英文)关于外国直接投资在越南进行药品美容个体医疗服务活动的法规和手续总则

1、GENERAL LEGAL FRAMEWORK AND PROCEDURE OF FOREIGN DIRECT INVESTMENT IN DOING BUSINESS OF PHARMACEUTICAL, COSMETIC PRODUCTS AND PRIVATE HEALTH CARE SERVICES IN VIETNAMPrepared by: September 20111英文)关于外国直接投资在越南进行药品美容个体医疗服务活动的法规和手续总则LEGAL FRAMEWORKLaws & Regulations for general investmentVietnams WTO Ac

2、cession Commitment in ServicesLaw on Investment and documents detailing and guiding its implementationLaw on Enterprises and documents detailing and guiding its implementationLaw on Land and documents detailing and guiding its implementationLaw on Construction and documents detailing and guiding its

3、 implementationLaw on CommerceDecree No. 23/2007/ND-CP of the Government detailing Commercial Law regarding goods purchase and sale activities or goods purchase and sale related activities of foreign invested enterprises in VietnamDecree No. 12/2006/ND-CP of the Government making detailed provisions

4、 for implementation of the Government Law with respect to international purchase and sales of goods; and agency for sale and purchase, processing and transit of goods involving foreign partiesDecree No. 59/2006/ND-CP of the Government detailing the Commercial Law on goods and services, banned from b

5、usiness, subject to restrictions and conditions.2英文)关于外国直接投资在越南进行药品美容个体医疗服务活动的法规和手续总则LEGAL FRAMEWORK (continued)2. Laws & Regulations for pharmaceutical, cosmetic and health care projectsAgreement on the ASEAN Harmonized Cosmetic Regulatory SchemeLaw on Medical Examination and Treatment Law on Pharm

6、acyLaw on Product and Goods QualityDecree No. 79/2006/ND-CP of the Government detailing and guiding the implementation of a number of articles of Law on PharmacyDecree No. 132/2008/ND-CP of the Government detailing the implementation of a number of articles of the Law on product and goods qualityCir

7、cular No. 02/2007/TT-BYT of the Ministry of Health guiding in detail the implementation of a number of articles on drug-dealing conditions prescribed by the Pharmacy Law and the Governments Decree No. 79/2006/ND-CP dated August 9, 2006, detailing the implementation of a number of articles of the Pha

8、rmacy LawCircular No. 47/2010/TT-BYT of the Ministry of the Health guiding on import, export activities of drug and packing directly touching with drug Circular No. 06/2011/TT-BYT of the Ministry of Health providing on management of cosmetic products3英文)关于外国直接投资在越南进行药品美容个体医疗服务活动的法规和手续总则FOREIGN INVES

9、TMENT IN VIETNAMSetting up a business in VietnamVietnam laws offer following primary forms of direct investment to foreigners in Vietnam:A Business cooperation contract (BCC)This form allows foreign investors to pursue business interests in cooperation with Vietnamese companies without establishment

10、 of legal entity.A Joint Venture (JV)A JV may take a form of a limited liability company with more than one member, a joint stock company or a partnership and is a legal entity with limited liability. JV like all different business entities, have advantages and disadvantages. On the positive site, V

11、ietnamese partners can bring in their already existing distribution channels, relationships, access for qualified staff and/or ability to invest in sectors where investment is conditional. However, there are many potential liabilities with a Vietnamese partner. Their organizational structure is also

12、 cumbersome. Their points of view are often different, especially in strategic business planning.A 100% foreign owned enterprise (FOC)A FOC may take a form of a sole member limited liability, a limited liability company with more than one member or a joint stock company. FOC have become increasingly

13、 common, as investors have learned to navigate the local system on their own and as problems with joint venture partners have become more apparent. However, notable disadvantages of a FOC in comparison to other forms of investment include more difficult access to land-use rights (except land in indu

