Medicinal product regulation and product liability in Vietnam: overview

A Q&A guide to medicinal product regulation and product liability law in Vietnam.

The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability.

For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in Vietnam: overview.

To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool.

The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

Contents

Regulatory overview

1. What are the main legislation and regulatory authorities for pharmaceuticals in your jurisdiction?

Legislation

The Law on Pharmacy No. 34/2005/QH11 issued on 14 June 2005 and its implementing regulations governs the management of drugs and biologicals in Vietnam, including:

  • Decree No. 79/2006/ND-CP issued by the Government on 9 August 2006 (amended by Decree No. 89/2012/ND-CP issued on 24 October 2012).

  • Circular No. 22/2009/TT-BYT issued by the Ministry of Health on 24 November 2009 (amended by Circular No. 45/2011/TT-BYT issued on 21 December 2011).

The regulations provide guidelines on:

  • Manufacture.

  • Registration.

  • Circulation and use.

  • Clinical trials.

  • Promotion, advertising and authorisation.

Vietnamese regulations on drug registration are in line with the Association of Southeast Asian Nations (ASEAN) Common Technical Dossier and ASEAN Common Technical Requirements.

Regulatory authorities

The Ministry of Health (www.moh.gov.vn) has overall responsibility for the management of drugs, biologicals, and medical devices. Certain of its subdivisions, such as the Drug Administration of Vietnam (www.dav.gov.vn) have specific responsibilities in certain areas. The main areas of the Drug Administration of Vietnam's responsibility are:

  • Developing and issuing legal documents on pharmaceuticals and cosmetics.

  • Managing the registration and circulation of medicinal products and cosmetics.

  • Granting, suspending and revoking related certificates of pharmaceutical trading, manufacturing, import, export and circulation of drugs.

  • Co-ordinating with the Science and Training Department, under the Ministry of Health, regarding clinical trials in Vietnam.

  • Managing drug and cosmetics advertising.

  • Managing and co-ordinating with the competent authorities to manage drug prices, stabilisation measures within the drug market, and tenders in hospitals.

  • Inspecting the implementation of provisions relating to drugs and cosmetics and punishing violations.

 
2. Briefly outline how biologicals and combination products are regulated in your jurisdiction.

Though there are no separate regulations on registration of biologicals, including vaccines, the registration procedures for biologicals are different from those for chemical medicinal products. The most notable differences are:

  • All vaccines must undergo clinical trials in Vietnam for registration purposes.

  • All vaccines must be tested by the National Institute for Control of Vaccines and Biologicals (NICVB) to obtain the Certificate of Analysis for the registration dossier.

  • All vaccines and biologicals being serum containing antigens for human disease prevention and treatment must be tested by the NICVB for each imported batch before circulation.

There are no separate regulations or classification for combination products. Instead, they are classified into chemical/biological/diagnosis/medical device categories by the regulatory authority on a case-by-case basis, and undergo the same procedures as the category in which they are classified.

 
3. Briefly outline how medical devices and diagnostics are regulated in your jurisdiction. Is there any specific regulation of health IT issues and mobile medical applications?

In Vietnam medical devices are mainly regulated by:

  • Circular No. 07/2002/TT-BYT issued by the Ministry of Health on 30 May 2002, which gives guidance on registration for circulation of medical devices made in Vietnam.

  • Circular No. 24/2011/TT-BYT issued by the Ministry of Health on 21 June 2011, which regulates import of medical devices.

The Medical Devices and Facilities Service Department is the regulatory authority for management of medical devices in Vietnam.

Under Circular No. 24/2011/TT-BYT, importers can obtain an import certificate to import medical devices into Vietnam in the following two cases:

  • The medical device is included in the list of medical devices already approved for circulation. The list consists of 50 types of medical devices in three groups: diagnostic equipment, treatment equipment, and other equipment.

  • The medical device is not included in this list, but uses new methods of diagnosis or treatment and is imported into Vietnam for the first time. Apart from satisfying the conditions applicable to the approved devices, the registration application dossier must include results of clinical evaluation that have been assessed and approved by the Science and Technology Council of the Ministry of Health. However, the Ministry of Health may waive the clinical evaluation requirement for a medical device outside the list that has been recommended by an international organisation.

Before importing medical devices into Vietnam, an importer must have a certificate of business registration or investment authorising trading in and importing of medical devices, and satisfy the specific requirements on personnel and infrastructure and labelling.

Further, the importer must have a qualified chief technology officer and sufficient warehouse space to safely store and preserve the equipment.

It is prohibited to import second-hand consumer medical devices.

Currently, there is no specific regulation for health IT issues or mobile medical applications.

 

Pricing, state funding and reimbursement

4. What is the structure of the national healthcare system, and how is it funded?

Currently, the national healthcare system is composed of three sub-schemes (Law on Health Insurance passed on 1 July 2009):

  • Compulsory health insurance scheme. The following are included in this scheme:

    • all active workers and retired people in the public sector;

    • salaried workers in the private sector;

    • certain other groups, such as veterans and foreign students in Vietnam.

    The scheme is partially funded by contributions from those included.

  • Voluntary health insurance scheme. This provides health insurance for:

    • pupils and students;

    • farmers in agriculture, forestry and fishing;

    • salt-making households;

    • relatives of salaried workers;

    • members of co-operatives and individual business households.

    This scheme is funded by per capita contributions collected by the institution.

  • Scheme fully subsidised by the government. This includes:

    • reward schemes for merit;

    • free health cards for the poor.

