itself, product/trade compliance costs, and consultancy fees. The 3–4-plus-month timeframe may only be presented as a non-guaranteed estimate for the service provider to organise documents, assist with submission, prepare for inspections and follow up on requests for further information; no special channel or decision by the regulatory authority within a fixed number of months may be promised.

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After licensing, the priority is to continue meeting the licensing requirements and ensure that the Chinese Medicines Board’s records, the premises specified in the licence and actual business operations remain consistent. Renewal is not automatic, and a move must not be followed by an application after the fact.

A 1C licensee may apply for renewal no earlier than 6 months before the licence expires, using Form 11 and the renewal document checklist (11R), together with the listed documents. The official renewal notes explain that, generally, an application must continue to meet the relevant licensing requirements and practice conditions. When approving a renewal, the Chinese Medicines Board may amend or leave unchanged the existing conditions or restrictions, depending on the case.

If information about the licensee differs from the Chinese Medicines Board’s records, for example because of a change of company director or person responsible, the official notes require the Board to be notified as soon as possible and the difference to be stated in the renewal application document checklist. For an ordinary 1C licence, do not wrongly present the one-month notification rule for persons responsible that applies specifically to manufacture or retail dispensing as a uniform personnel requirement for 1C. However, changes to directors, senior staff and actual operating information should still be checked without delay.

To change the address of premises specified in the licence, apply to the Chinese Medicines Board in advance as early as possible, and no later than the 3rd day from the date the change occurs; the address must not be changed until approval is granted. The application should be supported by Form 12, documents proving the address change and a simple plan of the new business premises. The new premises must also meet the licensing requirements.

If an address change is not approved, the licence will expire when 1 month has elapsed from the date of the change. Without approval, the licensee must not conduct the relevant Chinese medicine business at the new premises. This is a compliance step that must be addressed in advance when moving a warehouse, selling a business or reaching the end of a lease.

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Acquiring a business that holds a 1C licence must not be described as “buying the licence and the matter is settled”. The transaction should be structured only after establishing that, following completion, the business can continue operating within the authorised entity and premises and in a manner that meets the actual requirements.

Before the transaction, confirm exactly what licence the seller holds, the licence expiry date, specified premises, existing conditions / restrictions, the status of any renewal or address application, and whether all actual SKUs fall within the scope of wholesale of proprietary Chinese medicines. If the seller also deals in Chinese herbal medicines, retail dispensing, manufacturing or cross-border activities, include each separately in due diligence; a 1C licence alone cannot stand in for an overall compliance conclusion.

For continuity of the entity, check the company name, Business Registration, directors, senior staff, actual control, signing authority and licence-record details. The verified materials do not state that a simple share transaction is automatically approved or automatically invalid. The safest approach is therefore not to guarantee that “the licence automatically transfers with the shares”, but to prepare a list of changes before completion and, as appropriate, check with the Chinese Medicines Board whether notification, supplementary information or an application is required.

For continuity of operations, take stock of the warehouse address, lease, inventory, batch numbers, expiry dates, suppliers, customer destinations, complaints, recalls, transaction documents and outstanding regulatory correspondence. At a minimum, the transaction documents should address continued operation at the old address, a move pending approval, whether the holder of product registration certificates will change, and whether import / export authorisations and account details will change; these should be included as conditions precedent, completion handover items or post-completion actions.

Drew Tang recommends dividing completion into four stages: first, conduct due diligence on the licence and product matrix; then identify differences in the entity, personnel and premises; take stock of inventory and documents on the completion date; and after completion, carry out any identified notification, renewal, address, product registration or trade permit work. This is a project-management recommendation and does not mean that the regulatory authority has approved any transaction structure in advance.

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A 1C licence covers the qualification to conduct wholesale business; it does not make every product a registered proprietary Chinese medicine that may be sold in Hong Kong. Manage product-level registration, packaging, labels and package inserts separately from the licence records.

Section 119 of the Chinese Medicine Ordinance provides that, unless exempted, proprietary Chinese medicines must not be sold, imported or possessed in Hong Kong unless registered with the Chinese Medicines Board. The practice guidelines for wholesalers of proprietary Chinese medicines also expressly state that unregistered proprietary Chinese medicines must not be sold in Hong Kong. Therefore, before procuring or bringing in a product, the licensee should check the registration status, product name, specification, manufacturer and proposed sales packaging for each SKU, rather than checking only whether the supplier holds a 1C licence.

For products manufactured outside Hong Kong, an application for registration of proprietary Chinese medicines must be made by a licensed wholesaler of proprietary Chinese medicines; for products manufactured in Hong Kong, it must be made by a licensed manufacturer of proprietary Chinese medicines. This shows that eligibility to apply for product registration is related to 1C, but a 1C licence itself does not mean that any specific product registration certificate has been obtained. Product registration applications, registration renewals, certificates of sale and changes to registration details also have separate forms and information requirements.

Labels and package inserts are independently regulated product information. The practice guidelines require labels and package inserts on proprietary Chinese medicines sold or possessed for sale in Hong Kong to be clear, explicit and free from false or misleading information, and to include the statutory particulars applicable to the circumstances. Requirements are not identical for the outermost packaging sold to end users and packaging not intended for end users; a generic self-made sticker or printing text only on the outer carton should not replace case-specific checks.

Drew Tang recommends maintaining a product master file recording the registration number, certificate holder, manufacturer, sales packaging, label / package-insert versions, batch-number format, expiry date and storage instructions. Before dispatch, assess whether a product name change, change in pack size, manufacturer change or addition or removal of sales packaging involves a change to registration details or an update to the label / package insert. Do not use website examples as a substitute for product classification conclusions when the specific ingredients and dosage have not been verified.

