The Pharma Legal Handbook: Vietnam

1. What is the definition of Rare Diseases in your country?

There are no legal documents in Vietnam providing a definition of “rare diseases.”

 

2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?)

An orphan drug is a drug that is used for prevention, diagnosis, or treatment of a rare disease or a drug that is not always available as stipulated by the Minister of Health or Ministry of Health (MOH).

The MOH has issued Circular No. 26/2019/TT-BYT dated 30 August 2019 promulgating the list of orphan drugs. Under this list, the name of the active ingredients, route of administration, dosage form, concentration/strength, and indication are included.

 

3. What is the regulatory framework for the authorization of an Orphan Drug? (Is this regulatory framework based on Rare Disease status or can it alternatively be based on Orphan Drug foreign status?)

The primary legislation for pharmaceuticals in Vietnam is the Law on Pharmacy No. 105/2016/QH13, which was issued on 6 April 2016 and took effect on 1 January 2017.

Subordinate legislation includes Decree No. 54/2017/ND-CP guiding the implementation of the Law on Pharmacy, which was issued on 8 May 2017 and took effect on 1 July 2017, as amended by Decree No. 155/2018/ND-CP, which was issued and took effect on 12 November 2018. 

Further regulations on other matters such as labelling and package inserts, drug quality, clinical trials of drugs and marketing authorization (“MA”) are regulated by the Ministry of Health in its ministerial circulars. In particular, the marketing authorization of drugs follows Circular No. 32/2018/TT-BYT of the MOH dated 12 November 2018 on MA for drugs and medicinal ingredients (“Circular 32”), as amended by Circular No. 29/2020/TT-BYT dated 31 December 2020 and Circular No. 23/2021/TT-BYT dated 9 December 2021.

In short, there are two routes for obtaining authorization for circulation of an orphan drug in Vietnam:

(i) Obtaining an import license: This is applicable to an orphan drug granted marketing authorization in at least one country in the world. The import license is valid for a maximum of one year and there is a limit on the drug quantity.

(ii) Obtaining a MA: This is applicable to all drugs including orphan drugs. The MA is valid for a maximum of five years and there is no limit on the drug quantity.

 

4. Does your country have provisions for relaxed clinical trial/scientific evidence requirements in respect of Orphan Drugs as compared to other drugs?

No, there are no specific provisions for relaxed clinical trials/scientific evidence requirements in respect of orphan drugs.

 

5. Is there an expedited pathway for Orphan Drugs?

The registration dossier for obtaining a MA for an orphan drug may be subject to the quick evaluation procedure of the DAV if requested by the applicant. The theoretical timeline for this evaluation procedure is only six months from the receipt date of a complete drug registration dossier, while it is 12 months for the normal evaluation procedure.

 

6. Are foreign marketing authorizations recognized in your jurisdiction for Orphan Drugs? If yes, marketing authorizations from which countries are recognized?

No; foreign MA licenses are not recognized in Vietnam for any drugs, including orphan drugs.

 

7. Can Orphan Drugs be reimbursed? If so, is there a specific reimbursement procedure for Orphan drugs?

Yes, orphan drugs can be reimbursed in Vietnam but there is no specific reimbursement procedure for this type of drug.

 

8. How are the prices of Orphan Drugs regulated?

As with other types of drugs, pharmaceutical establishments must declare their drug prices to the DAV. After an MA has been issued, the importer/manufacturer must declare to the DAV the estimated wholesale price and (optionally) the estimated retail price for the drug before the first lot is circulated in Vietnam. Any change in the declared price must be re-declared to the DAV.

Distributors should not sell drugs at prices higher than the declared prices, and the declared prices should not be higher than the prices of the same drugs in ASEAN countries where such drugs are imported and sold. 

 

9. In case of reference price based on a basket of countries, what countries are included?

The prices in other ASEAN countries will be referred to.

 

10. Have there been any significant legal/judicial developments in relation to Orphan Drugs in your country?

No.

 

11. Are there proposals for reform or significant change to the regulation of Orphan Drugs? If yes, when are they likely to come into force?

No.

Also from this Legal Handbook

1. Are there proposals for reform or significant change to the healthcare system?

Law on Medical Examination and Treatment

The draft version of an amended Law on Medical Examination and Treatment was submitted to the National Assembly in May 2022 for discussion. Once adopted, the new law will repeal the current Law on Medical Examination and Treatment No. 40/2009/QH12 dated 23 November 2009. 

Among other changes, the draft law provides for a mandatory requirement on Vietnamese language that will be applicable to non-local healthcare practitioners. Under the draft law, foreign and overseas Vietnamese practitioners are required to be fluent in Vietnamese and to use Vietnamese in examination and giving prescriptions. The satisfaction of Vietnamese proficiency must be examined by a medical education institution appointed by the MOH. A practitioner that does not satisfy this requirement must register the language that will be used in their practice and equip themselves with a translator. Such translator, if non-Vietnamese, also needs to satisfy the examination on Vietnamese proficiency hosted by a medical education institution appointed by the MOH.

