Bridging Pharmacy and Technology

First, It depends on the ingredients. If the product contains any active pharmaceutical ingredient, which needs professional judgement, it will likely be regarded as a pharmaceutical product. Second, if the product labels involves any health claim, it will still likely be regarded as a pharmaceutical product even it does not contain any active pharmaceutical ingredient. For more details about the Pharmacy and Poisons Ordinance, please refer to the websites: https://www.elegislation.gov.hk/index/chapternumber?p0=1&TYPE=1&TYPE=2&TYPE=3&CAP_NO_FR=138&_lang=en, https://www.gld.gov.hk/egazette/pdf/20202430/es12020243019.pdf. For further details, we'd be more than happy to answer every question you have in mind.

To apply for the initial registration of a pharmaceutical product or substance, you must know if the product is manufactured in Hong Kong. If the product is manufactured in Hong Kong, the responsibility for registration lies with the licensed manufacturer or the licensed wholesale dealer working with the manufacturer. If the product is made outside Hong Kong, the responsibility falls to the licensed wholesale dealer who imports the product, or the Hong Kong branch, subsidiary, agent, or distributor of the overseas manufacturer. Once the application is approved, the applicant will receive the Certificate of Drug/Product Registration after paying the necessary fee. A pharmaceutical product will only be registered if it meets safety, efficacy, and quality standards. For more details on the required documents, please refer to the 'Guidance Notes on Registration of Pharmaceutical Products/Substances' available on the website: http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/guid.pdf New applications for registration should be submitted via PRS 2.0 at the following website: https://www.drugoffice.gov.hk/prs2-ext/client_authentication.jsp. For further guidelines, you can visit the Drug Evaluation and Import/Export Control Division at Suite 2002-05, 20/F, AIA Kowloon Tower, Landmark East, 100 How Ming Street, Kwun Tong, Kowloon, or refer to the webpage here: http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/pr_guide_main.html

Yes, Hong Kong has implemented the Medical Device Administrative Control System (MDACS) since December 1, 2004. Medical devices must be listed before they can be sold or supplied in Hong Kong. The system classifies devices into four risk classes (I, II, III, IV), with Class I devices requiring notification and higher classes requiring more comprehensive documentation. Visit our Medical Device Guide for detailed information on the registration process and requirements.

Local serious adverse events should be reported within 15 calendar days. For details, please refer to the the webpage here: For details, please refer to the webpage here: https://www.drugoffice.gov.hk/eps/do/en/doc/Guidance_for_Pharmaceutical_Industry_en.pdf

To handle various classes of drugs, you must first obtain the appropriate trader license. (For more information, please refer to the FAQ on Licensing.) For each import or export transaction, you must apply for an Import License (Form 3) or Export License (Form 6) through the Drug Evaluation and Import/Export Control Division of the Department of Health. For further details, please see the guidelines and forms on "Import and Export," available on the office's webpage: http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/useful_guidelines_forms.html

Wholesale and/or import/export of poisons and/or pharmaceutical products → Wholesale Dealer Licence(WDL) Manufacture of pharmaceutical products →Licence for Manufacturer Premises of an authorized seller of poisons(Part 1 or above) where poisons are kept for retail purposes→ Certificate for Registration of Premises of an Authorized Seller of Poisons(ASP) Retail sale of Part 2 poisons→Licence for Listed Sellers of Poisons(LSP) Wholesale and/or import/export of poisons and/or of antibiotics→Antibiotics Permit Manufacture of dangerous drugs(DD)→Licence to Manufacture Dangerous Drug Wholesale of dangerous drugs(DD)→Wholesale Dealer's Licence to Supply Dangerous Drug

To obtain a Wholesale Dealer License (WDL), you need: (1) Suitable premises that meet storage and handling requirements, (2) A Responsible Person who is a registered pharmacist with at least 2 years of relevant experience, (3) Compliance with Good Distribution Practice (GDP) guidelines, (4) Proper record-keeping systems for procurement, storage, and distribution. The license is valid for one year and must be renewed annually. Inspection of premises by the Drug Office is required before license issuance.

Yes, all pharmaceutical manufacturers in Hong Kong must comply with Good Manufacturing Practice (GMP) standards. The Drug Office conducts regular GMP inspections to ensure compliance. Manufacturers must obtain a Manufacturer's License, which requires demonstration of compliance with PIC/S GMP standards. The facility, equipment, quality control systems, and documentation must all meet GMP requirements. Manufacturers should refer to the GMP guidelines published by the Drug Office.

Parallel imported pharmaceutical products refer to products that are imported into Hong Kong by parties other than the original registration holder. These products must be identical to the registered product in Hong Kong in terms of composition, dosage form, and strength. A separate registration is required for parallel imported products. The importer must hold a valid Wholesale Dealer License and comply with all regulatory requirements including proper labeling in English and Chinese.

Clinical trials in Hong Kong must comply with the guidelines issued by the Department of Health. Key requirements include: (1) Approval from a recognized Research Ethics Committee, (2) Certificate for Clinical Trial (CTX) from the Drug Office for pharmaceutical products, (3) Compliance with Good Clinical Practice (GCP) guidelines, (4) Informed consent from trial subjects, (5) Proper import license for investigational products. Submit applications through the Clinical Trials Section of the Drug Office.