 
5. How are the prices of medicinal products regulated?

The main policy for medicinal product pricing in Vietnam is that medicinal product manufacturers, exporters, importers, marketing authorisation holders and wholesalers/distributors are free to set the prices of their products, and compete on prices, but are liable by law. Pharmaceutical establishments must declare their medicinal product prices to the Drug Administration of Vietnam.

For imported medicinal products, when an application for registration of a drug in Vietnam is submitted, the applicant (marketing authorisation holder for drugs in Vietnam) must declare to the Drug Administration of Vietnam the estimated cost insurance and freight (CIF) price at the Vietnamese port of the drug in question. When the applicant has obtained a marketing authorisation for the drug, but before the first lot of the drug is circulated in Vietnam, the distributor must declare to the Drug Administration of Vietnam the:

  • Actual CIF price at the Vietnamese port.

  • Estimated wholesale price.

  • Estimated retail price for the drug.

If there is a change in the declared price, the drug establishment must re-declare the new price with the Drug Administration of Vietnam.

Declared drug prices must not be higher than the corresponding prices of drugs of the same types in regional countries with similar medical and commercial conditions to Vietnam. The Ministry of Health is responsible for publishing the list of those regional countries, on the basis that those countries have similar economic conditions and healthcare provision.

The Drug Administration of Vietnam announces on its website the reference price list for medicinal products that have won tenders in hospitals in Vietnam (www.dav.gov.vn).

 
6. When is the cost of a medicinal product funded by the state or reimbursed? How is the pharmacist compensated for his dispensing services?

Drugs listed on the List of Essential Drugs Mainly Used at the Healthcare Establishments (Essential Drugs List), are funded through the Health Insurance Fund. The Essential Drugs 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 essential drugs directly to the patients. Essential drugs are not distributed through pharmacists.

 

Clinical trials

7. Outline the regulation of clinical trials.

Legislation and regulatory authorities

Clinical trials must be conducted for medicinal products in certain cases for registration purposes. At present there are two main regulations generally governing clinical trials that apply to finished medicines, pharmaceutical chemicals, pharmaceutical materials, vaccines and medical biological products:

  • Circular No. 03/2012/TT-BYT of the Ministry of Health dated 2 February 2012, providing Guidance on Clinical Trials.

  • Decision No. 799/QD-BYT of the Ministry of Health dated 7 March 2008, promulgating guidelines of good clinical practice.

The key regulatory authorities responsible for evaluating and approving applications for clinical trials are:

  • The Science and Training Department of the Ministry of Health.

  • The Ministerial-level Science and Technology Council of the Ministry of Health.

  • The Ministerial-level Biomedical Research Ethics Council of the Ministry of Health.

Authorisations

The sponsor prepares and submits an application dossier for registration of a clinical trial to the Science and Training Department.

Within 15 working days from the date of receiving a valid and complete dossier, the Ministry of Health issues an approval letter allowing the sponsor to take the next steps. Based on the approval letter, the sponsor and principal researcher submit a product dossier and the protocol for the clinical trial to the Science and Training Department for evaluation.

The Science and Technology Council evaluates the scientific basis for the trial and the Biomedical Research Ethics Council examines the ethical aspects. The period for both authorities to evaluate the dossier is 60 working days. Within the following 15 working days, the Science and Training Department collects the evaluation results and either notifies the sponsors and institution that they need to supplement their application or sends the results to the Minister for approval.

Consent

Volunteers participating in the trial must:

  • Have full legal capacity to consent.

  • Meet medical requirements.

  • Sign written commitments with the organisation agreeing to conduct clinical trials of medicines.

The participation of people who do not have legal capacity to consent is subject to the permission of their lawful representatives.

Pregnant women can only participate in a trial subject to:

  • The Ministry of Health's consideration and approval on the basis of each clinical trial dossier evaluation.

  • Findings and approval of the Biomedical Council.

Trial pre-conditions

Before conducting a clinical trial, all parties must reach agreement on research protocols and monitoring and supervision of work. This is done to ensure that studies are conducted according to schedule and that the parties fully perform their duties. The clinical trial agency, principal investigator and researchers must be evaluated and authorised by the Ministry of Health:

Clinical trial agencies. Clinical trial agencies must:

  • Have scientific research functions.

  • Operate independently (that is, without economic or organisational relations to individuals or organisations that have medicines under trial).

  • Maintain satisfactory conditions for material foundations, medical equipment and facilities.

  • Make sure that research personnel are relevant for each trial.

This ensures principles of good clinical trial practice are carried out and that safe and effective studies are conducted.

Principal investigator. The principal investigator must:

  • Be a physical doctor who possesses extensive clinical knowledge, experience and practice capability (in accordance with principles of good clinical trial practice).

  • Have a firm understanding of the regulation of clinical trials of medicines and be able to carry out the approved research protocols according to the time schedule set out by the Drug Administration of Vietnam.

Researchers. Researchers must:

  • Have relevant specialised knowledge.

  • Be trained and skilled in conducting research.

In addition, research managers and responsible agencies must prepare cost estimates for clinical trials in the total research fund and manage the allocated resources for research. This responsibility includes:

  • Assessment, approval, management, monitoring and supervision.

  • Evaluation of takeover tests, payment of labour costs, procurement of supplies, remuneration for research participants and related expenses.

Procedural requirements

There are four phases of clinical trial for pharmaceutical drugs:

  • Phase 1. The new active ingredient or new formula is first tested on humans (generally healthy people). This is a preliminary assessment of the safety and pharmacokinetic and pharmacodynamic characteristics of the new active ingredient, with a sample size of ten to 30 people.

  • Phase 2. Testing is on a restricted number of patients. The objective of the phase is to assess the treatment efficiency and safety of the active ingredient on patients, and to determine suitable dosage for the best treatment. The sample should consist of at least 50 patients.

