Loading...
|
Please use this identifier to cite or link to this item:
https://nccur.lib.nccu.edu.tw/handle/140.119/143908
|
| Title: | 個人使用藥品進口管制之比較法研究
A Comparative Legal Study on the Import Control of Medicine for Personal Use |
| Authors: | 黃意晴
Huang, Yi-Ching |
| Contributors: | 楊培侃
Yang, Pei-Kan
黃意晴
Huang, Yi-Ching |
| Keywords: | 個人自用
無證藥品
藥品進口
藥事法
藥物樣品贈品管理辦法
Personal use
Unlicensed drugs
Drugs import permission
Pharmaceutical Affairs Act
Regulations on Management of Medicament Samples and Gifts |
| Date: | 2023 |
| Issue Date: | 2023-03-09 18:55:49 (UTC+8) |
| Abstract: | 我國部分患者因無法負擔昂貴的原廠藥，選擇辦理申請個人自用藥品進口， 以取得較便宜的國外學名藥，而此等藥品或已取得或尚未有我國衛生主管機關核 發之藥品許可證。儘管這些進口的國外藥品較為便宜，但伴隨而來的是此等藥品 可能不具藥物相等性、且有帶來國內公共衛生安全之風險與侵害原廠藥品專利權 等疑慮。我國衛生福利部曾因上述疑慮未核准此類藥品進口申請案，但此舉遭認 為不當擴張《藥事法》、《藥物樣品贈品管理辦法》之要求。為使患者得以適當利 用我國個人使用藥品進口制度，本文建議應借鑒英國、澳洲以及美國之法制並考 量相關國際規範後進行適度的調整，以解決個人使用藥品取得與進口管制問題。
Given that the brand drugs are too expensive to afford, some patients in Taiwan choose to apply for special permission to import foreign generic drugs that are cheaper than brand drugs but with or without drug permit license for personal use. Despite the unlicensed drugs are cheap, they often accompanied with the doubts such as dissatisfaction with pharmaceutical equivalence, involvement of public health risks and infringement of pharmaceutical patents. The Ministry of Health and Welfare in Taiwan once disapproved the import application of special permission because of legal and policy issues mentioned above. But the Ministry’s decision of disapproval was criticized to be an overreaching of its authority in interpreting and implementing the Pharmaceutical Affairs Act and Regulations on Management of Medicament Samples and Gifts. In order to enable the patients to properly use special permission scheme in Taiwan, this thesis suggest that current regulations governing the import control of medicines for personal use can be revised accordingly based on the regulatory scheme adopted by the UK, Australia, USA and related international regulations such as Convention Concerning Customs Facilities for Touring. |
| Reference: | 中文文獻
書籍
傑瑞米．葛林（Greene, Jeremy A.），便宜沒好藥？一段學名藥和當代醫療的糾葛，2018年7月。
法規
藥事法，第22、27-2、39、48-2、55條。
藥物樣品贈品管理辦法，第2、4、13、14條。
特定藥品專案核准製造及輸入辦法，第3條。
入境旅客攜帶行李物品報驗稅放辦法，第4條。
網際網路
林以璿，肺癌藥物1天5000元病友吃不消 深圳「廁所牌」假藥流竄全台，Cancer，2019年9月18日，網站：https://cancer.heho.com.tw/archives/56679（最後瀏覽日：2022年12月19日）。
財政部關務署台北關稽查組，藥物及醫療器材，財政部關務署台北關，2022年8月24日，網址：https://taipei.customs.gov.tw/singlehtml/3392?cntId=cus2_3392_3392_1347（最後瀏覽日：2022月14日）。
黃文鴻，【專文】為什麼我們需要一個C肝治療的國家級政策，民報，2016年8月10日，網址：https://www.peoplemedia.tw/news/ce1d4cd6-9add-4396-87d3-c1ca0f7657f4（最後瀏覽日：2022年12月19日）。
衛生福利部食品藥物管理署，申辦說明—個人自用藥品專案進口申請，衛生福利部食品藥物管理署，最後更新日：2022年3月30日，https://oap.fda.gov.tw/B101/B101_2?ItemSEQ=11。
英文文獻
國際協定
Convention Concerning Customs Facilities for Touring art. 1, June 4, 1954, 276 U.N.T.S. 191.
