许你一生钟情: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由太平洋桥出版医学

July 2005 2005年7月

Introduction简介

Vietnam's 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。 While Vietnam's healthcare industry is still developing, 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 spent nearly $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，花费十倍于1993年。 Presently, more than 200 foreign pharmaceutical companies are registered in Vietnam, making up 90 percent of the country's 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 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。 Vietnam's medical device market, currently worth over $185 million, has been growing steadily at around 10 percent annually for the past 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 country's 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, Vietnam's Ministry of Health (MOH) released the Strategy for Protection and Care of the People's Health (No. 35/2001/QD-TTg), proposing a number of new measures to improve the country's 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，提出了多项措施，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 at hospitals, clinics and other healthcare centers.特别是，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。 A budget 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.外国制药公司药品在进入越南市场提供多种选择。 Some companies have established 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 companies that established 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 have established long-term goals in the country; not by companies looking for short-term gains.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.一家在越南的外国公司可以直接子公司分布在该国的产品。 However, establishing a subsidiary 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。 Local subsidiaries 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一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 companies 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 of foreign companies have chosen to work with foreign-owned distribution companies in Vietnam, most employ the services of local Vietnamese distribution companies.虽然有少数外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:外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 manufacturers established in Vietnam.药品生产企业在越南设立。 This includes foreign-invested companies licensed 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 issued with a trading license外国实体，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 Foreign Investment in Vietnam), have the option of 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到越南的选择。 The foreign company is responsible for obtaining a License for Foreign Companies to Conduct Operations in Medicines and Raw Medicinal Materials in Vietnam , which 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.此外，此内资公司注册，才能在越南进行药品经营活动。

Trading License Requirements 经营许可证要求

A foreign company should meet the following requirements in order to obtain a trading license:外国公司应符合下列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，拥有从哪些产品将运往国发行，这表明该公司已获准进口，出口，贸易和储存药品。 If the certificate does not specify these functions, the MOH will inspect the site (at the applicant's expense) and assess the work conducted there.如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 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 pharmaceutical 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 only permitted to supply their products to a Vietnamese importer/distributor that had applied for and held the product registration.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 necessary 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）可出售其药物， 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 companies 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，如果越南经销商“持有”的登记。 It is unlikely that the distributor will be willing to sign the amendment application without some type of compensation.这是不可能的分销商将愿意签署没有某种补偿型修改申请。

Representative Offices 代表办事处

Foreign companies that market their products through Vietnamese partners, but want to retain some control of the promotion 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 involved 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 selling of 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 外商投资概况

Foreign pharmaceutical 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。 The Law on Foreign Investment (LFI) in Vietnam allows foreign companies to establish FIEs in the form of 100 percent foreign-owned enterprises (FOEs), joint venture enterprises (JVEs) or business cooperation contracts (BCCs).对外商投资（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.外商投资企业必须在其投资经营许可证的规定。 FIEs are able to participate in profit-generating 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。 Only in very special circumstances would it possible to obtain 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 limited liability company established under the LFI; the foreign investor owns 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 100 percent FOE should be equal to at least 30 percent of the total investment capital of the project.一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 more 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 a limited liability company.它是一个独立的有限责任公司形式的法律实体。 A JVE's legal capital should typically be at least 30 percent of its total investment capital.阿JVE的法定资本通常应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 BCC does 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 for an investment license in order to establish a FIE 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 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
• 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 45 working 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，将已完成收到申请的日期。 However, it is not uncommon for the application review and approval process 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 company can choose to grant a license to a Vietnamese (foreign-invested or domestic) pharmaceutical company to manufacture and sell their products in Vietnam.外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 of a patent license, trademark license and/or technology transfer agreement.根据拥有和使用外国公司许可的权利，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 licenses 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 trademark license.一个专利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 is protected 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.) 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。。）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 manufacturer in Vietnam.外国制药公司，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 termed pharmaceutical manufacture under license . 根据这项交易被称为药品生产许可证 。 The application for this transaction requires a licensing agreement between the foreign and Vietnamese companies, agreeing that the product be registered and distributed in Vietnam.此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。 The Vietnamese 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 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 foreign pharmaceutical companies that hold a trading license may enter into contract manufacturing in Vietnam.唯一的外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 products have 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出售。 If the products have not been granted product registration, they should be exported from Vietnam.如果产品没有获得产品注册，他们应该从越南出口。