Chinese medicines are regulated under the Chinese Medicine Ordinance (Cap. 549). Proprietary Chinese Medicines (pCm) must be registered before sale or supply in Hong Kong. Registration requires submission of safety, efficacy, and quality data. Manufacturers and traders must be licensed by the Chinese Medicine Council. Traditional Chinese Medicine practitioners must also be registered. For more information, visit the Chinese Medicine Council of Hong Kong website.

First, you have to register with Environmental Protection Department as a Chemical Waste Producer. Second, you should contact the authorized chemical waste collectors to arrange for the disposal of the expired medicines. For details, please refer to the "Guidance on Disposal of Unserviceable/Expired Medicines for Licensed Pharmaceutical Traders" which is available at the webpage of the office: http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/drugdisposalguidance_eng.pdf. For further details, we'd be more than happy to answer [every question](https://www.notion.so/FAQs-16b41946dafc804d9815f23b152d1ed2?pvs=21) you have in mind.

All pharmaceutical products must have labels in both English and Chinese. The label must include: (1) Product name, (2) Active ingredients and their quantities, (3) Batch/lot number, (4) Manufacturing and expiry dates, (5) Storage conditions, (6) Manufacturer's name and address, (7) Registration number, (8) Dosage instructions and warnings. For prescription medicines, the word 'Prescription Only Medicine' or symbol 'POM' must be displayed. Labels must comply with the Pharmacy and Poisons Regulations.

If you need to recall a product, you must immediately notify the Drug Office and provide: (1) Reason for recall, (2) Product details (name, batch numbers, quantities), (3) Distribution records, (4) Proposed recall plan and timeline. You must retrieve all recalled products from the market and submit a recall completion report. The Drug Office may issue public announcements for serious safety concerns. Keep detailed records of all recall activities for inspection.

Stability data requirements depend on the product type and application. Generally, you need: (1) Long-term stability data under proposed storage conditions (minimum 12 months at submission), (2) Accelerated stability studies, (3) Stress testing data, (4) Photostability studies if applicable, (5) Stability protocol and commitment to continue testing. Data must follow ICH guidelines Q1A-Q1F. For biologics and complex products, additional studies may be required.

Variations are classified as Major or Minor. Major variations (e.g., changes in active ingredients, manufacturing site, therapeutic indications) require prior approval before implementation. Minor variations (e.g., administrative changes, minor label updates) can be implemented with notification. Submit variation applications through the Pharmaceutical Registration System (PRS 2.0). Include supporting data such as stability studies, comparative dissolution, or analytical data depending on the change type.

Licensed pharmaceutical traders must maintain comprehensive records including: (1) Purchase and sales records with supplier/customer details - retain for 2 years, (2) Import/export licenses and related documents - retain for 2 years, (3) Batch records and quality control certificates - retain until 1 year after expiry date, (4) Temperature logs for storage areas - retain for 2 years, (5) Adverse event reports - retain permanently. Records must be readily available for inspection by Drug Office officers.

Generally, no. All pharmaceutical products must be registered before sale or supply in Hong Kong. Limited exceptions include: (1) Products for clinical trials with valid Certificate for Clinical Trial (CTX), (2) Special import for individual patient use with doctor's prescription and Drug Office approval, (3) Products in transit not entering Hong Kong's market. Selling unregistered pharmaceutical products is a criminal offense with significant penalties including fines and imprisonment.

Registration holders must maintain a pharmacovigilance system to monitor product safety throughout its lifecycle. Requirements include: (1) Designated Qualified Person for Pharmacovigilance (QPPV), (2) Pharmacovigilance system master file, (3) Risk management plans for certain products, (4) Periodic safety update reports (PSURs), (5) Signal detection and evaluation processes, (6) Safety database for adverse event tracking. You must comply with international pharmacovigilance standards and local reporting timelines.

Pharmaceutical advertising is strictly regulated. Prescription medicines (Part 1 poisons and dangerous drugs) cannot be advertised to the general public - only to healthcare professionals. Over-the-counter medicines can be advertised but must: (1) Include product registration number, (2) Not make false or misleading claims, (3) Include appropriate warnings, (4) Not encourage inappropriate use, (5) Comply with the Undesirable Medical Advertisements Ordinance. Celebrity endorsements for medicines require special approval. Submit advertisements to Drug Office for vetting before publication.

If you encounter suspected counterfeit products, immediately: (1) Stop distribution and segregate the products, (2) Report to the Drug Office with product details, source, and evidence, (3) Preserve all documentation and packaging, (4) Do not destroy products until instructed by authorities. The Drug Office will investigate and may conduct laboratory testing. Importing or selling counterfeit medicines is a serious criminal offense. You can verify product authenticity through registration number verification on the Drug Office website.

Drug Office conducts regular and surprise inspections of licensed premises. During inspections, officers will: (1) Verify license and registration compliance, (2) Review premises conditions and storage facilities, (3) Check temperature monitoring records, (4) Examine purchase/sales/import/export records, (5) Inspect stock for proper storage and labeling, (6) Review quality management systems and SOPs, (7) Interview responsible persons. Prepare all required documents in advance. Non-compliance may result in warnings, license suspension, or prosecution. Full cooperation is mandatory.