2018年(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-文档资料-精选文档.pptx
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1、,LEGAL FRAMEWORK Laws and agency for sale and purchase, processing and transit of goods involving foreign parties Decree No. 59/2006/ND-CP of the Government detailing the Commercial Law on goods and services, banned from business, subject to restrictions and conditions.,1,LEGAL FRAMEWORK (continued)
2、 2. Laws & Regulations for pharmaceutical, cosmetic and health care projects Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme Law on Medical Examination and Treatment Law on Pharmacy Law on Product and Goods Quality Decree No. 79/2006/ND-CP of the Government detailing and guiding the imp
3、lementation of a number of articles of Law on Pharmacy Decree No. 132/2008/ND-CP of the Government detailing the implementation of a number of articles of the Law on product and goods quality Circular No. 02/2007/TT-BYT of the Ministry of Health guiding in detail the implementation of a number of ar
4、ticles 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 Pharmacy Law Circular No. 47/2010/TT-BYT of the Ministry of the Health guiding on import, export activities
5、of drug and packing directly touching with drug Circular No. 06/2011/TT-BYT of the Ministry of Health providing on management of cosmetic products,2,FOREIGN INVESTMENT IN VIETNAM Setting up a business in Vietnam Vietnam laws offer following primary forms of direct investment to foreigners in Vietnam
6、: A Business cooperation contract (BCC) This form allows foreign investors to pursue business interests in cooperation with Vietnamese companies without establishment 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 co
7、mpany 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, Vietnamese partners can bring in their already existing distribution channels, relationships, access for qualified staff and/or abili
8、ty to invest in sectors where investment is conditional. However, there are many potential liabilities with a Vietnamese partner. Their organizational structure is also cumbersome. Their points of view are often different, especially in strategic business planning. A 100% foreign owned enterprise (F
9、OC) 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 common, as investors have learned to navigate the local system on their own and as problems with joint venture partners have beco
10、me 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 industrial zones and export processing zones) and being considered for more limited duration of license.,3,FOREIGN INVESTMENT IN VIETN
11、AM Trading rights for foreign companies in Vietnam Foreign companies in Vietnam may directly be involved in distribution network to sell products they manufacture in Vietnam and export their products directly. However, according to Vietnams WTO Accession Commitment, the establishment of trading busi
12、nesses not associated with manufacturing activities is still limited as: Foreign companies are only entitled to conduct their investment to 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; Foreig
13、n companies are only entitled to conduct their investment to export goods which are neither subject on List of goods banned from import and export nor List of goods and schedule for implementation of export rights; and Foreign companies are only entitled to conduct their investment to distribute goo
14、ds which are neither subject on List of goods banned from distribution nor List of goods and schedule for implementation of distribution rights;,4,LEGAL CONSTRAINTS AND LIMITATION ON PHARMACY, COSMETIC & HEALTH CARE FOREIGN INVESTMENT PROJECT Limitations on Market Access,5,LEGAL CONSTRAINTS AND LIMI
15、TATION ON PHARMACY, COSMETIC & HEALTH CARE FOREIGN INVESTMENT PROJECT (continued) 2. Conditional constraints,6,LEGAL CONSTRAINTS AND LIMITATION ON PHARMACY, COSMETIC & HEALTH CARE FOREIGN INVESTMENT PROJECT (continued) 2. Conditional constraints,7,LEGAL CONSTRAINTS AND LIMITATION ON PHARMACY, COSMET
16、IC & HEALTH CARE FOREIGN INVESTMENT PROJECT (continued) 2. Conditional constraints (continued),8,INVESTMENT PROCEDURE 1. General The process and procedures for establishment and operation of an investment project shall include the following main stages: Stage 1: Preparation of pre-feasibility study
17、Stage 2: Approval in principle from competent authorities for investors to develop the project Stage 3: Preparation of feasibility study Stage 4: Application for investment certificate of the investment project from competent authorities Stage 5: Approvals to land, if any Stage 6: Project developmen
18、t Stage 7: License for operation, if any.,9,INVESTMENT PROCEDURE (continued) Procedure for establishment of an investment project including construction works (manufactory, warehouse or hospital) Stage 1: Preparation of pre-feasibility study Preliminary study the necessities for the investment Estim
19、ate size and form of investment Determine location and area where the project will be developed Preliminary analyze and select technology, machinery and equipments will be equipped to the project Outline construction method Preliminary calculate the eco-social effects brought by the project Others,1
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