越南藥政管理更新

1、越南藥政管理更新越南藥政管理更新By Ames Gross and Rachel Weintraub 用 Ames 格羅斯和雷切 爾溫特勞布Published by Pacific Bridge Medical 由太平洋橋由版醫(yī)學(xué) July 2005 2005 年 7 月Introduction 簡介Vietnams population totals around 84 million and its economy boasted a 7.7 percent GDP growth rate in 2004.越南的人口總 數(shù)約84萬，其經(jīng)濟在2004年吹噓百分之7.7國內(nèi)生產(chǎn)總值 的增長速度

2、。While Vietnams healthcare industry is stilldeveloping, it is one of the faster growing markets in the global healthcare industry.而越南的醫(yī)療行業(yè)還在發(fā)展，它是在全球 醫(yī)療保健行業(yè)增長最快的市場之一。In 2003, Vietnam spentnearly $420 million on pharmaceutical imports, ten times the amount spent in 1993. 2003年，越南花了近420美元的藥物進 口萬美元，花費十倍

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 多名外國制藥公司是注冊在越南，占全國 90的市場份額。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同樣，越南 醫(yī)療器械行業(yè)也幾乎都是國外進口，與美國保持近 40的市 場份額，與在市場上大量存在的其他國家包括日本和德國。Vietnams medical device market, currently worth over $185 million, has been growing steadily at around 10 percent annually for the past

5、several years.越南醫(yī)療器械市場,目前已超過1.85億美元的價值，一直在穩(wěn)步增長百分之十左右，每年為過去 數(shù)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，以改善和實現(xiàn)國家現(xiàn)代化的醫(yī)療體系。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，越南衛(wèi)生部(衛(wèi)生部)公布)戰(zhàn)略保護和照顧人民的健康(第35/2001/QD-TTg ,提由了多項措施，新的改善該國的衛(wèi)生部門之間和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， 政府強調(diào) 要提升在醫(yī)院，診所和其他醫(yī)療保健中心的醫(yī)療服務(wù)。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. 一個超過 15 億 美元的預(yù)算已分配給設(shè)立超過邁向新的醫(yī)療設(shè)備將預(yù)算的 一半以上在越南 50

8、個新醫(yī)院。Entering the Pharmaceutical Market 進入藥品市場Overview 概述Foreign pharmaceutical companies have several options when entering the Vietnamese pharmaceutical market.夕卜國制藥公司 藥品在進入越南市場提供多種選擇。Some companies haveestablished their own subsidiaries in Vietnam. 一些公司已經(jīng)在 越南設(shè)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.在過去，成立子公司被迫與當?shù)睾?資制藥企業(yè)，但現(xiàn)在百分之百的外國子公司允許外國公司。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.子公司能更好地對業(yè)務(wù)的整體控制，而且往往由那些在全國建立長期目標的公司注冊，不為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.家在越南的夕卜國公司可 以直接子公司分布在該國的產(chǎn)品。However, establishing asubsidia

11、ry can be a long and pain-staking process.然而，建立一 個子公司可以是一個漫長和痛苦，放樣程序。Localsubsidiaries are required to have a manufacturing facility in Vietnam so, generally, only companies with considerable business set up subsidiaries當?shù)氐淖庸径急仨氂袀€在越 南生產(chǎn)設(shè)施等，一般來說，只有具有相當?shù)纳虡I(yè)企業(yè)設(shè)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.一進入越南市場的外國公司的第二個選 擇是通過現(xiàn)有的促進越南公司的產(chǎn)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.雖然有少數(shù)夕卜國公司 選擇在越南工作的外資分銷企業(yè)，雇用當?shù)卦侥献盍魍ㄆ髽I(yè) 的服務(wù)。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:夕卜國公 司應(yīng)慎重考慮其在越南醫(yī)療市場的地位，因為只有實體以下 類型的產(chǎn)品在越南登記資格：Pharmaceutical man

14、ufacturers established in Vietnam.藥品生產(chǎn) 企業(yè)在越南設(shè)立。This includes foreign-invested companieslicensed to manufacture pharmaceuticals in Vietnam 這包括外 商投資企業(yè)獲準在越南生產(chǎn)藥品Domestic entities permitted to trade in pharmaceuticals 允許境 內(nèi)機構(gòu)在藥品貿(mào)易Foreign entities, including manufacturers and distributors, that have been

15、issued with a trading license 夕卜國實體，包括制造商 和分銷商，已與一家貿(mào)易許可證簽發(fā)Direct Sales through a Vietnamese Importer/Distributor 通過越 南進口商/分銷商直接銷售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.誰 是不成立的外國在越南（在越南作為投資的外國公司在外國 在越南投資法）公司，擁有通過本地供應(yīng)越南貿(mào)易公司自己 的產(chǎn)品至 越南的選擇。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 .外國公司負責(zé)外交牌照領(lǐng)牌公司進行運作藥 品和原料藥材在越南，這是一般貿(mào)易稱為公司執(zhí)照或公 司 。 Additionally, this local company should be registered to conduct pharmaceutical trading activities in Vietnam.止匕夕卜，止匕內(nèi) 資公司注冊，才能在越南進行藥品經(jīng)營活動。Trading License Requirements 經(jīng)營許可證要求A for

