《内地与香港关于建立更紧密经贸关系的安排》补充协议三
商务部 香港特别行政区财政司
《内地与香港关于建立更紧密经贸关系的安排》补充协议三
为进一步提高内地①与香港特别行政区（以下简称“香港”）经贸交流与合作的水平，根据：
2003年6月29日签署的《内地与香港关于建立更紧密经贸关系的安排》（以下简称“《安排》”）及于2003年9月29日签署的《安排》附件；
2004年10月27日签署的《〈安排〉补充协议》；
2005年10月18日签署的《〈安排〉补充协议二》，
双方决定，就内地在服务贸易领域对香港扩大开放及双方在贸易投资便利化领域增强合作签署本协议。
一、服务贸易
（一）自2007年1月1日起，内地在《安排》、《〈安排〉补充协议》和《〈安排〉补充协议二》开放服务贸易承诺的基础上，在法律、建筑、信息技术、会展、视听、分销、旅游、运输和个体工商户等领域进一步放宽市场准入的条件。具体内容载于本协议附件。
（二）本协议附件是《安排》附件4表1《内地向香港开放服务贸易的具体承诺》、《〈安排〉补充协议》附件3《内地向香港开放服务贸易的具体承诺的补充和修正》和《〈安排〉补充协议二》附件2《内地向香港开放服务贸易的具体承诺的补充和修正二》的补充和修正。与前三者条款产生抵触时，以本协议附件为准。
（三）本协议附件中的“服务提供者”，应符合《安排》附件5《关于“服务提供者”定义及相关规定》的有关规定。
二、贸易投资便利化
为推动两地在知识产权保护领域的合作，双方一致同意将知识产权保护补充列入《安排》贸易投资便利化领域，并据此：
（一）将《安排》第十七条第一款修改为：
“一、双方将在以下领域加强合作：
1.贸易投资促进；
2.通关便利化；
3.商品检验检疫、食品安全、质量标准；
4.电子商务；
5.法律法规透明度；
6.中小企业合作；
7.中医药产业合作；
8.知识产权保护。”
（二）将《安排》附件6第二条修改为：
“二、双方同意在贸易投资促进，通关便利化，商品检验检疫、食品安全、质量标准，电子商务，法律法规透明度，中小企业合作，中医药产业合作，知识产权保护8个领域开展贸易投资便利化合作，有关合作在根据《安排》第十九条设立的联合指导委员会的指导和协调下进行。”
（三）在《安排》附件6中增加一条作为第十条，其后条款序号依次顺延。第十条内容为：
“十、知识产权保护
双方认识到，加强知识产权保护对于推动两地经济发展和促进两地经贸交流与合作具有重要意义。双方同意加强在知识产权保护领域的合作。
（一）合作机制
通过两地政府部门间的合作机制，加强双方在知识产权保护领域的合作。
（二）合作内容
双方同意加强在以下方面的合作：
1.通过在香港设立保护知识产权协调中心，就两地知识产权保护的信息进行交流与沟通。
2.在知识产权保护的法律法规的制定和执行方面交换信息。
3.通过考察、举办研讨会、出版有关刊物及其他方式，分享有关知识产权保护的资料和信息。
4.就知识产权保护中出现的问题进行磋商。”
三、附件
本协议的附件构成本协议的组成部分。
四、生效
本协议自双方代表正式签署之日起生效。
本协议以中文书就，一式两份。
本协议于二○○六年六月二十七日在香港签署。
中华人民共和国 中华人民共和国
商务部副部长 香港特别行政区
财政司司长
廖 晓 淇 唐 英 年
（签字） （签字）
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① 《安排》中，内地系指中华人民共和国的全部关税领土。
附件
内地向香港开放服务贸易的具体承诺的补充和修正三①
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① 部门分类使用世界贸易组织《服务贸易总协定》服务部门分类（GNS/W/120），部门的内容参考相应的联合国中央产品分类（CPC，United Nations Provisional Central Product Classification）。
部门或分部门
1.商业服务
A.专业服务
a.法律服务（CPC861）
具体承诺
1.对与香港律师事务所进行联营的内地律师事务所的专职律师人数不作要求。
2.对香港律师事务所驻内地代表机构的代表在内地的居留时间不作要求。
3.允许取得内地律师资格或法律职业资格并获得内地律师执业证书的香港居民，以内地律师身份从事涉港婚姻、继承案件的代理活动。