  • Phase 3. Testing is on a larger number of patients. The conditions for clinical trial in this phase should be close to normal usage conditions. This phase is often conducted as a multicentre, randomised and placebo-controlled study. The objective is to assess the safety and the short-term and long-term efficacy of the active ingredients. This phase also assesses the general treatment efficiency, adverse reactions which frequently occur, and detects any special characteristics of the investigated drug. The sample should consist of at least 200 patients.

  • Phase 4. Post-marketing study. In this phase, the research design may be varied but scientific and ethical standards are the same as those before the drug was put into circulation. The objective of this phase is to conduct a clinical trial based on the approved characteristics of the drug, usually in the form of post-marketing monitoring or assessing the treatment efficiency or the treatment strategies. The sample should consist of at least 1,000 patients.

The report on the clinical trial results (produced in accordance with standard forms) must contain:

  • Complete information on the drugs.

  • A description of the research method.

  • The testing and data analysis processes used.

  • An evaluation of the results as compared with the research tasks and objectives.

  • Accurate, reliable and objective conclusions.

The report must be in line with the research objectives and content stated in the approved protocol.

The principal investigator is responsible for the scientific nature, accuracy and reliability of the data, conclusions, observations and other contents of the report.

 

Manufacturing

8. What is the authorisation process for manufacturing medicinal products?

Application

Applications for certificates to manufacture medicinal products must be made to the Ministry of Health or the Drug Administration of Vietnam (see below, Conditions).

Conditions

To obtain a manufacturing licence for medicinal products, a company must satisfy the conditions for good practice standards concerning materials, technical requirements, site facilities and personnel.

The usual company establishment procedures apply. The manufacturer must obtain a Certificate of Business Registration (for local companies) or a Certificate of Investment (for foreign companies).

In addition, the manufacturer must also obtain the following certificates to manufacture drugs:

  • Certificate of Satisfaction of Eligibility of Drug Business Conditions (Conditions Certificate). The manufacturer must obtain a Conditions Certificate, as manufacturing medicinal products is a restricted business line in Vietnam. The Drug Administration of Vietnam is responsible for examining and approving the application for such a certificate.

  • Certificate of Satisfaction of Principles and Standards of Good Manufacturing Practices (GMP Certificate). Manufacturers operating in Vietnam must apply the principles and standards of good manufacturing practice (GMP) issued by the World Health Organisation (WHO). The drug manufacturer must submit an application for registration based on compliance with WHO GMP, which the Drug Administration of Vietnam then evaluates. If a drug manufacturer meets these standards, the Drug Administration of Vietnam will issue the manufacturer with a GMP Certificate.

Restrictions on foreign applicants

No specific restrictions apply to foreign applicants.

Key stages and timing

Conditions Certificate. Under Decree No. 79/2006/ND-CP, the applicant must submit an application dossier for registration of the certificate to the Drug Administration of Vietnam.

If the medicine-trading establishment must be assessed, within 40 working days from the date of submission of the complete dossier for the issuance, expansion, or extension of the Conditions Certificate, the Drug Administration of Vietnam must arrange to assess it and issue, expand, or extend the Conditions Certificate.

If the assessment is not compulsory, within 20 working days from the date of submission of the complete dossier, the Drug Administration of Vietnam must issue, reissue, expand, or extend the Conditions Certificate.

If the dossier is deficient, the Drug Administration of Vietnam requires the applicant to amend and supplement the necessary documents within ten working days from the date of receiving the dossier.

GMP Certificate. To register for a GMP Certificate, the manufacturer submits an application dossier for examination of GMP to the Drug Administration of Vietnam. Within five working days from the date of receiving the application dossier and examination fees, the Drug Administration of Vietnam must issue a notice in writing to the manufacturer if the dossier is deficient or provide the applicant with details of the examination plan for the manufacturing site. Within 20 working days from the date of issue of the written notice to examine the site, the Drug Administration of Vietnam must examine the manufacturing site. If the manufacturing site meets standards and conditions of WHO-GMP, the Drug Administration of Vietnam will issue a GMP Certificate within five working days from the end date of the examination.

Fee

At present, the fee for the Conditions Certificate for wholesale or retail medicinal products is VND1 million to VND4 million (about US$50 to US$200), depending on the location of the establishment. The fee for a GMP Certificate is about VND20 million.

Period of authorisation and renewals

A Conditions Certificate is valid for five years from the date of issue. When it expires, the holder of the drug manufacturing licence can apply for a reissuance of this certificate.

A GMP Certificate is valid for three years from the date of issue. An application for renewal must be made two months before its expiry. The renewed GMP Certificate remains valid for three years from the date of issue.

Monitoring compliance and imposing penalties

Healthcare inspectorates from the local Department of Health (DOH) and the Ministry of Health are mainly responsible for carrying out inspections at drug manufacturing establishments. The inspectors may inspect conditions of hygiene, quality of staff and medicinal products.

Under Decree No. 176/2013/ND-CP of the Government on handling of administrative violations in the healthcare sector, depending on the seriousness of the violation, healthcare inspectorates can impose various administrative sanctions against drug manufacturer infringements, such as:

  • Impose a fine of up to VND70 million.

  • Revoke the Conditions Certificate for three to six months, depending on the seriousness of the violation.

  • Force the manufacturer to withdraw and destroy all drugs or withdraw the registration numbers of drugs before their expiry dates.

 

Marketing

Authorisation and abridged procedure

9. What is the authorisation process for marketing medicinal products?

Application

The Drug Administration of Vietnam is the competent authority issuing the drug registration numbers or marketing authorisations for medicinal products.

