Question 1

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 2

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 3

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 4

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 5

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 6

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 7

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 8

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 9

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 10

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 11

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 12

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。

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