General Agreement on Tariffs and Trade, Oct. 30, 1947, 61 Stat. A-11, 55 U.N.T.S. 194.
國際組織出版品
World Bank [WB], Parallel Imports of Pharmaceutical Products in the European Union, 7-8, World Bank Research Working Paper no. 2630 (July 2001), https://openknowledge.worldbank.org/bitstream/handle/10986/19584/multi0page.pdf?sequence=1&isAllowed=y.
World Health Organization [WHO], Sixty-Fifth World Health Assembly, WHA65/2012/REC/1 (May 21-26, 2012), https://apps.who.int/gb/ebwha/pdf_files/WHA65-REC1/A65_REC1-en.pdf.
World Intellectual Property Organization [WIPO], Parallel Imports in Pharmaceuticals: Implications for Competition and Prices in Developing Countries, 6 (April 2001), https://www.wipo.int/export/sites/www/about-ip/en/studies/pdf/ssa_maskus_pi.pdf.
政府文件
HHS & FDA, SAFE IMPORTATION ACTION PLAN 1 (2019), https://www.fda.gov/media/129528/download.
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY, THE SUPPLY OF UNLICENSED MEDICINAL PRODUCTS (“SPECIALS”): MHRA GUIDANCE NOTE (2014), https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/373505/The_supply_of_unlicensed_medicinal_products__specials_.pdf.
National Health Service, Use of “Specials”: Guidelines for Good Practice and Points to Consider, DERBYSHIRE MEDICINES MANAGEMENT (May 2018), http://www.derbyshiremedicinesmanagement.nhs.uk/assets/Specials/Local_resources/Use_of_Specials_Guidance_on_good_practice.pdf.
REGULATORY PROCEDURES MANUAL, FOOD AND DRUG ADMINISTRATION, 21 (2017), https://www.fda.gov/media/71776/download.
SARATA, AMANDA K. & DABROWSKA, A. CONG. RESEARCH SERV., IF11056 Ver. 2, PRESCRIPTION DRUG IMPORTATION 2 (2018), https://fas.org/sgp/crs/misc/IF11056.pdf.
SARATA, AMANDA K., CONG. RESEARCH SERV., IF11056 ver. 5, PRESCRIPTION DRUG IMPORTATION 3 (2021), https://crsreports.congress.gov/product/pdf/IF/IF11056.
Senate Select Committee on the Free Trade Agreement between Australia and the United States of America, Parliament of Australia, Final Report on the Free Trade Agreement between Australia and the United States of America (Report, August 2004) 132 [4.110-4.114].
THERAPEUTIC GOODS ADMINISTRATION, ACCESS TO UNAPPROVED THERAPEUTIC GOODS: CLINICAL TRIALS IN AUSTRALIA, 104 (2004), https://www.tga.gov.au/sites/default/files/clinical-trials-guidelines.pdf.
THERAPEUTIC GOODS ADMINISTRATION, ACCESS TO UNAPPROVED THERAPEUTIC GOODS: PERSONAL IMPORTATION, 6 (2004), https://www.tga.gov.au/sites/default/files/access-personal-import-guidelines.pdf.
THERAPEUTIC GOODS ADMINISTRATION, SPECIAL ACCESS SCHEME: GUIDANCE FOR HEALTH PRACTITIONERS AND SPONSORS, 28 (2017), at 7, https://www.tga.gov.au/sites/default/files/special-access-scheme-guidance-for-health-practitioners-and-sponsors.pdf.
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, FULFILLING PRESIDENT TRUMP’S EXECUTIVE ORDER ON FACILITATING DRUG IMPORTATION TO LOWER PRICES FOR AMERICAN PATIENTS REQUEST FOR INDUSTRY PROPOSALS FOR PERSONAL IMPORTATION OF PRESCRIPTION DRUGS PAGE 3 (2020), https://www.hhs.gov/sites/default/files/individual-prescription-drug-importation-faq.pdf.