 

Law on Pharmacy

The National Assembly published a draft of an amended Law on Pharmacy revising and supplementing some articles of the 2016 Law on Pharmacy. Among other changes, the draft provides a list of drugs for external use whose application dossiers for MA will be submitted to the provincial DOH (not the DAV), new regulations on bioequivalence of generic drugs, and new principles of the assessment of drug prices declared and re-declared by establishments trading drugs.

 

Circular on Drug Registration

The MOH published a new draft circular on the registration of drugs and medicinal ingredients to replace Circular 32/2018/TT-BYT on the same subject on 29 December 2021. Notable changes compared to the previous circular include, among others, requirements for a drug CPP and new specific provisions on quality documentation in the case of materials having a certificate of suitability (CEP).

 

2. When are they likely to come into force?

The revised Law on Medical Examination and Treatment, Law on Pharmacy and circular on drug registration are scheduled to be released in the near future.

 

Also from this Legal Handbook

1. What are the basic requirements to obtain patent and trademark protection?

PATENT

To qualify for patent protection, an invention must meet the following basic conditions:

• Be globally novel;
• Involve an inventive step; and
• Have its subject matter capable of industrial application.

TRADEMARK

To be eligible for protection as a trademark, a mark must be:

• A visible sign in the form of letters, words, drawings, or images, including three-dimensional images, or a combination of these, represented in one or more colors; or sound marks that can be represented in graphical form and

• Capable of distinguishing goods or services of the mark owner from those of other subjects (that is, it is distinctive).

 

2. What agencies or bodies regulate patents and trademarks?

The Intellectual Property Office of Vietnam (“IP Office”) under the Ministry of Science and Technology is the authority managing patents and trademarks.

 

3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?

PATENT

A technical solution in the form of a product or process which is intended to solve a problem by application of natural laws can be protected with a patent. The following subject matters are excluded from patentability:

• Discoveries, scientific theories and mathematical methods;
• Schemes, plans, rules and methods for performing mental acts, training domestic animals, playing games, or doing business; computer programs;
• Presentations of information;
• Aesthetic solutions;
• Plant varieties, animal varieties;
• Processes of essentially biological processes for the production of plants and animals, except microbiological processes;
• Prevention, diagnostic and therapy methods for treatment of human or animals.

TRADEMARK

 

Any sign used to distinguish goods or services of different organizations or individuals is eligible for registration for trademark protection. The following signs cannot be registered as trademarks:

• Signs that are identical or confusingly similar to (i) national flags or emblems, (ii) symbols, flags, insignias, full names, or abbreviated names of state agencies or other social organizations, (iii) names of Vietnamese or foreign national leaders, heroes and celebrities, or certification seals of international organizations.
• Signs that mislead, confuse or deceive consumers as to the origin, nature, intended purposes, quality, value or other characteristics of the goods or services.
• Signs that are the inherent shape of the goods or which are required by the technical characteristics of the goods.
• Signs containing a copy of a copyrighted work, except with the permission of the copyright owner.

 

4. How can patents and trademarks be revoked?

A patent or trademark can be wholly revoked if it is found that the applicant had neither the right to registration nor had been assigned such right, or the patented invention/trademark did not satisfy the protection requirements at the grant date of the patent/certificate. It can also be partially revoked if part(s) of it fail(s) to satisfy the protection requirements.

A trademark in Vietnam is subject to non-use cancellation if it has not been used for five consecutive years.

The amended Intellectual Property Law of 2022 (taking effect on 1 January 2023 introduces some additional grounds for patent and trademark invalidation.

 

Patent

A patent is invalidated in its entirety if:

• The patent application is filed in violation of the security control regulations; or
• The invention is directly created based on genetic resources or traditional knowledge about genetic resources but the patent application does not disclose or incorrectly discloses the origin of the genetic resources or traditional knowledge about genetic resources contained in that application.

A patent is invalidated in whole or in part if:

• An amendment expands the scope of the disclosed subject matters or changes the nature of the subject matters claimed in the application;
• The invention is not sufficiently and clearly disclosed in the specification;
• The patented invention extends beyond the scope of the disclosure in the original specification; or
• The invention does not meet the first-to-file principle.

 

Trademark

A trademark registration can be terminated if:

• Such registered trademark has become the common (generic) name of goods or services bearing that registered trademark; or
• The use of the protected trademark by the owner of the trademark or by a person authorized by the owner misleads consumers as to the nature, quality, or geographical origin of the goods or services.

A trademark registration can be partly or entirely invalidated if:

• The applicant for that trademark registration is ruled to have acted in bad faith; or
• The revision or modification of a trademark application has broadened or changed the nature of the originally filed trademark.

 

5. Are foreign patents and trademarks recognized and, if so, under what circumstances?

All foreign inventions need to undergo the local patent registration process at the IP Office. No foreign patents can be recognized in Vietnam.

While registration in Vietnam is generally a prerequisite for a mark to be protected as a trademark, well-known trademarks are recognized on the basis of use and their registration is not required. There are various criteria for the determination of whether a trademark is “well-known,” such as the number of protections obtained for such trademark in foreign countries, or the licensing value of such trademark. Other foreign trademarks need to undergo the local registration process at the IP Office.