Authorisation conditions

In general, a medicinal product circulating on the market must have obtained marketing authorisation (issued by the Drug Administration of Vietnam as part of the Ministry of Health).

Circular No. 22/2009/TT-BYT, as amended by Circular No.45/2011/TT-BYT, sets out conditions and requirements for obtaining marketing authorisation. The holder of marketing authorisation must hold the appropriate licences to operate in the pharmaceutical industry in Vietnam, which are either the:

  • Drug Trading Certificate, for local drug registration applicants.

  • Certificate of Operating in Medicinal Products and Raw Medicinal Materials in Vietnam, for foreign drug registration applicants.

Additionally, the manufacturer must satisfy WHO-GMP standards.

Because drug registration regulations in Vietnam are in line with the ASEAN technical common dossiers and ASEAN technical common requirements, application dossiers share the same common documents as ASEAN technical common dossiers.

Key stages and timing

The drug registration applicant must submit a marketing authorisation application dossier to the Drug Administration of Vietnam. Within six months from the date of receiving a complete and valid application, the Drug Administration of Vietnam grants marketing authorisation, unless the Drug Administration of Vietnam considers the application dossier to be inadequate or incomplete. In that case, the Drug Administration of Vietnam issues an official letter clearly stating the supplementary requirements necessary or the reason for refusal.

Fee

The fee for marketing authorisation is currently set at VND4.5 to VND6 million, depending on whether the medicinal products have data confidentiality requirements or bioequivalence dossier and/or clinical dossier requirements (Circular 03/2013/TT-BTC).

Period of authorisation and renewals

The maximum duration of validity for marketing authorisation is five years from the signing date of the marketing authorisation. In special cases the Ministry of Health will consider and issue separate regulations, such as in cases of new chemical entities, for which the duration of validity of marketing authorisation is one or two years. The drug registration applicant can submit a re-registration dossier within six months before and after a circulation registration number expires.

Monitoring compliance and imposing penalties

Healthcare inspectorates from the DOH and the Ministry of Health are mainly responsible for monitoring compliance.

A monetary fine of VND3 million to 5million can be imposed on establishments that do any of the following:

  • Fail to comply with the requirements of relevant state authorities on reporting about drugs during circulation without submitting a written explanation as to why this is the case.

  • Fail to keep adequate dossiers and submit drug registration documentation and the drug manufacturing lot to state authorities at their request.

A monetary fine of VND5 million to VND10 million can be imposed on establishments which fail to co-operate in withdrawing unsafe drugs from the market at the request of administrative agencies, or fail to withdraw drugs on discovery of a defect.

A monetary fine of VND15 million to VND20 million can be imposed on establishments that:

  • Fail to report to the Ministry of Health when the registration numbers of drugs have been withdrawn or drugs cease to be circulated in the country of origin or related countries due to their safety, effectiveness or quality.

  • Provide documents, data and information relating to technical documents (including quality standard, manufacturing method, and stabilisation documents), without referring to the research, experiment, and actual manufacturing of the drug manufacturing establishments or the drug registration establishments.

  • Provide documents, data and information on the effects, safety and effectiveness of drugs without scientific documents or evidence.

  • Submit drug samples for registration that are not researched or manufactured by the establishments mentioned in the drug registration dossiers.

Establishments failing to report to the Ministry of Health as in the first bullet point above may have their drug registration numbers revoked.

 
10. What commitments and pharmacovigilance obligations apply after a company has obtained marketing authorisation? Are there further conditions concerning how the drug is distributed and accessible to patients?

The product licence holder must annually report in writing to the Drug Administration of Vietnam on registered drugs in circulation to explain cases in which drugs have been registered but are not manufactured (in the case of domestic drugs) or imported (in the case of foreign drugs). Additionally, companies must notify the Drug Administration of Vietnam and relevant management agencies about:

  • New information relating to drug quality, safety and effect.

  • Drugs with valid registration numbers for circulation in Vietnam that have had their registration numbers revoked in any country in the world.

Patients can buy drugs at establishments retailing medicines, including pharmacies, internal medicine kiosks, agents trading in the sale of medicines, and medicine outlets of health clinics.

After obtaining the marketing authorisation, an organisation must comply with the quality and safety requirements registered with the marketing authorisation.

Additionally, within the validity duration of the registration numbers, the Ministry of Health can withdraw the marketing authorisation where:

  • Drugs are not manufactured in accordance with the registration dossiers.

  • Drugs fail to satisfy quality standards from two manufactured lots, or seriously breach quality standards once.

  • Manufacturers or establishments request that their Vietnamese registration numbers be withdrawn.

  • Drug registration numbers have been withdrawn in the host country.

  • Drugs contain active ingredients that are unsafe for users as recommended by the WHO or the Ministry of Health.

  • Drugs are found by competent agencies to infringe intellectual property rights (IPRs).

The product licence holders have the responsibility to report any adverse drug reactions from the approved medicinal product to the competent authorities (see Question 20).

 
11. Which medicinal products can benefit from the abridged procedure for marketing authorisation and what conditions and procedure apply? What information can the applicant rely on?

A pre-clinical and a clinical dossier are not required to register a generic drug. A generic drug is defined as a finished drug used to replace an invented drug, which is manufactured without the inventor's franchise licence and introduced into the market after the patent has expired.

In its application the applicant must provide administrative data, a product information dossier, and a quality dossier.

The quality dossier must contain the following information on drug substance:

  • Manufacturer name.

  • Manufacturing process.

  • Characterisation.

  • Control of drug substance.

  • Reference standards and materials.

  • Description of the container closure system. The description should include identification and specification of materials used and critical dimensions with drawings where appropriate.

