Import unapproved medicine into Hong Kong SAR China

Importing medicines into Hong Kong SAR China

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根據《藥劑業及毒藥條例》(1937年)：進口未經批准的救命藥物須知

在香港特別行政區，醫療體系對保障公眾健康至關重要。然而，對於患有罕見疾病或對現有治療無反應的患者來說，可能需要使用未經香港批准或未在本地供應的救命藥物。為確保這些患者能獲得必需的治療，同時維護藥物安全和公共衛生，政府制定了相關法規。本文將詳細介紹根據《藥劑業及毒藥條例》(1937年)，進口此類藥物所需的要求和程序。

《藥劑業及毒藥條例》(1937年)概述

《藥劑業及毒藥條例》(第138章)是規管香港藥物及毒藥的主要法例，旨在確保藥物的質量、安全性和有效性。條例涵蓋了藥物的製造、進口、分銷和銷售等方面，確保公眾能安全使用藥品。該法例由香港衛生署執行，並由藥劑業及毒藥管理局監管。

重要定義

未經批准或未註冊藥物

未經批准或未註冊藥物是指未在香港藥劑業及毒藥管理局註冊的藥物。根據條例規定，所有在香港進口、銷售或分發的藥物，必須經過註冊，以確保其質量和安全性。未經註冊的藥物在未獲特別許可的情況下，禁止在香港流通。

救命藥物

救命藥物指的是對治療嚴重、危及生命或罕見疾病必不可少的藥物，且在香港沒有經批准的替代品。這些藥物可能在其他地區已獲批准，並被證明對特定病症有效，但尚未在香港註冊。

進口未經批准的救命藥物的法律要求

為了保障公眾健康，同時滿足個別患者的緊急醫療需求，香港法律允許在特定條件下進口未經批准的救命藥物。然而，進口此類藥物必須遵守嚴格的規定，以確保藥物的安全性和使用的合法性。

個人用途豁免

根據《藥劑業及毒藥條例》，個人為自用目的，可以在特定條件下進口未經註冊的藥物。這適用於患者需要特定藥物進行治療，而該藥物在香港無法獲得。進口量必須僅限於個人治療所需，不得用於商業或分發目的。

申請進口許可證

即使是為個人用途，進口未經批准的藥物仍需獲得進口許可證。申請人必須向香港衛生署的藥物辦公室提交申請，並提供足夠的證明文件。審批過程旨在確保藥物的安全性，並確認其確實為患者所需。

有關申請程序的詳細資訊，可參閱香港衛生署藥物辦公室 - 進口未註冊藥物。

所需文件

在申請進口許可證時，申請人需提供以下文件：

註冊醫生的處方或醫學證明書：證明該藥物對患者的治療是必要的，且沒有其他替代品。
患者的身份證明文件：例如香港身份證或護照，以證明申請人的身份。
藥物詳細資訊：包括藥物名稱、劑量、製造商、預期用量和療程等。
藥物來源證明：提供藥物供應商的資料，以確保藥物來源合法可信。

進口藥物的程序

步驟一：諮詢醫生

患者應首先與其主診醫生討論，確定該未經批准的藥物對其治療的重要性。醫生將評估患者的情況，並決定是否需要該藥物。

步驟二：準備申請文件

在醫生確定需要後，患者需收集所需文件。這包括醫生的處方或證明書，以及其他相關資料。確保所有文件均為最新和完整，以加快申請進程。

步驟三：提交申請

申請人需將所有文件提交至香港衛生署藥物辦公室。可以親身遞交、郵寄或透過指定渠道提交。申請時可能需要支付相關費用，具體金額可向藥物辦公室查詢。

步驟四：審批過程

藥物辦公室將審核申請，確保所有資料齊全，並評估藥物的安全性和必要性。審批時間可能因個案而異，如有需要，官員可能會要求提供更多資訊。

步驟五：獲得許可並安排進口

在獲得進口許可證後，申請人可安排從合法來源進口藥物。需確保藥物的運輸和存儲符合相關規定，以維持藥物的品質和效力。

重要注意事項

數量限制：進口的藥物數量應僅限於個人療程所需，不得過量。
禁止商業用途：進口的藥物僅供個人使用，不得轉售或分發。
保存記錄：保留所有相關文件和許可證，以備日後查詢或檢查。

不遵守規定的罰則

未經許可進口未經批准的藥物屬違法行為。根據《藥劑業及毒藥條例》，違反者可被判處罰款最高100,000港元及監禁兩年。此外，違規行為可能對公眾健康造成風險，導致更嚴重的法律後果。

案例分享

過去曾有個別人士因未經許可進口藥物而被檢控。這強調了遵守法規的重要性。患者和家屬在尋求治療時，應遵循正確程序，確保自身和他人的安全。

結論

進口未經批准的救命藥物是一項嚴肅的事務，涉及法律和健康安全。遵守《藥劑業及毒藥條例》的規定，不僅保護了患者自身的安全，還保障了社會的公共衛生。患者和相關人士應充分了解並遵守相關程序，以合法、安全地獲取所需的藥物。

參考資料

Engelse versie

Requirements under the Pharmacy and Poisons Ordinance (1937) for Importing Unapproved Life-saving Medicines

In the Hong Kong Special Administrative Region, the healthcare system plays a crucial role in safeguarding public health. For patients suffering from rare diseases or who do not respond to existing treatments, accessing unapproved or unavailable life-saving medicines may be necessary. To ensure these patients receive essential treatments while maintaining drug safety and public health, the government has established relevant regulations. This document provides a detailed overview of the requirements and procedures for importing such medicines under the Pharmacy and Poisons Ordinance (1937).