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，很少有整体的协调。 Partially-regulated situations, or regulations 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.此外，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 can face numerous challenges when attempting to navigate the pharmaceutical sector in Vietnam.因此，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 are more 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。

Registration 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 MOH only states that pharmaceutical products are products intended for human consumption for the purpose of prevention, treatment, relief or diagnosis of diseases, or for 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 in English.该产品的应用大部分都可以用英语完成。 The following 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 origin.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 detailed description of the product manufacturing process and the in-process control procedures.该产品的制造过程和在??过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 application and if approved, will issue the approval license (locally known as a visa).卫生部审查申请，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 applications 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 meets once 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 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样品分析，虽然这仅发生在约10百分之所有应用程序。 In this case, the product application and sample will be forwarded to the Vietnam Institute of 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。 The Institute 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 the testing fee; the amount depends on the number and complexity of the test(s).申请人须支付检测费负责的金额的数量和测试（s）的复杂性而定。

Pharmaceutical Advertising医药广告

Overview概述

All advertising activities in Vietnam should comply with the country's general advertising regulations.在越南所有的广告活动，应当遵守国家的总体广告法规。 These regulations lay out the basic framework for advertising in Vietnam, and specify the accepted types of advertisements.这些法规奠定了在越南广告的基本框架，并指定接受广告的类型。 Pharmaceutical advertising is restricted and certain types of pharmaceuticals are prohibited from advertisements, including toxins, addictive drugs, pharmaceuticals that are not registered in Vietnam and psychotropic medicines.药品广告是药品的限制，某些类型是从广告，包括毒素，成瘾药物，且没有在越南注册的药品和精神药品的行为。 Prescription drugs cannot be directly advertised to consumers, but can be marketed to health officers.处方药不能直接向消费??者做广告，但可以销售给医疗人员。

Advertisement Registration Process广告登记流程

Advertising materials should be registered with the Drug Administration of Vietnam (DAV), under the MOH.广告材料必须进行登记，与越南药品管理局（DAV）的，根据卫生部。 The approval/non-approval decision is made within 15 days of application submission.批准/不批准决定作出后15日内递交申请。 Unless the DAV rejects the proposal or requests that the advertisement be modified within the 15 day period, one can assume that the advertisement has been approved.除非DAV的建议或拒绝该广告将在15天期限修改要求，我们可以假定该广告已被批准。 Registered advertising material should be renewed on a yearly basis.注册广告材料应每年续期。

Advertisement Requirements and Restrictions广告要求和限制

Most non-prescription drugs can only be advertised to the public via magazine and newspaper advertisements, leaflets, etc. A designated list of pharmaceuticals issued by the MOH can be advertised to the public through television, radio, and other media on occasion.大多数非处方药，只能通过向公众宣传杂志和报纸广告，传单等一个由卫生部指定的药品名单issued通告到可通过电视，电台宣传，有时其他媒体。 Printed advertisements are required to provide the registration number of the advertisement and the date of printing on the front page of the advertisement.印刷广告须提供该广告的登记号码和印刷广告上的头版日期。

Pharmaceutical advertisements should contain the following information:药品广告应包含下列资料：

• Pharmaceutical name as given by the manufacturer and the names of active substances药品名称，给出了制造商和活性物质的名称
• Name and address of the product manufacturer and distributor名称和产品制造商和分销商的地址
• Formula(s) and information relating to the interaction of pharmaceuticals公式（s）和有关的资料的药品相互作用
• Instructions for use and indications使用说明和指示
• Instruction: “Read the instructions carefully before use.”说明：“前请仔细阅读使用说明书。”
• Contraindications, side-effects, adverse reactions, special warnings and precautions禁忌症，副作用，不良反应，特别警告和注意事项

