Vietnam's life sciences sector has seen a major transformation since the issuance of a new Pharmacy Law in 2016. The execution of new free trade agreements (FTAs) with foreign countries and the improved implementation of existing FTAs, especially the EU-Vietnam FTA (EVFTA), have brought many positive reforms to the life sciences sector, particularly for pharmaceuticals. Changes to the legal framework for medical, pharmaceutical, medical device and health care products in recent years have further revitalised foreign investment in these sectors. Although there are still many restrictions and barriers imposed on foreign investments to protect the domestic market, the government has shown that those intending to do business in Vietnam are welcomed and supported.

The 2016 Pharmacy Law provided for the first time a clear legal basis for the incorporation of a foreign-invested enterprise (FIE) for the supply of pharmaceuticals to the Vietnam market. Although the scope of activities of these FIEs is still limited to importing drugs and selling them to local distributors (they are commonly called "drug import FIEs"), and they are not allowed to sell drugs directly to hospitals, clinics, drugstores or patients, this still marks a significant development in the pharmaceutical market. Most of the largest global pharmaceutical companies have now set up their own drug import FIEs in Vietnam. As of August 2022, around 30 drug import FIEs had been granted regulatory licences to carry out the import of drugs.

The government has also issued two decrees over the past six years governing all aspects of medical devices. The latest medical device decree took effect on 1 January 2022 and is seen as an effort from the government to provide more efficient mechanisms and reduce burdensome administrative procedures, enabling medical device companies to have more flexibility in doing business.

An M&A trend in the medical sector has been visible in the past few years in relation to medical services. Many large transactions with the target being a local company owning a chain of private hospitals and clinics have been reported, in addition to the formation of new private medical establishments with foreign investment across the whole country.

Funding sources for the life sciences industry in Vietnam differ based on the status of the receiving establishments. Funding to private entities is typically in the form of capital contributions by shareholders or owners, as well as loans from onshore or offshore credit institutions, affiliates or other organisations. Public entities primarily receive funding from the government. Sponsorship is also used as additional funding for public entities in some cases.

The national health care system includes:

The central hospitals are under the management of the Ministry of Health. The other hospitals and health centres are under the management of the provincial Departments of Health.

All health care establishments in the national health care system are funded by social health insurance. Under the Amended Law on Health Insurance, from 1 January 2015, it is compulsory for all people to participate in the social health insurance system. The social health insurance system covers all medicines, medical services and health procedures that are listed on the government's insurance product lists, including the List of Chemical Medicines, Biologicals, Radiopharmaceuticals and Tracers Covered by the Health Insurance Body (Health Insurance Medicines List), and that have won drug bidding procedures. Other medicines, medical services and procedures must be funded by the patients themselves. The payment system is not linked to product approval procedures.

Drugs are mostly sold through public hospitals, which procure the drugs through tender processes rather than through pharmacies. The tender regulations are therefore significant for the health care system, especially as the system is going through a growth period where the number of hospitals keeps growing to adopt to the greater public demand for health care.

Medicinal product manufacturers, exporters, importers, marketing authorisation holders and wholesalers/distributors are free to set the prices of their products and to compete on prices. Pharmaceutical establishments must declare their medicinal product prices to the Drug Administration of Vietnam (DAV).

For imported medicinal products, once the applicant has obtained a marketing authorisation for the drug, but before the first lot of the drug is circulated in Vietnam, the importer must declare the drug's estimated wholesale and retail prices to the DAV. If there is a change in a declared price, the pharmaceutical establishment must re-declare the new price to the DAV. A distributor must not sell the drugs at prices higher than the declared prices.

The declared drug prices of drugs imported and circulated in Vietnam must not be higher than the prices of the same drugs in Association of Southeast Asian Nations (ASEAN) countries.

Drugs listed on the Health Insurance Medicines List are funded through the social insurance system. The Health Insurance Medicines List applies to private and government health establishments that have signed a medical care contract with a health insurance institution. These establishments, which are mainly hospitals, supply drugs to the patients through pharmacy departments.