14、strial zones and export processing zones) and being considered for more limited duration of license.4英文)关于外国直接投资在越南进行药品美容个体医疗服务活动的法规和手续总则FOREIGN INVESTMENT IN VIETNAMTrading rights for foreign companies in VietnamForeign companies in Vietnam may directly be involved in distribution network to sell p

15、roducts they manufacture in Vietnam and export their products directly. However, according to Vietnams WTO Accession Commitment, the establishment of trading businesses not associated with manufacturing activities is still limited as:Foreign companies are only entitled to conduct their investment to

16、 import goods which are neither subject on List of goods banned from import and export nor List of goods and schedule for implementation of import rights;Foreign companies are only entitled to conduct their investment to export goods which are neither subject on List of goods banned from import and

17、export nor List of goods and schedule for implementation of export rights; andForeign companies are only entitled to conduct their investment to distribute goods which are neither subject on List of goods banned from distribution nor List of goods and schedule for implementation of distribution righ

18、ts;5英文)关于外国直接投资在越南进行药品美容个体医疗服务活动的法规和手续总则LEGAL CONSTRAINTS AND LIMITATION ON PHARMACY, COSMETIC & HEALTH CARE FOREIGN INVESTMENT PROJECTLimitations on Market Access6英文)关于外国直接投资在越南进行药品美容个体医疗服务活动的法规和手续总则LEGAL CONSTRAINTS AND LIMITATION ON PHARMACY, COSMETIC & HEALTH CARE FOREIGN INVESTMENT PROJECT (con

19、tinued)2.Conditional constraints7英文)关于外国直接投资在越南进行药品美容个体医疗服务活动的法规和手续总则LEGAL CONSTRAINTS AND LIMITATION ON PHARMACY, COSMETIC & HEALTH CARE FOREIGN INVESTMENT PROJECT (continued)2.Conditional constraints8英文)关于外国直接投资在越南进行药品美容个体医疗服务活动的法规和手续总则LEGAL CONSTRAINTS AND LIMITATION ON PHARMACY, COSMETIC & HEALT

20、H CARE FOREIGN INVESTMENT PROJECT (continued)2.Conditional constraints (continued)9英文)关于外国直接投资在越南进行药品美容个体医疗服务活动的法规和手续总则INVESTMENT PROCEDURE1. GeneralThe process and procedures for establishment and operation of an investment project shall include the following main stages:Stage 1: Preparation of pre

21、-feasibility studyStage 2: Approval in principle from competent authorities for investors to develop the projectStage 3: Preparation of feasibility studyStage 4: Application for investment certificate of the investment project from competent authorities Stage 5: Approvals to land, if anyStage 6: Pro

22、ject developmentStage 7: License for operation, if any.10英文)关于外国直接投资在越南进行药品美容个体医疗服务活动的法规和手续总则INVESTMENT PROCEDURE (continued)Procedure for establishment of an investment project including construction works (manufactory, warehouse or hospital)Stage 1: Preparation of pre-feasibility studyPreliminary

23、study the necessities for the investmentEstimate size and form of investmentDetermine location and area where the project will be developedPreliminary analyze and select technology, machinery and equipments will be equipped to the project Outline construction methodPreliminary calculate the eco-soci

24、al effects brought by the projectOthers11英文)关于外国直接投资在越南进行药品美容个体医疗服务活动的法规和手续总则INVESTMENT PROCEDURE (continued)Procedure for establishment of an investment project including construction works (manufactory, warehouse or hospital)Stage 2: Approval in principle from competent authorities for investors t

25、o develop the project.Contacting authority: State management agencies of planning & investment (i.e. DPI, provincial industrial zones administrations)Involved authorities: Central government: Ministry of Health, Ministry of Industry and TradeLocal authorities: DPI, DOH, DOIT, DNRE, DOCDecision maker

26、: Provincial committee or the Government depending on size and/or complexity of the project12英文)关于外国直接投资在越南进行药品美容个体医疗服务活动的法规和手续总则INVESTMENT PROCEDURE (continued)Procedure for establishment of an investment project including construction works (manufactory, warehouse or hospital)Stage 3: Preparation

