Decree No. 93/2011/NĐ-CP on administrative sanctions for violations concerning drugs, cosmetics, and medical devices

DECREE

Provisions on administrative penalties for violations concerning drugs, cosmetics, and medical devices

_______________________

 

THE GOVERNMENT

Pursuant to the Law on Organization of the Government dated December 25, 2001;

Pursuant to the Drug Law dated June 14, 2005;

Pursuant to the Law on Trade dated June 14, 2005;

Pursuant to the Law on Product Quality and Commodities dated November 21, 2007;

Based on the Administrative Violation Handling Ordinance dated July 2, 2002, and the Ordinance amending and supplementing certain articles of the Administrative Violation Handling Ordinance dated April 2, 2008;

Based on Decree No. 128/2008/NĐ-CP dated December 16, 2008, detailing the implementation of certain articles of the Administrative Violation Handling Ordinance in 2002 and the Ordinance amending and supplementing certain articles of the Administrative Violation Handling Ordinance in 2008;

Considering the proposal of the Minister of Health,

DECREE

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

1. This Decree stipulates acts of violation, forms and levels of penalties, measures to remedy consequences, authority and procedures for imposing administrative penalties concerning drugs, cosmetics, and medical devices.

2. Acts of administrative violations concerning drugs, cosmetics, and medical devices include:

a) Violations of regulations on production, business, information, and advertising of drugs;

b) Violations of regulations on production, business, information, and advertising of cosmetics;

c) Violations of regulations on production, business, information, and advertising of medical devices.

Article 2. Applicability

1. Individuals and organizations that intentionally or negligently commit administrative violations concerning drugs, cosmetics, and medical devices as prescribed in Chapter II of this Decree, which are not criminal offenses.

Administrative penalties shall not be applied to violations stipulated in this Decree committed by civil servants, public officials, or employees while performing their duties or tasks assigned. The handling of such violations shall be carried out according to the laws on civil servants, public officials, and employees.

2. Foreign individuals and organizations operating within the territory of Vietnam that commit administrative violations concerning drugs, cosmetics, and medical devices as prescribed in Chapter II of this Decree, except where international treaties to which the Socialist Republic of Vietnam is a party provide otherwise, shall be handled according to those treaties.

Article 3. Explanation of Terms

1. Cosmetics products are substances or preparations intended to be applied to external body parts of humans (skin, hair system, nails, lips, and external genital organs) or teeth and oral mucosa with the primary purpose of cleansing, perfuming, altering appearance, form, adjusting body odor, protecting the body, or maintaining the body in good condition.

2. Medical devices are types of equipment, tools, medical supplies (implants, consumables), chemicals, diagnostic biological products (accompanying medical devices), and specialized transportation means serving activities for caring for, protecting, and enhancing people's health.

Article 4. Application of legal provisions on administrative penalties

1. Acts of administrative violations related to trading in counterfeit goods; intellectual property rights violations; price stabilization violations; price monopoly agreements; violations of subsidy, freight rate, and other supportive measures to implement pricing policies; and other administrative violations concerning drugs, cosmetics, and medical devices not specified in this Decree shall be handled according to the relevant laws on administrative penalties in the respective areas of state management.

2. In cases where the acceptance and examination of registration files for drugs, registration files for foreign companies' operations concerning drugs in Vietnam, registration files for good practices in the drug sector, import files for drugs without registration numbers, registration files for drug and cosmetic information and advertising, declaration files for cosmetic products, registration files for organizing seminars and events introducing cosmetics, and other state management measures are temporarily suspended, they shall be handled according to the regulations of the Ministry of Health.

3. Principles of penalty imposition; handling of administrative violations by minors; mitigating or aggravating circumstances; statute of limitations and penalty deadlines; deadlines considered as not having been penalized; calculation of deadlines and statutes of limitation; determination of authority to impose administrative penalties; issuance of administrative violation records; issuance of administrative penalty decisions; procedures for fines and collection of fines; procedures for confiscation and handling of evidence and means of administrative violations; enforcement of administrative penalty decisions, suspension of execution of fine decisions, compulsory enforcement of administrative penalty decisions, and transfer of administrative penalty decisions concerning drugs, cosmetics, and medical devices for execution shall be carried out according to the laws on administrative violation handling and Decree No. 128/2008/NĐ-CP dated December 16, 2008, detailing the implementation of certain articles of the Administrative Violation Handling Ordinance in 2002 and the Ordinance amending and supplementing certain articles of the Administrative Violation Handling Ordinance in 2008 (hereinafter referred to as Decree No. 128/2008/NĐ-CP).

Article 5. Forms of Administrative Sanctions

1. For each administrative violation concerning drugs, cosmetics, and medical devices, the violator, whether an individual or organization, shall be subject to one of the following main forms of administrative sanctions:

a) Warning;

b) Fine: The maximum fine for administrative violations concerning drugs, cosmetics, and medical devices is forty million Vietnamese dong (VND 40,000,000).

2. Depending on the nature and degree of the violation, individuals and organizations may also be subject to one or more of the following additional forms of administrative sanctions:

a) Revocation of the certificate of eligibility to operate drug retail businesses, permits for drug activities and raw materials for drugs in Vietnam, export and import permits for drugs, professional certificates with or without a time limit, and import permits for medical devices;

b) Confiscation of objects and means used to commit administrative violations.

3. In addition to the main forms of administrative sanctions prescribed in Clauses 1 and 2 of this Article, individuals and organizations may also be subject to one or more of the following measures to remedy consequences:

a) Compel to cancel or report and provide accurate information about products and advertisements;

b) Compel to correct or publicly apologize through mass media;

c) Compel to comply strictly with the specialized regulations of the Ministry of Health;

d) Compel to remedy the consequences caused by defective products;

đ) Compel to reapply for professional certificates, certificates of eligibility to operate drug retail businesses, good manufacturing practice (GMP) certificates, and permits for drug activities and raw materials for drugs in Vietnam;

e) Compel to recall, destroy, or recycle drugs, cosmetics, non-drug products, or medical devices that violate regulations; compel to recall and destroy any violating documents and means, except when they must be retained as evidence for subsequent proceedings;

g) Withdraw registration numbers for drugs within their validity period due to violations of specialized regulations;

h) Recall acceptance numbers for cosmetic product declarations;

i) Withdraw registration numbers for circulating cosmetics;

k) Compel to return all proceeds or the difference in proceeds obtained from the violation;

l) Compel to re-export or remove from the territory of Vietnam;

4. Main forms of administrative sanctions can be applied independently or together with additional forms of administrative sanctions and remedial measures. Additional forms of administrative sanctions can only be applied together with main forms of administrative sanctions.

