Import unapproved medicine into Taiwan, Province of China
Importing medicines into Taiwan, Province of China
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引言
在臺灣，個人從國外攜帶或郵寄未經核准的藥品進口，特別是救命藥品，涉及複雜的法規和程序。這些規定旨在確保藥品的安全性和有效性，防止假冒或劣質藥品流入市場，保護公眾健康。根據《藥事法》（1970年制定），個人若須進口未核准或國內無法取得的救命藥品，必須遵守特定的法律要求和程序。
法律依據
《藥事法》是臺灣管理藥品、醫療器材和化妝品的重要法規，其目的是確保藥品的品質、安全性和有效性。該法規定了藥品的製造、進口、販售和使用等各方面的管理措施。針對個人進口藥品，特別是未經核准的藥品，《藥事法》設立了嚴格的規範，以防止未經檢驗或可能危害健康的藥品流入國內。
個人進口未核准救命藥品的要求
進口的正當性
個人進口未經核准的救命藥品，必須基於以下正當理由：
- 醫療必要性：患者患有嚴重或危及生命的疾病，且國內無適當的治療藥物或替代品。
- 無替代療法：該藥品在國內尚未核准或無法取得，導致治療中斷的風險。
所需文件與證明
為了合法進口未核准的救命藥品，個人需準備並提交以下文件：
- 醫師證明文件：由合格醫師開立的處方、診斷證明或醫療報告，詳細說明患者的病情、需要使用該藥品的理由，以及無替代療法的情況。
- 藥品資訊：藥品的名稱、成分、劑量、製造商資訊，以及在原產國的核准情況。
- 個人身份證明：申請人的有效身份證件，如身分證或護照。
- 進口申請表：根據衛生福利部食品藥物管理署（TFDA）的要求，填寫相關進口申請表格。
數量限制
為防止藥品被濫用或非法販售，進口的藥品數量受到以下限制：
- 自用原則：藥品僅供個人使用，不得轉讓或販售。
- 治療所需量：進口量一般不得超過三個月的治療所需劑量。若需進口超過此限度的藥品，須取得衛生福利部的特別批准。
進口程序
進口未核准救命藥品的主要步驟包括：
- 事前申請：向衛生福利部食品藥物管理署提交進口申請，附上所有所需文件和證明。
- 審核批准：TFDA將審核申請資料，確認藥品的必要性和安全性。若審核通過，將核發進口許可。
- 報關進口：藥品抵達臺灣時，須向海關申報並提交進口許可和相關文件。
- 檢驗放行：海關和相關檢驗機構將對藥品進行檢驗，確認無違規後予以放行。
注意事項
在進口過程中，應注意以下事項：
- 確保提供的所有資料和文件完整且真實。
- 遵守進口藥品的包裝、標示和運輸要求，確保藥品品質。
- 如有任何問題，及時與TFDA或海關單位聯繫。
違反規定的後果
未經合法程序進口未核准藥品，可能面臨以下法律責任：
- 罰款：根據《藥事法》，違規者可能被處以罰款。
- 刑事責任：情節嚴重者，可能涉及刑事犯罪，面臨更嚴重的處罰。
- 沒收物品：違規進口的藥品將被沒收，可能造成財產損失。
結論
按照《藥事法》的規定，個人進口未經核准的救命藥品需要遵守嚴格的程序和要求。為了保護個人和公眾的健康，必須確保所進口的藥品安全、有效且符合法律規範。建議在進口前仔細瞭解相關規定，並與專業人士或主管機關聯繫，確保進口過程順利合法。
參考資料
English version
Introduction
In Taiwan, importing unapproved medicines, especially life-saving ones, for personal use from abroad involves complex regulations and procedures. These rules aim to ensure the safety and efficacy of medicines, prevent counterfeit or substandard drugs from entering the market, and protect public health. According to the Pharmaceutical Affairs Act (enacted in 1970), individuals who need to import life-saving medicines that are unapproved or unavailable in Taiwan must comply with specific legal requirements and procedures.
Legal Basis
The Pharmaceutical Affairs Act is a crucial legislation in Taiwan that governs the management of pharmaceuticals, medical devices, and cosmetics. Its purpose is to ensure the quality, safety, and effectiveness of medicines. The Act stipulates management measures for the manufacturing, importing, selling, and using of pharmaceuticals. For individuals importing medicines, especially unapproved ones, the Act establishes strict regulations to prevent untested or potentially harmful drugs from entering the country.
Requirements for Personal Importation of Unapproved Life-Saving Medicines
Legitimacy of Importation
Importing unapproved life-saving medicines for personal use must be based on the following legitimate reasons:
- Medical Necessity: The patient is suffering from a severe or life-threatening condition, and no suitable therapeutic drugs or alternatives are available domestically.
- No Alternative Treatment: The medicine is unapproved or unavailable in Taiwan, posing a risk of interrupted treatment.
Required Documents and Proof
To legally import unapproved life-saving medicines, individuals need to prepare and submit the following documents:
- Physician's Certification: A prescription, diagnosis certificate, or medical report issued by a qualified physician, detailing the patient's condition, the necessity of using the medicine, and the lack of alternative treatments.
- Medicine Information: Details about the medicine, including its name, ingredients, dosage, manufacturer information, and approval status in the country of origin.
- Personal Identification: Valid identification documents of the applicant, such as an ID card or passport.
- Import Application Form: Fill out the relevant import application forms as required by the Taiwan Food and Drug Administration (TFDA).
Quantity Restrictions
To prevent misuse or illegal sale of medicines, the imported quantity is subject to the following restrictions:
- Personal Use Only: The medicine is solely for personal use and must not be transferred or sold.
- Therapeutic Amount: The import quantity generally must not exceed a three-month supply. Importing quantities exceeding this limit requires special approval from the Ministry of Health and Welfare.
Importation Procedures
The main steps for importing unapproved life-saving medicines include:
- Pre-Application: Submit an import application to the TFDA, including all required documents and certifications.
- Review and Approval: The TFDA will review the application to confirm the necessity and safety of the medicine. If approved, an import permit will be issued.
- Customs Declaration: When the medicine arrives in Taiwan, declare it to customs and provide the import permit and related documents.
- Inspection and Release: Customs and relevant inspection agencies will examine the medicine. If no violations are found, the medicine will be released.
Precautions
During the importation process, individuals should pay attention to the following:
- Ensure all provided information and documents are complete and authentic.
- Comply with packaging, labeling, and transportation requirements to maintain the quality of the medicine.
- If any issues arise, promptly contact the TFDA or customs authorities.
Consequences of Non-Compliance
Importing unapproved medicines without following legal procedures may result in the following legal liabilities:
- Fines: Violators may be subject to fines according to the Pharmaceutical Affairs Act.
- Criminal Liability: In severe cases, individuals may face criminal charges and more severe penalties.
- Confiscation of Goods: The illegally imported medicines will be confiscated, leading to potential financial loss.
Conclusion
Under the regulations of the Pharmaceutical Affairs Act, individuals importing unapproved life-saving medicines must adhere to strict procedures and requirements. To protect personal and public health, it is essential to ensure that imported medicines are safe, effective, and comply with legal standards. It is recommended to thoroughly understand the relevant regulations before importation and consult professionals or competent authorities to ensure a smooth and lawful import process.