4.允许香港大律师以公民身份担任内地民事诉讼的代理人。
5.允许取得内地律师资格或法律职业资格的香港居民，在内地律师事务所设在香港的分所，按照内地规定的实习培训大纲和实务训练指南进行实习。
部门或分部门 1.商业服务
A.专业服务
工程造价咨询服务
具体承诺 1.允许香港服务提供者在内地设立独资工程造价咨询企业。
2.香港服务提供者在香港和内地的业绩，可共同作为评定其在内地设立工程造价咨询企业申请资质的依据。
部门或分部门 1.商业服务
B.计算机及其相关服务
信息技术服务
具体承诺
香港服务提供者申请内地计算机信息系统集成资质，按照下列条件进行评定：
（1）不考核职称要求，但应考核相关学历及从业经历；
（2）系统集成的业绩包括在内地和香港从事的项目；
（3）申请三级资质的企业，从事软件开发与系统集成相关工作的人员不少于40人，其中大学本科以上学历人员所占比例不低于80%。
其他评定条件按照内地有关规定执行。
部门或分部门 1.商业服务
F.其他商业服务
会议服务和展览服务（CPC87909）
具体承诺 允许香港服务提供者在内地设立独资、合资或合作企业，经营到香港、澳门的展览业务。
部门或分部门 2.通信服务
D.视听服务
录像分销服务（CPC83202），录音制品的分销服务
电影院服务
华语影片和合拍影片
有线电视技术服务
合拍电视剧
其他
具体承诺 国家广电总局将各省、自治区或直辖市所属制作机构生产的有香港演职人员参与拍摄的国产电视剧完成片的审查工作，交由省级广播电视行政部门负责。
部门或分部门 4.分销服务
A.佣金代理服务（不包括盐和烟草）
B.批发服务（不包括盐和烟草）
C.零售服务（不包括烟草）
D.特许经营
具体承诺 对于同一香港服务提供者在内地累计开设店铺超过30家的，如经营商品包括图书、报纸、杂志、药品、农药、农膜、化肥、粮食、植物油、食糖、棉花等商品，且上述商品属于不同品牌，来自不同供应商的，允许香港服务提供者控股，出资比例不得超过65%。①
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① 如经营商品为成品油，仍按内地对世界贸易组织成员的承诺处理。
部门或分部门 9.旅游和与旅游相关的服务
A.饭店（包括公寓楼）和餐馆（CPC641—643）
B.旅行社和旅游经营者（CPC7471）
D.其他
具体承诺 允许在广东省的香港独资或合资旅行社，申请试点经营广东省居民（具有广东省正式户籍的居民）前往香港、澳门的团队旅游业务。
部门或分部门 11.运输服务
C.航空运输服务
机场管理服务（不包括货物装卸）（CPC74610）
其他空运支持性服务（CPC74690）
空运服务的销售和营销服务
具体承诺 允许香港航空销售代理企业在内地设立独资航空运输销售代理企业，注册资本要求与内地企业相同。
部门或分部门 11.运输服务
F.公路运输服务
公路卡车和汽车货运（CPC7123）
公路客运（CPC7121，7122）
道路货物运输站（场）
机动车维修
具体承诺 允许香港服务提供者在内地设立独资企业，经营下列道路运输相关业务﹕
-道路货物运输站（场）；及
-机动车维修。
部门或分部门 服务部门分类（GNS/W/120）未列出的部门
个体工商户
具体承诺 允许香港永久性居民中的中国公民依照内地有关法律、法规和行政规章，在内地各省、自治区、直辖市设立个体工商户，无需经过外资审批。营业范围为：种植业、饲养业、养殖业、计算机修理服务业、科技交流和推广业，但不包括特许经营。其从业人员不超过8人。
Provisions for Supervision of Drug Distribution
Commissioner of SFDA
Provisions for Supervision of Drug Distribution
(SFDA Decree No.26)
The Provisions for Supervision of Drug Distribution, adopted at the executive meeting of the State Food and Drug Administration on December 8, 2006, is hereby promulgated and shall go into effect as of May 1, 2007.