Drug costs are not reimbursed if the drugs are supplied by pharmacists individually.

The Law on Pharmacy (No 105/2016/QH13), which was issued on 6 April 2016 and took effect on 1 January 2017, replacing the previous Law on Pharmacy of 2005, sets out restrictions on selling medicinal products and trading in medicines, and prohibits, among other things:

There are no specific regulations on the sale of medicinal products on the internet, by email and by mail order. Providing information relating to medicinal products for sales purposes on the internet, companies' websites and by email can be considered to be drug advertising, which is subject to various restrictions (see Question 15).

Under Circular No 03/2018/TT-BYT, the "distribution of medicine" means the division, delivery and storage of pharmaceutical products from the warehouse of the manufacturer or importer of such products, or from the distributor to the end user, or to a distribution point or between distribution points, by means of various transport methods. "Distributors" include:

To conduct wholesale distribution, a distributor must normally be granted a Certificate of Eligibility for Pharmacy Business issued by the Ministry of Health (MOH), which requires, among other things, the fulfilment of:

Issuance of the GSP Certificate is under the authority of the Drug Administration of Vietnam or the Traditional Medicine Administration of Vietnam, while issuance of the GDP Certificate is under the authority of provincial Departments of Health. GSP and GDP Certificates have a maximum term of three years, while the Certificate of Eligibility for Pharmacy Business has an unlimited term.

Statutorily, after complete and valid applications are submitted it takes about 30 days for a GSP/GDP Certificate to be issued, and the same timeline for issuance of the Certificate of Eligibility for Pharmacy Business. However, in practice, the issuance of these certificates may take six to 12 months.

After being licensed, a distributor can carry out the wholesale distribution of medicine within the licensed scope with regard to the medicines licensed for import into or circulation within Vietnam. Distributors can only purchase medicines from licensed medicine manufacturers, wholesalers or suppliers, and can only distribute the medicines to other licensed distributors, health facilities or retailers.

Foreign-invested enterprises can only be licensed to import medicines or medicinal materials, and will not be licensed to implement any other distribution rights in relation to medicines or medicinal materials in Vietnam.

Pharmaceutical products (including drugs and biologicals) are under the overall management of the Ministry of Health (MOH). The MOH is organised into a number of divisions, in which the Drug Administration of Vietnam has the overall responsibility for pharmaceutical products.

Any non-compliance with the medicine distribution laws can give rise to warning penalties or monetary fines. Depending on the nature and severity of the violation, the violator may face penalties and remedial measures such as:

A local importer or distributor must have a physical presence with qualifying personnel and conditions to conduct drug-trading activities in Vietnam. An overseas company that trades through a local importer or distributor is not required to have a representative office in Vietnam.

An importer that is a drug production and trading enterprise established in Vietnam must be recognised by the Ministry of Health (MOH) as being fully qualified and eligible to undertake drug import and export business.

Before importing drugs for sale on the Vietnam market, the drugs must be registered with the Vietnamese authorities. In particular, the importer must obtain drug marketing authorisations or import licences from the Drug Administration of Vietnam (DAV) under the MOH.

Drugs must bear labels according to drug labelling regulations in Vietnam.

Customs clearance procedures must be followed, under which imported drugs may require the following documents:

The maximum retail price of the imported drug must be declared to the DAV before trading in the drug.

Parallel imports are permitted for drugs:

Wholesale and retail prices of parallel imported medicines can be determined by the importing enterprise, but must be lower than the wholesale and retail prices of medicines with the same specific names and a valid marketing authorisation in Vietnam.

Importers must submit an application for registration of a parallel import permit to the DAV. The DAV must evaluate the permit within 15 working days from the date of receiving the complete dossier. If the application dossier is deficient, the DAV will issue an official letter requesting supplementary documents or clarification. No other authorisations, notices, documents or testing are required for approved imports.

Parallel importation can be raised as a defence to patent infringement claims.

