越南药政管理更新

1、越南药政管理更新越南药政管理更新By Ames Gross and Rachel Weintraub 用 Ames 格罗斯和雷切 尔温特劳布Published by Pacific Bridge Medical 由太平洋桥由版医学 July 2005 2005 年 7 月Introduction 简介Vietnams population totals around 84 million and its economy boasted a 7.7 percent GDP growth rate in 2004.越南的人口总 数约84万，其经济在2004年吹嘘百分之7.7国内生产总值 的增长速度

2、。While Vietnams healthcare industry is stilldeveloping, it is one of the faster growing markets in the global healthcare industry.而越南的医疗行业还在发展，它是在全球 医疗保健行业增长最快的市场之一。In 2003, Vietnam spentnearly $420 million on pharmaceutical imports, ten times the amount spent in 1993. 2003年，越南花了近420美元的药物进 口万美元，花费十倍

3、于 1993 年。Presently, more than 200 foreign pharmaceutical companies are registered in Vietnam, making up 90 percent of the countrys market share.目前，200 多名外国制药公司是注册在越南，占全国 90的市场份额。Likewise, the medical device industry in Vietnam is also comprised mostly of foreign imports, with the US holding close to

4、 40 percent of the market; other countries with a large presence in the market include Japan and Germany同样，越南 医疗器械行业也几乎都是国外进口，与美国保持近 40的市 场份额，与在市场上大量存在的其他国家包括日本和德国。Vietnams medical device market, currently worth over $185 million, has been growing steadily at around 10 percent annually for the past

5、several years.越南医疗器械市场,目前已超过1.85亿美元的价值，一直在稳步增长百分之十左右，每年为过去 数年。Recently, the Vietnamese government has increased its efforts to improve and modernize the countrys healthcare system.最近， 越南政府加大努力，以改善和实现国家现代化的医疗体系。In 2001, Vietnams Ministry of Health (MOH) released the Strategy for Protection and Care o

6、f the Peoples Health (No. 35/2001/QD-TTg), proposing a number of new measures to improve the countrys healthcare sector between 2001 and 2010. 2001年，越南卫生部(卫生部)公布)战略保护和照顾人民的健康(第35/2001/QD-TTg ,提由了多项措施，新的改善该国的卫生部门之间和2010年的2001年。In particular,the government stresses the need to upgrade medical services

7、 athospitals, clinics and other healthcare centers.特另U是， 政府强调 要提升在医院，诊所和其他医疗保健中心的医疗服务。Abudget of over $1.5 billion has been allocated to set up more than 50 new hospitals in Vietnam, with more than half of the budget going towards new medical equipment. 一个超过 15 亿 美元的预算已分配给设立超过迈向新的医疗设备将预算的 一半以上在越南 50

8、个新医院。Entering the Pharmaceutical Market 进入药品市场Overview 概述Foreign pharmaceutical companies have several options when entering the Vietnamese pharmaceutical market.夕卜国制药公司 药品在进入越南市场提供多种选择。Some companies haveestablished their own subsidiaries in Vietnam. 一些公司已经在 越南设立自己的子公司。In the past, foreign companie

9、s thatestablished subsidiaries were forced into joint ventures with local pharmaceutical companies, but now 100 percent foreign subsidiaries are permitted.在过去，成立子公司被迫与当地合 资制药企业，但现在百分之百的外国子公司允许外国公司。Subsidiaries allow for better overall control of the business and are often set up by companies that ha

10、ve established long-term goals in the country; not by companies looking for short-termgains.子公司能更好地对业务的整体控制，而且往往由那些在全国建立长期目标的公司注册，不为短期利益前瞻性的公司。A foreign company with a subsidiary in Vietnam can directly distribute its products in the country.家在越南的夕卜国公司可 以直接子公司分布在该国的产品。However, establishing asubsidia

11、ry can be a long and pain-staking process.然而，建立一 个子公司可以是一个漫长和痛苦，放样程序。Localsubsidiaries are required to have a manufacturing facility in Vietnam so, generally, only companies with considerable business set up subsidiaries当地的子公司都必须有个在越 南生产设施等，一般来说，只有具有相当的商业企业设立的 子公司。A second option for foreign compani