United States Department of Health And Human Services, Request for Proposals Regarding Waivers for Individual Prescription Drug Importation Programs 1 (2020), https://www.hhs.gov/sites/default/files/individual-prescription-drug-importation-programs.pdf.
外國法規
21 U.S.C. § 510 (2018).
21 U.S.C. § 804 (2018).
Consolidated Versions of the Treaty on European Union and the Treaty on the Functioning of the European Union, art. 168(7), 2012 O.J. C326 47.
Customs (Prohibited Imports) Regulations 1956 (Cth) (Austl.).
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use, 2001 O.J. (L 311) 67.
Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984).
Exec. Order No. 13,938, 85 Fed. Reg. 45,757 (July 24, 2020).
Importation of Certain Food and Drug Administration-Approved Human Prescription Drugs, Including Biological Products, and Combination Products Under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry [hereinafter Final Guidance], 85 Fed. Reg. 61,955 (Oct. 1, 2020).
Importation of Prescription Drugs, 85 Fed. Reg. 62,094 (Oct. 1, 2020) (to be codified at 21 C.F.R. pt.1, 251).
Proceeds of Crime Act 2002, c. 29 (Eng.).
The Human Medicines (Amendment) Regulations 2017, SI 2017/715.
The Human Medicines (Amendment) Regulations 2017, SR 2017/241.
The Human Medicines Regulations 2012, SI 2012/1916.
Therapeutic Goods (Authorised Supply of Specified Biologicals) Rules September 2017 (Cth) (Austl.).
Therapeutic Goods (Authorised Supply of Specified Medical Devices) Rules September 2017 (Cth) (Austl.).
Therapeutic Goods (Authorised Supply of Specified Medicines) Rules September 2017 (Cth) (Austl.).
Therapeutic Goods (Medical Devices) Regulation 2002 (Cth)(Austl.).
Therapeutic Goods Act 1989 (Cth)(Austl.).
Therapeutic Goods Regulation 1990 (Cth)(Austl.).
Trade Marks Act 1994, c. 26 (Eng.)
書籍
KYLE, MARGARET K., PARALLEL TRADE IN PHARMACEUTICALS: FIRM RESPONSES AND COMPETITION POLICY, 344, (Barry Hawk ed., 1th ed. 2010).
期刊論文
Andre, Cote & Bernard, Keating, What Is Wrong with Orphan Drug Policies?, 15(22) VALUE IN HEALTH 1185, 1185 (2012).
Aronson, Jeffrey K. & Ferner, Robin E., Unlicensed and Off‐Label Uses of Medicines: Definitions and Clarification of Terminology, 83(12) BRITISH JOURNAL OF CLINICAL PHARMACOLOGY 2615, (2017).
Donovan, Gemma, et al., Unlicensed Medicines Use: A UK Guideline Analysis Using Agree II, 26(6) INTERNATIONAL JOURNAL OF PHARMACY PRACTICE 515, (2018).
Donovan, Gemma., et al., Special Unlicensed Medicines: What We Do and Do not Know about Them, 65(641) BRITISH JOURNAL OF GENERAL PRACTICE 861, (2015).
Donovan, Peter, et al., Access to Unregistered Drugs in Australia, 40(5) AUSTRALIAN PRESCRIBER 194, (2017).
Sutherland, A. & Waldek, S., It Is Time to Review How Unlicensed Medicines Are Used, 71(9) EUR. J. CLIN. PHARMACOL, (2015).
Wale, Alesha, et al., Unlicensed “Special” Medicines: Understanding the Community Pharmacist Perspective, 9 INTEGRATED PHARMACY RESEARCH & PRACTICE 93, (2020).
機構報告與文件
Case C-185/10, European Comm’n v. Republic of Poland, 2012 CURIA ECLI:EU:C:2012:181 (Mar. 29, 2012).
Case C-535/11, Novartis Pharma GmbH v. Apozyt GmbH, https://curia.europa.eu/juris/document/document.jsf;jsessionid=26F03C176AFAC4F57FEFE5811DF134A8?text=&docid=136142&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=4771372 (Jan. 31, 2013).