 

6. Are there any non-patent/ trademark barriers to competition to protect medicines or devices?

Vietnam has a data exclusivity period for drugs, which lasts from the date the trial data is filed to the date of expiration of the five-year validity of the MA granted to an applicant with confidential trial data. However, the protection mechanism is not very effective in practice.

 

7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?

Generally, there is no restriction on the types of medicines and devices that can be granted patent and trademark protection. However, prevention, diagnostic and therapy methods for treatment of humans or animals cannot be protected by patents.

 

8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?

It is not mandatory to obtain an approval or acceptance of patent or trademark license agreements, including one with a foreign licensor, in order for such agreements to be valid against the contracting parties. However, for a patent license agreement, it is only valid against any third party upon registration with the IP Office.

 

Also from this Legal Handbook

1. What types of liability are recognized in your jurisdiction?

The following types of liability are recognized under Vietnamese laws: disciplinary liability, administrative liability, civil liability and criminal liability.

 

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

Provisions on product liability can be found in a variety of legislation, as follows:

• Law on Quality of Products and Goods No. 05/2007/QH12 dated 21 November 2007;
• Law on Consumer Protection No. 59/2010/QH12 dated 17 November 2010; and
• Civil Code No. 91/2015/QH13 dated 24 November 2015.

This legislation provides mostly for administrative liability, i.e., the administrative fines and additional penalties in case of defective medicines or devices. The Civil Code provides for the tortious basis for a consumer/victim to claim damages against the tortfeasor.

 

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

Under the Law on Consumer Protection, liability extends to the following entities:

• The manufacturer, importer, holder of affixed trademarks, and direct supplier (such as retailer) of the product are liable for all actual damages directly caused by defective products, regardless of intent.
• The goods trader is responsible for providing accurate information about the product to the consumer.

For defective medicinal products, the following entities can be liable under the Law on Pharmacy, the Law on Consumer Protection and Circular 32:

• Manufacturers, importers, and import commission agents are liable for the quality of the medicine they manufacture or import.

MA holders are liable for the safety, effectiveness, and quality of their medicines, and for ensuring that the medicines are distributed in the market in accordance with the MA dossiers.

4. How can a liability claim be brought?

COMPLAINTS

Consumers have the right to lodge complaints on inferior-quality medicines with a consumer protection authority (e.g., the Consumer Protection Division under the Vietnam Competition and Consumer Protection Administration of the Ministry of Industry and Trade, the provincial People’s Committees, the provincial Departments of Industry and Trade, and units under the district People’s Committees) and claim compensation from the manufacturers and traders for damages caused by the medicines.The law does not state any limitation periods that apply to a consumer protection rights’ claim. 

CLASS ACTIONS

Vietnam does not provide for class-action lawsuits of the kind found in other jurisdictions. Under the 2015 Civil Procedure Code, multiple parties (co-plaintiffs) can bring a lawsuit against another party regarding one legal relation or many interrelated legal relations for settlement in the same case.

Also, depending on the case, organizations protecting consumer and social interests are allowed to bring civil lawsuits to request courts to protect the public interest.

 

5. What defences are available?

For product liability claims, the Law on Consumer Protection sets out that:

• The claimant has the burden of proof to show that it has suffered damage as a direct and foreseeable result of a product defect, and her or she was not at fault for causing the loss and damage;
• The defendant is not liable to pay compensation for loss and damage if it can prove that the defect in the goods was undiscoverable by scientific or technical standards at the time the trader supplied goods to the consumer.

Also from this Legal Handbook

1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?

The Law on Pharmacy and its implementing regulations are equally applicable to modern drugs and traditional and herbal drugs.

There is no notion of alternative devices in Vietnamese law and therefore the legal framework for devices is applicable to all devices.

 

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

Please see question 17 of Marketing, Manufacturing, Packaging & Labeling, Advertising.

 

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

A drug advertiser may only make advertising claims that conform to the drug label and leaflet, the dissertation on the drug in the National Pharmacopoeia of Vietnam, and related instructions provided or recognized by the MOH.

 

4. What are the regulatory requirements for over-the-counter (non-prescription) medications?

The MOH is responsible for issuing a list of approved OTC medications in Vietnam. This list was included in Circular No. 07/2017/TT-BYT dated 3 May 2017.

Drugs are considered for selection for the OTC list when they meet the following criteria:

• Low toxicity, no toxic degradation products, and no serious adverse reactions that are known or warned against by the World Health Organization, regulatory authorities of Vietnam or foreign countries;
• Dosage range is wide and safe for various age groups, with no significant effect on the diagnosis and treatment of diseases that need clinical monitoring;
• Drugs are indicated to treat common diseases which can be administered by patients themselves without a prescription or monitoring from medical practitioners;
• Simple dosage forms (oral, topical administration), and appropriate concentration for self-treatment by patients;
• Rare interaction with other drugs or common foods and drinks;
• Limited possibility to cause dependence;
• Limited risks of overdose or misuse affecting the safety of the users;
• Have been sold in Vietnam for at least five years.

 

5. Are there any limitations on locations or channels through which OTC products may be sold?

OTC drugs can only be sold at pharmaceutical retailing establishments, including pharmacies, internal medicine kiosks, and medicine stations of communal health clinics.

 

6. What health, advertising, and marketing claims may be made for OTC products?

Please see question 3 (above).

