Summary of fines for violations in pharmaceutical production and trading in Vietnam

No.

Type of violation

Violation

Fine

1

Violations against regulations on conditions for pharmaceutical trading, pharmaceutical practice certificates, certificate of eligibility for drug business, licenses for drug and drug ingredient business in Vietnam

The person in charge of expertise being absent without delegating the job to another person

A fine of VND 3,000,000 - VND 5,000,000 for a drug retailer; a fine of VND 8,000,000 - VND 8,000,000 for a drug wholesaler, a provider of preservation services, a provider of drug testing services, or a foreign doing drug and drug ingredient business in Vietnam

Manufacturing, wholesaling, retailing, providing preservation services or testing services without the certificate of good practice; or using an expired certificate of good practice

Failure to keep a log of the sale and purchase of drugs as prescribed by law

Selling drugs without a pharmaceutical practice certificate or while the certificate is being suspended

A fine of VND 5,000,000 - VND 10,000,000 for a drug retailer; a fine of VND 10,000,000 - VND 20,000,000 for a drug wholesaler, a provider of preservation services, a provider of drug testing services, or a foreign doing drug and drug ingredient business in Vietnam

Selling drugs without a certificate of eligibility for drug business or while the certificate is being suspended

Using a fabricated, rented, or borrowed pharmaceutical practice certificate, certificate of eligibility for drug business, relevant qualifications, or license for drug and drug ingredient business in Vietnam

Selling drugs at a place other than that written in the certificate of eligibility for drug business

Selling drugs beyond the scope written on the certificate of eligibility for drug business, or providing drugs beyond the license for drug and drug ingredient business in Vietnam

2

Violations against regulations on drug registration

Failure to send reports or provide information about the registration of drugs in Vietnam, responsibilities of drug-registering facilities, drug-manufacturing facilities for competent authorities, unless a written satisfactory explanation is provided

VND 3,000,000 - VND 5,000,000

Failure to retain and present the application for drug registration and documents about drug batches to competent authorities at their request

The applicant’s failure to cooperate with the manufacturer, or importer to recall the drugs with inadequate quality, safety, or effectiveness at the request of a competent authority or upon the applicant’s discovery

VND 5,000,000 - VND 10,000,000

Failure to notify competent authorities of Vietnam of the drugs that have been banned or have had their registration numbers revoked by the authority of the home country because of their quality, safety, or effectiveness

VND 15,000,000 - VND 20,000,000

Providing technical documents and relevant information, including documents about quality standards, manufacturing methods, and stability without actual experiments or manufacturing; providing the application for drug registration that is not conformable with law

Submitting drug samples other than those written in the application for drug registration

Providing documents and information about the effects, safety, and effectiveness of drugs without supporting documents or scientific evidence

3

Violations against regulations on drug manufacturing

Failure to notify competent authorities of minor changes or change of the manufacturing location in the application for drug registration

VND 10,000,000 - VND 15,000,000

Failure to employ qualified for drugs inspection and drug management

Failure to retain drug samples as prescribed by law

Failure to retain drug manufacturing documents as prescribed by law

Failure to follow the standard operating procedure during the registered drug manufacturing process

VND 15,000,000 - VND 25,000,000

Failure to comply with the laws on manufacturing or traditional medicines and herbal medicines

Failure to reach quality standard level 3 as prescribed by law

Manufacturing products other than drugs using the drug manufacturing line

Failure to comply with the laws on changes to the application for drug registration, except for the case in Point a Clause 1 Article 44 of Decree No. 176/2013/ND-CP of Vietnam’s Government

VND 30,000,000 - VND 40,000,000

Failure to recall drugs with inadequate quality or safety at the request of competent authorities or upon the manufacturer’s discovery

Failure to reach quality standard level 2 as prescribed by law

Manufacturing drugs for sales after the registration number has expired, unless otherwise permitted the Minister of Health

Using substandard packages in physical contact with drugs

Manufacturing drugs that fail to reach quality standards level 1 as prescribed by law