27、of the investment project (feasibility study)Upon obtaining the approval in principle, investors have to prepare the investment project with the following contents:Grounds of the necessities for the investmentForm of investmentLocation and area where the project will be developedSite clearance, if a

28、nyDetailed analysis and selection of technology, machinery and equipmentsHuman resources & manpower deploymentConstruction design methodSolutions of environment protectionCapital sourcesInvestment effectsImplementation schedule13英文)关于外国直接投资在越南进行药品美容个体医疗服务活动的法规和手续总则INVESTMENT PROCEDURE (continued)Pro

29、cedure for establishment of an investment project including construction works (manufactory, warehouse or hospital)Stage 4: Application for investment certificate of the investment project from competent authorities This stage will include following sub-stages:Approval to master planAppraisal & appr

30、oval to Environment Impact Assessment StudyContacting authority: State management agencies of planning & investment (i.e. DPI, provincial industrial zones administrations)Involved authorities: Central government: Ministry of Health, Ministry of Industry and TradeLocal authorities: DPI, DOH, DOIT, DN

31、RE, DOCDecision maker: Provincial committee or the Government depending on size and/or complexity of the project14英文)关于外国直接投资在越南进行药品美容个体医疗服务活动的法规和手续总则INVESTMENT PROCEDURE (continued)Procedure for establishment of an investment project including construction works (manufactory, warehouse or hospital)

32、Stage 5: Approval to landSub-stages:Submission of dossier for allocation or lease of land Surrender of land by current landlords Allocation of land to the investorInvolved authorities: DNRE, DOC, People Committees of related district and commune.Decision maker: Provincial People Committee15英文)关于外国直接

33、投资在越南进行药品美容个体医疗服务活动的法规和手续总则INVESTMENT PROCEDURE (continued)Procedure for establishment of an investment project including construction works (manufactory, warehouse or hospital)Stage 6: Project developmentDevelopment of constructionApplication for construction permit (including fire fighting permit)

34、Erection of construction works (i.e. manufactory, warehouse or hospital)Installation of machinery & equipmentsBuilding up necessary human resourcesRecruit sufficient eligible & capable employeesEstablish HR structure & organizationOrganize necessary training courses for employeesFacilitation of nece

35、ssary services Water, power supply;Sewage drainage and treatmentSolid Waste Disposal16英文)关于外国直接投资在越南进行药品美容个体医疗服务活动的法规和手续总则INVESTMENT PROCEDURE (continued)Procedure for establishment of an investment project including construction works (manufactory, warehouse or hospital)Stage 7: Obtaining operation

36、 license (Certificate of satisfaction of eligible conditions for operation)Preparation and submission of complete dossier with appropriate explanation to MOHSite inspection of MOHs delegation for verification and appraisal of the projectFinalize the appraisal and issuance of the operation license to

37、 the project17英文)关于外国直接投资在越南进行药品美容个体医疗服务活动的法规和手续总则INVESTMENT PROCEDURE (continued)3. Procedure for establishment of an investment project without construction worksProcedure and process applicable to such project is nearly the same with above, except to stages related to land & construction.18英文)关于外

38、国直接投资在越南进行药品美容个体医疗服务活动的法规和手续总则V. ALIAT LEGAL INTRODUCTIONAliat Legal is a leading dynamic commercial law firm in Vietnam. Practicing in two offices in Ho Chi Minh City and Hanoi, Aliat Legal offers specialist advice and consultancy to Vietnamese and international clients in corporate and commercial,

39、 intellectual property and business operation by blending local knowledge and global standards.Aliat Legal recognizes the importance and vital role of legal as well as cost-effective solutions in our clients business. That is why we actively strive to maintain a strong relationship with our clients,

40、 and to adopt a pro-active approach to practice, often becoming involved at the deal structuring stage. We promise a commercial approach along with tailored and high quality advice at all times. We are keen on developing a constructive rapport with our clients and becoming the allied attorneys partnering with our clie