The principal legislation regulating the advertising of drugs includes:

The Drug Administration of Vietnam is the regulatory authority that examines and approves drug advertisement dossiers. It can co-ordinate with responsible authorities, which may include the People's Committee, the Department of Culture, Sports and Tourism, and the local Department of Health of a province or city.

There is no specific definition of advertising in relation to pharmaceuticals in Vietnam. The Law on Advertising defines advertising in general as the use of various means to present the public with profitable and non-profitable products and services, or the organisations and individuals trading in them, other than news and social policies and personal information.

Fairs, seminars, conventions, events, exhibitions, sports events and cultural programmes are included as means of advertising under the Law on Advertising.

There are no specific regulations on internal procedures for advertising. In practice, companies, especially big companies, normally set up internal procedures for managing and approving their advertising of pharmaceuticals.

Only non-prescription medicines can be promoted to the general public through drug advertising activities. Prescription and non-prescription drugs can be presented to health care professionals through drug information provision activities. The requirements are as follows:

Before providing drug information documents or seminars, an approval certificate for drug information content must be obtained from the DAV (for drug information documents) or the provincial heath authority (for drug introduction seminars).

No approval is necessary for providing medical representatives. Medical representatives have specific authorisation cards for their activities.

All advertising using direct comparisons of the price, quality, or efficiency of the products with products of the same type from other organisations and individuals is prohibited.

All scientific data provided in drug information for provision to health care professionals must be based on either:

All scientific data used in drug advertisements for the general public must be based on these and/or medicine labels approved by the MOH.

It is therefore prohibited to advertise or to provide information to health care professionals on unlicensed pharmaceuticals or indications.

If a website advertisement does not have audio, the same information requirements apply as for other forms of drug advertising.

If the advertisement does have audio, the advertisement must state the:

All this information, except for the name and address of the manufacturer, must be clearly read aloud. If there are three active ingredients or more, the generic names of vitamins, minerals and herbs can be read instead of the APIs.

If the advertising content has multiple pages or is a sound or video recording with multiple scenes:

The advertising script included in the application for content approval must describe how the content pages will appear for multi-page advertisements.

The advertisement of medicines in this form must be separate and must not advertise multiple medicines at the same time, to avoid misunderstanding.

Penalties are applied for non-compliance with the drug advertising regulations such as advertising a prescription drug to the public or providing non-compliant information about a drug.

The regulatory authority is the Drug Administration of Vietnam (DAV).

Violations may be discovered by the inspectorate or functional departments under the DAV, or reported by other parties or the media.

On receiving information about violations, the relevant officials will review the situation, determine the level of violation and suggest penalties (including fines or remedial measures) for the further evaluation/decision of other departments and the head of the DAV.

Depending on the specific violation, fines range from VND2 million to VND200 million.

The penalty for advertising drugs that are prohibited from advertising range from VND100 million to VND140 million.

In addition, the relevant entities (including the marketing authorisation/import licence holder and entities providing advertising services) must also correct/remove any non-compliant advertising information and/or officially apologise to the affected entities.

It is strictly prohibited to advertise to the general public:

Drug information documents on prescription drugs can only be distributed to medical professionals, not to the general public.

Advertising non-prescription drugs to the general public and providing drug information to medical professionals both require prior approval from the Drug Administration of Vietnam for various aspects of the material, including content, layout and form. The applicant must comply with any approval conditions imposed.

The following acts are prohibited in relation to advertising:

While providing samples of goods is in general a permissible form of trade promotion, samples of drugs can only be provided to drug traders, and not to health care professionals or the general public.

In addition, it is prohibited to provide material or financial benefits in any form to induce health care professionals to promote the prescription and use of drugs. Therefore, giving samples of products to health care professionals for promotional purposes is also illegal under the restrictions on providing incentives to health care professionals (see Question 21).