VND 40,000,000 - VND 50,000,000

Manufacturing drugs at a facility that has not obtained a certificate of eligibility for drug business

Manufacturing drugs for sale without registration number, except for traditional medicines and raw herbal ingredients

VND 50,000,000 - VND 70,000,000

Using expired drug ingredients, using ingredients that are not meant for manufacture of drugs for humans, or using the ingredients advised against by WHO or a competent authority because they are not safe for humans

Using ingredients of unknown origins, ingredients that are not undergo quality inspection, or ingredients that fail to reach quality standards to manufacture drugs

4

Violations against regulations on wholesaling and retailing of drugs

Retailing prescription drugs without prescriptions

A warning or a fine of VND 200,000 - VND 500,000

Retailing preprocessed herbal ingredients that fail to meet the quality standards approved by competent authorities

VND 1,000,000 - VND 3,000,000

The drug seller’s or their assistants’ failure to obtain appropriate qualifications as prescribed by law

Selling drugs against the prescription

VND 3,000,000 - VND 5,000,000

Failure to recall drugs or report the recall result at the request of competent authorities

VND 5,000,000 - VND 10,000,000

Wholesaling preprocessed herbal ingredients that fail to meet the quality standards approved by competent authorities

Failure to have a preparation room in the drug-retailing store that prepares drugs according to prescriptions

Failure to have a preservation room in the drug-retailing store that registered a preservation room

Selling drugs that belong to the national programs, selling drugs covered by health insurance, or selling donated drugs that are not for sale, selling drugs provided as humanitarian aid, non-commercial imported drugs, rare drugs, or drugs serving special cases of treatment in the hospitals

Retailing drugs that fail to reach quality standards or have expired

VND 10,000,000 - VND 20,000,000

Selling drugs that have been recalled by a competent authority

Selling drugs that are undergoing a clinical trial; selling drugs that are prepared according to prescriptions meant to be used within the drugstore or medical facility

Selling drug ingredients, finished drugs, vaccines, or biologicals to a facility that is not licensed for drug business

Wholesaling drugs to an unlawful pharmaceutical facility or one that is not permitted by law to by such drugs

Wholesaling drugs that fail to reach quality standards or have expired

VND 40,000,000 - VND 50,000,000

Selling drugs without certificates of free sale

Selling drugs of unknown origins or banned drugs

5

Violations against regulations on drug export and import

Importing drugs without certificates of free sale

VND 40,000,000 - VND 50,000,000

Importing a drug after it is banned in its home country

Importing drugs with insufficient remaining shelf life when they arrive at Vietnam’s port without permission of the Minister of Health

Failure to recall drugs with inadequate quality or safety at the request of competent authorities

Importing drug ingredients, finished drugs, vaccines, or biologicals under entrustment by an entity that does not have a certificate of eligibility for drug business

Import of drugs without acceptable quality and safety, or import of expired drugs

VND 50,000,000 - VND 70,000,000

6

Violations against regulations drug preservation

Retailing drugs that do not meet preservation conditions on their labels

VND 500,000 - VND 1,000,000

Failure to separate drugs from other products

Failure to comply with the regulations on good storage practice (GSP) introduced by competent authorities

VND 5,000,000 - VND 10,000,000

Failure to comply with regulations on drug preservation during the preservation or transportation of drugs

Failure to separate drugs from other products in the drugstore

7

Violations against regulations drug testing

Failure to follow the regulations on good laboratory practice in the drug testing facility

VND 5,000,000 - VND 10,000,000

Failure to comply with regulations on good testing practice

Providing drug testing services without permission of the Minister of Health

VND 10,000,000 - VND 20,000,000

Falsifying analysis data

Testing the drug samples other than the samples provided by the researching or manufacturing, which are written in the application for drug registration

8

Violations against regulations drug packages and labels

Changing the package without permission of competent authorities

VND 10,000,000 - VND 20,000,000

Selling drugs without intact packages or labels as described in the granted application

Falsifying the information about expiration dates, indications, contraindications, dosage, and effects on the approved labels, or using labels that are not consistent with the granted application