 

7. Can OTC products be marketed or advertised directly to the public?

Please see question 17 of Marketing, Manufacturing, Packaging & Labeling, Advertising.

 

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

There is no clear-cut mechanism for a conversion. Pharmaceutical business entities and healthcare establishments can make proposals to the DAV regarding an amendment or addition of new drugs to the list of OTC products based on the market situation and the demand of drugs for treatment to the DAV. The DAV then makes its recommendations to the MOH for the amendment of the list of OTC products based on such proposals or the conclusion of the MA Advisory Council.

 

9. What are the requirements for the importation of either traditional medicines or OTC products?

Drugs for which an MA has been granted can be imported into Vietnam with the desired volume without the need of an import license.

An import license must be obtained for importation of the following:

• Drugs without an MA;
• Drugs for which an MA has been granted but the available quantity is not sufficient for treatment;
• Drugs that contain an herbal ingredient that is used in drugs for the first time in Vietnam;
• Drugs that contain an herbal ingredient of which the quantity is not sufficient for treatment;
• Drugs for urgent demand of national defense, security, prevention and elimination of epidemics, disaster recovery, or special treatment;
• Rare drugs;
• Drugs with the same trade name, active ingredients, concentrations, and dosage form as an original brand name drug which is granted an MA in Vietnam, manufactured by the same manufacturer of the original brand-name drug or an authorized manufacturer, and whose price is lower than that of the original brand name drug being sold in Vietnam at the request of the Minister of Health (parallel imports);
• Drugs for a health program of the state;
• Donation drugs;
• Drugs used for clinical trial, bioequivalence study, bioavailability assessment, as a sample for registration, testing, scientific research, or as a display at a fair or exhibition;
• Drugs for other non-commercial purposes.

The holder of the import license can only import the drugs within the quantity/quota specified in the import license.

Also from this Legal Handbook

1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?

PHARMACEUTICAL PRODUCTS

Under Vietnamese law, pharmaceutical products or drugs are defined to cover all modern drugs, herbal drugs, traditional drugs, vaccines, and biologicals.

In general, a pharmaceutical product circulating on the market must have an MA or drug registration number, which is issued by the DAV.

The MA applicant must submit an application dossier (new registration) to the DAV. Within 12 months from the date of receiving a complete and valid application, the DAV will grant the MA. If the DAV considers the application dossier to be inadequate or incomplete, it will issue an official letter clearly stating the supplementary requirements necessary or the reason for refusal. In practice, the timeline for obtaining an MA can be prolonged from 12 to 36 months.

MEDICAL DEVICES

By law, to be circulated in Vietnam, all medical devices must be granted a valid registration number or import license.

The registration number for Class A and B (lowest-risk) medical devices is simply the number of a declaration letter from the DOH of the province where the registrant is located, acknowledging that a dossier on declaration of applicable standards has been submitted. The DOH will give the dossier a preliminary evaluation and grant a declaration letter.

The registration number for Class C and D (higher-risk) medical devices is found on an MA license, the application dossier for which must be submitted to the DMEC, which will review the dossier and grant the MA license within 45 days, while the timeline under the quick and emergency procedures will be only 10 days from the submission date of the complete dossier. In practice, however, the DMEC normally does not yet have the capacity to evaluate these dossiers in a timely manner.

During the transition period as the latest regulations are phased in, import licenses for medical devices that were granted after 1 January 2018 will be valid until 31 December 2022 while Class C/D medical devices that are not subject to import licenses, and whose classification results were published on the Portal of Medical Device Management, can continue to be imported until 31 December 2022, with no limit on quantity and without an approval letter from the MOH.

 

2. What is the authorization process for the marketing of generic versions of these products?

Please see question 1 (above).

 

3. What are the typical fees for marketing approval?

Please see question 4 of Regulatory, Pricing and Reimbursement Overview.

 

4. What is the period of authorization and the renewal process?

Please see question 5 of Regulatory, Pricing and Reimbursement Overview.

 

5. What are the requirements, if any, for post-approval pharmacovigilance?

The MA holder, after obtaining the MA, is obligated to comply with the quality and safety requirements registered in the MA dossier.

If drugs with valid MAs for circulation in Vietnam have had their registration numbers revoked in any country in the world, the MA holders must notify the DAV and relevant authorities. Similarly, MA holders have the responsibility to report any adverse reactions from registered drugs to the competent authorities.

The MOH can also withdraw a valid MA in certain cases, such as when a drug is found not to be manufactured at the registered address.

 

6. Are foreign marketing authorizations recognized?

The MOH does not recognize foreign MAs, but the certification of the drug/medical device in the country of origin is one of the required documents for the MA application dossier in Vietnam.

 

7. Are parallel imports of medicines or devices allowed?

There is no specific regulation on parallel import of medical devices. In practice, parallel imports of medical devices are permitted.

Parallel imports are permitted for drugs, provided the following:

• The drug has the same trade name, active ingredient(s), concentration and dosage form as an original brand-name drug with valid registration number for circulation in Vietnam;
• The drug is manufactured by the same manufacturer as the original brand-name drug, or by another authorized manufacturer; and
• The drug has a lower price than the original brand name drug being sold in Vietnam.