Chapter II

VIOLATIONS OF ADMINISTRATIVE REGULATIONS ON DRUGS, COSMETICS AND MEDICAL DEVICES, FORMS AND AMOUNTS OF SANCTIONS

Section 1

VIOLATIONS OF ADMINISTRATIVE REGULATIONS ON THE PRODUCTION, DISTRIBUTION, INFORMATION AND ADVERTISING OF DRUGS, FORMS AND AMOUNTS OF SANCTIONS

Article 6. Violations of regulations on business conditions and the use of professional certificates, certificates of eligibility to operate drug retail businesses; permits for drug activities and raw materials for drugs in Vietnam

1. A fine of VND 3,000,000 to VND 5,000,000 for retail drug establishments or VND 5,000,000 to VND 8,000,000 for wholesale drug establishments, service storage establishments, service testing establishments, and foreign companies operating in drugs and raw materials for drugs in Vietnam, if they commit any of the following acts:

a) The professional manager is absent but does not delegate authority or appoint a substitute in accordance with the provisions of the law;

b) Producing, wholesaling, retailing, providing storage services, or testing services for drugs without Good Manufacturing Practice (GMP) certificates according to the schedule of the Ministry of Health or GMP certificates that have expired and not renewed according to the regulations of the Ministry of Health;

c) Operating drugs with expired professional certificates without renewing them according to the regulations;

d) Operating or supplying drugs when the certificate of eligibility to operate drug retail businesses or permit for drug activities and raw materials for drugs in Vietnam has expired and not renewed according to the regulations;

đ) Operating or supplying drugs when the professional certificate or certificate of eligibility to operate drug retail businesses or permit for drug activities and raw materials for drugs in Vietnam has been revoked or the right to use it has been revoked according to the law;

e) Drug retail establishments do not have signs or signs with incorrect content according to the regulations;

g) Drug retail establishments do not implement record-keeping or means to monitor drug purchasing and selling activities according to the regulations.

2. A fine of VND 5,000,000 to VND 10,000,000 for retail drug establishments or VND 10,000,000 to VND 20,000,000 for wholesale drug establishments, service storage establishments, service testing establishments, and foreign companies operating in drugs and raw materials for drugs in Vietnam, if they commit any of the following acts:

a) Operating drugs without a professional certificate;

b) Operating drugs without a certificate of eligibility to operate drug retail businesses or supplying drugs without a permit for drug activities and raw materials for drugs in Vietnam;

c) Forgery, renting, lending, or allowing other individuals or organizations to rent or lend professional certificates, certificates of eligibility to operate drug retail businesses, related professional qualifications, or permits for drug activities and raw materials for drugs in Vietnam;

d) Operating drugs at addresses different from those stated in the certificate of eligibility to operate drug retail businesses;

đ) Operating drugs not in accordance with the form and scope of operation stated in the certificate of eligibility to operate drug retail businesses or supplying drugs not in accordance with the scope of activity stated in the permit for drug activities and raw materials for drugs in Vietnam.

3. Additional forms of punishment:

a) Revocation of the right to use the professional certificate for three months for the act specified in point a Clause 1 of this Article;

b) Revocation of the right to use the certificate of eligibility to operate drug retail businesses, permit for drug activities and raw materials for drugs in Vietnam, and professional certificate for six to twelve months for the acts specified in points c, d, and đ Clause 2 of this Article.

4. Measures to remedy consequences:

a) Compel to comply strictly with the law for the acts specified in points a, đ, e, and g Clause 1, and points a, b, d, and đ Clause 2 of this Article;

b) Compel to go through the procedures for reissuing the practice certificate, business registration certificate for pharmaceuticals, good manufacturing practice certificate, and permit for pharmaceutical activities and medicinal raw materials in Vietnam in cases specified in points b, c, d, Clause 1 of this Article;

c) Seize in cases of forgery of the practice certificate, business registration certificate for pharmaceuticals, or related professional qualifications as specified in point c, Clause 2 of this Article.

Article 7. Violations concerning drug registration

||| 1. A fine of from 3,000,000 VND to 5,000,000 VND shall be imposed for any of the following acts:

a) Failure to comply with the requirements of competent state agencies regarding reports related to drugs during circulation without providing an explanatory document for reasons;

b) Failure to retain sufficient files and provide drug registration files to competent state management agencies upon request;

c) The drug registration entity fails to cooperate with the production entity or the import entity to recall from the market drugs that do not meet quality and safety standards according to the requirements of the management agency or discovered by the entity itself.

2. A fine of from VND 15,000,000 to VND 20,000,000 shall be imposed for any of the following acts:

a) Failure to notify the competent authority of Vietnam in cases where drugs have been withdrawn from registration and discontinued from circulation in the country of origin or related countries due to safety, efficacy, and quality issues;

b) Providing files, data, and information related to technical dossier including quality standard files, production methods, stability data not based on research, experimentation, or actual production of the production entity or the registration entity;

c) Submitting drug samples for registration not produced by the entity listed in the drug registration file;

d) Providing files, data, and information about the effects, safety, and efficacy of drugs without scientific evidence to prove them;

3. Additional forms of punishment:

a) Revoking the right to use the business registration certificate for pharmaceuticals or permit for pharmaceutical activities and medicinal raw materials in Vietnam for a period of six months to one year for violations specified in point c, Clause 1 of this Article occurring two times or more;

b) Revoking the right to use the business registration certificate for pharmaceuticals or permit for pharmaceutical activities and medicinal raw materials in Vietnam indefinitely for violations specified in Clause 2 of this Article occurring two times or more;

4. Measures to remedy consequences:

a) Compel compliance with legal provisions for violations specified in Clause 1 of this Article;

b) Withdraw registration numbers and compel destruction of all non-compliant drugs for violations specified in Clause 2 of this Article;

Article 8. Violations concerning drug production

1. A fine of from five million to ten million Vietnamese dong shall be imposed for any of the following acts:

a) Producing drugs without ensuring adequate hygiene conditions as prescribed by the Ministry of Health;

b) Producing drugs without reporting to the competent state agency when there are minor changes (as defined by the Ministry of Health) compared to the drug registration file or producing drugs at addresses different from those listed in the registration file;

c) The drug production entity does not have qualified staff to check drug quality and manage drugs;

d) The drug production entity does not retain drug samples as required;