  • Stability.

The quality dossier must also contain the following information about the drug product:

  • Description and composition.

  • Pharmaceutical development.

  • Manufacturing process.

  • Control of excipients.

  • Control of finished product.

  • Reference standards and materials.

  • Details on the container closure system (see above).

  • Stability.

  • Product interchangeability equivalence evidence (which includes comparative dissolution study and bioequivalence study). The bioequivalence data is only required for unconventional pharmaceutical dosage form and generics containing 12 active ingredients stipulated in Circular 08/2010/TT-BYT.

 
12. Are foreign marketing authorisations recognised in your jurisdiction?

The Ministry of Health does not recognise foreign marketing authorisations. However, the certification of the pharmaceutical product in the original country is one of the required documents for the application dossier for marketing authorisation in Vietnam (see Question 9).

 

Parallel imports

13. Are parallel imports of medicinal products into your jurisdiction allowed?

Parallel import is permitted for drugs with the same brand names, active ingredients, contents and pharmaceutical form as drugs with valid registration numbers for circulation in Vietnam, when the drug is either:

  • In insufficient supply for treatment.

  • Currently sold in Vietnam at prices higher than the retail price in either:

    • the host country; or

    • countries with economic conditions similar to Vietnam.

To obtain a parallel import permit, the establishment must satisfy:

  • Conditions on the quality and price of drugs.

  • The legal requirements for operating in drugs trading (see Question 9, Authorisation conditions).

Wholesale and retail prices of parallel imported medicines may be determined by the importing enterprise, but must be lower than the wholesale and retail prices of medicines with the same specific names and valid registration numbers that have higher prices in Vietnam.

Importers must submit an application for registration of a parallel import permit to the Drug Administration of Vietnam. Within 15 working days from the date of receiving the complete dossier, the Drug Administration of Vietnam must evaluate and approve the permit, unless the application dossier is deficient. In that case, the Drug Administration of Vietnam will issue an official letter requesting supplementary documents or clarification (Decision No. 1906/2004/QD-BYT).

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

For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in Vietnam: overview (www.practicallaw.com/0-560-3825).

 

Restrictions on dealings with healthcare professionals

14. What are the restrictions on marketing practices such as gifts, sponsoring, consultancy agreements or incentive schemes for healthcare establishments or individual medical practitioners?

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

Companies and individuals may provide financial and material assistance for health professional conferences voluntarily, publicly and unconditionally. Therefore, it is likely that pharmaceutical companies can sponsor continuing medical education, provided this sponsorship is unconditional. The restrictions apply to all Vietnamese healthcare establishments and individuals, regardless of whether the conduct took place in Vietnam or abroad.

Under the Anti-Corruption Law, state officials are strictly forbidden from taking advantage of the giving or receiving of gifts in order to bribe or perform other acts for self-seeking interests. The threshold for criminal liability is generally VND2 million.

 

Sales and marketing

15. What are the restrictions on selling medicinal products? Are there specific regulations for the sale of medicinal products on the internet, by e-mail and by mail order?

The Law on Pharmacy sets out some restrictions on selling medicinal products and trading in medicines. It is prohibited to, among other things:

  • Conduct business in medicines without a Conditions Certificate.

  • Conduct professional pharmaceutical practice without a Pharmacy Practising Certificate.

  • Sell certain medicines, including counterfeit medicines and poor quality medicines.

  • Sell medicines at locations which are not legal outlets for selling medicines.

  • Sell prescription medicines without a prescription.

There are no specific regulations for the sale of medicinal products on the internet, by e-mail and by mail order. Providing information relating to medicinal products on the internet, companies' websites, and e-mail for selling purposes can be considered as drug advertising and subject to various restrictions (see Question 16).

 

Advertising

16. What are the restrictions on advertising medicinal products?

Legislation and regulatory authority

The principal legislation regulating the advertisement of drugs is Circular No. 13/2009/TT-BYT and its implementing regulations.

The Drug Administration of Vietnam is the regulatory authority that examines and approves drug advertisement dossiers and can co-ordinate with responsible authorities, which may include the People's Committee, the Department of Culture, Sports and Tourism, and the DOH (of provinces or cities).

Restrictions

It is prohibited to advertise:

  • Prescription drugs.

  • Vaccines and medical biologicals for disease prevention.

  • Drugs that are:

    • subject to limited use;

    • subject to use under the supervision of a physician;

    • without valid registration numbers.

In particular, the advertisement of prescription drugs to the general public in any form is strictly prohibited. Drug information documents can only be distributed to medical professionals, not to the general public. Advertising drugs before obtaining the approvals from the Drug Administration of Vietnam is also prohibited.

To advertise drugs to the general public, or provide drug information to medical professionals, the applicant must obtain approval from the competent authorities (the Drug Administration of Vietnam) for various aspects of the advertisement, such as advertising content, layout, and form, and the applicant must comply with the approval during the advertisement.

The following acts are also prohibited in relation to advertising:

  • Use of names, symbols, images, positions, reputation and mail addresses of medical and pharmaceutical organisations or medical workers to advertise or recommend drugs.

  • Use of patient thank you letters to advertise or recommend drugs.

  • Use of drug circulation registration numbers granted by the Drug Administration of Vietnam or foreign drug management agencies to advertise drugs.

  • Advertising drugs in the form of physicians' instruction on disease prevention and treatment in newspaper articles and radio or television broadcast programmes.

  • Use of clinical research results which lack scientific grounds and medical evidence when advertising or providing drug information.

  • Use of test results and certifications issued by competent agencies to advertise drugs.

  • Use of medals awarded to products and/or units in exhibitions and fairs to advertise drugs.