 

8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?

It is prohibited to use material or financial benefits in any form to induce physicians or other drug prescribers to promote the prescription and use of drugs. Therefore, giving samples of products to healthcare professionals for promotional purposes is illegal.

Financial and material assistance can be provided for healthcare professional conferences, provided it is done voluntarily, publicly and unconditionally. Therefore, it is likely that pharmaceutical companies (subject to their compliance and other internal policies) can sponsor continuing medical education, provided this sponsorship is unconditional.

The restrictions apply to all Vietnamese healthcare establishments and individuals, regardless of whether the act took place in Vietnam or abroad.

Under the 2018 Law on Anti-Corruption, persons with positions and/or power that are offered a gift must refuse receipt. If he/she cannot refuse, he/she must report to his/her management and hand over the gift to the responsible department within five days of receipt. If the gift is valued at VND 2 million (approximately USD 86) or higher, the giver and receiver may also be subject to criminal liability if the offering of the gift is for corruptive purposes.

 

9. How is the manufacturing of medicines and devices regulated and by which agencies?

The DAV and DMEC have the overall responsibility to supervise the manufacturing of drugs and medical devices, respectively.

A company that wishes to manufacture drugs is required to satisfy regulatory requirements on facilities, techniques and personnel. In particular, such a company needs to obtain necessary licenses to qualify as a drug manufacturing entity, including the Investment Registration Certificate (in the case of a foreign-invested pharmaceutical business entity) and/or the Enterprise Registration Certificate, the Certificate of Eligibility for Pharmaceutical Business and the GMP Certificate.

Companies that engage in the manufacturing of medical devices are required to satisfy regulatory requirements on facilities, equipment, quality management and personnel. The medical device manufacturing entities must self-declare by uploading the required dossier on the Portal of Medical Device Management under the MOH, and then the provincial DOH will publish the relevant information and the declared dossier on the Portal. After that, the entities are allowed to manufacture medical devices. 

 

10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?

The local requirements on GMPs incorporate the GMP standards of the WHO, the Pharmaceutical Inspection Co-operation Scheme (“PIC/S”) and the EMA. The drug manufacturer can apply the GMP standards of either the WHO, the PIC/S or the EMA.

 

11. What is the inspection regime for manufacturing facilities?

Health Inspectorates from the MOH and the local DOHs are primarily responsible for carrying out inspections at drug manufacturing establishments, which may cover conditions of hygiene, quality of staff, and quality of products.

 

12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?

Generally, foreign inspectors or third-party inspectors do not have the authority to perform inspections of manufacturing facilities in Vietnam.

 

13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?

Drug storage service providers must ensure that the site, warehouse, storage equipment, vehicles, quality management system, professional materials and personnel meet the standards of Good Storage Practice. For instance, the warehouse must be at a defined location, divided into specialized areas and constructed with firm ceilings, walls and roof.

Packaging of drugs is categorized as a phase of drug manufacturing and the requirements of drug manufacturers are applicable to those engaging in packaging of drugs as well.

 

14. What information must be included in medicine and device labeling?

DRUG LABELING

The external (secondary) drug package label must show the following:

• Drug name;
• Dosage form;
• Ingredients and the content, volume or concentration of active ingredients;
• Package size;
• Indications, administration, and contraindications;
• Registration number or import license number (if any);
• Lot number, manufacture date, expiry date, quality standard and storage conditions;
• Precautions and recommendations;
• Name and address of the manufacturer;
• Name and address of the importer (for imported medicinal products);
• Origin of the medicine.

The inner (primary) drug package label must show the following:

• Drug name;
• Composition of the product;
• Net weight or volume (not applicable to blister packs);
• Lot number and expiry date;
• Name of the manufacturer.

MEDICAL DEVICE LABELING

The following contents must be shown on labels of medical devices:

• Product name;
• Name and address of registration license holder;
• Name and address of the product owner;
• Origin (specify the place(s) where the final production stage is conducted to complete the products if the origin cannot be determined);
• Registration license or import license number;
• Lot number or serial number;
• Manufacturing date or expiry date;
• Information or instructions to look up information on alerts, instructions for use and storage, and maintenance outlets for the device.

 

15. What additional information may be included in labeling and packaging?

Drug labels may show other contents as necessary, provided that they are legal, not aiming at drug advertising and accurately reflect the nature and usage of the drug. Additional contents must not block the mandatory contents and must not use, among other things, information or images prohibited in advertising or product labeling.

Labels for devices may include numeric codes, bar codes, certificate standard marks, certificate regulation marks and other information. Such additional information must be legal and accurate as to the substance of the products, and it must not block or mislead the mandatory information on the label.

 

16. What items may not be included in labeling and packaging?

A label must not show any picture or information relating to a sovereignty dispute or other sensitive information which may affect the security, politics, economy, society, diplomatic relations, and public decency of Vietnam.

 

17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?

It is strictly prohibited to advertise prescription drugs or drugs that are subject to limited use or physician-supervised use, or drugs without valid MAs. Drug information documents can be distributed to medical professionals, but not to the general public. 