đ) The drug production entity does not keep the drug production registration file in accordance with the registered file with the competent state agency;

e) The drug production entity does not comply with regulations on traditional medicine and herbal drug production as prescribed by the Ministry of Health;

g) Producing and circulating, using drugs that do not meet quality standards level 3 as defined by the Ministry of Health's drug quality management regulations;

2. Imposing a fine of VND 20,000,000 to VND 30,000,000 for each drug product for one of the following acts:

a) Producing drugs without reporting to the competent state agency when there are major changes and other changes (as defined by the Ministry of Health) compared to the drug registration file or producing drugs not in accordance with the approved registration file by the competent state management agency, except for point b, Clause 1 of this Article and other acts stipulated in Article 14 of this Decree;

b) Failure to recall drugs that do not meet quality and safety standards according to the requirements of the management agency or discovered by the entity itself;

c) Producing non-drug products on drug production lines;

d) Producing and circulating, using drugs that do not meet quality standards level 2 as defined by the Ministry of Health's drug quality management regulations;

đ) Producing drugs when the registration number has expired to circulate on the market, except in special cases permitted by the Ministry of Health;

3. Imposing a fine of VND 30,000,000 to VND 40,000,000 for each drug product for one of the following acts:

a) Producing drugs without a registration number issued by the competent health authority to circulate on the market, except for decoctions, prescriptions made at traditional medicine clinics, crude herbs, and tablets;

b) Using medicinal raw materials beyond their expiration date or raw materials not intended for human drug production or raw materials that have been warned by the World Health Organization or relevant authorities as unsafe for human use;

c) Using raw materials of unclear origin, untested raw materials, or raw materials that do not meet quality standards to produce drugs;

d) Producing and circulating, using drugs that do not meet quality standards level 1 as defined by the Ministry of Health's drug quality management regulations;

đ) Producing drugs at a facility (address) that has not obtained a business registration certificate for pharmaceuticals (drug production type);

4. Additional forms of administrative punishment:

a) Revoking the right to use the business registration certificate for pharmaceuticals for a period of three months to six months for violations specified in points a, b, c, e, and g, Clause 1 of this Article;

b) Revoking the right to use the business registration certificate for pharmaceuticals indefinitely for violations specified in Clauses 2 and 3 of this Article;

5. Measures to remedy consequences:

a) Compel the recall and destruction of all drugs or non-drug products resulting from actions specified in points a, e, and g, Clause 1 and Clauses 2 and 3 of this Article;

b) Withdraw registration numbers for drugs within the validity period of the registration number due to actions specified in points a, b, and d, Clause 2, and points b, c, d, and đ, Clause 3 of this Article.

Article 9. Violations of regulations on wholesale and retail of medicines

1. Warning or a fine of VND 500,000 to VND 1,000,000 for any of the following acts:

a) Retailing prescription medicines without a doctor's prescription; retailing processed herbal medicines that do not meet quality standards;

b) The medicine seller or person participating in selling medicines does not have a background file or has but it is incomplete as prescribed.

2. A fine of VND 3,000,000 to VND 5,000,000 for any of the following acts:

a) Selling medicines not in accordance with the treatment instructions of a medical practitioner or substituting medicines according to point c, Clause 1, Article 27 of the Medicine Law without the buyer's consent;

b) Wholesale or retail establishments of medicines do not have invoices or valid receipts;

c) Wholesaling medicines at places that are not legitimate medicine sales premises.

3. A fine of VND 5,000,000 to VND 7,000,000 for any of the following acts:

a) Not implementing or reporting the results of recalling medicines as required by competent state authorities;

b) Wholesaling processed herbal medicines that do not meet quality standards as specified;

c) Retailing medicines that do not meet quality standards or have exceeded their expiration date;

d) Not having a separate compounding room for retail establishments that compound medicines based on prescriptions;

đ) Not having a storage facility for retail establishments that have registered for storage facilities;

e) Trading in medicines used in national programs or medicines covered by health insurance payments or trading in humanitarian aid medicines, non-commercial trade import medicines, which are prohibited from sale;

4. A fine of VND 10,000,000 to VND 15,000,000 for any of the following acts:

a) Wholesaling medicines that do not meet quality standards or have exceeded their expiration date;

b) Trading in medicines that have been announced for recall or failing to recall medicines as required by competent state authorities;

c) Trading in medicines or making them widely available on the market during clinical trials, clinical observation and evaluation phases, or compounded medicines used within pharmacies or treatment facilities;

d) Promoting medicines contrary to legal provisions, taking unfair advantage of a monopoly in the pharmaceutical business;

đ) Trading in medicines listed as prohibited imports, trial medicines, medicines not yet permitted for circulation, sample medicines for registration;

5. A fine of more than VND 15,000,000 up to twice the value of the total quantity of medicines obtained at the business establishment's selling price, but not exceeding VND 40,000,000 for the act of trading in medicines of unknown origin, smuggled medicines, or medicines not permitted for circulation on the market.

6. Additional forms of punishment:

a) Revocation of the right to use the practice certificate, certificate of eligibility for pharmaceutical business operations for a period of three to six months for the acts stipulated in point b, Clause 2 and point a, Clause 3 of this Article;

b) Revocation of the right to use the practice certificate, certificate of eligibility for pharmaceutical business operations for a period of six to twelve months for the acts stipulated in points d, đ and e, Clause 3, points a, b, d and đ, Clause 4, Clause 5 of this Article;

c) Confiscation of all medicines resulting from the acts stipulated in points b and c, Clause 3, Clause 4 and Clause 5 of this Article.

7. Measures to remedy consequences:

a) Compel the return of all proceeds obtained from the acts stipulated in point e, Clause 3, Clause 4 and Clause 5 of this Article;

b) Compel compliance with legal provisions for the acts stipulated in points d and đ, Clause 3 of this Article.