GENERAL MEDICAL COUNCIL, GOOD PRACTICE IN PRESCRIBING AND MANAGING MEDICINES AND DEVICES 14 (2021), https://www.gmc-uk.org/-/media/documents/prescribing-guidance-before-cie_pdf-85470847.pdf?la=en&hash=EBC2C2FCDD5F7481667629E891F4BFB8A792F59D.
INTERNATIONAL ASSOCIATION FOR MEDICAL ASSISTANCE TO TRAVELLERS, TRAVELLING WITH MEDICATIONS: A GUIDE 9 (2019), https://www.iamat.org/elibrary/view/id/561897.
MEDICAL BOARD OF AUSTRALIA, GOOD MEDICAL PRACTICE: A CODE OF CONDUCT FOR DOCTORS IN AUSTRALIA 27 (2020), https://www.ahpra.gov.au/documents/default.aspx?record=WD20%2f30051&dbid=AP&chksum=9BSTs75R4%2fcPJY7vrmzHPg%3d%3d.
Medicines and Healthcare products Regulatory Agency & Department of Health and Social Care, Guidance: Import a Human Medicine, GOV.UK (Aug. 9, 2015), https://www.gov.uk/guidance/import-a-human-medicine#import-an-unlicensed-medicine (last updated Dec. 31, 2020).
National Health Service, Alternatives to using an Unlicensed ‘‘Special’’, NHS (Mar. 2021), https://www.nottsapc.nhs.uk/media/1300/current_specials-a-z-notts.pdf.
THE INTERNATIONAL SOCIETY OF TRAVEL MEDICINE, ISTM PHARMACIST PROFESSIONAL GROUP DATABASE ON INTERNATIONAL REGULATIONS ON IMPORTATION OF MEDICINES FOR PERSONAL USE 129 (2019), https://www.istm.org/files/Documents/Groups/PPG/2nd%20Edition%20Carrying%20Medicines%20Database.pdf.
網際網路
Australian Border Force, Can You Bring It In?: Medicines and Substances, AUSTRALIAN BORDER FORCE (last updated Mar. 18, 2020), https://www.abf.gov.au/entering-and-leaving-australia/can-you-bring-it-in/categories/medicines-and-substances.
Australian Government Department of Health, About the PBS, PBS, https://www.pbs.gov.au/info/about-the-pbs (last updated Jan. 1, 2021).
Better Health Channel, Seeing a Doctor or General Practitioner (GP), BETTER HEALTH CHANNEL, https://www.betterhealth.vic.gov.au/health/servicesandsupport/seeing-a-doctor-or-general-practitioner#bhc-content (last visited Apr. 13, 2021).
Center for Drug Evaluation and Research United States, Warning Letter: CanaRx Services Inc., U.S. FOOD & DRUG ADMINISTRATION (Feb. 28, 2019), https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/canarx-services-inc-554740-02262019.
Cosgrove, Tom, et al., HHS and FDA Actions on Importation of Prescription Drugs from Canada and other Countries, COVINGTON (Sept. 30, 2020), https://www.cov.com/-/media/files/corporate/publications/2020/10/hhs-and-fda-actions-on-importation-of-prescription-drugs-from-canada-and-other-countries.pdf.
Dennis, Alison & Wessing, Taylor, Distribution and Marketing of Drugs in the UK (England and Wales): Overview, THOMSON REUTERS PRACTICAL LAW (Nov. 1, 2019), http://global.practicallaw.com/2-618-6661.
Dodds-Smith, Ian, et al., Practical Law: Unlicensed Medical Products in the UK, THOMSON REUTERS 4, https://www.arnoldporter.com/~/media/files/perspectives/publications/2017/02/unlicensed-medicinal-products-in-the-uk.pdf (last visited Apr. 6, 2021).
Food and Drug Administration, 5 Tips for Traveling to the U.S. With Medications, U.S. FOOD & DRUG ADMINISTRATION (Feb. 2, 2016), https://www.fda.gov/consumers/consumer-updates/5-tips-traveling-us-medications.
