Can Foreign Invested Enterprises Distribute Pharmaceutical Products in Vietnam?

 Currently, with the complicated developments of the Covid-19 epidemic in the world in general and in Vietnam in particular, the research, production and import of Covid-19 vaccines are the matter that everyone is concerned about. On February 24th, 2021, the first batch of vaccine approved for import was transported to Vietnam by the Vietnam Vaccine Joint Stock Company.

Facing this situation, a number of foreign enterprises have expressed their opinions on the limitations imposed on foreign-invested enterprises in the field of distribution of pharmaceutical products in Vietnam. Vietnam has reserved no commitment to open the distribution of pharmaceutical products service market and has not committed to opening the distribution of pharmaceutical products service market under any trade agreement or international treaty up to the moment, because the pharmaceutical sector is sensitive, directly related to access to drugs and people’s health.

According to the provisions of the law, “distribution of pharmaceutical products” means the division, movement and storage of pharmaceutical products from the warehouse of the manufacturer/importer of such products or from a distributor to the end user thereof or to a distribution point or between distribution points by means of various transport methods. For distribution services, in the WTO Commitments, it is clear that pharmaceutical distribution services are excluded from the scope of commitments for all modes of supply. In addition, Appendix 03 of Circular 24/2016/TT- publicizing roadmaps for goods trade and goods trading directly related activities of foreign-invested enterprises in Vietnam, it is also recognized that pharmaceutical products are on the list of goods not entitled to distribution.

Regarding this issue, the Drug Administration of Vietnam expressed the following viewpoint: “The suspension of allowing foreign-invested enterprises in Vietnam to provide drug storage and transportation services is to prevent the distribution of disguised drugs in Vietnam, contributing to health security and towards the professionalization of the medicine distribution system in Vietnam.”

Point c, Clause 10, Article 91 of Decree 54/2017/ND-CP, effective from May 8, 2017, provides for cases ineligible to distribute drugs as follows:

“10. The entities that are entitled to import but not entitled to distribute drugs and medicinal ingredients in Vietnam must do activities related to distribution of drugs and medicinal ingredients in Vietnam except for drugs and medicinal ingredients they manufacture in Vietnam, including:

c) Providing drug/medicinal ingredient transport or storage services.”

According to this content, foreign-invested enterprises in Vietnam are not allowed to transport and preserve drugs, except for drugs and medicinal ingredients manufactured by that enterprise in Vietnam. It can be seen that the restriction on the right to distribute drugs to foreign-invested enterprises is aimed at ensuring health security, being proactive in drug supply and distribution, towards to professionalize the domestic drug distribution system as a foundation to support the development of the domestic pharmaceutical industry and contributing to better control of drug prices in the market.

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Which Court Could Grant a Decision to Arrest a Ship in Vietnam?

 According to Article 130 of Vietnam Maritime Law, the following courts could issue decision to arrest a ship in Vietnam.

The People’s Court at the level of a province where the seaport at which a ship subject to a request for arrest of a ship is having marine operations is located shall be vested with authority to grant a decision to arrest that ship.

Where a seaport has different port terminals located within different centrally-affiliated cities and provinces, the People’s Court at the level of a province where the seaport at which a ship subject to an arrest request is having marine operations is located shall be vested with authority to grant a decision to arrest that ship.

The People’s Court that is dealing with a civil case, or the People’s Court at the level of a province where the Arbitration Council is resolving any dispute, shall be accorded authority to impose an arrest of a ship as an interim injunction.

The Chief Justice of the People’s Supreme Court shall consider and decide whether the lower Court has been accorded authority to grant a decision on arrest of a ship in the event that there is any dispute over jurisdiction between the People’s Courts at the provincial level.

We help clients overcome cultural barriers and achieve their strategic and financial outcomes, while ensuring the best interest rate protection, risk mitigation and regulatory compliance. ANT lawyers have Attorneys in Hanoi, Attorneys in Ho Chi Minh and Attorneys in Danang.

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Conditions of Setting up Import and Export Company in Vietnam

Before Vietnam joined World Trading Organization (WTO), distribution and import, export activities conducted by foreign owned entities are strictly regulated by Vietnam government. As such, foreigners could only conduct the import of goods through the Vietnam agents.