Article 10. Violations of regulations on export and import of medicines

1. A fine of VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts:

a) Importing medicines that have not been permitted for circulation by the Ministry of Health;

b) Importing medicines after the producing country has announced a ban on their circulation in the market;

c) Importing medicines without their original packaging as registered or permitted for import by the Ministry of Health (or as commercial products of medicines);

d) Importing medicines with expiration dates that do not comply with remaining shelf life requirements upon arrival at Vietnamese ports without permission from the Ministry of Health;

đ) Importing or exporting medicines listed in the prohibited import/export list or importing or exporting beyond authorized authority;

e) Importing or exporting medicines that have exceeded their expiry date;

g) An importing entity failing to recall or cooperate in recalling medicines that do not meet quality and safety standards as required by management authorities or discovered by the entity itself.

2. Additional forms of punishment:

a) Revoking the right to use the medicine import permit in Vietnam for a period of six months to twelve months for the acts specified in point c and d of Clause 1 of this Article;

b) Revoking the right to use the practice certificate; medicine export/import permit; certificate of eligibility for medicine business; registration activity permit for medicines in Vietnam indefinitely for the acts specified in points a, b, đ, e, and g of Clause 1 of this Article.

3. Measures to remedy consequences:

Recovering and compelling removal from Vietnamese territory or re-exportation, destruction of medicines or raw materials for medicines due to the implementation of acts specified in Clause 1 of this Article.

Article 11. Violations of regulations on storage of medicines

1. Imposing a fine of VND 500,000 to VND 1,000,000 on retail establishments implementing any of the following acts:

a) Selling medicines that do not meet the storage requirements indicated on the medicine label;

b) Mixing non-medicinal items with medicines.

2. A fine of VND 5,000,000 to VND 10,000,000 shall be imposed on any of the following acts:

a) Failing to comply with the GSP regulations of the Ministry of Health for service providers storing medicines;

b) Failing to meet the conditions for storing medicines during the storage or transportation process for wholesale establishments;

c) Failing to meet the requirements for storing vaccines and medical biological products during transportation, delivery, packaging, and storage of vaccines and medical biological products;

d) Mixing non-medicinal items with medicines for wholesale medicine establishments.

3. Additional forms of punishment:

Revoking the right to use the practice certificate, certificate of eligibility for medicine business for a period of six months to twelve months for the acts specified in point a, b, and c of Clause 2 of this Article.

4. Measures to remedy consequences:

a) Compelling the destruction of all medicines that do not meet quality standards due to the implementation of acts specified in point a of Clause 1, points b, c, and d of Clause 2 of this Article;

b) Compelling compliance with legal provisions for the acts specified in Clauses 1 and 2 of this Article.

Article 12. Violations of regulations on testing of medicines

1. A fine of VND 5,000,000 to VND 10,000,000 shall be imposed for one of the following acts:

a) Failing to comply with the GLP regulations of the Ministry of Health for service providers testing medicines;

b) Failing to adhere to good practices in testing medicines.

2. A fine of VND 10,000,000 to VND 20,000,000 shall be imposed on any of the following acts:

a) Providing testing services for medicines without permission from the Ministry of Health;

b) Altering or falsifying analytical data;

c) Using test samples of medicines that are not produced or researched by the entity itself as recorded in the medicine registration dossier.

3. Additional forms of punishment:

Revoking the right to use the certificate of eligibility for medicine business for a period of six months to twelve months for the acts specified in Clause 2 of this Article.

4. Measures to remedy consequences:

Compelling compliance with legal provisions for the acts specified in Clauses 1 and 2 of this Article.

Article 13. Violations of regulations on drug information and advertising

1. Warning for the act of drug promoters not wearing the drug promoter card when operating.

2. A fine of VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts:

a) Not sending a notification letter to the Provincial Health Department when the drug promoter operates in a province different from the province where the card was issued.

b) Not sending a notification letter along with the receipt and content of the advertisement to the Provincial Health Department when advertising drugs on local radio and television stations.

c) Organizing a seminar to introduce drugs before submitting the registration dossier for organizing the drug introduction seminar to the competent state management agency or during the period of examination and resolution of the dossier according to regulations.

||| 3. A fine of from 10,000,000 VND to 20,000,000 VND shall be imposed for any of the following acts:

a) Providing drug information and advertising that does not match the registered content at the competent state management agency; providing drug information and advertising during the period of examination and resolution of the dossier according to regulations; providing drug information and advertising based on promotional materials whose validity has expired; providing drug information and advertising without submitting the registration dossier for drug information and advertising to the competent state management agency (except in cases where drug information does not need to be registered).

b) Advertising and providing information about drugs that have not been granted a registration number or whose registration number has expired, except in cases where drug information does not need to be registered and seminars introducing drugs to healthcare workers.

c) Not promptly monitoring and reporting new drug information, adverse drug reactions, and signs of drug quality deterioration to the Ministry of Health (Drug Administration) and the National Center for Drug Information and Adverse Reaction Monitoring by the business unit.

d) Providing inaccurate drug information and promotional materials.

4. A fine of VND 30,000,000 to VND 40,000,000 for any of the following acts:

a) Advertising prescription drugs; vaccines, medical products used for disease prevention; non-prescription drugs but recommended by the competent state management agency in writing to be used restrictively or under physician supervision.

b) Providing information and advertising cosmetics, health supplements, and other non-drug products with unclear content causing consumers to misunderstand these products as drugs.

c) Using material or financial benefits in any form to influence physicians or drug users to promote drug prescriptions and usage.

d) Exploiting the form of physician guidance on disease prevention, treatment, or drug usage through articles in newspapers, radio programs, or television broadcasts to advertise drugs.

đ) Operating as a drug promoter without being issued a drug promoter card.

e) Failing to report and implement corrective measures as required by the state management agency when there is a violation of drug information and advertising.

5. Additional forms of punishment:

a) Revoking the right to use the professional certificate, the certificate of eligibility for drug business, and the license for drug and raw material activities in Vietnam for a period of three to six months for the act stipulated in Clause 3 of this Article occurring three times or more within twelve months.

b) Revoking the right to use the professional certificate, the certificate of eligibility for drug business, and the license for drug and raw material activities in Vietnam for a period of six to twelve months for the act stipulated in Clause 4 of this Article occurring three times or more within twelve months.

6. Measures to remedy consequences:

a) Compelling compliance with legal provisions for the act stipulated in Clause 1, Point c Clause 4 of this Article.

b) Compelling reporting and providing accurate drug information for the acts stipulated in Points c and d Clause 3, Point e Clause 4 of this Article.

c) Compelling the cancellation and correction of drug information and advertising for the acts stipulated in Points a, b, and d Clause 3, Points a, b, and d Clause 4 of this Article.

d) Compelling the destruction of all violating materials and means for the acts stipulated in Clauses 2, 3, and 4 of this Article.

