Decree No. 93/2011/ND-CP on sanctioning of administrative violations related

• Official number: 93/2011/ND-CP
• Legislation Type: Decree of Government
• Organization: The Government
• Signer: Nguyen Tan Dung
• Issued Date: 18/10/2011

THE GOVERNMENT -------	SOCIALIST REPUBLIC OF VIET NAM Independence - Freedom – Happiness ---------
No. 93/2011/ND-CP	Hanoi, October 18, 2011

DECREE

ON SANCTIONING OF ADMINISTRATIVE VIOLATIONS RELATED TO MEDICINES, COSMETICS AND MEDICAL EQUIPMENT

THE GOVERNMENT

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

Pursuant to the June 14, 2005 Pharmacy Law;

Pursuant to the June 14, 2005 Commercial Law;

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

Pursuant to the July 2, 2002 Ordinance on Handling of Administrative Violations, and the April 2, 2008 Ordinance Amending and Supplementing a Number of Articles of the Ordinance on Handling of Administrative Violations;

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At the proposal of the Minister of Health,

DECREES:

Chapter I

GENERAL PROVISIONS

Article 1. Scope of application

1. This Decree specifies acts of violation, sanctioning forms and levels, remedial measures, competence and procedures for sanctioning administrative violations related to medicines, cosmetics and medical equipment.

2. Administrative violations related to medicines, cosmetics and medical equipment include:

a/ Violations of regulations on medicine manufacture, trading, information and advertisement;

b/ Violations of regulations on cosmetic manufacture, trading, information and advertisement;

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Article 2. Subjects of application

I. Individuals and organizations that intentionally or unintentionally commit administrative violations related to medicines, cosmetics or medical equipment specified in Chapter II of this Decree which are not crimes.

Administrative sanctions are not imposed for violations of this Decree's provisions committed by cadres, civil servants and public employees while performing their assigned official duties and tasks. The handling of their violations complies with the law on cadres, civil servants and public employees.

2. Foreign individuals and organizations that operate in the Vietnamese territory and commit administrative violations related to medicines, cosmetics or medical equipment specified in Chapter II of this Decree, unless otherwise provided in treaties to which the Socialist Republic of Vietnam is contracting party. In this case, such treaties prevail.

Article 3. Interpretation of terms

1. Cosmetic product means a substance or preparation used in contact with external human body parts (skin, hair, nails, lips and external sexual organs) or teeth and oral mucosa, for the main purposes of cleansing, refreshing, uplifting appearance or form, controlling body odor, protecting body or keeping body in good conditions.

2. Medical equipment means medical equipment, instruments, supplies (for transplanting or wear-out use purpose), diagnostic chemicals and biologicals (accompanying medical equipment) and special-use vehicles for the care for, protection and improvement of people's health.

Article 4. Application of the law on sanctioning of administrative violations

1. Administrative violations related to trading of counterfeit goods; intellectual property infringements; violations of regulations on price valorization, price monopoly syndication, price and freight subsidies, supports for implementation of price policies and other administrative violations related to medicines, cosmetics or medical equipment not specified in this Decree are subject to the laws on sanctioning of administrative violations in related state management fields.

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3. Sanctioning principles; handling of administrative violators being minors; extenuating or aggravating circumstances; statute of limitations and time limit for sanctioning; duration upon the expiration of which a violator is regarded as having never been sanctioned; method of calculating time limits and statute of limitations; determination of competence to sanction administrative violations; making of administrative violation minutes; issuance of decisions on sanctioning of administrative violations; procedures for imposing, collecting and paying fines; procedures for confiscating and handling material evidences and means used in administrative violations; execution of decisions on sanctioning of administrative violations, delay of execution of decisions on fines, enforcement of decisions on sanctioning of administrative violations, and transfer of decisions on sanctioning of administrative violations related to medicines, cosmetics and medical equipment for execution comply with the law on handling of administrative violations and Decree No. 128/2008/ND-CP of December 16, 2008, detailing a number of articles of the 2002 Ordinance on Handling of Administrative Violations and the 2008 Ordinance Amending and Supplementing a Number of Articles of the Ordinance on Handling of Administrative Violations (below referred to as Decree No. 128/ 2008/ND-CP).

Article 5. Sanctioning forms

1. For each act of administrative violation related to medicines, cosmetics or medical equipment, a violator is subject to either of the following principal sanctions:

a/ Caution;

b/ Fine: The maximum fine for sanctioning administrative violations related to medicines, cosmetics and medical equipment is VND 40,000,000 (forty million dong).