To advertise drugs to the general public, or provide drug information to medical professionals, the approval must be obtained from the DAV for various aspects of the advertisement, such as the content, layout, and form, and the applicant must comply with the approval in the course of advertising. The advertising of drugs before obtaining the DAV approvals is prohibited.

The holders of medical device registration numbers or their authorized entities will be responsible for publicly declaring the intended content and form of the advertising on the Portal of Medical Device Management before conducting the advertising.

 

18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?

Patients can buy drugs at pharmaceutical retail establishments, including drug stores, internal medicine kiosks, and medical stations of communal health clinics. Many medical devices can be purchased in drug stores as well. The purchase of drugs and medical devices by healthcare establishments is done via a tender process.

There are no specific regulations for the sale of medicinal products by mail order. Providing information relating to medicinal products on the internet, company websites, and email for selling purposes can be considered drug advertising, and thus subject to various restrictions (see question 17, above).

 

19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?

Drugs can be advertised by various means including websites and e-newspapers. The advertisement of drugs by this means must be done separately, i.e., there must be no advertisement of more than one drug (in one designated space) to avoid confusion.

Entities advertising their own products cannot send an e-mail or text message advertisement without prior consent of the recipients.

 

20. May medicines and devices be advertised or sold directly to consumers?

MEDICINE ADVERTISING
Please see question 17 (above).

DEVICE ADVERTISING

Medical devices can be advertised directly to consumers via permitted means of advertising for which the intended content and the form of the advertising are publicly declared on the Portal of Medical Device Management.

 

21. How is compliance monitored?

Compliance is monitored by the MOH and provincial DOHs. Health Inspectorates of the MOH and the DOHs are competent to impose penalties in case of non-compliance.

 

22. What are the potential penalties for noncompliance?

Non-compliance with the regulations on advertising of drugs and devices can subject the advertiser to monetary fines and additional penalties.

For instance, a fine of up to VND 40 million (approximately USD 1,700) is applicable to the following: 

• Advertising contrary to the features and effects of the medical devices;
• Concealing warnings related to incidents and undesirable effects of medical devices;
• Advertising without the name, model, manufacturer, manufacturing country or the name and address of the organization or individual responsible for bringing the product to market and the organization or individual responsible for the warranty.

A fine of up to VND 80 million (approximately USD 3,400) is applicable to the following acts, among others:

• Advertising a drug using information that has not been confirmed by the DAV or is not consistent with the content confirmed by the DAV, the MA certificate or the drug leaflet;
• Advertising a drug for which an MA has not been obtained, or for which the MA is expired;
• Advertising that does not show the drug name, active ingredient name, indications, etc.

A noncompliant advertiser may also have to make a public correction or remove the advertisement.

Also from this Legal Handbook

1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?

By law, clinical research documentation for the purpose of obtaining the MA must conform to the guidance of the International Council for Harmonization (ICH), the MOH, or reference authorities recognized by Vietnam, including the European Medicines Agency (EMA) and drug regulatory authorities of the U.S., Japan, France, Germany, Sweden, England, Switzerland, Australia, Canada, Belgium, Austria, Ireland, Denmark and the Netherlands. Clinical data of a pharmaceutical product must consist of (i) sufficient data for the analysis and justification of the safety and effectiveness of the drug in Asian populations for the purpose of extrapolating clinical data on Asian populations according to guidance of the recognized reference authorities, or (ii) bridging study data according to ICH-E5 guidance for extrapolating clinical data from Asian populations.

Thus, clinical trials are not required to be conducted locally as a condition for MA approval, as long as the clinical data provided by the MA applicant meets the above-mentioned requirements.

 

2. How are clinical trials funded?

Clinical trials are funded by sponsors (drug developers or third-party sponsors).

 

3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?

Pre-clinical trials

Pre-clinical trial documentation for the purpose of obtaining an MA must conform to the guidance of the International Council for Harmonization (ICH) and Association of Southeast Asian Nations (ASEAN).  There is no specific regulation on pre-clinical trial protocols and there is no need to obtain any authority’s approval for this protocol.

 

Clinical trials

There are four phases of clinical trials for pharmaceuticals:

• Phase 1. The new active ingredient or new formula is first tested on humans. This is a preliminary assessment of the safety of the drug.
• Phase 2. Testing to determine optimal dosage for the trial and to demonstrate the treatment efficiency and safety of the drug on the target subject.
• Phase 3. Testing on a larger number of patients. The objective is to determine the stability of the drug formula, the safety and the general treatment efficiency, or to assess the protective effectiveness and the safety of the tested vaccine on the target subject.
• Phase 4. Post-marketing study. The objective of this phase is to continue assessing the safety and the treatment efficiency during post-marketing in compliance with the conditions for use.

The entity carrying out clinical trials (i.e., clinical trial service provider) must register the trials by submitting an application dossier to the Administration of Science, Technology and Training under the MOH. Within 25 days from the date of receiving a valid and complete dossier, the MOH must convene a meeting of the Biomedical Research Ethics Council to examine the trial protocol. Within five working days from the day the Biomedical Research Ethics Council issues their minutes on the examination of the trial protocol, the Administration of Science, Technology and Training will collect the evaluation results and either send the results to the minister for approval or notify the sponsors and institution that they need to supplement their application.