Article 14. Violations concerning packaging and labeling of drugs (including the drug usage instructions sheet)

1. A fine of VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts:

a) The drug label contains content or form that does not match the approved dossier, except for the contents specified in Clause 2 of this Article;

b) Changing the packaging or labeling of drugs without the written consent of the Ministry of Health;

c) Trading drugs whose packaging or labeling does not match the approved dossier.

2. A fine of from VND 30,000,000 to VND 40,000,000 shall be imposed for the act of erasing, deleting, or altering the expiration date, indications, contraindications, dosage, functions, and effects on the drug label compared to the approved dossier.

3. Additional forms of punishment:

Revoking indefinitely the certificate of eligibility for drug trading for the business entity or revoking indefinitely the permit for drug activities and raw materials for drug production in Vietnam for the supplier entity due to implementing the act stipulated in Clause 2 of this Article.

4. Measures to remedy consequences:

a) Compelling compliance with the relevant legal provisions for the act stipulated in Clause 1 of this Article;

b) Compelling the destruction of all drugs violating the act stipulated in Clause 2 of this Article.

Article 15. Violations concerning narcotic drugs, psychotropic substances, and precursor chemicals used in drugs

1. A fine of from VND 5,000,000 to VND 10,000,000 shall be imposed for the act of prescribing, distributing, or using narcotic drugs, psychotropic substances, and precursor chemicals used in drugs contrary to the regulations of the Ministry of Health.

2. A fine of VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts:

a) Purchasing or selling narcotic drugs, psychotropic substances, and precursor chemicals used in drugs without an approved plan;

b) Storing or distributing narcotic drugs, psychotropic substances, and precursor chemicals used in drugs contrary to the regulations of the Ministry of Health;

c) Transporting, receiving, or packing contrary to the regulations;

d) Destroying drugs contrary to the regulations;

đ) Failing to record and retain fully related documents, files, and books concerning narcotic drugs, psychotropic substances, and precursor chemicals used in drugs;

e) Exporting or importing narcotic drugs, psychotropic substances, and precursor chemicals without the permission of the competent state agency and at ports not in accordance with the regulations.

3. A fine of from VND 10,000,000 to VND 20,000,000 shall be imposed on retail establishments or a fine of from VND 30,000,000 to VND 40,000,000 shall be imposed on wholesale establishments for the act of selling narcotic drugs, psychotropic substances, and precursor chemicals used in drugs to unauthorized users or establishments without the function of trading narcotic drugs, psychotropic substances, and precursor chemicals used in drugs according to the regulations.

4. Additional forms of administrative punishment:

a) Revoking the right to use the certificate of eligibility for drug trading for a period of six months to twelve months for the acts stipulated in Clause 2 and Clause 3 of this Article two times or more within twelve months;

b) Revoking indefinitely the right to use the certificate of eligibility for drug trading for the acts stipulated in Clauses 2 and 3 of this Article three times or more within twelve months.

5. Measures to remedy consequences:

a) Compelling the recall and destruction of all drugs due to the implementation of the act stipulated in point e of Clause 2 and Clause 3 of this Article;

b) Compelling compliance with the relevant legal provisions for the acts stipulated in points c, d, and đ of Clause 2 of this Article.

Article 16. Violations concerning scientific research, testing, and clinical trials of drugs

1. A fine of from VND 5,000,000 to VND 10,000,000 shall be imposed for the act of concealing information or failing to provide complete and truthful information about clinical drug trials to participants, about the trial process, and potential risks;

2. A fine of between 10,000,000 VND and 20,000,000 VND shall be imposed for one of the following acts:

a) Providing personal information of clinical trial subjects without their consent;

b) Failing to report the trial process and results as required;

c) Failing to comply with good clinical practice regulations.

3. A fine of VND 30,000,000 to VND 40,000,000 for any of the following acts:

a) Conducting clinical trials without the approval of the Ministry of Health;

b) Modifying or supplementing the content of the clinical drug trial dossier and protocol already approved by the Ministry of Health;

c) Using clinical trial drugs for other purposes;

d) Coercing research participants;

đ) Altering test results for samples that have been tested.

4. Additional forms of administrative punishment:

Revoking the certificate of eligibility for drug trading and the certificate of compliance with good clinical practice standards for a period of six months to twelve months for the acts stipulated in Clause 2 and Clause 3 of this Article.

5. Measures to remedy consequences:

Compelling compliance with the relevant legal provisions for the acts stipulated in Clause 1, points b and c of Clause 2, and Clause 3 of this Article.

Article 17. Violations of regulations on drug pricing management

1. Violations in declaring drug prices:

A fine of from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts:

a) Not declaring, or declaring incompletely the drug price as prescribed;

b) Not adjusting the declared price after receiving written comments from the competent state agency on drug pricing;

c) Selling drugs at a higher price than the declared price;

d) Not informing customers about the declared drug price.

2. Violations of regulations on displaying drug prices:

A fine of from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts:

a) Not displaying, or displaying incompletely the prices of drugs currently being sold, or not displaying prices according to the prescribed regulations;

b) Selling drugs at a higher price than the displayed price.

3. Violations of regulations on retail mark-up or drug pricing for hospital pharmacies:

A fine of from VND 5,000,000 to VND 10,000,000 shall be imposed for selling at a higher price than the maximum retail mark-up allowed as prescribed by the competent authority.

4. Additional forms of administrative punishment:

Revocation of the certificate of eligibility for drug business operations or the license for foreign enterprises engaged in drug and raw material production activities in Vietnam for a period of three to six months for repeated violations (two or more times within twelve months from the date of the first violation) as stipulated in points a, c, and d of Clause 1, point b of Clause 2 of this Article.

5. Measures to remedy consequences:

a) Compel compliance with the relevant laws for the acts stipulated in point a of Clause 1, point a of Clause 2, and Clause 3 of this Article;

b) Compel repayment of the entire difference in price due to the acts stipulated in point c of Clause 1 and point b of Clause 2 of this Article.