2. Depending on the nature and severity of their violations, violators may be subject to either or all of the following additional sanctioning forms:

a/ Deprivation of the right to use certificates of eligibility for medicine trading, licenses for medicine and medicine material-related activities in Vietnam, medicine export or import licenses, definite or indefinite-term pharmaceutical practice certificates, or medical equipment import licenses;

b/ Confiscation of material evidences and means used in administrative violations.

3. In addition to the sanctioning forms specified in Clauses 1 and 2 of this Article, administrative violators may be subject to one or several of the following remedial measures:

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b/ Forcible making of corrections or public apologies in the mass media;

c/ Forcible strict compliance with professional regulations of the Ministry of Health;

d/ Forcible remedying of consequences caused by faulty products;

e/ Forcible completion of procedures for re-grant of practice certificates, certificates of eligible for medicine trading, good practice certificates, licenses for medicine and medicine material-related activities in Vietnam;

f/ Forcible recall, destruction or recycling of infringing medicines, cosmetics, non-medicinal products or medical equipment; forcible recall or destruction of materials and means used in violations, except when necessary to seize them for use as evidence or proof for further handling;

g/ Revocation of registration numbers of medicines due to violations of professional regulations;

h/ Withdrawal of numbers of receipt of cosmetic product announcement cards;

i/ Revocation of cosmetic circulation registration numbers;

j/ Forcible refund of whole proceeds or margin amounts earned from the commission of violations;

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4. The principal sanctioning forms may be applied independently or together with additional sanctioning forms or remedial measures. Additional sanctioning forms cannot be applied independently but together with a principal sanction.

Chapter II

ADMINISTRATIVE VIOLATIONS RELATED TO MEDICINES, COSMETICS AND MEDICAL EQUIPMENT, SANCTIONING FORMS AND LEVELS

Section 1: ADMINISTRATIVE VIOLATIONS IN MEDICINE MANUFACTURE, TRADING, INFORMATION AND ADVERTISEMENT, SANCTIONING FORMS AND LEVELS

Article 6. Violations of regulations on business conditions and use of practice certificates, certificates of eligibility for medicine trading or licenses for medicines and medicine materials-related activities in Vietnam

1. A fine of between VND 3,000,000 and 5,000,000 shall be imposed on medicine retail establishments or a fine of between VND 5,000,000 and 8,000,000 on medicine wholesale, preservation or testing service establishments or foreign companies conducting medicines and medicine materials-related activities in Vietnam for one of the following violations:

a/ Failing by an absent professional operation manager to authorize or appoint another person to act on his/her behalf under law;

b/ Manufacturing, wholesaling, retailing or providing the service of preserving or testing medicines without good practice certificates granted according to the Ministry of Health's roadmap or with expired good practice certificates and failing to carry out procedures for re-grant of these certificates under the Ministry of Health's regulations;

c/ Trading in medicines with expired practice certificates and failing to carry out procedures for re-grant of these certificates under regulations',

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e/ Trading in or supplying medicines after practice certificates or certificates of eligibility for medicine trading or licenses for medicines and medicine materials-related activities in Vietnam are revoked by state management agencies or the right to use these certificates or licenses is deprived under law;

f/ Failing to put up signboards or putting up signboards with contents incompliant with regulations;

g/ Keeping no books or having no devices for monitoring medicine purchase and sale as required.

2. A fine of between VND 5,000,000 and 10,000,000 shall be imposed on medicine retail establishments or a fine of between VND 10,000,000 and 20,000,000 on medicine wholesale, preservation or testing service establishments or foreign companies conducting medicines and medicine materials-related activities in Vietnam for one of the following violations:

a/ Trading in medicines without practice certificates;

b/ Trading in medicines without certificates of eligibility for medicine trading or supplying medicines without licenses for medicines and medicine materials-related activities in Vietnam;

c/ Forging, hiring, borrowing or lending to others practice certificates, certificates of eligibility for medicine trading, related professional degrees or diplomas or licenses for medicines and medicine materials-related activities in Vietnam;

d/ Trading in medicines at addresses other than those indicated in certificates of eligibility for medicine trading;

e/Trading in medicines in forms other than those or beyond the scope indicated in certificates of eligibility for medicine trading, or supplying medicines beyond the scope indicated in licenses for medicines and medicine materials-related activities in Vietnam.