Overview of the Pharmacy and Poisons Ordinance (1937)

The Pharmacy and Poisons Ordinance (Cap. 138) is the principal legislation regulating pharmaceuticals and poisons in Hong Kong. Its purpose is to ensure the quality, safety, and efficacy of medicines. The ordinance covers various aspects of drug manufacture, importation, distribution, and sale to ensure the public can safely use medications. The legislation is enforced by the Department of Health and overseen by the Pharmacy and Poisons Board.

Key Definitions

Unapproved or Unregistered Medicines

Unapproved or unregistered medicines refer to drugs that have not been registered with the Pharmacy and Poisons Board of Hong Kong. According to the ordinance, all medicines intended for importation, sale, or distribution in Hong Kong must be registered to ensure their quality and safety. Unregistered medicines are prohibited from circulation in Hong Kong without special permission.

Life-saving Medicines

Life-saving medicines are those essential for treating severe, life-threatening, or rare diseases for which no approved alternatives are available in Hong Kong. These medicines may have been approved in other regions and proven effective for specific conditions but are not yet registered locally.

Legal Requirements for Importing Unapproved Life-saving Medicines

To balance public health protection with individual patients' urgent medical needs, Hong Kong law permits the importation of unapproved life-saving medicines under specific conditions. Importing such medicines must comply with strict regulations to ensure their safety and legal use.

Personal Use Exemption

Under the Pharmacy and Poisons Ordinance, individuals may import unregistered medicines for personal use under certain conditions. This applies when patients require specific medicines for treatment that are not available in Hong Kong. The quantity imported must be limited to what is necessary for personal treatment and not for commercial distribution.

Application for Import License

Even for personal use, importing unapproved medicines requires an import license. Applicants must submit an application to the Drug Office of the Department of Health, providing sufficient supporting documents. The approval process ensures the medicine's safety and verifies its necessity for the patient.

Detailed application procedures can be found on the Drug Office of the Department of Health - Importing Unregistered Medicines.

Vereiste documentatie

When applying for an import license, applicants must provide the following documents:

Prescription or Medical Certificate from a Registered Doctor: Confirms that the medicine is necessary for the patient's treatment and that no alternatives are available.
Patient's Identification Documents: Such as a Hong Kong Identity Card or passport to verify the applicant's identity.
Detailed Information about the Medicine: Including the name, dosage, manufacturer, intended dosage regimen, and treatment duration.
Proof of Medicine Source: Information about the supplier to ensure the medicine's legitimacy and quality.

Procedures for Importing Medicines

Step 1: Consult the Doctor

The patient should first discuss with their attending physician to determine the necessity of the unapproved medicine. The doctor will assess the patient's condition and decide whether the medicine is required.

Step 2: Prepare Application Documents

Once the need is confirmed, the patient should gather the required documents, including the doctor's prescription or certification and other relevant information. Ensuring that all documents are current and complete will expedite the application process.

Step 3: Submit the Application

The applicant must submit all documents to the Drug Office of the Department of Health. Submissions can be made in person, by mail, or through designated channels. There may be associated fees for the application; applicants should inquire with the Drug Office for specific amounts.

Step 4: Approval Process

The Drug Office will review the application to ensure all information is complete and will assess the medicine's safety and necessity. The approval time may vary depending on the case, and officials may request additional information if needed.

Step 5: Obtain License and Arrange Importation

After obtaining the import license, the applicant can arrange for the medicine to be imported from a legitimate source. It is essential to ensure that the transportation and storage of the medicine comply with relevant regulations to maintain its quality and efficacy.

Belangrijke overwegingen

Quantity Limitations: The amount of medicine imported should be limited to what is necessary for personal treatment and not in excess.
Prohibition of Commercial Use: The imported medicine is for personal use only and must not be resold or distributed.
Record Keeping: Retain all relevant documents and licenses for future reference or inspection.

Contact Information of Relevant Authorities

For any inquiries regarding the importation of unapproved medicines, please contact:

Drug Office of the Department of Health
Address: 16th Floor, AIA Kowloon Tower, Landmark East, 100 How Ming Street, Kwun Tong, Kowloon, Hong Kong
Telephone: +852 2319 8460
Fax: +852 2803 4962
Email: [email protected]

Penalties for Non-Compliance

Importing unapproved medicines without permission is illegal. Under the Pharmacy and Poisons Ordinance, offenders may be liable to a maximum fine of HKD 100,000 and imprisonment for two years. Additionally, such violations may pose risks to public health, leading to more severe legal consequences.

Case Studies

There have been instances where individuals were prosecuted for importing medicines without proper authorization. These cases highlight the importance of adhering to regulations. Patients and their families seeking treatment should follow the correct procedures to ensure their safety and that of others.

Conclusie

Importing unapproved life-saving medicines is a serious matter involving legal and health considerations. Compliance with the Pharmacy and Poisons Ordinance protects not only the patient's safety but also public health. Patients and relevant parties should fully understand and adhere to the prescribed procedures to legally and safely obtain the necessary medicines.

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