12、es entering the Vietnamese market is to promote their products through an existing Vietnamese company.一进入越南市场的外国公司的第二个选 择是通过现有的促进越南公司的产品。While a handful offoreign companies have chosen to work with foreign-owned distribution companies in Vietnam, most employ the services of local Vietnamese distribu

13、tion companies.虽然有少数夕卜国公司 选择在越南工作的外资分销企业，雇用当地越南最流通企业 的服务。Foreign companies should carefully consider their status in the Vietnamese medical market, as only the following types of entities are eligible for product registration in Vietnam:夕卜国公 司应慎重考虑其在越南医疗市场的地位，因为只有实体以下 类型的产品在越南登记资格：Pharmaceutical man

14、ufacturers established in Vietnam.药品生产 企业在越南设立。This includes foreign-invested companieslicensed to manufacture pharmaceuticals in Vietnam 这包括外 商投资企业获准在越南生产药品Domestic entities permitted to trade in pharmaceuticals 允许境 内机构在药品贸易Foreign entities, including manufacturers and distributors, that have been

15、issued with a trading license 夕卜国实体，包括制造商 和分销商，已与一家贸易许可证签发Direct Sales through a Vietnamese Importer/Distributor 通过越 南进口商/分销商直接销售Overview 概述Foreign companies who are not established in Vietnam (as a foreign-invested company in Vietnam under the Law on ForeignInvestment in Vietnam）, have the option o

16、f supplying their products to Vietnam via a local Vietnamese trading company.谁 是不成立的外国在越南（在越南作为投资的外国公司在外国 在越南投资法）公司，拥有通过本地供应越南贸易公司自己 的产品至 越南的选择。The foreign company is responsible forobtaining a License for Foreign Companies to Conduct Operations in Medicines and Raw Medicinal Materials inVietnam , w

17、hich is generally referred to as a company license or trading license .外国公司负责外交牌照领牌公司进行运作药 品和原料药材在越南，这是一般贸易称为公司执照或公 司 。 Additionally, this local company should be registered to conduct pharmaceutical trading activities in Vietnam.止匕夕卜，止匕内 资公司注册，才能在越南进行药品经营活动。Trading License Requirements 经营许可证要求A for

18、eign company should meet the following requirements in order to obtain a trading license:夕卜国公司应符合下歹U要求才 能获得经营许可证：Possess a GMP certificate issued by the country from which products will be shipped, demonstrating that the firm is permitted to import, export, trade and store pharmaceuticals.通 过GMP认证，拥

19、有从哪些产品将运往国发行，这表明该公 司已获准进口，由口，贸易和储存药品。If the certificate does not specify these functions, the MOH will inspect the site (at the applicants expense) and assess the work conducted there.果 该证书不指定这些功能，卫生部将检查站点(根据申请人的 费用)，评估那里进行的工作。Be established in its country of origin as a pharmaceutical manufacturer

20、or trader.在其作为药品生产商或贸易商原产地 确定。Have three years of experience operating as a pharmaceutical manufacturer or trader.有三个经验，药品制造商或贸易商经营 多年。Audited accounts for the past financial year must demonstrate annual turnovers of US$15 million for a pharmaceutical trader, US$5 million per year for a pharmaceutic

21、al manufacturer, and US$3 million per year for a traditional medicine manufacturer. 在过去的财政年度之经审核帐目必须展示美国每年营业额 1500万美元的制药商，500万美元，每年用于药品制造商， 美国300万美元，每年为传统医药制造商。In the past, foreign pharmaceutical companies were onlypermitted to supply their products to a Vietnameseimporter/distributor that had appli

22、ed for and held the productregistration.在过去，外国制药公司只允许其产品供应到越南 进口商/分销商已申请并举行了产品注册。 But now, it appears that a foreign pharmaceutical company (with a trading license that “holds” its own product registration) can sell its pharmaceutical products to any Vietnamese importer/distributor that meets the ne

23、cessary importing conditions.但现在，似乎外国制药公司(一家贸易许可证 “认为”自己的产品注册)可由售其药物， 任 何越南进口商/分销商，以满足必要的进口条件。Therefore,it is generally best that foreign companies currently applying for product registration “hold” the product registration themselves.因此，人们普遍认为目前最好的产品 申请注册的外国公司 “持有”的产品注册自己。 This will allow foreign c