  • Misleading consumers by providing information on and advertising with contents contrary to Vietnam's fine traditions and customs. There is no official definition of Vietnam's fine traditions and customs; it is at the discretion of the authorities to determine what actions constitute a violation.

  • Use of animal images or other irrelevant images to provide information on and advertise drugs.

  • Publicising drug information documents for medical workers.

  • Use of sentences, words, images and sounds giving the impression to the public that:

    • a particular drug is the best;

    • use of a particular drug is the best solution;

    • a particular drug can be used without a physician's advice;

    • a particular drug is harmless or has no side effects or contraindications.

  • Making comparisons for the purpose of advertising to suggest that one organisation's drugs are better than those of other organisations and individuals.

Internet advertising

The general restrictions on drug advertising apply (see above, Restrictions). In addition, an organisation trading in medicines can only advertise medicines on its lawful website and cannot advertise medicines it does not trade in.

Authorised establishments can only advertise medicines on websites of advertising service providers when these service providers possess appropriate licences, and can only advertise in a separate section titled "For medicine advertising only". To avoid misleading consumers, each medicine must be advertised in a separate window and not included with advertisements for other medicines.

Under anti-spam regulations, e-mail and text message advertising can only be conducted by:

  • Enterprises advertising their own products.

  • Licensed advertising service providers.

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

There are no special provisions dealing with marketing of drugs through mail order. The general provisions on drug advertising apply.

 

Data protection

17. Do data protection laws impact on pharmaceutical regulation in your jurisdiction?

Privacy matters are regulated in various areas of Vietnamese law. These include the:

  • Civil Code (Article 38).

  • Penal Code (Articles 125 and 226).

  • IT Law (Articles 21 and 22).

  • Law on Telecommunications (Article 6).

  • Consumer Protection Law (Article 6).

  • Law on E-Transactions (Article 46).

  • Law on Medical Examination and Treatment (Article 8).

  • Law on Pharmacy (Article 57).

The Civil Code, for example, indirectly refers to personal data as the information of the private life of an individual, and that the honour, dignity and reputation of an individual will be respected and protected by law.

Mail, telephone, e-mail, and other forms of electronic information of an individual must be protected and kept confidential. Such information cannot be accessed or controlled without the individual's permission or a decision issued by an authorised state body. The Civil Code further protects "personal rights". Unauthorised access to, collection of, or publication of an individual's personal information, data, mail, telephone, or e-mail is a violation of the individual's personal rights.

Patients have the right to have their health status and private information in their case history dossiers kept confidential. In general, such information can only be disclosed when agreed by patients, or for exchange of information and experience between practitioners directly treating the patients to improve the quality of diagnosis, care and treatment of patients, or in other cases provided by law (Article 8, Law on Medical Examination and Treatment).

Persons who participate in a clinical trial have the right to have their relevant personal information kept secret (Article 57, Law on Pharmacy).

Under Decree 176, a fine of VND1million to VND3 million can be imposed on an individual for activities disrespecting the rights of a patient (including the right of protection of individual privacy). This fine can be doubled for an organisation.

A fine of VND5 million to VND10 million can be imposed on an individual for disclosing the information of a person having HIV without his/her agreement, except for cases of information response to the epidemiology supervision of HIV/AIDS and informing of the results of HIV tests. This fine can be doubled for an organisation.

A fine of VND10 million to VND20 million can be imposed on an individual for disclosing information of a person participating in a clinical trial without his/her agreement. This fine can be doubled for an organisation.

 

Packaging and labelling

18. Outline the regulation of the packaging and labelling of medicinal products.

Legislation and regulatory authority

Circular 04/2008/TT-BYT is the legislation on the packaging and labelling of medical products. This legislation is enforced by the Ministry of Health, particularly the Drug Administration of Vietnam.

Information requirements

The following content is mandatory for medicine labels and labels on medicine blister packs:

  • Name of the medicine.

  • Active ingredients and their contents or concentrations.

  • Package size.

  • Indications, administration, and contraindications.

  • Preparation form, registration number, import permit or manufacture batch number.

  • Manufacture date, expiry date, lot number and storage conditions of the medicine.

  • Important signs (for example prescription medicines should show the sign Rx in the left corner above the name of the medicine, alongside the phrase "Thuoc ban theo don" (to be dispensed only by doctor's prescription), while eye drops should have the phrase "thuoc tra mat" (eye drops)).

  • Name and address of the organisation or individual responsible for the medicine.

  • Origin of the medicine.

  • Use instructions.

A package insert in Vietnamese must be included in the commercial packaging.

Other conditions

If the original labels of medical products imported into Vietnam do not bear, or fail to adequately bear mandatory content in Vietnamese, they must have auxiliary labels bearing that mandatory content in Vietnamese while the original labels must be kept intact. Label content and use instruction inserts must:

  • Be truthful, clear and accurate.

  • Not be misleading about the true nature and effect of the medicine.

 

Product liability

19. Outline the key regulators and their powers in relation to medicinal product liability.

The medicinal product quality inspection agencies are the:

  • Drug Administration of Vietnam under the Ministry of Health, at central level. The Drug Administration of Vietnam issues notices of medicinal product circulation suspensions and recalls to be conducted nationwide.

  • The provincial health departments, at local level. Provincial health departments and healthcare sections of other branches issue notices of medicinal product circulation suspension and recall, at local level.

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

  • State-owned medicinal product testing establishments, such as the Central Institute of Drug Quality Control, the Ho Chi Minh City Institute of Drug Quality Control, and the National Institute for Control of Vaccine and Biologicals.

  • Regional and provincial pharmaceutical and cosmetic testing centres.