Shao Mingli
Commissioner of SFDA
January 31, 2007
Provisions for Supervision of Drug Distribution
Chapter I
Article 1 These Provisions are formulated for the purposes of strengthening drug supervision, regulating drug distribution order and ensuring drug quality in accordance with the Drug Administration Law of the People’s Republic of China (hereinafter referred to as Drug Administration Law), the Regulations for Implementation of the Drug Administration Law of the People’s Republic of China (hereinafter referred to as Regulations for Implementation of the Drug Administration Law) and the requirements of the relevant law and regulations.
Article 2 Any institutions or individuals engaged in the purchase, sales and supervision of drugs in the People’s Republic of China shall abide by the Provisions.
Article 3 Drug manufacturers, distributors and medical institutions shall be responsible for the quality of the drugs that they produce, distribute or use.
Drug manufacturers and distributors shall carry out reforms and innovations in the direction of pharmaceutical logistics provided that drug quality is assured.
Article 4 The drug regulatory departments encourage individuals and organizations to involve in the social supervision on drug distribution. Individuals or organizations have the right to report or accuse of any violation of the Provisions to the drug regulatory departments.
Chapter II Supervision on Drug Purchase and Sales by Manufacturers and Distributors
Article 5 Drug manufacturers or distributors shall be responsible for their drug purchases and sales, and liable for the purchases and sales activities of their sales staff or offices in the name of their enterprise.
Article 6 Drug manufacturers or distributors shall train their purchase and sales staff on drug related laws, regulations and professional knowledge, and establish training records including time, venue, content and trainees.
Article 7 Drug manufacturers or distributors shall strengthen the management of the sales staff and set up specific rules for their sales behaviors.
Article 8 Drug manufacturers or distributors shall not store or spot trade drugs on the premises not approved by the drug regulatory departments.
Article 9 Drug manufacturers shall sell drugs that they produce in the name of themselves, and shall not sell any drug that they produce for contract manufacturing or any drugs produced by others.
Article 10 Where a drug manufacturer or wholesaler sells drugs, it shall provide the following materials:
(1) Copies of the Drug Manufacturing Certificate or Drug Supply Certificate, stamped with the seal of the enterprise, and the business license;
(2) Copies of the approval documents for the drug to be sold, stamped with the seal of the enterprise ;
(3) For import drug sales, relevant proof documents should be provided in accordance with the related provisions of the State.
Where a drug manufacturer or wholesaler sends any of its sales staff to sell drugs, it shall, in addition to the materials prescribed in the previous paragraph of this Article, provide a copy of the authorization letter with the seal of the enterprise. The original authorization letter shall contain the authorized drugs, regions and time of validity for drug sales, indicate the identity card numbers of the sales staff, and be stamped with the enterprise seal and legal representative seal (or signature). The sales staff shall show the original authorization letter and identity card for the check by drug purchasers.
Article 11 Where a drug manufacturer or wholesaler sells drugs, it shall provide sales document indicating supplier’s name, drug name, manufacturer, batch number, quantity, price, etc.
Where a drug retailer sells drugs, it shall provide sales document indicating drug name, manufacturer, quantity, price, batch number, etc.
Article 12 Where a drug manufacturer or distributor purchases drugs, it shall request, examine and retain the relevant certificates and documents of the supplier in accordance with the requirements set forth in Article 10 of the Provisions, and request and retain sales document in accordance with the requirements set forth in Article 11 of the Provisions.
The documents retained by the drug manufacturer or distributor in accordance with the previous paragraph of this Article shall be kept till one year after the date of expiry, but not less than three years.
Article 13 Where a drug manufacturer or distributor knows or should know that any person without certificates produces or distributes drugs, it shall not provide the person with any drug.
Article 14 A drug manufacturer or distributor shall not provide premises, qualifications documents, notes, etc. as conveniences for others to distribute drugs in its own name.
Article 15 A drug manufacturer or distributor shall not spot trade drugs by means of exhibition, exposition, trade fair, commodity fair or product promotion event.
Article 16 A drug distributor shall not purchase or sell pharmaceutical preparations prepared by medical institutions.
Article 17 A drug distributor shall not change its distribution mode without approval of the drug regulatory department.
A drug distributor shall operate within the approved distribution scope in the Drug Supply Certificate.
Article 18 A drug retailer shall, pursuant to the requirements of drug classification regulations set forth by the State Food and Drug Administration, sell prescription drugs in the presence of prescriptions.
Any drug retailer selling prescription drugs or Class A non-prescription drugs shall, in the absence of its licensed pharmacists and other qualified pharmaceutical professionals, put up a public notice and stop selling prescription drugs and Class A non-prescription drugs.