Since 2007, Vietnam has become an official member of WTO and it had to commit a route to open local market to foreign companies and traders, including foreign distributors. Within 02 years from the date of accession to WTO, regulations with services and trading activities have been eased up gradually to be more open. Since 2009, foreigner investors have been entitled to set up 100% foreign-owned companies to conduct activities related to the sale and purchase of goods including import and export, and distribution including acting as agents for purchase and sale, wholesale, retail and franchising. This opens up opportunities for foreign investors to expand their trading activities in Vietnam.

1. Conditions for foreign-owned company in import and export or distribution field:

According to Article 4, Decree No. 23/2007/ND-CP on 12 February 2007 by the Government providing regulation for implementation of Commercial Law regarding purchase and sale of goods and activities directly related to the purchase and sale of goods by enterprises with foreign owned capital in Vietnam (“Decree No. 23”), the conditions for an enterprise with foreign owned capital to be granted a business license for activities of purchase and sale of goods and activities related to purchase and sale of goods in Vietnam shall comprise:

a. It is an investor belonging to a country or territory participating in an international treaty of which the Socialist Republic of Vietnam is a member and in such treaty Vietnam has undertaken to open the market on activities of purchase and sale of goods and activities directly related to purchase and sale of goods;

b. The form of investment is consistent with the schedules undertaken in international treaties of which the Socialist Republic of Vietnam is a member and is consistent with the law of Vietnam;

c. The goods and services in which business is conducted are consistent with Vietnam’s undertaking to open the market and are consistent with the law of Vietnam;

d. The scope of operation is consistent with Vietnam’s undertaking to open the market and is consistent with the law of Vietnam;

e. It has approval from the competent State body.

With respect to foreign investors not in the category stipulated in clause (a) above, the Minister of Industry and Trade shall consider each application on a case by case basis and must approve activities of purchase and sale of goods and activities directly related to purchase and sale of goods before the authorized State body grants a business license.

2. Conditions of foreign-invested enterprises on implementation export rights

According to Circular No. 08/2013/TT-BTC dated on April 22, 2013 issued by the Ministry of Industry and Trade detailing the goods trading and directly related activities of foreign-invested enterprises in Vietnam (“Circular No.08”), foreign-owned enterprises which have been licensed to conduct export activities are permitted to export, purchase goods in Vietnam for export, including goods imported in Vietnam by them or other enterprises already finished tax liability and other financial obligations, under the following conditions:

a. Export goods which are not in the list of those banned from export, list of those temporarily suspended from export, list of those of which the right to export is not granted according to international commitments;

b. For export goods in the list of conditional export goods, enterprises must meet conditions as prescribed by law;

c. For export goods in the list of goods to be exported under roadmaps specified in international commitments, enterprises must comply with the committed roadmap;

d. The export commodities must be suitable with content of the right to export which enterprises have been licensed for implementation.

The foreign-invested enterprises already licensed for right to export are entitled to directly do procedures for export of goods at customs agencies as prescribed by law.

The foreign-invested enterprises already licensed for right to export are entitled to directly purchase only goods of Vietnamese traders who have business registration or right to import, right to distribute such goods for export; not entitled to organize the network of goods purchase in Vietnam for export, unless otherwise provided by law of Vietnam or International treaties to which the Socialist Republic of Vietnam is a contracting party.

3. Conditions of foreign-invested enterprises on implementation import rights:

Under Circular No. 08, foreign-owned enterprises which are licensed to import goods are permitted:

a. Import goods which are not in the list of those banned from import, list of those temporarily suspended from import, list of those of which the right to import is not granted according to international commitments;

b. Import goods belong in the list of conditional import goods, enterprises must meet conditions as prescribed by law;

c. Import goods belong in the list of goods to be imported under roadmaps specified in international commitments, enterprises must comply with the committed roadmap;

d. The import commodities must be suitable with content of the right to import which enterprises have been licensed for implementation.

The foreign-invested enterprises already licensed for right to import are entitle to directly do procedures for import of goods at customs agencies as prescribed by law.