Food and Drug Administration, FDA News Release: FDA Warns CanaRx for Selling unapproved, Misbranded and Unsafe Imported Drugs to Unsuspecting Americans, U.S. FOOD & DRUG ADMINISTRATION (Feb. 28, 2019), https://www.fda.gov/news-events/press-announcements/fda-warns-canarx-selling-unapproved-misbranded-and-unsafe-imported-drugs-unsuspecting-americans.
Food and Drug Administration, Frequently Asked Questions About Drugs, U.S. FOOD & DRUG ADMINISTRATION (Nov. 27, 2015), https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/frequently-asked-questions-about-drugs#1.
Food and Drug Administration, Human Drugs, U.S. FOOD & DRUG ADMINISTRATION (Mar. 5, 2021), https://www.fda.gov/industry/regulated-products/human-drugs.
Food and Drug Administration, Import Alerts, U.S. FOOD AND DRUG ADMINISTRATION (May 14, 2019), https://www.fda.gov/industry/actions-enforcement/import-alerts.
Food and Drug Administration, News Release: FDA Takes Actions to Help Lower U.S. Prescription Drug Prices, U.S. FOOD & DRUG ADMINISTRATION (Sept. 24, 2020), https://www.fda.gov/news-events/press-announcements/fda-takes-actions-help-lower-us-prescription-drug-prices.
Food and Drug Administration, Personal Importation Policy (PIP) Frequently Asked Questions (FAQs), U.S. FOOD & DRUG ADMINISTRATION, https://www.fda.gov/media/83411/download (last visited May 24, 2021).
Food and Drug Administration, Personal Importation, U.S. FOOD & DRUG ADMINISTRATION (Nov. 10, 2020), https://www.fda.gov/industry/import-basics/personal-importation.
Food and Drug Administration, Trump Administration Takes Historic Steps to Lower U.S. Prescription Drug Prices, U.S. FOOD & DRUG ADMINISTRATION (Dec. 18, 2019), https://www.fda.gov/news-events/press-announcements/trump-administration-takes-historic-steps-lower-us-prescription-drug-prices.
Freed, Meredith, et al., 10 FAQs on Prescription Drug Importation, KFF (Oct. 8, 2020), https://www.kff.org/medicare/issue-brief/10-faqs-on-prescription-drug-importation/.
Government of United Kingdom, Bringing Medicine Containing a Controlled Drug into the UK, Gov.UK, https://www.gov.uk/travelling-controlled-drugs (last visited Mar. 22, 2021).
Government of United Kingdom, Guidance: Controlled Drugs: Personal Licences, Gov.UK (Aug. 16, 2019), https://www.gov.uk/guidance/controlled-drugs-personal-licences.
Government of United Kingdom, Guidance: List of Most Commonly Encountered Drugs Currently Controlled under the Misuse of Drugs Legislation, Gov.UK (Dec. 2, 2019), https://www.gov.uk/government/publications/controlled-drugs-list--2/list-of-most-commonly-encountered-drugs-currently-controlled-under-the-misuse-of-drugs-legislation.
Government of United Kingdom, Hand Luggage Restrictions at UK Airports, Gov.UK, https://www.gov.uk/hand-luggage-restrictions/essential-medicines-and-medical-equipment (last visited Sept. 5, 2021).
International Association For Medical Assistance To Travellers, What You Need to Know about Travelling with Medications, IAMAT (Jan. 9, 2020), https://www.iamat.org/blog/what-you-need-to-know-about-travelling-with-medications-2/.
McLoughlin, Peter. Use of Unlicensed Medicines – Legal and Ethical Issues, BIRCHAM DYSON BELL (Jan. 11, 2012), https://s3.amazonaws.com/documents.lexology.com/a5fc2449-d220-460a-86e5-1e1a5c616dea.pdf?AWSAccessKeyId=AKIAVYILUYJ754JTDY6T&Expires=1672676409&Signature=eYDtPG8ytVhpYztnwetgUhdsC8c%3D.