Information about adverse drug reactions must be reported to the:

  • National Centre of Drug Information and Adverse Drug Reactions Monitoring (National DI and ADR Centre).

  • Regional Centre of Drug Information and Adverse Drug Reactions Monitoring in Ho Chi Minh City (for provinces from Da Nang to the south of Vietnam).

After receiving reports on adverse drug reactions, the centres will 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).

 
20. Are there any mandatory requirements relating to medicinal product safety?

Managing the quality of medicines in the process of manufacturing, import, circulation and use in Vietnam is mainly regulated by Circular 09/2010/TT-BYT of the Ministry of Health dated 28 April 2010.

According to this circular, medicinal products must satisfy the registered quality standards, including regulations on:

  • Technical specifications and requirements.

  • Testing methods.

  • Packaging, labelling, transportation, and storage.

  • Other requirements related to medicine quality.

Additionally, medicine trading establishments (marketing authorisation holders, manufacturers, exporters, importers or import commission agents) must:

  • Apply good practice principles and standards to medicine manufacture, quality inspection, and storage.

  • Take appropriate quality management measures to assure the quality of medicines in the process of manufacturing, import, storage, circulation and distribution, and ensure that only quality medicines are delivered to users.

Medicinal products can be recalled or suspended for circulation if they:

  • Are not in the right categories due to mistakes in the course of dispensation and delivery.

  • Do not satisfy registered quality standards.

  • Fail to fully satisfy medicine labelling requirements.

  • Have packaging materials and forms which fail to satisfy requirements of medicine quality assurance.

  • Do not have registration numbers or are not yet permitted for import.

  • Are the subject of recall notices of Vietnamese or foreign manufacturers or medicine management or state quality inspection agencies for unsafe medicines (that is, counterfeit medicines, smuggled medicines, medicines containing substances banned from use, and expired medicines).

These drugs can be voluntarily recalled by medicine traders or under decisions of medicine management or state quality inspection agencies.

In relation to voluntary recall, when detecting that medicines are of inferior quality or not in line with other requirements, heads of medicine trading establishments must:

  • Promptly report to the relevant drug administration (the Drug Administration of Vietnam or provincial health department) on the reasons for and level of the danger, and the anticipated extent of the recall.

  • After obtaining the opinions of the medicine management agencies, issue recall notices to localities where their medicines are circulated, recall all medicines circulated in the market, and monitor and remedy the consequences caused by these medicines.

In relation to compulsory recall, at the request of the relevant medicine management and state inspection agencies, trading establishments must promptly recall medicines identified as violating or suspected of violating regulations, which seriously affect the health of users and the community.

The Drug Administration of Vietnam requires that local medicinal product manufacturers and distributors and foreign pharmaceutical companies operating under licence in Vietnam must report adverse drug reactions to the competent authorities as follows:

  • Once a year, all adverse drug reactions occurring in Vietnam from 1 January to 31 December must be reported to the National DI & ADR Centre, at the latest on 25 January of the next year.

  • All serious adverse drug reactions or unexpected adverse drug reactions occurring in Vietnam must be reported to the National DI and ADR Centre, within ten working days from the date of receipt of information on adverse drug reactions.

  • Notification of changes in information relating to the safety of drugs, such as updated information on the label, restrictions, withdrawal of drugs, or withdrawal of registration, must be reported to the Drug Administration of Vietnam, within three working days from the date of receipt of the information.

  • Withdrawal of medicinal product registration numbers in any country must be reported to the Drug Administration of Vietnam, immediately after receiving the information.

The Consumer Protection Law promulgates regulations on liability for defective goods (see Question 22).

According to Decree 185, a fine of VND10 million to VND50 million can be imposed on the liable parties relating to defective products, who violate regulations on recall of the defective products. A double monetary fine can be applied to an organisation.

 
21. Outline the key areas of law applicable to medicinal product liability, including key legislation and recent case law.

Legal provisions

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

  • Civil Code No. 33/2005/QH11.

  • Commercial Law No. 36/2005/QH11.

  • Consumer Protection Law No. 59/2010/QH12.

  • Law on Quality of Products and Goods No. 05/2007/QH12.

  • Law on Pharmacy No. 34/2005/QH11.

  • Law on Standards and Technical Regulations No. 68/2006/QH11.

  • Circular 09/2010/TT-BYT of the Ministry of Health dated 28 April 2010 guiding the quality control of medicines.

Substantive test

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 which 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 22) are liable to 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 23).

The Consumer Protection Law is relatively new and there is some information regarding the recall of defective motorbikes and floor cleaner products published on the website of the Consumer Protection Board under the Vietnam Competition Administration. However, although there is no tort law in Vietnam, the language of the provision is consistent with strict liability tort laws.

 
22. Who is potentially liable for defective medicinal products?

Under the Consumer Protection Law, the following are liable:

  • The manufacturer, importer, holder of trade marks affixed to the goods, direct supplier of the product and retailer. They are liable for the quality and safety of medical products and for all actual damage directly caused by defective medical products, regardless of intent.

  • The trader of goods 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 Medicine, the Consumer Protection Law and Circular 22 on drug registration:

  • Manufacturers, importers, and import commission establishments are liable for the quality of their manufactured or imported medicines.

  • Wholesalers and retailers are liable by law and to their customers for their medicines' quality and product information.

  • Marketing authorisation holders are liable for the safety, effectiveness or quality of medicines, and for ensuring that the medicines are circulating in the market according to the registered drug registration dossiers.

 
23. What defences are available to product liability claims? Is it possible to limit liability for defective medicinal products?

In relation to product liability claims, the Consumer Protection Law regulates 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 (the defendant has the burden of proving it was not at fault causing loss and damage).