The foreign-invested enterprises already licensed for right to import but not yet licensed for right to distribute are entitled to directly sell import goods for Vietnamese traders who have business registration or right to export, right to distribute such goods; not entitled to organize or participate in the network of goods distribution in Vietnam, unless otherwise provided by law of Vietnam or International treaties to which the Socialist Republic of Vietnam is a contracting party.

4. Conditions of foreign-owned enterprises on implementation distribution rights:

Distribution is defined as Decree 23 as “activities of wholesaling, retailing, agency for purchase and sale of goods and franchising in accordance with the law of Vietnam”. The right to distribution is defined as “the right to undertake directly activities of distribution”.

Under Circular No. 08, foreign-owned enterprises which have been licensed to conduct distribution activities shall be permitted:

a) To conduct wholesaling, retailing, franchising and agency for trading goods manufactured in Vietnam and goods imported into Vietnam, except:

i) For goods on the list of those banned from business and list of those of which the right to distribution is not granted under international commitments;

ii) For goods restrained for business or goods of conditional business, enterprises must meet conditions as prescribed by law;

iii) For distribution goods in the list of goods to be distributed under roadmaps specified in international commitments, enterprises must comply with the committed roadmap.

b) The distribution commodities must be suitable with content of the right to distribution which enterprises have been licensed for implementation.

Depending on the method of business, investor could choose one of activities belonging to distributions rights. With each method, the investor needs to apply a suitable business registration issued by competent authorities.

Further, foreign invested enterprises whose investment registered retail business line in their investment certificate could open a single retail outlet in order to sell their goods to the end of user or customers. The setting up of retail establishments including the first retail establishments must abide by law regulations on state management for retail activities and be conformable with the related master plans of central-affiliated cities and provinces, where are expected for setting up of retail establishments. The setting up of retail establishments in addition to the first retail establishments are considered for each specific case based on the examination on economic demand of each locality where place retail establishment under the criteria: Quantity of retail establishments, stability of market, residential density and scale of district-level localities where are expected for the setting up of retail establishments.

Our lawyers of foreign investment practice at ANT Lawyers, a law firms in Vietnam are available to advise and provide client with service and representation for setting up a trading company in Vietnam.

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FM Logistic Builds 30 Million USD Distribution Center in Bac Ninh

On April 10th, FM Logistics – French logistics and transportation company officially started construction of a 30 million USD distribution center in VSIP Bac Ninh Industrial Park, laying the foundation for the company to explore the developing logistics market of Vietnam.

Once completed, this center will use about 300 employees, providing an area of 52,000 m2 for a maximum of 70,000 inventory boards. Phase I with an area of 21,000 m2 will be completed in the first quarter of 2020.

Logistics demand is growing strongly in Vietnam, one of the fastest growing economies in the world with GDP growth of about 7% in 2018. The growth of domestic production, wages and consumption, the young population and the explosion of e-commerce are also factors that promote the development of Vietnam’s logistics market. This is an opportunity for international 3PL companies to provide added value of logistics and door-to-door delivery services.

The distribution center and warehouse in Bac Ninh will support the development of food, retail, fast-moving consumer goods, industrial goods and cosmetics in the booming Vietnamese market. The center also supports increasing storage space of FM Logistic in Vietnam by nearly 10 times, at the time of increasing demand for Grade A storage. This proves FM Logistics commitment to invest in Vietnam.

The entire facility of this distribution center is designed by FM Logistic member company – NG Concept, including a wide range of utilities to accommodate temperature sensitive products, fast-moving consumer goods, electronic equipment, spare parts and even hazardous products.

Services that will be provided by the center include storage (with different temperature ranges), reception, packaging (or value-added services) and distribution. Optimize internal and external flow of facilities to match the increasing needs of modern retail operations.

From May 2019, FM Logistic will also start operating a rental warehouse with an area of 6,500 m2 in An Phu, Binh Duong province, 30km away from Ho Chi Minh City. The company officially operated in Vietnam in August 2017. In 2018, the company began providing nationwide shipping services, using its partner network.