Advertising to Health Officers广告的卫生官员

Pharmaceutical companies are permitted to advertise pharmaceutical products to health officers using any of the following methods:制药公司被允许做广告药物，保健人员使用下列方法之一：

• Via medical representatives of pharmaceutical companies that have a university degree in pharmacy or medicine这种药在药房或大学学位的制药企业通过医药代表
• Through advertising and information materials通过广告和宣传材料
• Introducing products at conferences在会议上介绍产品
• Displaying pharmaceuticals at conferences and seminars for health officers显示卫生官员在各种会议和研讨会药品

Foreign pharmaceutical companies are required to obtain permission from a provincial health department prior to holding a conference.国外制药公司必须取得省级卫生会议之前举行一次部门许可。 In particular, the provincial health department must be aware of any pharmaceutical displays at the conference.特别是，省级卫生部门必须成为本次会议的任何药品显示器知道。 With approval from the MOH, unregistered pharmaceuticals can also be introduced at a conference.由卫生部批准，未注册的药品，也可以在一个投资会议。 However, it is not entirely clear to what extent scientific information may be provided to health officers for toxic, addictive and psychotropic pharmaceuticals.然而，它并不完全清楚到什么程度，可提供科学信息有毒，成瘾，精神药品保健人员。

Pharmaceutical Promotion药品促销

Overview概述

Under Vietnam's Commercial Law, promotion is defined as a business activity aimed at enhancing the sale of goods and/or services, whereby certain benefits are given to customers .在越南的商业法，推广被定义为给予客户的好处是企业活动旨在提高销售商品和/或服务，据此确定 。 In the case of pharmaceuticals, the definition of customer also includes hospitals and consumers of pharmaceutical products.在药品案件， 客户的定义还包括医院和医药产品的消费者。 In Vietnam, pharmaceutical promotion is limited to Vietnamese enterprises, foreign-invested enterprises, and branches of Vietnamese and foreign enterprises.在越南，药品促销仅限于越南企业，外商投资企业和外国企业分支机构及越南。 Foreign enterprises without a branch in Vietnam, as well as both domestic and foreign representative offices, are not permitted to promote their products and services.外国企业在越南没有分支机构，以及国内和国外代表处，不得推广其产品和服务。 Oftentimes, pharmaceutical companies allow their distributors or trading partners to carry out promotion activities, as these types of local entities are not subject to such restrictions.通常情况下，制药公司允许他们的分销商或贸易伙伴进行推广活动，为这些类型的地方实体不受这些限制。

Some forms of promotional activities include:某些形式的宣传活动包括：

• Giving gifts or providing free services to customers送礼或为客户提供免费服务
• Giving free trial samples to customers给予客户免费试用样品
• Selling goods or services at reduced prices during a promotional period在降低销售价格在促销期间的商品或服务
• Selling goods or services with coupons or other types of vouchers for prize-winning games出售，优惠券或其他类型的医疗券获奖游戏产品或服务
• Selling goods or services with contest forms for customers; winners will be chosen in accordance with procedures销售竞赛的形式，为客户的商品或服务;得奖者将按照程序选出

Promotion Material Approval and Requirements宣传材料的批准和要求

The Information and Advertising Division of the DAV is responsible for approving all promotion material prior to distribution.作者：DAV的信息和广告司负责审核所有宣传材料分发之前负责。 The promotional material should include general prescribing information of the product, the name of the product license holder, the name and address of the manufacturer and distributor, the Vietnamese registration number, indications, side effects and precautions.宣传材料应包括一般产品的处方信息，该产品的许可证持有人的姓名，名称和制造商和分销商的地址，越南注册号码，适应症，副作用和注意事项。 All promotion material should be in Vietnamese, though additional languages can also be included in the material.所有宣传材料应在越南，尽管其他语言也可以在材料中。 Approved promotional material is assigned a registration number and can be distributed to medical professionals.核准宣传材料被分配一个登记号码，并可以分发到医疗专业人员。

