世界の製薬関連法とその実務
International Pharmaceutical Law and Practice
特価 ￥113,510
薬品の製造から販売までの様々な場面に関わってくる法と実務‐特許・商標法、新薬承認制度、薬価統制など‐について、国ごとに解説した文献。
【主な内容】
○特許権の取得と保護の範囲 ○特許性要件 ○商標、トレードドレス保護 ○試験データの独占利用 ○新薬承認申請 ○ジェネリック医薬品 ○ラベリングおよび包装 ○薬価規制 等
【収録国】
アルゼンチン／オーストラリア／ベルギー／ブラジル／カナダ／チリ／中国／チェコ共和国／デンマーク／ヨーロッパ／フランス／ドイツ／インド／イスラエル／イタリア／日本／韓国／メキシコ／オランダ／ポーランド／ポルトガル／ロシア／南アフリカ／スペイン／スウェーデン／スイス／台湾／タイ／トルコ／英国／米国
【各章の構成例 Mexico】
§ 19.01 Patents
[1] General
[2] Filing a Patent Application
[3] Patentable Subject Matter for Pharmaceutical Inventions
[4] Novelty, Utility, Inventiveness (non-obviousness) and Support/enablement Requirements for Pharmaceutical Inventions
[5] Patent Term and Term Extensions
[6] Opposition Procedures
[7] Mexico Subscribes to the Patent Prosecution Highway (PPH) Pilot Program
[8] Patent Infringement
[9] Compulsory Licensing
§ 19.02 Trademark Protection for Pharmaceuticals
[1] General
[2] Trade Dress
[3] Parallel Imports and Trademarks
[4] Enforcement of Trademark Rights
[5] Madrid Protocol
[6] The Trademark Opposition System
§ 19.03 Data Exclusivity and Public Access to Information
§ 19.04 The Drug Approval Process
[1] Overview
[1A] Biotechnological Medicaments in Mexico
[1B] Registration of New Drugs
[2] Modification of Information in Marketing Authorizations
[3] Clinical Trials
[4] Obtaining an Approval for a Generic Version of a Drug
§ 19.05 Packaging and Labeling
§ 19.06 Government Price Controls on Pharmaceuticals
§ 19.07 Government Drug Payment Plans
[1] Overview of Access to Health Care in Mexico
[2] Access to Medicaments
【収録国】
1 ARGENTINA
2 AUSTRALIA
3 BELGIUM
4 BRAZIL
5 CANADA
6 CHILE
7 CHINA
8 [Reserved]
9 CZECH REPUBLIC
10 DENMARK
11 EUROPE
12 FRANCE
13 GERMANY
14 INDIA
15 ISRAEL
16 ITALY
17 JAPAN
18 KOREA, REPUBLIC OF (SOUTH KOREA)
19 MEXICO
20 THE NETHERLANDS
21 POLAND
22 PORTUGAL
23 RUSSIAN FEDERATION
24 SOUTH AFRICA
25 SPAIN
26 SWEDEN
27 SWITZERLAND
28 TAIWAN
29 THAILAND
30 TURKEY
31 UNITED KINGDOM
32 UNITED STATES