  • The defendant is not liable to pay compensation for loss and damage on proving that the defect in the goods was undiscoverable by scientific or technical standards at the time the trader supplied goods to the consumer.

 
24. How can a product liability claim be brought?

Limitation periods

The following limitation periods apply to civil actions:

  • Breach of contract: two years from the date on which the lawful rights and interests of the claimant were infringed.

  • Non-contractual dispute: two years from the date of the injury.

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

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

  • Access information on medicine quality. Instructions on medicine use and storage must comply with instructions for the safe and rational use and storage of medicines.

  • Lodge complaints about and claim compensation from medicine manufacturers and traders for damage caused by their inferior-quality medicines. They can lodge a claim with a state management agency of consumer right protection. These include the Consumer Protection Board under the Competition 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. However, the Consumer Protection Law does not state the limitation periods that apply to a consumer protection rights' claim.

Class actions

The Civil Procedure Code No. 24/2004/QH11 does not provide for class action lawsuits of the kind found in the US and other jurisdictions. Under the Civil Procedure Code, the courts can consolidate two or more cases that have already been submitted and accept them as a single case if doing so will "ensure compliance with the law". Vietnamese law does not provide further details on the criteria for consolidation.

 
25. What remedies are available to the claimant? Are punitive damages allowed for product liability claims?

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:

  • Compensation for property damage can include:

    • actual losses to property, and the interests associated with the use or exploitation of this property;

    • reasonable expenses for preventing, mitigating or remedying the damage caused.

  • Damages for personal injury or loss of life can include:

    • reasonable medical, rehabilitation and caregiver expenses;

    • lost income incurred by the victim and his or her caregiver;

    • compensation for mental suffering, funeral expenses in the case of death and support allowances for the victim's legal dependants.

Punitive damages are not available under Vietnamese law.

 

Reform

26. Are there proposals for reform and when are they likely to come into force?

Circular No. 45/2013/TT-BYT of the Ministry of Health takes effect from 14 February 2014. This issues the Essential Drugs List for chemical medicinal products, and replaces the previous list in Decision No. 17/2005/QD-BYT dated 1 July 2005. In August 2013, the Ministry of Health issued a new Circular No. 23/2013/TT-BYT to regulate drug processing activities.

For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in Vietnam: overview (www.practicallaw.com/0-560-3825).

 

Online resources

Vietnam Ministry of Justice

W http://vbqppl.moj.gov.vn/vbpq/en/pages/vbpq.aspx

Description. The Ministry of Justice website. It provides legal documents in Vietnamese and they are mostly up-to-date. The website also provides English translations for reference only.



Contributor details

Tu Ngoc Trinh

Tilleke & Gibbins

T +84 4 3772 5556
F +84 4 3772 5568
E ngoctu.t@tilleke.com
W www.tilleke.com

Professional qualifications. Vietnam, 2007

Areas of practice. Life sciences; corporate; commercial; regulatory affairs.

Recent transactions

  • Assisted multiple pharmaceutical companies in obtaining operating licences in the area of medicinal products, and set up the legal entities in Vietnam.
  • Provided leading manufacturers and trading companies with general background on regulatory affairs related to the registration and circulation of drugs, food, cosmetics, medical devices and veterinary services in Vietnam.
  • Advised companies on various regulatory issues (clinical trials, hospitality and sponsorship, internal promotional practice policies, regulatory compliance issues) and reviewed relevant agreements.
  • Advised on the advertising of food and drugs. Helped a leading pharmaceutical company obtain drug advertising licences from the Ministry of Health of Vietnam.

Tu Thanh Pham

Tilleke & Gibbins

T +84 4 3772 5586
F +84 4 3772 5568
E tu.p@tilleke.com
W www.tilleke.com

Professional qualifications. MS in Pharmacy

Areas of practice. Life sciences; regulatory affairs.

Recent transactions

  • Provided leading manufacturers and trading companies with general background on regulatory affairs related to the registration and circulation of drugs, food, cosmetics and medical devices in Vietnam.
  • Assisted multiple pharmaceutical companies with registration of medicinal products in Vietnam.
  • Assisted international pharmaceutical companies with intellectual property enforcement in Vietnam.

Hien Thi Thu Vu

Tilleke & Gibbins

T +84 4 3772 5606
F +84 4 3772 5568
E hien.v@tilleke.com
W www.tilleke.com

Professional qualifications. Vietnam, 2010

Areas of practice. Life sciences; intellectual property registration and enforcement; regulatory affairs.

Recent transactions

  • Consulted clients on both legal, practical and technical aspects in intellectual property matters.
  • Completed full patent dossiers for submitting to the National Office of Intellectual Property of Vietnam and followed up on their prosecutions in an effective and timely manner.
  • Provided a freedom-to-operate opinion pertaining to several vaccines and medicines.
  • Obtained professional conclusions on patent infringement by the Vietnam Intellectual Property Research Institute in several patent infringement cases.

{ "siteName" : "PLC", "objType" : "PLC_Doc_C", "objID" : "1247610188765", "objName" : "Medicinal product regulation and product liability in Vietnam", "userID" : "2", "objUrl" : "http://us.practicallaw.com/cs/Satellite/us/resource/6-518-6504?source=relatedcontent", "pageType" : "Resource", "academicUserID" : "", "contentAccessed" : "true", "analyticsPermCookie" : "2-5c60ffcb:1477ed9a4f1:-757f", "analyticsSessionCookie" : "2-5c60ffcb:1477ed9a4f1:-757e", "statisticSensorPath" : "http://analytics.practicallaw.com/sensor/statistic" }