VND 30,000,000 - VND 40,000,000

9

Violations against regulations on addictive drugs, psychotropic drugs, and drug precursors

Prescribing, dispensing, or using addictive drugs, psychotropic drugs, and drug precursors against the law

VND 5,000,000 - VND 10,000,000

Selling or buying addictive drugs, psychotropic medicines, and drug precursors without a plan approved by a competent authority

VND 20,000,000 - VND 30,000,000

Preserving, providing addictive drugs, psychotropic drugs, and drug precursors against the law

Transporting, delivery, packaging addictive drugs, psychotropic drugs, and drug precursors against the law

Destroying addictive drugs, psychotropic drugs, and drug precursors against the law

Failure to keep records of and retain sufficient documents about addictive drugs, psychotropic medicines, and drug precursors

Exporting, importing addictive drugs, psychotropic medicines, and drug precursors without license granted by a competent authority and through an improper border checkpoint

Selling addictive drugs, psychotropic drugs, and drug precursors to ineligible users or to a facility that does not have a certificate of eligibility to trade in addictive drugs, psychotropic drugs, and drug precursors

A fine of VND 10,000,000 - VND 20,000,000 for a retailer; a fine of VND 30,000,00 - VND 40,000,000 for a wholesaler

10

Violations against regulations scientific research and clinical trials

Concealing information or providing insufficient or untruthful information about the clinical trial for the human test subjects about the testing process and possible risks

VND 5,000,000 - VND 10,000,000

Providing personal information about participants without their consents

VND 10,000,000 - VND 20,000,000

Failure to report the progress or result of the clinical trial as prescribed by law

Failure to comply with regulations on good clinical trial practice

Conducting a clinical trial without permission of the Minister of Health

VND 50,000,000 - VND 70,000,000

Changing the clinical trial outlines or documents that have been approved by the Minister of Health

Using experimental drugs for other purposes

Forcing other people to participate in the trial

Falsifying the clinical trial results

11

Violations against regulations on drug price management

Failure to declare or sufficiently declare drug prices as prescribed by law

VND 10,000,000 - VND 20,000,000

Failure to adjust the declared prices after a written opinion is given by a competent authority

Selling drugs at a higher price than the declared one

Failure to notify the correct prices that have been declared to customers

The hospital dispensary purchasing drugs at higher wholesaling prices than that in the declaration, or failing to declare drug prices as prescribed by law

Any hospital dispensary that sells more drugs at higher prices than the maximum rate of retail profit imposed by competent authorities

VND 10,000,000 - VND 20,000,000

Buying drugs of which the difference between the successful bid and the cost price exceeds the maximum rate of retail profit imposed by competent authorities

VND 20,000,000 - VND 30,000,000

12

Violations against regulations on information about pharmacy, cosmetics, and medical equipment

Any pharmaceutical sales representative (hereinafter referred to as drug rep) that does not wear a drug rep’s card while working

Warning

Failure to send a notification to the Service of Health when the drug rep works in a province other than that on the drug rep’s card

VND 5,000,000 - VND 10,000,000

Holding a conference to introduce drugs before submitting an application for permission to hold the conference to a competent authority, or before the application is granted

Providing drug information that is not consistent with that registered with competent authorities; providing drug information before the application is granted; providing drug information according to an expired document; providing drug information before submitting the application for registration to a competent authority, unless the drug information is exempt from registration

VND 10,000,000 - VND 20,000,000

Providing information about the drugs that do not have registration numbers or that have expired registration number, except for the drug information exempt from registration and the conferences to introduce drugs to health officials

Failure to monitor and report information about drugs, their harmful effects, new information the drugs, and deterioration in quality of the drugs to the Ministry of Health and National Drug Intelligence Center

Providing inaccurate documents about drug information

Providing obscure information about dietary supplements and products other than drugs in a way that make consumers confuse them with drugs

VND 30,000,000 - VND 40,000,000

Persuading physicians or patients into prescribing or using drugs by means of financial benefits

Introducing drugs before obtaining a drug rep's card

Failure to provide explanation and rectify illegal information at the request of competent authorities