24、ompanies to easily choose or change distributors.这将允许外国公司能够轻松选择或改变分销商。 Moreover, a foreign pharmaceutical company planning to change its Vietnamese distributor will need to amend their product registration if the Vietnamese distributor “holds” the registration.此外，外国制药公司计 划将其越南经销商将需要修改他们的产品注册，如果越南经 销

25、商 “持有 ”的登记。It is unlikely that the distributor will be willing to sign the amendment applicationwithout some type of compensation.这是不可能的分销商将愿 意签署没有莫种补偿型修改申请。Representative Offices 代表办事处Foreign companies that market their products through Vietnamese partners, but want to retain some control of the pr

26、omotion of their products, can opt to establish a representative office.外国公司的市场销售其产品通过越南的合作伙伴，但 想保留一些自己的产品推广的控制，可以选择设立代表处。A representative office, which must be fully funded from overseas, can hold a product registration, promote products and oversee local distributors, but it cannot be directly inv

27、olved in importing and selling products.代表处，必须完全由外商投资， 可容纳一个产品注册，产品推广和监督本地分销商，但它不 能直接从事进口和销售产品涉及。The importing and sellingof products can only be done by a Vietnamese-registered company.进口和销售产品，只能由一个越南注册的公司。Manufacturing and Distribution 制造及分销 Foreign Investment Overview 夕卜商投资概况 Foreign pharmaceutic

28、al companies have the option of applying for an investment license in order to establish a Foreign-Invested Enterprise FIE).外国制药公司有一个投资许可证的申请，以设立外商投资企业外商投资企业）选项。TheLaw on Foreign Investment （LFI） in Vietnam allows foreign companies to establish FIEs in the form of 100 percent foreign-owned enterpris

29、es （FOEs）, joint venture enterprises （JVEs） or business cooperation contracts （BCCs）.对夕卜商投资（利比里亚森林倡议）允许外国公司在越南设立了百分之百 的外商独资企业（FOE的），合资企业（JVEs）或商业合作 合同（基底细胞癌）的形式的外商投资企业法。A FIE must operate in accordance with its investment license.夕卜 商投资企业必须在其投资经营许可证的规定。FIEs are ableto participate in profit-generatin

30、g activities and can employ foreign and/or local staff in Vietnam.外商投资企业能够参与营 利性活动，并可以聘请外国和/或当地工作人员在越南。Importing, trading and distribution services by the FIE are restricted to products manufactured in Vietnam.由外商投资企 业进口，贸易及分销服务，被限制在越南制造的产品。Onlyin very special circumstances would it possible to obta

31、in an investment license to engage in importing, trading and distribution services of products manufactured outside of Vietnam.只有在非常特殊的情况下，将有可能获得投资许可 证从事进口，贸易和境外越南制造的产品分销服务。A 100 percent FOE is a separate legal entity and a limitedliability company established under the LFI; the foreign investor own

32、s 100 percent of the company.百分之百的敌人是一个独立 的法人实体和有限责任公司根据利比里亚森林倡议成立；外国投资者拥有该公司百分之100。The legal capital of a 100percent FOE should be equal to at least 30 percent of the total investment capital of the project.个百分之百的地球之友法 定资本应至少相当于 30项目总投资资本的百分之。A JVE is set up by means of a contract between one or mo

33、re foreign investors and one or more Vietnamese parties.阿 JVE 是 设立一个与一个或更多的外国投资者和越南的一个或多个 合同当事人的手段。It is a separate legal entity in the form of alimited liability company.它是一个独立的有限责任公司形式 的法律实体。A JVEs legal capital should typically be at least30 percent of its total investment capital.阿 JVE 的法定资本通 常应

34、至少占其投资总金额30资本的百分之。A BCC is a contract with one or more Vietnamese partners.基底 细胞癌是一个有一个或更多越南合作伙伴的合同。A BCCdoes not create a separate legal entity and the investors have unlimited liability for the debts of the BCC.基底细胞癌不创建 一个独立的法律实体和投资者中广为债务负无限责任。 Investment License Application 申请投资许可证An application

35、for an investment license in order to establish aFIE should include: 一种投资许可证申请，以建立一个外商投资企业应包括：Investment license application 投资许可证的申请Charter (for the 100 percent FOE or JVE) or Business Cooperation Contract (for a BCC)宪章(为百分之百的敌人或JVE)或商业合作合同(为基底细胞癌)Documentation verifying legal and financial status