Founded in France in 1967, FM Logistic is an independent logistics company with family scale, with a revenue of 1.2 billion EUR in fiscal year 2018, two thirds of which come from the international market. The company operates in 14 countries across Europe, Asia and Latin America (Brazil) and has about 26,000 employees.

FM Logistic invests in innovation to bring logistics, shipping and classifying solutions to meet the changing needs of consumers, the development of e-commerce and the distribution of multichannel sales. FM Logistic has served many international and domestic companies in the field of fast-moving consumption, retail, perfume, cosmetics, industrial production and health care.

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How Cross-Border Supply of Services Works?

Bilateral or multilateral free trade agreements between countries are formed majorly based on the WTO agreement system. In particular, GATS as an Agreement under the WTO system, is the first and only set of multilateral rules governing international trade in services. Ways or modes of trading services are basic provisions of GATS, including: Cross-border supply (mode 1), Consumption abroad (mode 2), Commercial presence (mode 3), Presence of natural person (mode 4). The categorization of modes covering its own regulations depends on the territorial presence of the supplier and the consumer at the time of the transaction.

According to GATS, cross -border supply means supply of a service from the territory of one Member into the territory of any other member, and supplier and consumer of a member do not present within the territory of another member. Consumption abroad means supply of a service in the territory of one Member to the service consumer of any other member. Presence of a natural person means supply of a service by a service supplier of one member, through presence of natural persons of a member in the territory of any other member. It should be noted that cross-border supply of services is defined depending on each Agreement. Under CPTPP, cross-border supply includes modes 1, 2 and 4 above. In this article, cross-border supply is equivalent to mode 1, under GATS.

When participating in GATS, members make commitments for market access with respect to each mode of service supply and sub-sector. The GATS provides a set of general principles that all WTO members must adhere to, which there are no unnecessary barriers applied to trade. However, GATS expressly recognizes the rights of member governments to manage and regulate the supply of services in pursuit of their own policy objectives. GATS also does not interfere in internal affairs and policies of members. Therefore, the governments absolutely have the right to decide and adopt their trade policies. The enterprise of a member must comply with domestic regulations in the territory of another member where they conduct business and trade in services and refer to that Member’s Schedule of Specific Commitments to understand market access obligations and national treatment.

Most sub-sectors do not restrict market access and national treatment for foreign suppliers providing cross-border services in Vietnam (legal, accounting, auditing, tax, architecture, advertising, management consulting, …). Although the market access is not restricted, it does not mean that the foreign suppliers freely provide services in Vietnam without satisfaction of conditions or without the consent of the competent state authorities. To consider this matter and have a correct understanding, the national treatment principle should be reviewed, it requires that each member shall accord to services and service suppliers of any other member the treatment no less favourable than that it accords to its own like services and service suppliers. Having said that, in the event that a member maintains business conditions for the domestic services and service suppliers, these conditions may also apply to the foreign services and service suppliers.

Such as accounting service business, foreign service suppliers are not restricted in market access and national treatment under the Schedule of Specific Commitments in Services. It means that a foreign accounting firm can provide accounting services to a Vietnamese enterprise. However, accounting service is a conditional business applicable to domestic firms. According to the national treatment principle, Vietnam has the right to impose similar conditions on foreign suppliers. Reference to the provisions of Vietnamese laws, the foreign accounting firm must fully meet the conditions of head office and personnel to be licensed its business in Vietnam. Further, there are tax liabilities arisen which obligations of registration and declaration depend on particulars of transactions. It is suggested that international trade lawyers are consulted to avoid potential disputes or non-compliance of cross-border supply of services.

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Multimodal Transport Business Regulations in Vietnam

On October 16th, 2018, Vietnam Government issued Decree No. 144/2018/ND-CP amending, supplementing the decrees on multimodal transport. Under the law of Vietnam, multimodal transport (“MT”) is the transportation of goods performed with at least two different modes of transport under the multimodal transport contract from an original place to a place designated for delivery, the carrier is liable for the entire carriage. MT business includes: International multimodal transport (“IMT”) and Domestic multimodal transport (“DMT”).

