Question 1

Why use ElendiLabs instead of contacting regulatory consultancies directly?

Accepted Answer

ElendiLabs is a marketplace of vetted regulatory consultancies: you post once, compare fee structures, invite multiple consultants to respond in parallel (saving time versus emailing firms one by one), seek second opinions easily, and collaborate through familiar in-platform messaging—while every consultancy on the platform is reviewed by ElendiLabs.

Question 2

What is considered as a 'pharmaceutical product' or 'medicine' in Hong Kong?

Accepted Answer

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.

Question 3

How should I register drugs or pharmaceutical products or medicine in Hong Kong and what documents should I prepare?

Accepted Answer

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

Question 4

What kinds of adverse events should I report? What is the timeline?

Accepted Answer

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.

Question 5

What should I do when importing / exporting a pharmaceutical product or medicine?

Accepted Answer

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

Question 6

What licences should I apply for when engaging in pharmaceutical trade?

Accepted Answer

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

Question 7

How should I deal with expired medicines or pharmaceutical products?

Accepted Answer

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.

Question 8

在香港，什麼被視為'藥品'或'藥物'？

Accepted Answer

首先，這取決於成分。如果產品含有任何活性藥物成分，需要專業判斷，則可能被視為藥品。其次，如果產品標籤涉及任何健康聲明，即使不含任何活性藥物成分，也可能被視為藥品。更多關於《藥劑及毒藥條例》的詳情，請參閱以下網站：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。更多詳情，我們樂意回答您所有的疑問。

Question 9

在香港，我應如何註冊藥品或藥物？需要準備哪些文件？

Accepted Answer

要申請藥品或藥物的首次註冊，您必須知道該產品是否在香港製造。如果產品在香港製造，註冊責任在於已獲授權的製造商或與製造商合作的已獲授權批發商。如果產品在香港境外製造，責任落在已獲授權的批發商，或該產品的香港分公司、子公司、代理或分銷商。一旦申請獲批，申請人將收到藥品/產品註冊證書，並支付必要費用。藥品只有在符合安全、有效性和質量標準的情況下才會被註冊。更多關於所需文件的詳情，請參閱以下網站：http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/guid.pdf。新申請應通過PRS 2.0提交，網址為：https://www.drugoffice.gov.hk/prs2-ext/client_authentication.jsp。更多指引，您可以訪問藥物評估及進出口控制部門，地址為：Suite 2002-05, 20/F, AIA Kowloon Tower, Landmark East, 100 How Ming Street, Kwun Tong, Kowloon，或參閱以下網站：http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/pr_guide_main.html

Question 10

我應該報告哪些藥物不良事件？時間線是什麼？

Accepted Answer

本地嚴重不良事件應在15個日曆日內報告。更多詳情，請參閱以下網站：https://www.drugoffice.gov.hk/eps/do/en/doc/Guidance_for_Pharmaceutical_Industry_en.pdf

Question 11

當進口或出口藥品或藥物時，我應該做什麼？

Accepted Answer

要處理各類藥品，您必須首先獲得適當的貿易商牌照。（更多信息，請參閱許可證的常見問題解答。）對於每次進口或出口交易，您必須通過藥物評估及進出口控制部門申請進口許可證（Form 3）或出口許可證（Form 6）。更多詳情，請參閱以下網站：http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/useful_guidelines_forms.html

Question 12

當從事藥品貿易時，我應該申請哪些許可證？

Accepted Answer

毒藥和/或藥品進出口 → 批發商牌照（WDL） 藥品製造 → 授權毒藥零售商（Part 1或以上）的製造場所註冊 → 授權毒藥零售商（ASP）的製造場所註冊 毒藥零售 → 列明毒藥銷售商（LSP）牌照 毒藥和/或抗生素進出口 → 抗生素許可證 危險藥物製造 → 危險藥物製造許可證 危險藥物批發 → 危險藥物批發商牌照

Question 13

我應該如何處理過期藥品或藥品？

Accepted Answer

首先，您必須向環境保護署註冊為化學廢物生產商。其次，您應聯繫授權的化學廢物收集者，安排處理過期藥品。更多詳情，請參閱以下網站：http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/drugdisposalguidance_eng.pdf。更多詳情，我們樂意回答您所有的疑問。

Question 14

Do I need to register medical devices in Hong Kong?

Accepted Answer

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.

Question 15

What are the requirements for obtaining a Wholesale Dealer License?

Accepted Answer

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.

Question 16

Is GMP certification required for pharmaceutical manufacturing in Hong Kong?

Accepted Answer

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.

Question 17

Can I engage in parallel importation of pharmaceutical products?

Accepted Answer

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.

Question 18

What are the requirements for conducting clinical trials in Hong Kong?

Accepted Answer

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, (3) Compliance with Good Clinical Practice (GCP) guidelines, (4) Informed consent from trial subjects, (5) Proper import license for investigational products.

Question 19

How are Chinese medicines regulated in Hong Kong?

Accepted Answer

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.

Question 20

What are the labeling requirements for pharmaceutical products in Hong Kong?

Accepted Answer

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.

Question 21

What should I do if I need to recall a pharmaceutical product?

Accepted Answer

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.

Question 22

What stability data is required for drug registration in Hong Kong?

Accepted Answer

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.

Question 23

How do I apply for variations to an existing drug registration?

Accepted Answer

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).

Question 24

What records must pharmaceutical traders retain and for how long?

Accepted Answer

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.

Question 25

Can unregistered pharmaceutical products be sold in Hong Kong?

Accepted Answer

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.

Question 26

What are the pharmacovigilance requirements for registered products?

Accepted Answer

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.

Question 27

What are the rules for advertising pharmaceutical products?

Accepted Answer

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.

Question 28

What should I do if I suspect counterfeit pharmaceutical products?

Accepted Answer

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.

Question 29

What happens during a Drug Office inspection?

Accepted Answer

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.

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