Section 2

ADMINISTRATIVE VIOLATIONS IN THE PRODUCTION, DISTRIBUTION, INFORMATION, AND ADVERTISING OF COSMETICS, FORMS AND AMOUNTS OF FINES

Article 18. Violations of regulations on cosmetic distribution

1. A fine of from VND 1,000,000 to VND 5,000,000 shall be imposed for cases where the total value of the batch of goods in violation is less than VND 10,000,000, or a fine of from VND 5,000,000 to VND 10,000,000 shall be imposed for cases where the total value of the batch of goods in violation is VND 10,000,000 or more, calculated based on the selling price, for non-organizations or individuals who are not responsible for bringing products to market when committing any of the following acts:

a) Distributing cosmetics that are not in their original packaging;

b) Distributing smuggled cosmetics, cosmetics of unknown origin, or source;

c) Distributing expired cosmetics;

d) Distributing cosmetics without product registration;

đ) Distributing cosmetics containing prohibited ingredients or exceeding the permitted limits for substances with specified concentration or usage levels under current laws;

e) Distributing cosmetics that do not meet quality standards and are unsafe for users;

g) Distributing cosmetics that have been recalled by the competent state management agency due to violations of laws.

2. A fine of from VND 10,000,000 to VND 20,000,000 shall be imposed on organizations or individuals responsible for bringing products to market when committing any of the following acts:

a) Distributing cosmetics with product information files (PIFs) stored at the enterprise that do not comply with regulations;

b) Distributing cosmetics that do not meet quality standards and are unsafe for users;

c) Distributing cosmetics that are not in their original packaging or of unknown origin;

d) Distributing cosmetics that have exceeded their expiration date or the recommended usage period by the manufacturer.

3. A fine of from VND 20,000,000 to VND 30,000,000 shall be imposed on organizations or individuals responsible for bringing products to market when committing any of the following acts:

a) Distributing cosmetics containing prohibited ingredients or exceeding the permitted limits for substances with specified concentration or usage levels under current laws;

b) Distributing cosmetics without a product information file (PIF) as required;

c) Distributing cosmetics with formulas that do not match the approved registration dossier;

d) Distributing cosmetics that have been banned from circulation by the country of manufacture;

đ) Failing to recall cosmetics in violation of regulations as required by the competent state management agency.

4. Measures to remedy consequences:

a) Compel the recall and destruction of all cosmetics resulting from the acts stipulated in Clause 1, points b, c, and d of Clause 2, and points a, c, and d of Clause 3 of this Article;

b) Recall the acceptance number of the product registration dossier or withdraw the registration number for circulation of cosmetics for the acts stipulated in points a, b, c, and d of Clause 3 of this Article;

c) Compel compliance with the relevant laws for the acts stipulated in point a of Clause 2 and point đ of Clause 3 of this Article.

Article 19. Violations of regulations on importing cosmetics

1. A fine of VND 10,000,000 to VND 20,000,000 shall be imposed for the act of importing cosmetics that are not in their original packaging or with unclear origin.

2. A fine of VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts:

a) Importing cosmetics containing prohibited substances or exceeding the permitted limits for substances with specified concentration or usage levels as stipulated by current laws;

b) Importing cosmetics that have been banned from circulation by the country of production.

3. Measures to remedy consequences:

a) Order the recall and destruction of all cosmetics due to the acts prescribed in Clause 1 and 2 of this Article;

b) Revoke the registration number for product declaration or withdraw the registration number for circulation of cosmetics for the acts prescribed in Clause 2 of this Article.

Article 20. Violations of regulations on manufacturing cosmetics

1. A fine of VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts:

a) Manufacturing cosmetics without adhering to the Good Manufacturing Practices (GMP) standards of the Association of Southeast Asian Nations (ASEAN) or equivalent standards recognized by the ASEAN Cosmetics Council;

b) Manufacturing cosmetics containing prohibited substances or exceeding the permitted limits for substances with specified concentration or usage levels as stipulated by current laws, or manufacturing cosmetics that do not meet quality standards and are unsafe for users;

c) Manufacturing cosmetics with formulas that do not match the declared documentation.

2. Measures to remedy consequences:

a) Order the recall and destruction of all cosmetics due to the acts prescribed at points b and c of Clause 1 of this Article;

b) Revoke the registration number for product declaration or withdraw the registration number for circulation of cosmetics for the acts prescribed at points b and c of Clause 1 of this Article;

c) Order compliance with legal provisions for the act prescribed at point a of Clause 1 of this Article.

Article 21. Violations of regulations on declaring cosmetics

1. A fine of VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following acts:

a) Falsely declaring contents in the cosmetic product declaration form;

b) Placing cosmetics on the market without declaring them as required by law for domestic manufacturers or foreign importers.

2. Measures to remedy consequences:

a) Order the recall and destruction of all cosmetics due to the acts prescribed in Clause 1 of this Article;

b) Revoke the registration number for product declaration or withdraw the registration number for circulation of cosmetics for the acts prescribed at point b of Clause 1 of this Article.

Article 22. Violations of regulations on information and advertising of cosmetics

1. A fine of VND 5,000,000 to VND 10,000,000 shall be imposed for one of the following acts:

a) Advertising cosmetics that do not correspond to the approved advertising registration dossier or are inconsistent with the safety and efficacy documentation of the cosmetic products;

b) Organizing seminars or events to introduce cosmetics that do not correspond to the approved seminar or event introduction registration dossier;

c) Advertising cosmetics with expired registered content or advertising cosmetics during the period when the application is under review and resolution;

d) Organizing seminars or events to introduce cosmetics with expired registered content; organizing seminars or events to introduce cosmetics during the period when the application is under review and resolution;

đ) Advertising cosmetics that have been accepted by the local Department of Health but have not notified the Department of Health of the advertising location before advertising in another locality;

e) Organizing seminars or events to introduce cosmetics that have been accepted by the local Department of Health but have not notified the local Department of Health of changes in time and place before organizing the event;

2. A fine of between 10,000,000 VND and 20,000,000 VND shall be imposed for one of the following acts:

a) Advertising cosmetics without obtaining the registration number for product declaration or submitting the cosmetic advertising registration dossier from the competent state management agency;

b) Organizing seminars or events to introduce cosmetics without obtaining the registration number for product declaration or submitting the seminar or event introduction registration dossier from the competent state management agency;

c) Providing information or advertising cosmetics with effects similar to those of drugs, leading consumers to mistakenly believe that the product is a drug.