Under the Pharma Group (a sectoral committee of the European Chamber of Commerce in Vietnam) Code of Ethical Practices (PG Code), member companies are prohibited from giving samples to health care professionals, with the exception of:

Similar prohibitions are found in the Vietnam Pharmaceutical & Biopharmaceutical Sector of the Vietnam Pharmaceutical Companies Association (VNPCA) Voluntary Codes on Business Ethics.

Under the PG Code, Pharma Group members can support the work of independent patient organisations but must ensure that:

Pharma Group members must not influence the operation of the funded patient organisations. The independence of the organisation must be fully maintained.

Under the VNPCA Voluntary Codes on Business Ethics, companies are also required to respect the independence of patient organisations.

There are no official definitions of health care professionals or health care organisations under the current regulations in Vietnam. In practice, pharmacists are considered to be health care professionals.

Under the PG Code:

There are no specific restrictions on the information included in advertising to health care professionals. However, before providing drug information documents or seminars, a drug information content approval certificate must be obtained from the DAV (for drug information documents) or the provincial heath authority (for drug introduction seminars). Any scientific data provided must be based on the Vietnamese national medicine formulary or approved by the Ministry of Health, meaning it is not possible to provide information to health care professionals about unlicensed pharmaceuticals or indications (see Question 14).

Using material or financial benefits in any form to induce health care professionals to promote the prescription and use of drugs is prohibited. Therefore, giving samples of products to health professionals for promotional purposes is illegal. The restrictions apply to all Vietnamese health care establishments and individuals, regardless of whether the conduct took place in Vietnam or abroad.

Companies (subject to their compliance and other internal policies) and individuals can provide financial and material assistance for health professional conferences if it is voluntary, public and unconditional. Therefore, pharmaceutical companies can sponsor continuing medical education if the sponsorship is unconditional.

Under the Anti-Corruption Law, state officials are strictly forbidden from taking advantage of the giving or receiving of gifts or bribes for the performance of acts for self-serving reasons. Under the Criminal Code, the threshold for criminal liability is generally VND2 million.

There are no specific provisions on or any obligation to disclose details of transfers of value to health care professionals or health care organisations. However, in practice, companies may need to disclose and present relevant documents for such transfers as a part of a tax audit or inspection conducted by the MOH, DOH or any relevant authority from time to time.

See Question 16 and Question 21.

Patents are regulated by the:

There are currently two types of patents for technical solutions in Vietnam:

Both types are granted for an invention or a group of inventions that fulfil the unity requirements. The claimed invention must satisfy the following criteria:

Patents can protect products or processes.

Patents can protect products or processes, except for the following:

In general, it is impossible to patent a health care procedure because methods of human disease prevention, diagnosis or therapy are not patentable subject matters. However, inventions relating to organisms, genetic sequences and biological material are patentable in Vietnam.

A new medical use of a known substance is not patentable in Vietnam.

A new plant variety is not patentable in Vietnam, but can be protected by a Plant Variety Protection Certificate issued by the Ministry of Agriculture and Rural Development rather than the Intellectual Property Office of Vietnam.

Applications to register a patent are made to the Intellectual Property Office of Vietnam (IP Office), formerly known as the National Office of Intellectual Property (NOIP). Guidance on the application procedure is provided on the IP Office's website in Vietnamese (www.noip.gov.vn).

Although there are two types of patents for technical solutions in Vietnam, procedures to obtain an invention patent or a utility solution patent are only materially different in the timeline indicated in legal regulations, and the other requirements in the dossier are the same. Due to the backlog at the IP Office, the timelines are not different in practice.

There are three patent application types in Vietnam:

While the dossier requirements and timelines differ, the IP Office will treat all patent applications similarly.

First, a patent application dossier is filed at the IP Office and is given a filing date and application number. Generally, an application dossier must include the following:

After filing, the patent application is examined as to formal requirements:

Once the application passes the formality examination and the decision of acceptance of a valid application is issued, it is published in the Industrial Property Gazette. A request for substantive examination must then be filed at the IP Office within 42 months from the priority date or the filing date (if the application does not claim any priority right).

The patent application is then substantively examined:

The patent is issued after the fees indicated in the invitation to pay the granting fee and first annuity are paid.