Medicines and Healthcare Products Regulatory Agency, About Yellow Card, YELLOW CARD, https://yellowcard.mhra.gov.uk/the-yellow-card-scheme/ (last visited Mar. 28, 2021).
Medicines and Healthcare products Regulatory Agency, Guidance to Medicines: Packaging, Labelling and Patient Information Leaflets, GOV.UK (Dec. 18, 2014), https://www.gov.uk/guidance/medicines-packaging-labelling-and-patient-information-leaflets (last updated Dec. 31, 2020).
Medicines and Healthcare products Regulatory Agency, Guidance: EU Guidance Documents Referred to in the Human Medicines Regulations 2012, GOV.UK (Jan. 23, 2019), https://www.gov.uk/guidance/eu-guidance-documents-referred-to-in-the-human-medicines-regulations-2012#history.
Medicines and Healthcare products Regulatory Agency, Guidance: Medicines: Apply for A Parallel Import Licence, GOV.UK (Jan. 21, 2015), https://www.gov.uk/guidance/medicines-apply-for-a-parallel-import-licence#history (last updated Mar. 1, 2021).
Medicines and Healthcare products Regulatory Agency, Off-Label or Unlicensed Use of Medicines: Prescribers’ Responsibilities, GOV.UK (Dec. 11, 2014), https://www.gov.uk/drug-safety-update/off-label-or-unlicensed-use-of-medicines-prescribers-responsibilities.
Medicines and Healthcare products Regulatory Agency, Supply of Unlicensed Medicines When An Equivalent Licensed Product Becomes Available, GOV.UK (Oct. 9, 2015), https://mhrainspectorate.blog.gov.uk/2015/10/09/supply-of-unlicensed-medicines-when-an-equivalent-licensed-product-becomes-available/.
Office of Drug Control, Controlled Substances, AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH (Aug. 12, 2020), https://www.odc.gov.au/ws-lps-index.
Ray, Seth S., A Guide to FDA’s Final Rule on the Importation of Prescription Drugs from Canada, ARNALL GOLDEN GREGORY LLP (Oct. 27, 2020), https://www.agg.com/news-insights/publications/a-guide-to-fdas-final-rule-on-the-importation-of-prescription-drugs-from-canada/.
Rockoff, Johnathan D., How Pfizer Set the Cost of Its New Drug at $9,850 a Month, WALL STREET JOURNAL (Dec. 9, 2015), https://www.wsj.com/articles/the-art-of-setting-a-drug-price-1449628081.
Schlanger, Serra J., et al., HHS and FDA Finalize Drug Importation Rule and Guidance for New Multi-Market Approved (MMA) Product Category; CMS Provides Guidance for MMA Products under the Medicaid Drug Rebate Program, HYMAN, PHELPS & MCNAMARA (Oct. 7, 2020), https://www.fdalawblog.net/2020/10/hhs-and-fda-finalize-drug-importation-rule-and-guidance-for-new-multi-market-approved-mma-product-category-cms-provides-guidance-for-mma-products-under-the-medicaid-drug-rebate-program/.
Stephenson, Terence, Rapid Response to GMC Is Criticised for Refusing to Disclose Reasons Behind Its Advice to Support Prescribing for Lucentis Rather Than Avastin for Wet AMD, THEBMJ (Apr. 16, 2015), https://www.bmj.com/content/350/bmj.h1981/rr-0.
Stone, Kathlyn, What Is an Active Pharmaceutical Ingredient (API)?, VERYWELLHELTH (Aug. 19, 2020), https://www.verywellhealth.com/api-active-pharmaceutical-ingredient-2663020.
The Partnership for Safemedicines, HHS Secretary Sent Congress The Certification to Allow Canadian Drug Importation, THE PARTNERSHIP FOR SAFEMEDICINES (Sept. 24, 2020), https://www.safemedicines.org/2020/09/hhs-secretary-sent-congress-the-certification-to-allow-canadian-drug-importation.html.
Therapeutic Goods Administration, Accessing Medicines During a Shortage, AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH (May 20, 2020), https://www.tga.gov.au/accessing-medicines-during-shortage.