3. Measures to remedy consequences:

Order compliance with legal provisions for the acts prescribed in Clause 1 and Clause 2 of this Article.

Article 23. Violations of labeling regulations for cosmetics

1. A fine of VND 5,000,000 to VND 10,000,000 shall be imposed for one of the following acts:

a) Producing or trading in cosmetics with labels that do not meet the current requirements for cosmetic labeling;

b) Producing or trading in cosmetics with labels stating product features and functions that are inconsistent with the published dossier.

2. A fine of between 10,000,000 VND and 20,000,000 VND shall be imposed for one of the following acts:

a) Counterfeiting the label of another product that has been permitted to circulate;

b) Labeling with false information about the origin or place of manufacture of goods;

c) Labels failing to indicate the name and address of the organization or individual responsible for bringing the product to market;

d) Labels stating product features and functions that are inconsistent with the inherent nature of the product.

3. Measures to remedy consequences:

a) Compel the recall and destruction of all cosmetics produced through actions specified in points a, b, and d, Clause 2, Article 23 of this Law;

b) Recall the registration number for the declaration of cosmetic products or withdraw the registration number for circulation of cosmetics for violations specified in points a, b, and d, Clause 2, Article 23 of this Law;

c) Compel compliance with legal provisions for actions specified in Clause 1, point c, Clause 2, Article 23 of this Law.

Section 3

ADMINISTRATIVE VIOLATIONS IN THE PRODUCTION, DISTRIBUTION, INFORMATION,

ADVERTISING OF MEDICAL DEVICES, FORMS AND AMOUNTS OF PENALTIES

Article 24. Violations of conditions for trading in medical devices

1. A fine of VND 5,000,000 to VND 10,000,000 shall be imposed for one of the following acts:

a) Trading in medical devices without a business registration certificate;

b) Physical facilities, technical equipment, and personnel for the production and trading in medical devices not complying with the regulations of the Ministry of Health;

c) Medical device trading establishments not posting prices;

d) Medical device trading establishments selling at prices higher than posted prices.

2. A fine of between 10,000,000 VND and 20,000,000 VND shall be imposed for one of the following acts:

a) Trading in medical devices without a registration number for circulation; without a health ministry import permit or without documentation proving clear origin and place of manufacture;

b) Trading beyond the scope of business registration.

3. Additional forms of punishment:

Confiscate medical devices for actions specified in point a, Clause 2, Article 24 of this Law.

4. Measures to remedy consequences:

a) Compelling compliance with the relevant legal provisions for the act stipulated in Clause 1 of this Article;

b) Compel the return of the difference in money obtained from actions specified in point d, Clause 1, Article 24 of this Law;

c) Compel the recall of medical devices traded beyond the scope of business registration for actions specified in point b, Clause 2, Article 24 of this Law.

Article 25. Violations of regulations on the production of medical devices

1. Fine from 5,000,000 VND to 10,000,000 VND for failure to promptly notify competent authorities of changes in product items, production facilities, or principal persons responsible for production.

2. Fine from 10,000,000 VND to 20,000,000 VND for evading responsibility and failing to rectify consequences caused by defective medical devices.

3. Fine from 20,000,000 VND to 30,000,000 VND for producing medical devices that do not conform to declared standards and quality.

4. A fine of VND 30,000,000 to VND 40,000,000 for any of the following acts:

a) Producing medical devices without a certificate of eligibility for medical device production;

b) Producing medical devices without a registration certificate for circulation or a free circulation certificate (CFS) for market circulation or export;

c) Producing medical devices without conducting clinical trials or conducting incorrect clinical trials for products requiring such trials.

5. Additional forms of punishment:

Suspend the right to operate the license for three to six months for actions specified in Clause 3, point b and c, Clause 4 of this Article.

6. Measures to remedy consequences:

a) Compel responsibility for remedying consequences caused by defective medical devices for actions specified in Clause 2 of this Article;

b) Compel the recall and destruction or recycling of all medical devices produced through actions specified in Clauses 3 and 4 of this Article;

c) Compel compliance with legal provisions for actions specified in Clauses 3 and 4 of this Article.

Article 26. Violations of regulations on importing medical equipment and devices

1. A fine of VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts:

a) Importing medical equipment and devices without an import permit as prescribed by the Ministry of Health;

b) Importing into Vietnam medical equipment and devices that are not allowed to circulate in the country of production, prohibited from circulation in Vietnam, or banned for circulation by the World Health Organization;

c) Importing medical equipment and devices that have not undergone clinical trials at certain healthcare facilities according to international practices or as prescribed by Vietnamese law;

d) Importing medical equipment and devices that have not been quality tested by inspection agencies or state quality control agencies for equipment requiring accuracy and other specified equipment as prescribed by law;

đ) Importing medical equipment and devices with quality defects, ineffective in diagnosis and treatment, causing harmful side effects to humans;

e) Importing used medical equipment (for business purposes, not as gifts);

2. Additional forms of punishment:

a) Revoking indefinitely the right to use the import permit for medical equipment and devices for the violation stipulated in Clause 1 of this Article;

b) Confiscating the medical equipment and devices for the violation stipulated in Clause 1 of this Article;

3. Measures to remedy consequences:

Compelling compliance with the provisions of the law for the violation stipulated in Point d Clause 1 of this Article;

Article 27. Violations of regulations on information and advertising of medical equipment and devices

1. A fine of VND 5,000,000 to VND 10,000,000 shall be imposed for one of the following acts:

a) The content of information and advertising of medical equipment and devices does not match the registered dossier or fails to amend the advertising content as required by the competent health authority;

b) Organizing seminars or events to introduce medical equipment and devices before the competent state management agency has accepted the registration dossier;

2. A fine of between 10,000,000 VND and 20,000,000 VND shall be imposed for one of the following acts:

a) Advertising medical equipment and devices inaccurately regarding their functions and effects;

b) Advertising medical equipment and devices without a receipt for the acceptance of the registration dossier for advertising from the competent health authority or without permission to circulate in Vietnam;

c) Intentionally concealing or failing to promptly inform the management authority and customers about warnings concerning incidents, unwanted effects of the medical equipment and devices;

3. Measures to remedy consequences:

Compelling reporting and providing accurate information or issuing a public apology and correction through mass media for the violations stipulated in Point a Clause 1 and Clause 2 of this Article;