Vietnam is a party to the Paris Convention. The patent priority system in Vietnam complies with the relevant provisions of the Paris Convention. Any third party can submit opinions to the IP Office to challenge the patentability of a pending patent application. The existence of a patent dispute does not prevent the regulatory review of an application for approval of a pharmaceutical.

Invention patent. Protection starts from the issue of the patent and lasts for 20 years from the date of filing.

Utility solution patent. Protection starts from the issue of the patent and lasts for ten years from the date of filing.

Patent term extension is not available in Vietnam.

A patent owner in Vietnam has the rights to:

A patent owner can grant a licence to a third party to use the protected invention. The patent owner can also assign the invention to a third party through sale or transfer. Unlike the sale or transfer of a patent to another party, a licensor continues to have property rights over the patented invention. The assignment contract or licence should be recorded at the IP Office of Vietnam.

After being granted a patent in Vietnam, the patent owner has the right to enforce its patent rights under the administrative and/or civil route under the laws of Vietnam.

The unauthorised use of a patent during its term of validity will constitute infringement of the patent (Article 126, Law on Intellectual Property). Slightly more detailed provisions for determining infringement are set out in Article 8.1 of Decree 105/2006/ND-CP as amended and supplemented by Decree 119/2010/ND-CP and Article 11 of Circular 11/2015/TT-BKHCN, which provide that infringement occurs when the product or a product part is identical or similar to a product or product part within the invention's scope.

A similar definition of infringement is found in Decree 105 in relation to processes. Specifically, a process used by an alleged infringer is an infringing process if it is "identical or similar to the process" of the invention. Vietnam applies the doctrines of equivalent and literal infringement. Therefore, patent infringement can take any of the following forms:

In practice, most patent infringement cases in Vietnam involve literal infringement. Therefore, the courts in Vietnam have not had much practice applying the law on equivalent infringement.

Using an invention means carrying out the following acts:

(Article 124.1, Law on Intellectual Property.)

Administrative action. A patentee brings an administrative action by filing a complaint with the competent Inspectorate, such as the Inspectorate of the Ministry of Science and Technology. The proceedings, final decision on the case, and enforcement of the decision are set out in Chapter IV of Decree 99/2013/ND-CP and Chapter III of the Law on Handling of Administrative Violations.

In a typical patent infringement case, administrative remedies often include:

Court action. As an alternative to administrative action, a patentee can bring a court action to enforce its patent rights. The proceedings are set out in the Code of Civil Procedure. The enforcement of the court's judgment/decision is regulated by the Law on Enforcement of Civil Judgment 2008.

Remedies include:

In principle, attorneys' fees can be recovered from the losing party in a civil action.

Border control measures. Border control measures, particularly customs seizure, are another specific measure of administrative action that can be used.

No criminal actions are available for patent infringement.

Research Exemption. Bolar-style exemptions are available in Vietnam.

IP Exhaustion. According to Article 125(2)(b) of the Law on Intellectual Property, an IP rights holder has no right to prevent others from circulating, importing, or exploiting the utilities of products that were lawfully put on the market, including overseas markets. As such, parallel imports are not an infringement of patent rights. See Question 8, Parallel Imports.

Other Exemptions. The following further defences are available in patent infringement actions:

(Article 125.2, Law on Intellectual Property.)

The defendant can also make a counterclaim of invalidity of the patent.

Vietnam is a party to the:

Vietnam is a party to the Patent Cooperation Treaty 1970 (PCT).

Vietnam is a party to the:

The legislation applicable to trade mark registration in Vietnam includes:

Brand owners can seek trade mark registration through either the national registration system or the Madrid System. The IP Office applies the same basic conditions and legislation for both procedures. However, in practice, the IP Office only issues trade mark certificates for national trade mark registrations, and issues decisions of acceptance for international registrations.