36、of the involved parties验证文件的法律和财务状况有关各方Joint venture contract (only required for JVEs) 合资合同 (仅适 用于JVEs需要)Feasibility Study 可行性研究Documents relating to land or premises leasing 有关文件， 土地或房屋租赁Documentation relating to technology transfers 技术转让有关 的文件Preliminary designs of proposed architecture 拟议的架构初步 设计

37、Environmental impact evaluation report, if required 环境影响评 价报告，如果需要的话The investment license approval will be issued within 45working days from the date of receipt of the completed application,投资许可证颁发批准将在45个工作日内，将已完成收至 ij 申请的日期。However, it is not uncommon for theapplication review and approval process

38、 to exceed the 45 day time period,但是，它不适合申请审查和批准程序，以超过 45 天的时间内罕见。 Currently, there is no licensing fee to establish a FIE in Vietnam.目前，还没有授权费，在越南设立 外商投资企业。Licensing a Vietnamese Company to Manufacture and Sell Your Products牌照，越南公司的生产和销售您的产品 Licensing Regulations 许可办法A foreign pharmaceutical compan

39、y can choose to grant a license to a Vietnamese (foreign-invested or domestic) pharmaceutical company to manufacture and sell their products in Vietnam.夕卜国 制药公司可以选择发牌予越南(外资或国内)制药公司在越 南生产和销售其产品。 Depending on the rights owned and licensed by the foreign company, the license may be granted in the form

40、of a patent license, trademark license and/or technology transfer agreement.根据拥有和使用夕卜国公司许可 的权利，许可证可能被授予专利的许可，商标许可和/或技术转让协议的形式。In order for a patent or trademark license to be effective in Vietnam, it should be registered with the National Office of Intellectual Property (NOIP); technology transfer l

41、icenses should be registered with the Ministry of Science and Technology (MOST).为了使专利或商标使用许可将在越南有 效，它应该是注册了知识产权(NOIP)全国办公室，技术转 让牌照应与国家科学技术部(MOST)的注册。The validity term of a patent or trademark license is agreed to by the parties, but cannot exceed the remaining duration of protection of the patent or

42、 trademark license.个专禾 U或商标 使用许可有效期由双方商定，但不能超过专利或商标使用许 可保护剩余的时间。(A patent for an invention in Vietnam isprotected for 20 years; a trademark is protected for 10 years.The protection period of a trademark may be renewed for additional terms of 10 years each, but the term of a patent cannot be extended

43、.) The term of a technology transfer is seven years. (A为在越南的发明专利是保护了 20年的商标为10 年的保护商标的保护期为10年，每年额外条款续期，但专利的期限不能延长。O)一个技术转让期限为七年。Manufacturing Options 制造选项A foreign pharmaceutical company that has obtained product registration in Vietnam (or elsewhere) can grant the license to another pharmaceutical

44、manufacturer in Vietnam.夕卜国制药公司，已获得越南（或其他地方）产品注册可以批给牌照的另 一个越南药品生产商。This transaction is termedpharmaceutical manufacture under license . 根据这项交易被称 为药品生产许可证。 The application for this transactionrequires a licensing agreement between the foreign and Vietnamese companies, agreeing that the product be reg

45、istered and distributed in Vietnam.止匕交易应用程序需要与国外和越南 公司许可协议，同意该产品进行登记，并在越南发行。TheVietnamese manufacturer will hold the product registration and title to the products manufactured under the license.越南制造商 将举行产品注册和所有权的许可下生产的产品。A foreign pharmaceutical company also has the option of enlisting a Vietnamese

46、 pharmaceutical company to carry out some or all stages of the manufacturing process of a product.外 国制药公司也有争取越南的制药公司开展的一个产品的制 造过程中的一些或全部阶段的选项。Only foreignpharmaceutical companies that hold a trading license may enter into contract manufacturing in Vietnam. 唯的夕卜国经营许可 证持有一制药公司可订立合约，在越南制造。If the produc

47、tshave been issued with a Vietnamese product registration, the foreign company can arrange for the sale of the products via a Vietnamese distributor.如果该产品已与越南产品注册发行，外国公司可以安排产品的分销商通过越南由售。If the productshave not been granted product registration, they should be exported from Vietnam.如果产品没有获得产品注册，他们应 该