Chapter III

AUTHORITY AND PROCEDURES FOR IMPOSING ADMINISTRATIVE PENALTIES FOR VIOLATIONS

Article 28. Competence of Chairpersons of People's Committees at all levels to impose administrative penalties

1. The Chairperson of the People's Committee of communes, wards, towns has the authority:

a) To issue warnings;

b) To impose a fine up to VND 2,000,000;

c) To confiscate contraband items, means, tools of violation valued up to VND 2,000,000;

d) To apply remedial measures as prescribed in Points a, b, c, d, e, and k Clause 3 Article 5 of this Decree;

2. The Chairperson of the People's Committee of districts, towns, cities under provinces has the authority:

a) To issue warnings;

b) Impose fines up to thirty million dong;

c) To apply supplementary sanctions as prescribed by laws on handling administrative violations;

d) To apply remedial measures as prescribed in Points a, b, c, d, e, and k Clause 3 Article 5 of this Decree;

3. The Chairperson of the People's Committee of provinces, centrally governed cities has the authority:

a) To issue warnings;

b) Impose fines up to 40,000,000 VND;

c) To apply supplementary sanctions as prescribed by laws on handling administrative violations;

d) To apply remedial measures as prescribed in Clause 3 Article 5 of this Decree;

Article 29. Competence of the Health Inspectorate to impose administrative penalties

1. Health Inspectors while performing their duties within their functional scope have the authority:

a) To issue warnings;

b) Impose a fine up to 500,000 VND;

c) To confiscate contraband items, means, tools of violation valued up to VND 2,000,000;

d) To apply remedial measures as prescribed in Points a, b, c, d, e, and k Clause 3 Article 5 of this Decree;

2. The Head of the Health Inspectorate of the Department of Health has the authority:

a) To issue warnings;

b) Impose fines up to thirty million dong;

c) To apply supplementary sanctions as prescribed by laws on handling administrative violations;

d) To apply remedial measures as prescribed in Points a, b, c, d, e, and k Clause 3 Article 5 of this Decree;

3. The Head of the Health Inspectorate of the Ministry of Health has the authority:

a) To issue warnings;

b) Impose fines up to 40,000,000 VND;

c) To apply supplementary sanctions as prescribed by laws on handling administrative violations;

d) To apply remedial measures as prescribed in Clause 3 Article 5 of this Decree;

4. The head of the agency entrusted with specialized inspection functions, or the person entrusted with specialized inspection tasks has the authority to impose administrative penalties as prescribed by laws on handling administrative violations and related laws.

Article 30. Competence to impose administrative penalties of other agencies

In addition to those persons specified in Articles 28 and 29 of this Decree, other persons, as provided for in the Administrative Violation Handling Ordinance dated July 2, 2002 and the Ordinance Amending and Supplementing Certain Provisions of the Administrative Violation Handling Ordinance dated April 2, 2008 (hereinafter referred to as the Administrative Violation Handling Ordinance), within their assigned functions and tasks, who discover administrative violations stipulated in this Decree within their areas or jurisdictions shall have the right to impose penalties in accordance with the provisions of the Administrative Violation Handling Ordinance.

Article 31. Delegation and principles for determining competence to impose administrative penalties in the field of drugs, cosmetics, and medical devices

1. Delegation to impose administrative penalties in the field of drugs, cosmetics, and medical devices shall be applied in accordance with the provisions of Article 41 of the Administrative Violation Handling Ordinance.

2. Principles for determining competence to impose administrative penalties in the field of drugs, cosmetics, and medical devices shall be applied in accordance with the provisions of Article 42 of the Administrative Violation Handling Ordinance.

Article 32. Procedures for imposing administrative penalties in the field of drugs, cosmetics, and medical devices

1. The procedures and steps for imposing administrative penalties in the field of drugs, cosmetics, and medical devices shall be carried out in accordance with the provisions of the Administrative Violation Handling Ordinance and Decree No. 128/2008/NĐ-CP.

2. Documents related to the imposition of administrative penalties in the field of drugs, cosmetics, and medical devices must be kept intact at the penalty-imposing agency. The administrative violation record shall be prepared according to the current model.

3. Individuals and organizations subject to fines must pay the fine within the time limit and at the place specified in the penalty decision, except in cases where they have paid the fine on the spot in accordance with the provisions of Articles 54 and 58 of the Administrative Violation Handling Ordinance and received a receipt for the fine payment.

4. When applying the form of confiscating contraband items and means of violation, the person authorized to impose penalties must comply with the provisions of Articles 60 and 61 of the Administrative Violation Handling Ordinance and Decree No. 128/2008/NĐ-CP.

Article 33. Execution of penalty decisions and enforcement of penalty decisions in the field of drugs, cosmetics, and medical devices

1. Individuals and organizations subject to administrative penalties in the field of drugs, cosmetics, and medical devices under this Decree must strictly comply with the penalty decision within ten days from the date of receiving the penalty decision, except in cases where the law provides otherwise. If individuals and organizations subject to penalties do not voluntarily comply with the penalty decision, they will be enforced to comply with the penalty decision in accordance with the provisions of Article 66 of the Administrative Violation Handling Ordinance and the provisions of the law on enforcing penalty decisions.

2. When applying measures to enforce penalty decisions in the field of drugs, cosmetics, and medical devices, agencies and persons authorized to impose penalties must follow the enforcement procedures and steps as stipulated in Articles 66 and 67 of the Administrative Violation Handling Ordinance and the provisions of the law on enforcing penalty decisions.

Article 34. Templates for minutes and decisions to be used in administrative penalties concerning drugs, cosmetics, and medical devices

Attached to this Decree are the appendices containing templates for minutes and decisions to be used in administrative penalties concerning drugs, cosmetics, and medical devices.

Chapter IV

IMPLEMENTING PROVISIONS

Article 35. Effective Date

This Decree takes effect from December 15, 2011.

The Articles 19, 20, 21, 22, 23, 24, and Articles 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44 of Decree No. 45/2005/NĐ-CP dated April 6, 2005 of the Government on administrative penalties in the field of health care are hereby repealed.

Article 36. Responsibilities for guidance and implementation

1. The Minister of Health shall be responsible for guiding, organizing, and supervising the implementation of this Decree.

2. Ministers, Heads of ministerial-level agencies, Heads of government agencies, Chairpersons of People's Committees at all levels, and related agencies, organizations, and individuals shall be responsible for implementing this Decree./.