Therapeutic Goods Administration, Australian Register of Therapeutic Goods, AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH (Oct. 29, 2019), https://www.tga.gov.au/australian-register-therapeutic-goods.
Therapeutic Goods Administration, Authorised Prescriber Scheme, AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH (Nov. 16, 2020), https://www.tga.gov.au/authorised-prescriber-scheme-0.
Therapeutic Goods Administration, Can I Import a Medicine for Personal Use?, AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH (Apr. 12, 2019), https://www.tga.gov.au/blogs/tga-topics/can-i-import-medicine-personal-use.
Therapeutic Goods Administration, Contacts for State/Territory Medicines & Poisons Regulation Units, AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH (Feb. 18, 2020), https://www.tga.gov.au/contacts-stateterritory-medicines-poisons-regulation-units.
Therapeutic Goods Administration, Counterfeit Medicines and Medical Devices, AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH (Nov. 6, 2015), https://www.tga.gov.au/counterfeit-medicines-and-medical-devices.
Therapeutic Goods Administration, Database of Section 19A Approvals to Import and Supply Medicines to Address Medicine Shortages, AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH (Apr. 6, 2021), https://www.tga.gov.au/ws-s19a-index.
Therapeutic Goods Administration, Entering Australia, AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH (Sept. 28, 2020), https://www.tga.gov.au/entering-australia.
Therapeutic Goods Administration, Guidance for Requesting Reconsideration of An Initial Decision, AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH (Jan. 20, 2017), https://www.tga.gov.au/publication/guidance-requesting-reconsideration-initial-decision.
Therapeutic Goods Administration, Guidance Tool for Access to Unapproved Therapeutic Goods, AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH (Oct. 12, 2020), https://www.tga.gov.au/guidance-tool-access-unapproved-therapeutic-goods.
Therapeutic Goods Administration, How the TGA Regulates, AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH, https://www.tga.gov.au/how-tga-regulates (last visited Apr. 11, 2021).
Therapeutic Goods Administration, Personal Importation Scheme, AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH (Mar. 18, 2015), https://www.tga.gov.au/personal-importation-scheme.
Therapeutic Goods Administration, Special Access Scheme and Authorised Prescriber Online System, AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH (Apr. 21, 2021), https://www.tga.gov.au/special-access-scheme-and-authorised-prescriber-online-system.
Therapeutic Goods Administration, Special Access Scheme: Frequently Asked Questions, AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH (Apr. 20, 2021), https://www.tga.gov.au/special-access-scheme-frequently-asked-questions.
Therapeutic Goods Administration, The Poisons Standard (the SUSMP), AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH (Feb. 1, 2021), https://www.tga.gov.au/publication/poisons-standard-susmp.
Therapeutic Goods Administration, The Therapeutic Goods Act 1989 & the Poisons Standard, AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH, https://www.tga.gov.au/therapeutic-goods-act-1989-poisons-standard (last visited Apr. 11, 2021).
Therapeutic Goods Administration, Travelling with Medicines and Medical Devices, AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH, https://www.tga.gov.au/travellers-visitors (last visited Oct. 3, 2021).
U.S. Food and Drug Administration, FDA Drug Competition Action Plan, U.S. FOOD AND DRUG ADMINISTRATION (Dec. 14, 2022), https://www.fda.gov/drugs/guidance-compliance-regulatory-information/fda-drug-competition-action-plan.
U.S. Food and Drug Administration, Generic Competition and Drug Prices, U.S. FOOD AND DRUG ADMINISTRATION (Aug. 12, 2022), https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/generic-competition-and-drug-prices. |
| Description: | 碩士
國立政治大學
國際經營與貿易學系
107351041 |
| Source URI: | http://thesis.lib.nccu.edu.tw/record/#G0107351041 |
| Data Type: | thesis |
| Appears in Collections: | [國際經營與貿易學系 ] 學位論文
|
Files in This Item:
| File |
Description |
Size | Format | |
|---|
| 104101.pdf | | 2334Kb | Adobe PDF2 | 319 | View/Open |
|
All items in 政大典藏 are protected by copyright, with all rights reserved.
|