Other Regulatory Issues其他规管事宜

New GMP Regulations新的GMP法规

In order for Vietnam to better ensure the standards of their pharmaceutical products, the MOH has begun implementing new regulations for Good Manufacturing Practice (GMP) requirements based on World Health Organization GMP standards.为了使越南更好地确保其药品的标准，卫生部已开始实施良好生产规范的新法规对世界卫生组织的GMP标准（GMP）的要求。 The first regulation for GMP compliance went into effect in November 2004.对于GMP认证的第一调控了2004年11月生效。 This regulation stipulated that all pharmaceutical manufacturing sites built after November 2004 must meet WHO GMP compliance before they are eligible to obtain a manufacturing operator's license.本规例规定，所有药品生产2004年11月建成后，网站必须符合世界卫生组织GMP认证之前，他们有资格取得制造经营执照。 Pharmaceutical manufacturing sites will be required to meet GMP standards in 2006; pharmaceutical material companies should comply by 2010.药品生产基地将在2006年必须符合GMP标准;医药原料公司应遵守2010年。

Vietnam's Department of Pharmaceutical Management (DPM) will be responsible for GMP inspections and granting GMP certificates.越南药品管理（DPM）部将负责发放GMP检查和GMP证书。 These licenses will be valid for two years.这些许可证的有效期为两年。 Pharmaceutical manufacturing sites which have already met the Association of Southeast Asian Nations (ASEAN) GMP standards may continue production with the ASEAN GMP certification.其中医药制造业已经满足了东南亚国家联盟（东盟）的GMP标准，可继续与东盟的GMP认证的生产基地。 However, once their ASEAN GMP certification expires, the factory will be required to obtain WHO GMP certification.然而，一旦他们的东盟GMP认证期满后，工厂将需要获得世界卫生组织的GMP认证。 These new regulations should increase export opportunities for pharmaceutical companies in Vietnam, since a large number of countries only accept internationally-recognized GMP pharmaceutical standards.这些新规例应增加对越南的制药公司的出口机会，因为大量的国家，只接受国际认可的GMP药品标准。

Drug Price Controls药品价格控制

As more and more foreign companies enter Vietnam's pharmaceutical market, the country faces an increase in drug prices.随着越来越多的外国公司进入越南的医药市场，该国面临着毒品价格上涨。 Moreover, the Vietnamese pharmaceutical regulations do not provide price controls or restrictions.此外，越南药品法规没有规定的价格管制或限制。 Drug prices in Vietnam had increased nearly 10 percent from 2003 to 2004, and many Vietnamese citizens were struggling to pay these higher prices.在越南的药品价格从2003年增加了近百分之十至2004年，许多越南公民都在努力付出这些更高的价格。 Therefore, the MOH has been taking measures to increase drug price controls in Vietnam.因此，卫生部已采取措施，增加在越南的药品价格管制。

Therefore, in January 2005, Vietnam's Drug Administration Department released a new regulation stating that foreign drug companies could not raise their drug prices without prior permission from the MOH.因此，在2005年1月，越南的药监部门发布了新规定指出，外国制药公司无法筹集未经卫生部批准前的药品价格。 The regulation also encourages foreign companies that are manufacturing and trading drugs in Vietnam to keep their drug prices stable.条例还鼓励那些在越南生产和毒品交易的药品价格保持稳定的外国公司。 Even in an urgent case, foreign companies will still be required obtain permission from the MOH and provide specific details of their planned price increase before it may be implemented.即使在紧急情况下，外国公司仍然需要获得卫生部的许可，并把计划价格提高的具体细节才可能实施。