18、eign company should meet the following requirements in order to obtain a trading license:夕卜國公司應(yīng)符合下歹U要求才 能獲得經(jīng)營許可證：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 過GMP認證，擁

19、有從哪些產(chǎn)品將運往國發(fā)行，這表明該公 司已獲準進口，由口，貿(mào)易和儲存藥品。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 該證書不指定這些功能，衛(wèi)生部將檢查站點(根據(jù)申請人的 費用)，評估那里進行的工作。Be established in its country of origin as a pharmaceutical manufacturer

20、or trader.在其作為藥品生產(chǎn)商或貿(mào)易商原產(chǎn)地 確定。Have three years of experience operating as a pharmaceutical manufacturer or trader.有三個經(jīng)驗，藥品制造商或貿(mào)易商經(jīng)營 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. 在過去的財政年度之經(jīng)審核帳目必須展示美國每年營業(yè)額 1500萬美元的制藥商，500萬美元，每年用于藥品制造商， 美國300萬美元，每年為傳統(tǒng)醫(yī)藥制造商。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.在過去，外國制藥公司只允許其產(chǎn)品供應(yīng)到越南 進口商/分銷商已申請并舉行了產(chǎn)品注冊。 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.但現(xiàn)在，似乎外國制藥公司(一家貿(mào)易許可證 “認為”自己的產(chǎn)品注冊)可由售其藥物， 任 何越南進口商/分銷商，以滿足必要的進口條件。Therefore,it is generally best that foreign companies currently applying for product registration “hold” the product registration themselves.因此，人們普遍認為目前最好的產(chǎn)品 申請注冊的外國公司 “持有”的產(chǎn)品注冊自己。 This will allow foreign c

24、ompanies to easily choose or change distributors.這將允許外國公司能夠輕松選擇或改變分銷商。 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，外國制藥公司計 劃將其越南經(jīng)銷商將需要修改他們的產(chǎn)品注冊，如果越南經(jīng) 銷

25、商 “持有 ”的登記。It is unlikely that the distributor will be willing to sign the amendment applicationwithout some type of compensation.這是不可能的分銷商將愿 意簽署沒有莫種補償型修改申請。Representative Offices 代表辦事處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.外國公司的市場銷售其產(chǎn)品通過越南的合作伙伴，但 想保留一些自己的產(chǎn)品推廣的控制，可以選擇設(shè)立代表處。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.代表處，必須完全由外商投資， 可容納一個產(chǎn)品注冊，產(chǎn)品推廣和監(jiān)督本地分銷商，但它不 能直接從事進口和銷售產(chǎn)品涉及。The importing and sellingof products can only be done by a Vietnamese-registered company.進口和銷售產(chǎn)品，只能由一個越南注冊的公司。Manufacturing and Distribution 制造及分銷 Foreign Investment Overview 夕卜商投資概況 Foreign pharmaceutic

28、al companies have the option of applying for an investment license in order to establish a Foreign-Invested Enterprise FIE).外國制藥公司有一個投資許可證的申請，以設(shè)立外商投資企業(yè)外商投資企業(yè)）選項。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）.對夕卜商投資（利比里亞森林倡議）允許外國公司在越南設(shè)立了百分之百 的外商獨資企業(yè)（FOE的），合資企業(yè)（JVEs）或商業(yè)合作 合同（基底細胞癌）的形式的外商投資企業(yè)法。A FIE must operate in accordance with its investment license.夕卜 商投資企業(yè)必須在其投資經(jīng)營許可證的規(guī)定。FIEs are ableto participate in profit-generatin

30、g activities and can employ foreign and/or local staff in Vietnam.外商投資企業(yè)能夠參與營 利性活動，并可以聘請外國和/或當?shù)毓ぷ魅藛T在越南。Importing, trading and distribution services by the FIE are restricted to products manufactured in Vietnam.由外商投資企 業(yè)進口，貿(mào)易及分銷服務(wù)，被限制在越南制造的產(chǎn)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況下，將有可能獲得投資許可 證從事進口，貿(mào)易和境外越南制造的產(chǎn)品分銷服務(wù)。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.百分之百的敵人是一個獨立 的法人實體和有限責(zé)任公司根據(jù)利比里亞森林倡議成立；外國投資者擁有該公司百分之100。The legal capital of a 100percent FOE should be equal to at least 30 percent of the total investment capital of the project.個百分之百的地球之友法 定資本應(yīng)至少相當于 30項目總投資資本的百分之。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 設(shè)立一個與一個或更多的外國投資者和越南的一個或多個 合同當事人的手段。It is a separate legal entity in the form of alimited liability company.它是一個獨立的有限責(zé)任公司形式 的法律實體。A JVEs legal capital should typically be at least30 percent of its total investment capital.阿 JVE 的法定資本通 常應(yīng)