Article 19 For drugs that need low-temperature or cold storage as specified in drug insert sheets, the drug manufacturer or distributor shall transport and store the drugs with low-temperature or cold storage facilities in accordance with the relevant provisions.
When finding any drug manufacturer or distributor violates the requirements in the previous paragraph of this article, the drug regulatory department shall seal up or seize the drugs concerned immediately and deal with the matter in accordance with law.
Article 20 A drug manufacturer or distributor shall not provide the public with prescription drug or Class A non-prescription drug by means of tie-in sale, offering free drugs in association with sales of drug or commodity sale, etc.
Article 21 A drug manufacturer or distributor shall not sell prescription drugs directly to the public by post or over internet.
Article 22 Any illegal purchase of drugs is prohibited.
Chapter III Supervision on Drug Purchase and Storage by Medical Institutions
Article 23 The pharmacy established by a medical institution shall have the premise, equipment, storage facilities, hygienic environment, and pharmaceutical professionals required for drug dispensing. It shall also have the drug quality control units or personnel, and establish a system for drug storage.
Article 24 Where a medical insititution purchases drugs, it shall request, examine and retain the relevant certificates, documents and notes of the supplier in accordance with the requirements set forth in Article 12 of the Provisions.
Article 25 Where a medical institution purchases drugs, it shall establish and apply an examination and acceptance system, and keep authentic and complete purchase records. Purchase records shall indicate the adopted name of the drug in China, manufacturer (for Chinese crude drug, the origin should be noted), dosage form, date of expiry, drug approval number, supplier, quantity, price and date of purchase.
Drug purchase records shall be kept till one year after the date of expiry, but not less than three years.
Article 26 A medical institution shall establish and apply a system for drug storage and maintenance, and take necessary measures to ensure drug quality, such as cold storage, protection against freeze and humidity, ventilation, moisture proof, protection from direct light and fire, and avoidance of insects and rodents.
A medical institution shall store drugs and non-drug products separately; Chinese crude drugs, prepared slices of Chinese crude drugs, pharmaceuticals, and traditional Chinese medicine preparations shall be stored separately by category.
Article 27 A medical institution or family planning technical service institution shall not directly provide drugs for patients without diagnosis or treatment.
Article 28 A medical institution shall not sell prescription drugs directly to the public by post or over internet.
Article 29 Where a medical institution purchases drugs via a centralized tendering, it shall comply with the relevant requirements of the Drug Administration Law, Regulations for Implementation of the Drug Administration Law and the Provisions.
Chapter IV Legal Liabilities
Article 30 In any of the following circumstances, the drug manufacturer or distributor shall be instructed to rectify within a time limit and given a disciplinary warning; and if the drug manufacturer or distributor fails to do so, it shall be fined not less than RMB 5,000 yuan but not more than RMB 20,000 yuan:
(1) any drug manufacturer or distributor in violation of Article 6 of the Provisions;
(2) any drug manufacturer or wholesaler in violation of the first paragraph of Article 11 of the Provisions;
(3) any drug manufacturer or distributor, in violation of Article 12 of the Provisions, failing to keep the relevant documents as required.
Article 31 Any drug manufacturer or distributor in violation of Article 7 of the Provisions shall be given a disciplinary warning and instructed to rectify within a time limit.
Article 32 In accordance with the provisions in Article 73 of the Drug Administration Law, in any of the following circumstances, the drugs illegally sold and the illegal gains therefrom shall be confiscated, and the drug manufacturer or distributor shall be fined not less than two times but not more than five times the value of the drugs illegally sold:
(1) any drug manufacturer or distributor, in violation of Article 8 of the Provisions, spot trading drugs on the premises not approved by the drug regulatory departments.
(2) any drug manufacturer in violation of Article 9 of the Provisions;
(3) any drug manufacturer or distributor in violation of Article 15 of the Provisions;
(4) any drug distributor in violation of Article 17 of the Provisions.
Article 33 Any drug manufacturer or distributor, in violation of Article 8 of the Provisions, storing drugs on the premises not approved by the drug regulatory departments，shall be punished pursuant to the provisions in Article 74 of the Regulations for Implementation of the Drug Administration Law.
Article 34 Any drug retailer in violation of the provisions in the second paragraph of Article 11 of the Provisions shall be instructed to rectify and given a disciplinary warning; and if the drug retailer fails to do so within a time limit, it shall be fined not more than RMB 500 yuan.