48、从越南由口。Product Registration 产品注册Overview 概述The MOH regulates pharmaceuticals in Vietnam, though the regulatory environment can often be unclear and inconsistent.在 越南卫生部药品监管，但监管环境往往是不明确和不一致。Regulations are frequently implemented on a case-by-case basis, with little overall coordination.经常实施条例的案件逐案基础 上

49、，很少有整体的协调。Partially-regulated situations, orregulations that are clearly contradictory, are not unheard of.部 分监管的情况下，或法规有明确的矛盾，不是闻所未闻的事 情。 Moreover, it can be difficult to determine what is permitted in Vietnam and what is illegal.止匕外，它可能很难确定哪些是允 许在越南和什么是非法的。Therefore, foreign companies canface nume

50、rous challenges when attempting to navigate the pharmaceutical sector in Vietnam.因止匕，外国公司可能面临许 多挑战，当试图在越南导航制药业。Foreign companies aremore likely to succeed in the market when paired up with a company or personnel who have previous experience in this sector.外国公司更容易在市场上取得成功配对时与一家公司 或人员谁在这一领域的经验了。Regist

51、ration Process 注册流程The definition of “pharmaceutical products” is somewhat ambiguous under Vietnamese law.对“药品 ”的定义是根据越南法律有点含糊不清。The MOHonly states that pharmaceutical products are products intended for human consumption for the purpose of prevention, treatment, relief or diagnosis of diseases, or f

52、or the modification of physiological functions .卫生部的生理功能，只有国家的药物 治疗或救济，产品，产品供人消费的目的，预防疾病的诊断，修改或 。 Any pharmaceutical products manufactured, sold or distributed in Vietnam must first be registered with the MOH. 任 何医药产品制造，销售或者分散在越南首先必须与国家卫生 部注册。The majority of the product application can be completed

53、in English.该产品的应用大部分都可以用英语完成。Thefollowing documents and information are required with the application package:下列文件和资料必须与应用程序包：Free Sale Certificate from the country of origin. 免费从原产国销售证明书The product to be sold in Vietnam must have the same specifications as the product on sale in the country of orig

54、in.该产品将销往越南必须为在原产国销售的产品相同的 规格。GMP Certification of the manufacturing facility from the country of origin. GMP 认证从原产国生产厂。Product information including indication for use, dosage, drug interactions, management of overdose, shelf life and storage conditions.产品信息，包括用法，用量，药物相互作用，药物 过量，保质期和储存条件的管理指标。A det

55、ailed description of the product manufacturing process and the in-process control procedures.该产品 的制造过程和在 ？M 程控制程序的详细说明。Real time stability data from three batches.实时从三个批次的 稳定性数据。Quality specifications and the relevant analytical methods for the finished product, raw materials and excipients.质量规范，为 成

56、品，原材料和辅料相关的分析方法。Three samples of the finished product with the Certificates of Analysis for the finished product, active ingredients and excipients.三个与成品，活性成分和辅料的分析证书成品样 品。Packaging material for the finished product including a Vietnamese language insert leaflet.包装成 品包括越南语插入 单张材料。The MOH reviews the

57、 application and if approved, will issue the approval license (locally known as a visa).卫生部审查中 请，如果获得批准，将发行的审批许可(在当地被称为签证) Generally, the review and approval process takes three to four months.一般来说，审查和审批过程需要三至四个月。Additionally, in April 2004, the MOH established a drug review panel to review applicat

58、ions for the approval of drugs not yet registered for distribution in Vietnam.此外，在 2004 年 4 月， 卫生部成立了药物审查小组审查批准的药品分布在越南尚 未登记的申请。The MOH intended for this panel, which meetsonce a week, to help speed up the application review process.卫 生部拟本小组，每星期开会一次，以加快申请的审查过程。Product registration is valid for five

59、years. 产品注册有效期为五 年。Some product approval processes will also include product sample analysis, though this occurs only in about ten percent of all application processes.一些产品的审批程序也将包括产品In样品分析，虽然这仅发生在约10百分之所有应用程序。this case, the product application and sample will be forwarded to the Vietnam Institute o

60、f Quality Control.在这种情况下，产品 的应用和样品将被转交给越南质量控制研究所。TheInstitute will analyze the sample and compare the results with the Certificate of Analysis included in the registration application.该研究所将分析样品的分析比较，结果证明在注 册程序包括在内。The applicant is responsible for paying thetesting fee; the amount depends on the numb