34、至少占其投資總金額30資本的百分之。A BCC is a contract with one or more Vietnamese partners.基底 細胞癌是一個有一個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.基底細胞癌不創(chuàng)建 一個獨立的法律實體和投資者中廣為債務(wù)負無限責(zé)任。 Investment License Application 申請投資許可證An application

35、for an investment license in order to establish aFIE should include: 一種投資許可證申請，以建立一個外商投資企業(yè)應(yīng)包括：Investment license application 投資許可證的申請Charter (for the 100 percent FOE or JVE) or Business Cooperation Contract (for a BCC)憲章(為百分之百的敵人或JVE)或商業(yè)合作合同(為基底細胞癌)Documentation verifying legal and financial status

36、of the involved parties驗證文件的法律和財務(wù)狀況有關(guān)各方Joint venture contract (only required for JVEs) 合資合同 (僅適 用于JVEs需要)Feasibility Study 可行性研究Documents relating to land or premises leasing 有關(guān)文件， 土地或房屋租賃Documentation relating to technology transfers 技術(shù)轉(zhuǎn)讓有關(guān) 的文件Preliminary designs of proposed architecture 擬議的架構(gòu)初步 設(shè)計

37、Environmental impact evaluation report, if required 環(huán)境影響評 價報告，如果需要的話The investment license approval will be issued within 45working days from the date of receipt of the completed application,投資許可證頒發(fā)批準將在45個工作日內(nèi)，將已完成收至 ij 申請的日期。However, it is not uncommon for theapplication review and approval process

38、 to exceed the 45 day time period,但是，它不適合申請審查和批準程序，以超過 45 天的時間內(nèi)罕見。 Currently, there is no licensing fee to establish a FIE in Vietnam.目前，還沒有授權(quán)費，在越南設(shè)立 外商投資企業(yè)。Licensing a Vietnamese Company to Manufacture and Sell Your Products牌照，越南公司的生產(chǎn)和銷售您的產(chǎn)品 Licensing Regulations 許可辦法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.夕卜國 制藥公司可以選擇發(fā)牌予越南(外資或國內(nèi))制藥公司在越 南生產(chǎn)和銷售其產(chǎn)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.根據(jù)擁有和使用夕卜國公司許可 的權(quán)利，許可證可能被授予專利的許可，商標許可和/或技術(shù)轉(zhuǎn)讓協(xié)議的形式。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).為了使專利或商標使用許可將在越南有 效，它應(yīng)該是注冊了知識產(chǎn)權(quán)(NOIP)全國辦公室，技術(shù)轉(zhuǎn) 讓牌照應(yīng)與國家科學(xué)技術(shù)部(MOST)的注冊。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.個專禾 U或商標 使用許可有效期由雙方商定，但不能超過專利或商標使用許 可保護剩余的時間。(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為在越南的發(fā)明專利是保護了 20年的商標為10 年的保護商標的保護期為10年，每年額外條款續(xù)期，但專利的期限不能延長。O)一個技術(shù)轉(zhuǎn)讓期限為七年。Manufacturing Options 制造選項A foreign pharmaceutical company that has obtained product registration in Vietnam (or elsewhere) can grant the license to another pharmaceutical

44、manufacturer in Vietnam.夕卜國制藥公司，已獲得越南（或其他地方）產(chǎn)品注冊可以批給牌照的另 一個越南藥品生產(chǎn)商。This transaction is termedpharmaceutical manufacture under license . 根據(jù)這項交易被稱 為藥品生產(chǎn)許可證。 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.止匕交易應(yīng)用程序需要與國外和越南 公司許可協(xié)議，同意該產(chǎn)品進行登記，并在越南發(fā)行。TheVietnamese manufacturer will hold the product registration and title to the products manufactured under the license.越南制造商 將舉行產(chǎn)品注冊和所有權(quán)的許可下生產(chǎn)的產(chǎn)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 國制藥公司也有爭取越南的制藥公司開展的一個產(chǎn)品的制 造過程中的一些或全部階段的選項。Only foreignpharmaceutical companies that hold a trading license may enter into contract manufacturing in Vietnam. 唯的夕卜國經(jīng)營許可 證持有一制藥公司可訂立合約，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.如果該產(chǎn)品已與越南產(chǎn)品注冊發(fā)行，外國公司可以安排產(chǎn)品的分銷商通過越南由售。If the productshave not been granted product registration, they should be exported from Vietnam.如果產(chǎn)品沒有獲得產(chǎn)品注冊，他們應(yīng) 該