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a/ Deprivation of the right to use a practice certificate for 3 months, for violations specified at Point a, Clause 1 of this Article;

b/ Deprivation of the right to use a certificate of eligibility for medicine trading, license for medicines and medicine materials-related activities in Vietnam or practice certificate for between 6 and 12 months, for the violations specified at Points c, d and e, Clause 2 of this Article.

4. Remedial measures:

a/ Forcible strict compliance with regulations, for the violations specified at Points a, e, f and g, Clause 1, and Points a, b, d and e, Clause 2 of this Article;

b/ Forcible completion of procedures for re-grant of practice certificates, certificates of eligibility for medicine trading, good practice certificates or licenses for medicines and medicine materials-related activities in Vietnam, for the violations specified at Points b, c and d, Clause 1 of this Article;

c/ Forcible recall, for the case of forging practice certificates, certificates of eligibility for medicine trading or related professional degrees or diplomas specified at Point c, Clause 2 of this Article.

Article 7. Violations of regulations on medicine registration

1. A fine of between VND 3,000,000 and 5,000,000 shall be imposed for one of the following violations:

a/ Failing to satisfy requests of competent state agencies for reports on medicines in circulation without explaining in writing the reason;

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c/ Failing to coordinate with medicine manufacturers or importers in recalling from the market medicines not up to quality and safety standards at the request of management agencies or upon detection by medicine registering establishments themselves.

2. A fine of between VND 15,000,000 and 20,000,000 shall be imposed for one of the following violations:

a/ Failing to notify competent Vietnamese agencies of the revocation of medicine registration numbers and the ban on medicines from circulation in countries of origin or related countries for medicine safety, effect and quality reasons;

b/ Providing files, data and information related to technical files, including files of medicine quality standards, manufacture methods and stability, not based on actual researches, experiments and manufacture of medicine manufacturing or registering establishments;

c/ Submitting medicine samples for registration which are neither researched nor manufactured by the submitting establishments as declared in medicine registration files;

d/ Providing files, data and information on medicine effect, safety and potency without showing scientific documents and evidences to prove them.

3. Additional sanctioning forms:

a/ Deprivation of the right to use a certificate of eligibility for medicine trading or license for medicines and medicine materials-related activities in Vietnam for between 6 and 12 months, for the violations specified at Point c, Clause 1 of this Article which are committed twice or more.

b/ Deprivation of the right to use a certificate of eligibility for medicine trading or license for medicines and medicine materials-related activities in Vietnam for an indefinite time, for the violations specified in Clause 2 of this Article which are committed twice or more.

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a/ Forcible strict compliance with regulations, for violations specified in Clause 1 of this Article;

b/ Revocation of registration numbers and forcible destruction of all infringing medicines, for violations specified in Clause 2 of this Article.

Article 8. Violations of regulations on medicine manufacture

1. A fine of between VND 5,000,000 and 10,000,000 shall be imposed for one of the following violations:

a/ Manufacturing medicines without satisfying the hygienic conditions set by the Ministry of Health;

b/ Manufacturing medicines without reporting to a competent state agency on small changes (as prescribed by the Ministry of Health) in their registration files or at addresses other than those indicated in medicine registration files;

c/ Having no professional staff qualified for medicine quality inspection and management;

d/ Failing to keep medicine samples under regulations;

e/ Failing to archive medicine manufacture registration files already registered with competent state agencies;

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g/ Manufacturing and circulating or using medicines of level-3 inferior quality under the Ministry of Health's regulations on medicine quality management.

2. A fine of between VND 20,000,000 and 30,000,000 shall be imposed for one of the following violations per medicine product:

a/ Manufacturing medicines without reporting to a competent state agency on big changes or other changes (as prescribed by the Ministry of Health) in medicine registration files or at variance with medicine registration files already appraised by a competent state agency, except the case specified at Point b, Clause 1 of this Article and other violations specified in Article 14 of this Decree;

b/ Failing to recall medicines not up to quality and safety standards at the request of management agencies or upon detection by establishments themselves;

c/ Manufacturing non-medicinal products on medicine manufacture chains;

d/ Manufacturing and circulating or using medicines of level-2 inferior quality under the Ministry of Health's regulations on medicine quality management;

e/ Manufacturing medicines with expired registration numbers for market circulation, except special cases permitted by the Ministry of Health.