General conditions and specific rules for naming medicines. To be eligible for protection, a mark (a sign used to distinguish the goods or services of different organisations and individuals) must be:

A mark is considered to be distinctive if it is both:

Article 73 of the Law on Intellectual Property also lists various signs that cannot be registered as trade marks, including:

A medicinal brand can be registered as a trade mark if it satisfies the conditions set out above. A drug registration applicant must take all responsibility for IP issues when registering the drug with the Drug Administration of Vietnam. Common reasons for refusal of protection of a medicinal brand include:

Applications for trade marks are filed at the IP Office through paper applications or online (the IP Office has recently adopted an online system that enables online filing of trade mark applications). Guidance on the application procedure for trade mark registration is provided on the IP Office website in Vietnamese (www.noip.gov.vn).

National trade mark registration. A national trade mark registration dossier is filed at the IP Office and is given a filing date and an application number.

The statutory time frame for prosecuting a trade mark application from filing to the grant of registration is 12 months. This includes the following stages:

In practice, if the case goes smoothly, the whole process for a trade mark to obtain registration can take about 14 to 15 months (because of a backlog of applications at the IP Office).

The requirements for a national application dossier are:

International trade mark registration designating Vietnam. Within 12 months from being informed by the WIPO, the IP Office will automatically examine the trade mark registration. The following then apply:

The key legislation in the competition law framework includes the:

The following legislation specifically applies to IP-related competition issues, particularly misleading trade indications and cybersquatting:

The Competition Authority under the Ministry of Industry and Trade is the main authority for competition matters. However, since the adoption of the Law on Handling of Administrative Violations in 2012, the Competition Authority under the Ministry of Industry and Trade is no longer entitled to deal with misleading trade indication cases. These cases now fall under the jurisdiction of the competent IP authorities, such as the courts and administrative authorities such as the Inspectorate of the Ministry of Science and Technology.

Vietnam has not laid down any specific regulations on competition relating to patents. The only IP-related competition issues in the pharmaceutical sector relate to misleading trade indications and cybersquatting. However, there have not been many cases on misleading trade indications in the past few years. In these cases, the offenders often imitate the packaging of a widely used drug for the purpose of trading on the goodwill of the product. The competent authorities for this kind of case include the courts and administrative authorities such as the Inspectorate of the Ministry of Science and Technology.

In certain situations, the purchase of patents for destruction or prevention from use of the patent may trigger some anti-trust remedies, in accordance with Decree No 71/2014/ND-CP.

Abuse of dominance issues are not known to have arisen in the pharmaceutical sector in Vietnam.

Parallel imports are legal in Vietnam (see Question 8, Parallel Imports). However, many pharmaceutical manufacturers are concerned that parallel importation could lead to diminished profits, thereby reducing research and development efforts, and leading to a slowdown in the innovation of new drugs. In certain situations, parallel imports may also put public health at risk. In a recent case a major European pharmaceutical innovator learned that a Vietnamese company was importing diabetes drugs into Vietnam that the company had manufactured for the Turkish market. While these drugs were "genuine" products of the manufacturer, and drugs under the same brand name had been authorised for circulation in Vietnam, the markets were not truly "parallel". Turkey requires different standards for storage than Vietnam, and the quality of the drugs could deteriorate more rapidly in Vietnam's tropical climate. With a view to protecting public health, the authorities decided to prohibit the distribution of the parallel imports by relying on regulatory aspects, especially labelling regulations, including imposing a monetary fine and seizing the products. They also brought the issue to the attention of the Drug Administration of Vietnam (DAV), which may lead it to take further precautions in granting licences for parallel importation.

In its recent practice, when weighing the decision to grant a parallel import licence, the DAV has focused on the price and the name of the drugs, but not the quality or any special characteristics of the original market.

Currently, the only IP-related competition issues in the pharmaceutical sector relate to misleading trade indications and cybersquatting. There are no specific regulations on competition in licensing and technology transfers.

Although there is a compulsory licensing regime, the competent authorities have not ruled on compulsory licensing in Vietnam.

