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

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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 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

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What Are Prohibited Acts Under the Law on Cyber Information Security?

   According to Article 12 of Vietnam Maritime Laws, 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 are Responsibility for Wrongful Request of Arrest of Ship?

According to Article 131 of Vietnam Maritime Law, the wrongful request of arrest of ship in Vietnam shall be subject to financial obligations. In particular:

The applicant for arrest of a ship must be held legally liable for his request. If the request for arrest of a ship is wrongful, which may lead to any loss, such applicant shall be responsible for compensating for any loss or damage possibly incurred.

Any loss or damage that may be incurred from consequence of such request for wrongful arrest shall be dealt with as agreed upon between parties. Where there is any disagreement or dispute that may arise, the Court or Arbitration Tribunal shall be requested to settle this disagreement and dispute in accordance with laws.

If the Court that grants a judgement on arrest of a ship which is not based on the reasons for a request for arrest or does not serve on the ship as the right subject matter of such request, which may cause any loss or damage, it shall be liable for any compensation in accordance with laws and regulations.

How ANT Lawyers Could Help Your Business?

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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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