 

4. What are the requirements for consent by participants in clinical trials?

Participants in clinical trials must participate voluntarily, have full legal capacity, meet medical requirements of the trial, and sign written commitments with the clinical trial service provider agreeing to participate.

The participation of people who do not have full legal capacity (such as minors) is subject to the permission of their lawful representatives. For pregnant or breast-feeding women, the trial documents must specify the reasons for the selection and measures must be taken to protect the selected people.

 

5. May participants in clinical trials be compensated?

Participants may receive remuneration as agreed with the clinical trial service provider.

 

6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?

Participants must be indemnified by the sponsor of the clinical trials in case of loss incurred during the trials.

Also from this Legal Handbook

1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?

In Vietnam, pharmaceutical products (including drugs and biologicals) and medical devices are under the overall management of the Ministry of Health (www.moh.gov.vn). The Ministry of Health (“MOH”) is organized into a number of divisions, in which the Drug Administration of Vietnam (https://dav.gov.vn) (“DAV”) has the overall responsibility for pharmaceutical products and the Department of Medical Equipment and Construction (www.dmec.moh.gov.vn) (“DMEC”) and provincial Departments of Health monitor the manufacturing, registration and trading of medical devices.

 

2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?

The primary legislation for pharmaceuticals in Vietnam is the Law No. 105/2016/QH13 on Pharmacy (the “Law on Pharmacy”), which was issued on 6 April 2016 and took effect on 1 January 2017, replacing the previous Law on Pharmacy of 2005.

Subordinate legislation includes Decree No. 54/2017/ND-CP guiding the implementation of the Law on Pharmacy, which was issued on 8 May 2017 and took effect on 1 July 2017, as amended by Decree No. 155/2018/ND-CP, which was issued and took effect on 12 November 2018. These decrees focus on drug import/export, pharmaceutical business, pharmacy practice certificates, drug recall, drug advertisement and drug price management.

Further regulations on other matters such as labeling and package inserts, drug quality, clinical trials of drugs and marketing authorization (“MA”) are regulated by the Ministry of Health in its ministerial circulars. In particular, the marketing authorization of drugs follows Circular No. 32/2018/TT-BYT of the MOH dated 12 November 2018 on MA for drugs and medicinal ingredients (“Circular 32”).

The management of medical devices is currently regulated by the following legislation:

• Decree No. 36/2016/ND-CP dated 15 May 2016, as amended by Decree No 169/2018/ND-CP dated 31 December 2018 and Decree 03/2020/ND-CP dated 1 January 2020 (collectively, “Decree 36”).
• Circular No. 07/2002/TT-BYT of the MOH dated 30 May 2002 guiding the registration for circulation of medical devices made in Vietnam;
• Circular No. 47/2010/TT-BYT of the MOH dated 29 December 2010 guiding the export and import of medicines and packaging in direct contact with medicines;
• Circular No. 30/2015/TT-BYT of the MOH dated 12 October 2015 regulating the import of medical devices; and
• Circular No. 39/2016/TT-BYT of the MOH dated 28 October 2016 on medical device classification.

Medicinal product pricing in Vietnam is based on the policy that medicinal product manufacturers, exporters, importers, MA holders and wholesalers/distributors are free to set their own prices for their products, and compete on price, but are liable by law. Pharmaceutical establishments must declare the prices of their medicinal products to the DAV.

 

3. What are the steps to obtain authorization to develop, test, and market a product?

Generally, there are three steps to obtaining marketing authorization for a drug. First, a company established in Vietnam must obtain either a drug manufacturing license or a drug trading license from the DAV. After obtaining one of these licenses, the company can submit a request to manufacture or import samples for various purposes (such as clinical trials or research and development). For research purposes, the clinical trial protocol must be approved by the relevant ethics committee, then the company must engage a licensed clinical trial establishment to test the drug. Once those first two steps are complete, the company can apply for marketing authorization of the particular drug product.

 

4. What are the approximate fees for each authorization?

The current government fees for authorization applications are as follows:

Authorization type	Fee per application
Drugs (new authorization)	VND 5.5 million	(approx. USD 237)
Drugs (renewal authorization)	VND 3 million	(approx. USD 130)
Medical devices (Class A)	VND 1 million	(approx. USD 43)
Medical devices (Class B)	VND 3 million	(approx. USD 130)
Medical devices (Class C and Class D)	VND 5 million	(approx. USD 215)

 

5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?

Generally, drug MAs have a maximum term of five years. In certain cases, such as the first authorization for a new drug, a new vaccine or where the safety and effectiveness report of the drug is not available or insufficient, the DAV will grant a marketing authorization with a three-year term. Within 12 months before the expiration date of the current marketing authorization, the MA holder may apply for an extension. By law, an extension to the current MA should be issued within three months from the receipt of a complete application dossier.

An MA for a Class A medical device is valid indefinitely, while MAs for Class B, C and D medical devices are valid for five years but can be renewed. The MA holder must apply for a renewal to the MA at least 60 days prior to the expiry of the validity term.

 

6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?

The authorization process for the registration of brand-name products, i.e., “new modern drugs” as defined in the Law on Pharmacy, must include, among other things, pre-clinical and clinical documentation, while this documentation may not be required for generic products.