No restrictions are known to have been placed on licensing or transferring patents to foreign parties, or on IP transfers for inventions funded, or partially funded, by public investment.

There is no requirement that remittance of royalties payable under a patent or trade mark licence agreement to a foreign licensor be approved by a regulatory body.

The registration of a trade mark licence is not compulsory in Vietnam. However, a patent licence is only valid and legally effective against a third party on registration with the IP Office.

The medicinal product quality inspection agencies are the:

The following assist the Minister of Health/directors of provincial DOHs in determining the quality of medicines nationwide/locally:

Information about adverse drug reactions must be reported to the:

After receiving reports on adverse drug reactions, the centres evaluate the reports and provide their feedback to the reporters (Decision 1088/QD-BYT of the Ministry of Health, 4 April 2013).

Information about serious adverse events occurring at clinical trial research sites must be reported to the Biomedical Research Ethics Council.

Depending on the types of violations, the main authorities entitled to issue penalties include the President of the People's Committees, health inspectorates, the market control departments, the police, and customs authorities (Decree 176).

General provisions on product liability applicable to medicinal product liability are included in the:

Where the terms of contracts are not of assistance, the main law is the Consumer Protection Law, which requires the liable parties to guarantee the quality and safety of products.

The Consumer Protection Law defines defective goods as goods that fail to ensure safety for consumers and that endanger their lives or health, or could cause loss and damage to their assets, including goods manufactured correctly in accordance with current technical standards or criteria in which the defect was undiscoverable at the time the goods were supplied to the consumer.

The liable parties (see Question 37) must pay compensation for loss and damage if goods supplied are defective and cause loss of life, damage to health, or loss and property damage to a consumer, even if the trader was unaware of or not at fault in causing the defect. Defences may be available (see Question 38).

While there is no tort law in Vietnam, the Consumer Protection Law is equivalent to a strict liability tort law.

Under the Consumer Protection Law:

For defective medicinal products, the following entities can be liable under the Law on Medicine, the Consumer Protection Law and Circular No 32/2018/TT-BYT on drug registration:

Conflicts between consumers and traders can be resolved through negotiation, mediation, arbitration, or in court. However, a dispute that relates to damage to the state, the interests of a number of consumers, or the public interest cannot be subject to negotiation or mediation.

In product liability claims, the claimant has the burden of proving that it has suffered damage as a direct and foreseeable result of a product defect (the defendant has the burden of proving it was not at fault causing loss and damage) (Consumer Protection Law).

The defendant is not liable to pay compensation for loss and damage if it proves that the defect in the goods could not have been identified using scientific or technical standards at the time the trader supplied goods to the consumer.

The following limitation periods apply to civil actions:

The statute of limitations for criminal prosecution of these acts is two to 20 years, depending on the circumstances of the incident and the seriousness of the crime.

The Consumer Protection Law does not state the limitation periods that apply to a consumer rights protection claim.

In the medicinal products sector, consumers have the right to:

The Civil Procedure Code 2015 does not provide for class action lawsuits of the kind found in the US and other jurisdictions. Under the Civil Procedure Code, multiple agencies, organisations and/or individuals (co-claimants) can bring a lawsuit against another agency, organisation or individual for settlement in the same case.

Depending on the case, authorities, agencies and organisations (such as family affairs authorities, children's affairs authorities, the Vietnam Women's Union, employee collective representative organisations and social organisations protecting interests of consumers) may (within the scope of their respective responsibilities) be able to bring civil lawsuits to request courts to protect the public interest.

In principle, compensation for property damage, personal injury and death is available to any person who is able to prove injury as a direct and foreseeable result of a product defect:

Vietnamese law does not use the term "punitive damages". However, the Civil Code has provisions that have equivalent effects to punitive damages, under which fines for violations can be contractually agreed so that a party in breach must pay a fine to the aggrieved party. The parties can agree that the violating party must only pay a fine for violations (without any compensation for damage), or that it must pay both a fine for violations and compensation for damages. Fines for violations are only enforced if they have been agreed by the parties.