3. A fine of between VND 30,000,000 and 40,000,000 shall be imposed for one of the following violations per medicine product:

a/ Manufacturing medicines without registration numbers granted by competent health agencies for market circulation, except patent medicaments or medicaments weighed according to formulas at oriental medicine establishments, raw and preliminarily processed medicinal herbs;

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c/ Using materials of unclear origin or materials not yet quality-inspected or materials not up to quality standards for medicine manufacture;

d/ Manufacturing and circulating or using medicines of level-1 inferior quality under the Ministry of Health's regulations on medicine quality management;

e/ Manufacturing medicines at establishments (addresses) having no certificates of eligibility for medicine trading (medicine manufacture).

4. Additional sanctioning forms:

a/ Deprivation of the right to use a certificate of eligibility for medicine trading for between 3 and 6 months, for the violations specified at Points a, b, c, f and g, Clause 1 of this Article;

b/ Deprivation of the right to use a certificate of eligibility for medicine trading for an indefinite time, for the violations specified in Clauses 2 and 3 of this Article.

5. Remedial measures:

a/ Forcible recall and destruction of all medicines or non-medicinal products, for violations specified at Points a, f and g, Clause 1, and in Clauses 2 and 3 of this Article;

b/ Revocation of registration numbers of medicines in the validity duration of these numbers, for violations specified at Points a, b and d, Clause 2, and Points b, c, d and e, Clause 3 of this Article.

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1. A caution or a fine of between VND 500,000 and 1,000,000 shall be imposed for one of the following violations:

a/ Retailing prescription medicines without doctor prescriptions; retailing preliminarily processed medicinal herbs of inferior quality;

b/ Having no personal resumes or having inadequate personal resumes under regulations, for medicine sellers or persons involved in medicine sale.

2. A fine of between VND 3,000,000 and 5,000,000 shall be imposed for one of the following violations:

a/ Selling medicines in contravention of treatment indications of doctors or selling alternative medicines specified at Point c, Clause 1, Article 27 of the Pharmacy Law without the consent of buyers;

b/ Wholesaling or retailing medicines without valid invoices or vouchers;

c/ Wholesaling medicines at places other than lawful drugstores.

3. A fine of between VND 5,000,000 and 7,000,000 shall be imposed for one of the following violations:

a/ Failing to recall or to report on results of recall of medicines at the request of competent state agencies;

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c/ Retailing medicines of inferior quality or after their expiry date;

d/ Having no separate preparing laboratory, for drugstores retailing medicines prepared according to prescriptions;

e/ Having no preservation storehouses, for retail drugstores having registered preservation storehouses;

f/ Trading in not-for-sale medicines used in national programs or medicines covered by health insurance or donated medicines, humanitarian aid medicines or non-commercially imported medicines.

4. A fine of between VND 10,000,000 and 15,000,000 shall be imposed for one of the following violations:

a/ Wholesaling medicines not up to quality standards or after their expiry date;

b/ Trading in medicines subject to recall notices or failing to recall medicines at the request of competent state agencies;

c/ Trading in or putting in market circulation medicines still in experimentation or subject to clinical test and assessment or medicines to be prepared according to prescriptions for use within drugstores or medical treatment establishments;

d/ Conducting medicine sales promotion in contravention of law or taking advantage of monopoly in medicine trading for illicit profits;

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5. A fine of between over VND 15,000,000 and twice the value of the whole confiscated medicine volume at the sale price of the trading establishment but not exceeding VND 40,000,000 shall be imposed for trading in medicines of unclear origin, smuggled medicines or medicines banned from market circulation.

6. Additional sanctioning forms:

a/ Deprivation of the right to use practice certificates or certificates of eligibility for medicine trading for between 3 and 6 months, for the violations specified at Point b, Clause 2 and Point a, Clause 3 of this Article;

b/ Deprivation of the right to use practice certificates or certificates of eligibility for medicine trading for between 6 and 12 months, for the violations specified at Points d, e and f. Clause 3 and Points a, b and d and e, Clause 4, and Clause 5 of this Article;

c/ Confiscation of the whole medicine volume, for the violations specified at Points b and c, Clause 3, and in Clauses 4 and 5 of this Article,

7. Remedial measures:

a/ Forcible remittance of the whole money amount earned from the violations specified at Point f. Clause 3, and in Clauses 4 and 5 of this Article;

b/ Forcible strict compliance with law, for the violations specified at Points d and e, Clause 3 of this Article.