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A 1C licence is relevant to cross-border business, but does not remove the requirement to obtain prior permits for imports and exports of proprietary Chinese medicines. Before shipment, check the purpose of each consignment, product registration status, applicant entity and any supplementary permits.

The Drug Office’s Chinese Medicines Regulatory Office states in its 2026 “Guidelines on Applications for Import/Export Licences for Proprietary Chinese Medicines” that an import or export licence must be obtained in advance to import or export proprietary Chinese medicines. This requirement is governed by the Import and Export Ordinance (Cap. 60) and related arrangements. A 1C licence, supplier invoice or registration number cannot replace the licence required for each consignment.

For imports of registered proprietary Chinese medicines, the guidelines identify a licensed manufacturer of proprietary Chinese medicines, or a licensed 1C holder that is the holder of the Certificate of Registration for Proprietary Chinese Medicines and whose wholesale business relates to the product, as eligible applicants. Exports may be applied for by a licensed manufacturer of proprietary Chinese medicines or a licensed 1C holder. Re-exports, and imports for registration, testing or packaging, have different information and declaration requirements. Before applying, select the route according to the actual purpose of the goods; do not present “re-export” as an alternative to selling in Hong Kong.

The guidelines state that, where the application information meets the issuance requirements, licences applied for through the online service can be processed and made available for download within 2 working days. Paper licences are generally issued within 2 working days after receipt of a completed application and all supporting documents. If information is missing or incorrect, or documents do not meet the requirements, the Drug Office will request corrections or supplementary documents within a specified period. This is the target processing arrangement for import and export licences, not the approval timeframe for a 1C licence or product registration.

If a proprietary Chinese medicine contains Chinese herbal medicines derived from endangered species, it may also have to meet the licensing requirements under the Protection of Endangered Species of Animals and Plants Ordinance. Drew Tang recommends that, before each shipment, trade, product and warehouse staff jointly check product registration, licences, invoices/packing information, transport dates and actual purpose, and keep a record of how used, unused and expired licences are handled.

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The Drug Office may enter and inspect premises at a reasonable time. Making inspection readiness part of routine controls will generally demonstrate the actual operating situation more effectively than rushing to assemble documents after receiving an inspection notice.

The Chinese Medicine Ordinance empowers Drug Office officers to enter and inspect relevant premises at a reasonable time; premises are also inspected during the 1C application stage. Licence holders should ensure that the displayed licence, actual address, inventory, storage facilities, staff responsibilities and transaction documents are consistent on every normal operating day, rather than making temporary arrangements solely for the initial inspection.

The Code of Practice for Wholesalers of Proprietary Chinese Medicines requires a complaint and recall system to be established and maintained. The complaint system should record complaint details, investigation findings and follow-up actions, and be reviewed comprehensively at regular intervals. Repeated problems should be examined and investigated, and the relevant supplier notified where necessary. The aim of the recall system is to retrieve products already sold or distributed promptly and as far as practicable. Information on adverse reactions obtained through complaints or other channels should be reported to the Chinese Medicines Board as soon as possible.

Drew Tang recommends dividing routine and periodic self-checks into tiers: daily, check cleanliness, pest control, shelf condition, quarantine areas, temperature and humidity or other storage conditions specified by the manufacturer, expiry dates and returned goods awaiting action; monthly, sample-check the traceability of incoming and outgoing goods and transaction documents; quarterly, have management review complaints, recall drills, training, supplier irregularities and product version changes. These frequencies are risk-management recommendations, not uniform frequencies prescribed by the authorities.

Prepare for inspections or interviews by answering with genuine documents and actual procedures. It is advisable to have the licence and premises layout plan, staff responsibilities, product and inventory lists, samples of receiving, dispatch and returns records, two years of transaction documents, complaint and recall records, and storage monitoring and cleaning records ready. Record any discrepancies, corrective actions and completion dates. Do not create a false appearance of consistency by backfilling or altering historical records.

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Correctly distinguishing regulatory regimes is essential to avoiding unnecessary personnel requirements in a 1C application and ensuring that any special permits relevant to product business are not overlooked.

The Drug Office explains that the sale, manufacture, distribution or compounding of ordinary Chinese herbal medicines, proprietary Chinese medicines and materials of plant, animal or mineral origin customarily used as Chinese medicines is regulated by the Chinese Medicine Ordinance (Cap. 549), not the Pharmacy and Poisons Ordinance (Cap. 138). Accordingly, an ordinary 1C operation should not simply adopt the authorised-person, registered-pharmacist and poisons-selling requirements applicable to wholesale or manufacture of pharmaceutical products.

This distinction does not mean that all product risks are excluded. An individual product containing Western medicine ingredients may trigger Cap. 138 or other regulatory regimes. Products containing endangered species, or involving imports or exports, may also be regulated by other ordinances and licensing requirements. Applicability should be checked item by item against the actual ingredients, dosage, claims, place of manufacture, movement of goods and purpose.

Advertising is also not automatically covered by a 1C licence. The Code of Practice lists the Undesirable Medical Advertisements Ordinance as one of the relevant ordinances wholesalers should note. Product and marketing teams should review labels, leaflets, sales statements and online promotions for consistency. Drew Tang recommends confirming product information and sales compliance before arranging any public promotion.

Until the ingredients, dosage and actual claims of a specific product have been verified, this page does not use hypothetical products to draw classification conclusions, or invent examples of approvals, successful transactions or regulatory recognition.