Article 35 Where a drug manufacturer or distributor, in violation of Article 13 of the Provisions, knows or should know that any person without certificates produces or distributes drugs, but still provide the person with drugs, they shall be given a disciplinary warning, instructed to rectify and fined not more than RMB 10,000 yuan. If the circumstances are serious, they shall be fined not less than RMB 10,000 yuan but not more than RMB 30,000 yuan.
Article 36 Drug manufacturers and distributors in violation of Article 14 of the Provisions shall be punished pursuant to the provisions in Article 82 of the Drug Administration Law.
Article 37 Where a drug distributor, in violation of Article 16 of the Provisions, purchases or sells pharmaceutical preparations dispensed by medical institutions, it shall be punished pursuant to the provisions in Article 80 of the Drug Administration Law.
Article 38 Any drug retailer in violation of the first paragraph of Article 18 of the Provisions shall be instructed to rectify within a time limit and given a disciplinary warning; if it fails to do so or the circumstances are serious, it shall be fined not more than RMB 1,000 yuan.
Where a drug retailer, in violation of the second paragraph of Article 18 of the Provisions, sells prescription drugs or Class A non-prescription drugs in absence of licensed pharmacists or other qualified pharmaceutical professionals, it shall be instructed to rectify within a time limit and given a disciplinary warning; if it fails to do so, it shall be fined not more than RMB 1,000 yuan.
Article 39 Where a drug manufacturer or wholesaler, in violation of Article 19 of the Provisions, fails to transport drugs under low-temperature or cold storage conditions as specified in insert sheets, it shall be given a disciplinary warning and instructed to rectify within a time limit; if it fails to do as instructed, it shall be fined not less than RMB 5,000 yuan but not more than RMB 20,000 yuan. Where the drugs concerned are legally proved to be counterfeit or substandard drugs, the drug manufacturer or wholesaler shall be punished in accordance with the relevant provisions of the Drug Administration Law.
Where a drug manufacturer or wholesaler, in violation of Article 19 of the Provisions, fails to store drugs under low-temperature or cold storage conditions as specified in insert sheets, it shall be punished pursuant to the provisions in Article 79 of the Drug Administration Law. Where the drugs concerned are legally proved to be counterfeit or substandard drugs, the drug manufacturer or wholesaler shall be punished in accordance with the relevant provisions of the Drug Administration Law.
Article 40 Any drug manufacturer or distributor in violation of Article 20 of the Provisions shall be instructed to rectify within a time limit and given a disciplinary warning; if the drug manufacturer or distributor fails to do so or the circumstances are serious, they shall be fined not more than two times the value of the free drugs offered, but not more than RMB 30,000 yuan.
Article 41 Any institution, in violation of Article 23 to Article 27 of the Provisions, shall be instructed to rectify within a time limit; if the circumstances are serious, it shall be announced.
Article 42 Where a drug manufacturer or distributor in violation of Article 21 of the Provisions or a medical institution in violation of Article 28 of the Provisions sells prescription drugs directly to the public by post, over internet, etc., they shall be instructed to rectify, given a disciplinary warning, and fined not more than two times the value of the drugs sold, but not more than RMB 30,000 yuan.
Article 43 Any illegal purchase of drugs, in violation of Article 22 of the Provisions, shall be punished pursuant to the provisions in Article 73 of the Drug Administration Law.
Article 44 Where a drug regulatory department or its staff that neglects its duty fails to stop or punish illegal activities that should be stopped or punished, administrative sanctions shall be imposed to the person directly in charge and other persons directly responsible. If a crime is constituted, criminal liabilities shall be investigated in accordance with law.
Chapter V Supplementary Provisions
Article 45 Spot trading of drugs in the Provisions refers to the activity that drug manufacturers, distributors or their appointed sales staff carry and sell drugs to unspecified objects on spot other than the premises approved by the drug regulatory departments.
Article 46 With respect to the supervision on the distribution of specially controlled drugs, vaccines, and military medicines, if otherwise provided by the relevant laws, regulations and provisions, they shall prevail.
Article 47 The Provisions shall come into force as of May 1, 2007. As of the date when the Provisions goes into effect, the Provisions for Supervision of Drug Distribution (Interim) (SFDA Decree No.7) implemented on August 1, 1999 shall be annulled therefrom.
