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.

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 Law firm in Hanoi, Law firm in Ho Chi Minh and Law firm in Danang.

Nguồn: https://antlawyers.vn/library/can-foreign-invested-enterprises-distribute-pharmaceutical-products-in-vietnam.html

Read More

Benefits of Representative Offices in Vietnam

 Following the trend of international economic integration, foreigners have been attracted by the benefits of doing business in Vietnam through setting up representative offices, setting up company, acquiring shares in Vietnam enterprise through M&A activity.

At the initial stage, foreign entity would try to research market, undertake due diligence on its clients, buyers, clients, or other business partners therefore many will be interested in establishing a representative office in Vietnam.

The foundation of representative office of foreign entity in Vietnam is governed under Vietnam Commercial Law 2005 and Decree 07/2016 / ND-CP dated 25 May, 2016.

Advantages of establishment of a representative office:

Establishing a representative office is a tool to research the market. For the first time, foreign enterprises entering the Vietnam market, the primary purpose is understanding the market, undertaking research on clients, or due diligence on their business partners, distributors, monitoring the performance of buyers and being familiar with the Vietnam market. The establishment of representative office in Vietnam turns out to be the most effective option both of cost and time.

The representative office in Vietnam is an effective tool to promote commercial activity, seeking partners, and increasing opportunities to expand business market in Vietnam.

Representative office form in Vietnam has allowed foreign entity to receive benefits such as recruiting Vietnamese employees, foreign employees working in offices whom could apply for work permit in Vietnam, then temporary residence card in Vietnam, opening bank accounts in foreign currencies or Vietnam dong at commercial banks, and to be allowed to use those accounts solely for their operations.

According to the laws of Vietnam, the establishment of representative offices does not require the investor’s capital. Instead, setting up a company in Vietnam, an economic organization requires capital contribution as per business plan, ranging from USD 50 k to million USD. Sometime, if the investment fall under conditional areas, setting up company seems more challenging. This relieves the foreign trader from advancing too much to achieve the purpose of expanding the market before the business plan has been proved to materialize.

Further, the establishment of representative office follows more simple procedures for licensing in Vietnam than establishing entity in Vietnam. Accordingly, the process has been taken less time which is more favorable for foreign traders.

Challenges of the establishment of representative office in Vietnam?

Vietnam law provides that, in order to establish a representative office in Vietnam, foreign traders have to prove the fulfillment of the financial responsibility in their country. In practice, the foreign entity is expected to provide audited financial statements. In some countries, the financial audited report is not available according to laws. The Vietnam Department of Trade and Commerce, which state authority would grand representative office operation certificate would require documents showing the fulfillment of tax liabilities or financial obligations of Following the trend of international economic integration, foreigners have been attracted by the benefits of doing business in Vietnam through setting up representative offices, setting up company, acquiring shares in Vietnam enterprise through M&A activity.

At the initial stage, foreign entity would try to research market, undertake due diligence on its clients, buyers, clients, or other business partners therefore many will be interested in establishing a representative office in Vietnam.

The foundation of representative office of foreign entity in Vietnam is governed under Vietnam Commercial Law 2005 and Decree 07/2016 / ND-CP dated 25 May, 2016.

Advantages of establishment of a representative office:

Establishing a representative office is a tool to research the market. For the first time, foreign enterprises entering the Vietnam market, the primary purpose is understanding the market, undertaking research on clients, or due diligence on their business partners, distributors, monitoring the performance of buyers and being familiar with the Vietnam market. The establishment of representative office in Vietnam turns out to be the most effective option both of cost and time.

The representative office in Vietnam is an effective tool to promote commercial activity, seeking partners, and increasing opportunities to expand business market in Vietnam.

Representative office form in Vietnam has allowed foreign entity to receive benefits such as recruiting Vietnamese employees, foreign employees working in offices whom could apply for work permit in Vietnam, then temporary residence card in Vietnam, opening bank accounts in foreign currencies or Vietnam dong at commercial banks, and to be allowed to use those accounts solely for their operations.

According to the laws of Vietnam, the establishment of representative offices does not require the investor’s capital. Instead, setting up a company in Vietnam, an economic organization requires capital contribution as per business plan, ranging from USD 50 k to million USD. Sometime, if the investment fall under conditional areas, setting up company seems more challenging. This relieves the foreign trader from advancing too much to achieve the purpose of expanding the market before the business plan has been proved to materialize.

Further, the establishment of representative office follows more simple procedures for licensing in Vietnam than establishing entity in Vietnam. Accordingly, the process has been taken less time which is more favorable for foreign traders.

Challenges of the establishment of representative office in Vietnam?

Vietnam law provides that, in order to establish a representative office in Vietnam, foreign traders have to prove the fulfillment of the financial responsibility in their country. In practice, the foreign entity is expected to provide audited financial statements. In some countries, the financial audited report is not available according to laws. The Vietnam Department of Trade and Commerce, which state authority would grand representative office operation certificate would require documents showing the fulfillment of tax liabilities or financial obligations of the last fiscal year, or equivalent documents as proof of existence and operation of the foreign trader issued or certified by competent authorities where such foreign trader is established. This provision may initially be difficult. However, if the foreign trader has been established and operated legally in their country, the implementation of this provision is not a major obstacle.

As a large potential market such a Vietnam, as well as the current rapid reform in administrative procedures, Vietnam Government has been more flexible to encourage foreign traders doing business in Vietnam, hence the establishment of representative offices is an optimal method to consider for market research, trade promotion and a stepping stone to penetrate the Vietnam market successfully.

The commercial law and other business laws in Vietnam are frequently changing toward attracting more quality investment projects into Vietnam. ANT Lawyers in Hanoi, Da Nang and Ho Chi Minh City continue to follow and provide update to its clients for their smooth operation in Vietnam.

Nguồn: https://antlawyers.vn/library/benefits-of-representative-offices-in-vietnam.html

the last fiscal year, or equivalent documents as proof of existence and operation of the foreign trader issued or certified by competent authorities where such foreign trader is established. This provision may initially be difficult. However, if the foreign trader has been established and operated legally in their country, the implementation of this provision is not a major obstacle.

As a large potential market such a Vietnam, as well as the current rapid reform in administrative procedures, Vietnam Government has been more flexible to encourage foreign traders doing business in Vietnam, hence the establishment of representative offices is an optimal method to consider for market research, trade promotion and a stepping stone to penetrate the Vietnam market successfully.

The commercial law and other business laws in Vietnam are frequently changing toward attracting more quality investment projects into Vietnam. ANT Lawyers in Hanoi, Da Nang and Ho Chi Minh City continue to follow and provide update to its clients for their smooth operation in Vietnam.

Nguồn: https://antlawyers.vn/library/benefits-of-representative-offices-in-vietnam.html

Read More

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 firms in Vietnam have always following up the legal development on transportation to provide our clients with regular update on the matters.

Nguồn:https://antlawyers.vn/library/multimodal-transport-business-regulations-in-vietnam.html

Read More

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.

Read More