The new decree eliminates and simplifies regulations on IMT business conditions and abolishes DMT business as a conditional business line. In fact, DMT including many transportations such as transport by sea, air,… is governed by specialized laws on each transport, hence it is not necessary to stipulate additional business conditions when conducting the combined transport.

Regarding the conditions of IMT business, the new Decree no longer differentiates between domestic and foreign enterprises as in the past, all enterprises therefore must meet the followings:

(1) Maintaining a minimum amount of assets equivalent to SDR 80,000 or provide an equivalent guarantee or an alternative of financial character as regulated by laws;

(2) Having a liability insurance policy for multimodal transport operator or an equivalent guarantee.

In addition, in order to facilitate member state of the ASEAN Framework Agreement on Multimodal Transport or another international treaty on multimodal transport to which Vietnam is a signatory, new regulations are stipulated as follows:

(1) Having a registration certificate of international multimodal transport or another document of equivalent validity issued by the competent national body of its country;

(2) Having a liability insurance policy for multimodal transport operator or an equivalent guarantee.

The licenses to provide international multimodal transport service issued by competent authorities of Vietnam before the date of entry into force of this Decree are still valid until their expiration dates.

With the role of supporting trading activities, modern transports need to meet the increasingly complex requirements of the domestic and international transport market, which not only deliver goods but also connect the transport process into an uninterrupted transport chain to ensure a faster and safer transport process.

Transport lawyers at ANT Lawyers, the law firm in Vietnam have always following up the legal development on transportation to provide our clients with regular update on the matters.

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ANT Lawyers is a law firm in Vietnam located in the business centers of Hanoi, Danang and Ho Chi Minh City. We provide convenient access to our clients. Please contact us to book your time in advanced to let us provide our best service.

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What are Prohibited Acts in Marine Operations in Vietnam?

According to Article 12 of Vietnam Maritime Law, the acts prohibited in marine operations in Vietnam are grouped in activities that negatively impact national security, people, traffic, environment, in particular:

Harm or pose threatened harms to national sovereignty and security.

Carry people, goods, baggage, weapons, radioactive substances, hazardous discarded substances and narcotics in contravention of laws.

Intentionally create obstacles which can pose dangers or obstructions to marine traffic.

Use and operate ships which have not been registered or inspected or exceed the validity duration of registration and inspection; use counterfeit registration and inspection.

Refuse to participate in marine search and rescue activities if practical conditions permit.

Cause environmental pollution.

Infringe upon life, health, honor and dignity of persons aboard ships; embezzle and intentionally damage or ruin property aboard ships; take flight after causing any shipwreck.

Cause the public disorder, impede or react against implementation of duties of law enforcers on board ships and at seaports.

Destroy, damage, disassemble or steal components, parts, raw materials, building materials and equipment of marine construction works.

Damage, destroy and intentionally move or reduce the efficacy of marine signaling systems.

Explode bombs or other explosive materials within the boundaries of a seaport, port water area or navigational channel without authorization granted by competent authorities.

Illegally build and operate seaports and other structures within the planned boundaries of approved seaports, navigational channels and within the protective enclosure of marine structures.

Develop construction projects which may reduce or eliminate effects of marine structures.

Commit abuse of title, position and authority to contravene regulations on port authority; abet and screen persons who commit violations against maritime laws from any punitive measures.

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What Goods Allowed to Be Imported into Vietnam?

Foreign owned companies in Vietnam wishing to import and distribute physical goods into Vietnam must comply with many regulations. It is imperative that the right to conduct import business of foreign investors and FDI companies differ from the right of Vietnamese traders having no foreign direct investment capital because trading activities are considered conditional investment area.

1.General Principles of Imported Goods

In principle, as other countries, the importers have to follow the general rules when importing and distributing physical goods into Vietnam:

-Not to import goods specified under the list of goods banned from import or suspended from import provided, published by Vietnam government;

-Follow the guideline or import regulations and conditions required by ministries and ministerial-level agencies. There are specific conditions for importing certain goods which the importers have to follow i.e. certain medical equipment have to be approved by the Ministry of Health; Food, cosmetics products need to be testedReceiving and transmitting telecom equipment must be inspected by Ministry of Information and Communication; Books, CDs will be checked and scanned for contents to be approved by Ministry of Cultures, Sport and Tourism; Equipment must satisfy energy, environmental regulations to be inspected and labeled by Ministry of Science and Technology…

-Implement other relevant laws, commitments of the Socialist Republic of Vietnam in treaties which it has signed or acceded to, and the roadmap announced by the Ministry of Industry and Trade.