All drug manufacturers must obtain an Enterprise Registration Certificate, the Certificate of Eligibility for Pharmaceutical Business, and a GMP Certificate in order to manufacture drugs. Foreign-owned manufacturers located in Vietnam, additionally, must obtain an Investment Registration Certificate as a pre-condition for the above-mentioned certificates.

 

7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?

At the moment, there are no official regulations on combination products in Vietnam. From a practical view, for a drug combination, the classification may be based on the product’s intended use; however, the DAV tends to classify them as drugs.

 

8. How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?

Health inspectorates from provincial Departments of Health (“DOHs”) and the Health Inspectorate under the MOH are mainly responsible for monitoring compliance for all pharmaceutical-related activities (manufacturing, marketing, authorization, etc.). Their specific practices are not publicized, thus, it is unknown if the local regime is comparable to the expectations and requirements of the FDA or the EMA.

 

9. What is the potential range of penalties for noncompliance?

Penalties imposed on pharmaceutical business entities for noncompliance are listed out in Decree 117/2020/ND-CP. These penalties include suspension of import licenses, revocation of marketing authorization licenses, fines, and a recall of the violating products.

 

10. Is there a national healthcare system? If so, how is it administered and funded?

Vietnam has a national healthcare system including central hospitals, provincial and district-level hospitals, and health centers at the district and commune level. The central hospitals are under the management of the MOH, while the other hospitals and health centers are under the management of the provincial DOHs.

Under the Law on Health Insurance No. 25/2008/QH12 (as amended in 2014), participation in health insurance is compulsory. The national healthcare system is funded by revenues generated from health insurance. However, only medicines, medical services and health procedures which are specifically indicated by the government are covered. Any others must be funded by the patients themselves.

 

11. How does the government (or public) healthcare system function with private sector healthcare?

The provincial Social Insurance Authorities publish their respective lists of healthcare establishments that are eligible for registration of initial health examination and treatment, which can be amended from time to time. The lists include most public hospitals and a number of healthcare establishments in the private sector (private hospitals). Patients who undergo health examinations at these establishments are covered for the examination and treatment expenses with the appropriate ratio.

If a patient uses the services of a healthcare establishment that is not in the respective eligibility list, their expenses are not covered by the Health Insurance Fund. They can cover the expenses either by themselves or with private insurance.

 

12. Are prices of drugs and devices regulated and, if so, how?

Pharmaceutical establishments must declare their drug prices to the DAV. After an MA has been issued, the importer/manufacturer must declare to the DAV the estimated wholesale price and (optionally) the estimated retail price for the drug before the first lot is circulated in Vietnam. Any change in the declared price must be re-declared to the DAV.

Distributors must not sell drugs at prices higher than the declared prices, and the declared prices should not be higher than the prices of the same drugs in ASEAN countries where such drugs are imported and sold.

 

13. How are drugs and devices used by patients paid for? What roles do public and private payers play?

Government payers:

The government issues lists of drugs and medical devices that are covered by government health insurance. Such lists apply to private and government health establishments that have signed contracts with health insurance institutions. Reimbursement for drugs and devices is only available for those included in the lists and prescribed appropriately by healthcare professionals.

 

Private payers:

Private health insurance providers are free to decide how they apply the procedure for reimbursement for drugs and devices.

 

14. Who dispenses drugs and devices to patients and how are those dispensers compensated?

Licensed healthcare professionals are permitted to prescribe drugs to patients. Following such prescription, patients can purchase the drugs at licensed drug retailers such as drugstores, including drugstores in hospitals. If the drugs or devices are covered by the Health Insurance Fund, the fund will reimburse the retailers.

 

15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?

Drug retailers must specify a person in charge of pharmacy expertise, who must be present during the working hours of the retail establishment and may only authorize someone with a pharmacy practice certificate (i.e., a licensed pharmacist) to take charge in his/her absence. A pharmacist can only be the person in charge of pharmacy expertise for one drug retail establishment.

Pharmacists must complete a training program and refresher program in pharmacy within three years from the issuance date of their pharmacy practice certificate or the issuance date of the latest certificate of completion of training program and refresher program in pharmacy. The pharmacist-in-charge of a drugstore may replace drugs in a prescription with other drugs that have the same active ingredients, usage, and dosage upon consent of the customer, and is responsible for such replacement. The pharmacist-in-charge of a drugstore needs to provide drug information to the customer, consult the customer when he/she finds the prescription not appropriate, and monitor the adverse effects of the drugs sold.

There are no specific regulations on dispensers of class-A medical devices. Dispensers of medical devices of classes B, C and D must have at least one person with a college degree (or higher) in a technical, medical or pharmacy discipline. Most drugstores sell both medicines and a number of medical devices.

Also from this Legal Handbook

The market for ­pharmaceuticals in Vietnam is developing rapidly, in step with the country’s growing and aging population, rising per capita income, and increasing awareness of foreign ­brand-name drugs, which many ­Vietnamese consumers consider to be more reliable than generics and local brands. ­Naturally, Vietnam has ­become an attractive ­investment ­destination for ­foreign pharmaceutical companies eager to ­target new ­customers.