48、從越南由口。Product Registration 產(chǎn)品注冊O(shè)verview 概述The MOH regulates pharmaceuticals in Vietnam, though the regulatory environment can often be unclear and inconsistent.在 越南衛(wèi)生部藥品監(jiān)管，但監(jiān)管環(huán)境往往是不明確和不一致。Regulations are frequently implemented on a case-by-case basis, with little overall coordination.經(jīng)常實施條例的案件逐案基礎(chǔ) 上

49、，很少有整體的協(xié)調(diào)。Partially-regulated situations, orregulations that are clearly contradictory, are not unheard of.部 分監(jiān)管的情況下，或法規(guī)有明確的矛盾，不是聞所未聞的事 情。 Moreover, it can be difficult to determine what is permitted in Vietnam and what is illegal.止匕外，它可能很難確定哪些是允 許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，外國公司可能面臨許 多挑戰(zhàn)，當試圖在越南導(dǎo)航制藥業(yè)。Foreign companies aremore likely to succeed in the market when paired up with a company or personnel who have previous experience in this sector.外國公司更容易在市場上取得成功配對時與一家公司 或人員誰在這一領(lǐng)域的經(jīng)驗了。Regist

51、ration Process 注冊流程The definition of “pharmaceutical products” is somewhat ambiguous under Vietnamese law.對“藥品 ”的定義是根據(jù)越南法律有點含糊不清。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 .衛(wèi)生部的生理功能，只有國家的藥物 治療或救濟，產(chǎn)品，產(chǎn)品供人消費的目的，預(yù)防疾病的診斷，修改或 。 Any pharmaceutical products manufactured, sold or distributed in Vietnam must first be registered with the MOH. 任 何醫(yī)藥產(chǎn)品制造，銷售或者分散在越南首先必須與國家衛(wèi)生 部注冊。The majority of the product application can be completed

53、in English.該產(chǎn)品的應(yīng)用大部分都可以用英語完成。Thefollowing documents and information are required with the application package:下列文件和資料必須與應(yīng)用程序包：Free Sale Certificate from the country of origin. 免費從原產(chǎn)國銷售證明書The product to be sold in Vietnam must have the same specifications as the product on sale in the country of orig

54、in.該產(chǎn)品將銷往越南必須為在原產(chǎn)國銷售的產(chǎn)品相同的 規(guī)格。GMP Certification of the manufacturing facility from the country of origin. GMP 認證從原產(chǎn)國生產(chǎn)廠。Product information including indication for use, dosage, drug interactions, management of overdose, shelf life and storage conditions.產(chǎn)品信息，包括用法，用量，藥物相互作用，藥物 過量，保質(zhì)期和儲存條件的管理指標。A det

55、ailed description of the product manufacturing process and the in-process control procedures.該產(chǎn)品 的制造過程和在 ？M 程控制程序的詳細說明。Real time stability data from three batches.實時從三個批次的 穩(wěn)定性數(shù)據(jù)。Quality specifications and the relevant analytical methods for the finished product, raw materials and excipients.質(zhì)量規(guī)范，為 成

56、品，原材料和輔料相關(guān)的分析方法。Three samples of the finished product with the Certificates of Analysis for the finished product, active ingredients and excipients.三個與成品，活性成分和輔料的分析證書成品樣 品。Packaging material for the finished product including a Vietnamese language insert leaflet.包裝成 品包括越南語插入 單張材料。The MOH reviews the

57、 application and if approved, will issue the approval license (locally known as a visa).衛(wèi)生部審查中 請，如果獲得批準，將發(fā)行的審批許可(在當?shù)乇环Q為簽證) Generally, the review and approval process takes three to four months.一般來說，審查和審批過程需要三至四個月。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， 衛(wèi)生部成立了藥物審查小組審查批準的藥品分布在越南尚 未登記的申請。The MOH intended for this panel, which meetsonce a week, to help speed up the application review process.衛(wèi) 生部擬本小組，每星期開會一次，以加快申請的審查過程。Product registration is valid for five

59、years. 產(chǎn)品注冊有效期為五 年。Some product approval processes will also include product sample analysis, though this occurs only in about ten percent of all application processes.一些產(chǎn)品的審批程序也將包括產(chǎn)品In樣品分析，雖然這僅發(fā)生在約10百分之所有應(yīng)用程序。this case, the product application and sample will be forwarded to the Vietnam Institute o

60、f Quality Control.在這種情況下，產(chǎn)品 的應(yīng)用和樣品將被轉(zhuǎn)交給越南質(zhì)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.該研究所將分析樣品的分析比較，結(jié)果證明在注 冊程序包括在內(nèi)。The applicant is responsible for paying thetesting fee; the amount depends on the numb