2.Goods Prohibited to Be Imported into Vietnam

-For the goods being banned to be imported and distributed in Vietnam, the importers have to follow strictly to avoid penalties:

-Weapons, ammunitions, explosives (excluding industrial explosives), military technical equipment.

-Assorted fireworks, sky lanterns, assorted devices causing interference to vehicle speedometers.

-Used consumer goods: Textiles and garments, footwear, clothes; Electronic appliances; Refrigerating appliances; Home electric appliances; Medical equipment; Interior decoration goods;

-Assorted publications banned from dissemination and circulation in Vietnam

-Assorted cultural publications banned from dissemination and circulation or decided to be suspended from dissemination and circulation in Vietnam.

-Right-hand drive means of transport; assorted automobiles and their spare parts which have their frame or engine numbers erased, modified or tampered with; Assorted motorcycles, special-use motorbikes and motorbikes which have their frame or engine numbers erased, modified or tampered with

-Used supplies and vehicles

-Chemicals in Annex III of the Rotterdam Convention.

-Pesticides banned from use in Vietnam.

-Wastes and scraps, refrigerating equipment using C.F.C.

-Products and materials containing asbestos of the amphibole group

-Schedule-I toxic chemicals; Chemicals on the list of banned chemicals

It is important for foreign trader wishing to establish a trading company in Vietnam to not only study the market demand in Vietnam but also the country’s law on import, export, customs law to ensure their compliance during the operation. If doubted, the Client is suggested to reach out for help and advisory of law firm in Vietnam by qualified lawyers in the area of import, export and customs.

How ANT Lawyers Could Help Your Business?

ANT Lawyers is a law firm in Vietnam located in the business centers of Hanoi, Danang and Ho Chi Minh City. We provide convenient access to our clients. Please contact us to book your time in advanced to let us provide our best service.

Call us at +84 28 730 86 529 or send us email ant@antlawyers.vn

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VietNam opens up logistics sector to foreign companies

Marine Insurance law firmin Vietnam

HCMC – Foreign investors will be given the go-ahead to set up companies in Vietnam, but with conditions on ownership and services, according to Government Decree 163 on logistics services which will come into force on February 20.

Foreign investors are given the green light to establish maritime shipping companies, except for domestic services.

They are required to meet some requirements such as their vessels carrying the Vietnamese flag, their captains and first vice captains being Vietnamese citizens, and the number of their foreign crewmen being less than one-third of the total on board.

Overseas investors who offer container loading and unloading services can set up their own companies, or hold a stake of below 50% in local enterprises.

Those providing goods customs clearance services can also do the aforementioned services. However, they have the right to establish a commercial presence in the form of business cooperation contract only.

Foreigners are allowed to set up companies specializing in goods shipping services by inland waterway and rail, or acquire stakes of less than 49% in local companies in the same sector.

Those active in road cargo transport can set up their own companies, but all of their drivers must be Vietnamese citizens.

According to the decree, they also must fulfill business investment requirements in line with regulations for their services. Besides, they must compensate their customers if goods become defective in their shipping process.

Statistics of the Vietnam Logistics Association indicate Vietnam has around 3,000 local companies, with 1,300 being small and medium enterprises, in the logistics sector. However, they hold a market share of a mere 25%. Meanwhile, 25 foreign companies make up the remaining proportion, mainly in international transport services.

The association said the domestic logistics sector has an annual growth rate of 15-16%. The Logistics Performance Index of the World Bank indicates that Vietnam was ranked 64th among 160 countries, and took the fourth place among ASEAN countries behind Singapore, Malaysia and Thailand in 2016.

However, logistics cost accounted for 20.8% of gross domestic product, totaling a whopping US$41.26 billion in 2016.

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