Article 10. Violations of regulations on medicine export and import

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a/ Importing medicines without circulation permits of the Ministry of Health;

b/ Importing medicines even after countries of manufacture announce the ban on market circulation thereof;

c/ Importing medicines with changed original packages as registered or permitted for import by the Ministry of Health (or commercial products of these medicines);

d/ Importing medicines with their expiry dates; failing to comply with regulations on expiry date upon their arrival at Vietnamese port without permission of the Ministry of Health;

e/ Importing or exporting medicines on the list of medicines banned from import or export or importing or exporting medicines beyond the importer's or exporter's competence;

f/ Importing or exporting medicines after their expiry date;

g/ Failing to recall or to coordinate with others in recalling imported medicines not up to quality and safety standards at the request of management agencies or upon detection by importers themselves.

2. Additional sanctioning forms:

a/ Deprivation of the right to use medicine import permits for between 6 and 12 months, for the violations specified at Points c and d, Clause 1 of this Article;

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3. Remedial measures:

Recall and forcible taking out of the Vietnamese territory or forcible re-export or destruction of medicines or medicine materials, for the violations specified in Clause 1 of this Article.

Article 11. Violations of regulations on medicine preservation

1. A fine of between VND 500,000 and 1,000,000 shall be imposed on retail establishments committing one of the following violations:

a/ Retailing medicines without meeting preservation requirements indicated on medicine labels;

b/ Mixing non-medicinal goods items and medicines.

2. A fine of between 5,000,000 and 10,000,000 shall be imposed for one of the following violations:

a/ Failing to comply with GSP regulations of the Ministry of Health, for medicine preservation service providers;

b/ Failing to meet conditions for medicine preservation in the course of medicine preservation or transportation, for medicine wholesalers;

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d/ Mixing non-medicinal goods items and medicines, for medicine wholesale establishments.

3. Additional sanctioning forms:

Deprivation of the right to use practice certificates or certificates of eligibility for medicine trading for between 6 and 12 months, for the violations specified at Points a, b and c, Clause 2 of this Article.

4. Remedial measures:

a/ Forcible destruction of the whole volume of medicines of inferior quality, for the violations specified at Point a, Clause 1, and Points b, c and d. Clause 2 of this Article;

b/ Forcible strict compliance with law, for the violations specified in Clauses 1 and 2 of this Article.

Article 12. Violations of regulations on medicine testing

1. A fine of between VND 5,000,000 and 10,000,000 shall be imposed for one of the following violations:

a/ Failing to comply with GLP regulations of the Ministry of Health, for medicine testing service providers;

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

a/ Providing medicine testing services without permission of the Ministry of Health;

b/ Modifying, falsifying or fraudulently declaring analysis data;

c/ Using sample medicines not researched or manufactured by establishments themselves as indicated in files for registering medicines for use as testing samples.

3. Additional sanctioning forms:

Deprivation of the right to use certificates of eligibility for medicine trading for between 6 and 12 months, for the violations specified in Clause 2 of this Article.

4. Remedial measures:

Forcible strict compliance of law, for the violations specified in Clauses 1 and 2 of this Article.

Article 13. Violations of regulations on medicine information and advertisement

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2. A fine of between VND 5,000,000 and 10,000,000 shall be imposed for one of the following violations:

a/ Failing to send to provincial-level Health Departments written notices of medicine representatives who come to work in their provinces which are other than provinces in which these medicine representatives have been granted cards;

b/ Failing to send written notices enclosed with requests for acceptance and advertisement contents to provincial-level Health Departments for medicine advertisements on local radio or television stations;

c/ Organizing seminars to introduce medicines without having submitted files for registration of such seminars to competent state management agencies or during the period of file examination under regulations.

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

a/ Informing or advertising medicines at variance with contents already registered with competent state management agencies; or during the period of file examination under regulations; or according to registered information or advertisement documents which are no longer valid; or without submitting medicine information or advertisement registration files to competent state management agencies (except medicine information not subject to registration);

b/ Advertising or informing medicines without registration numbers or with invalid registration numbers, except medicine information not subject to registration and seminars to introduce medicines to physicians;

c/ Failing to monitor or promptly report to the Ministry of Health (the Drug Administration) and the National Center for Medicine Information and Harmful Effect Surveillance on newly uncovered medicine information, harmful effects of medicines or signs of deteriorating quality of traded medicines;

d/ Providing inaccurate medicine information and advertisement documents.

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a/ Advertising prescription medicines; vaccines and medical biologicals used for preventive purpose; medicines not subject to prescriptions but recommended by competent state management agencies for restricted use or use under physician surveillance;

b/ Informing or advertising cosmetics, functional foods and non-medicinal products with unclear contents misleading consumers to take these products as medicines;

c/ Using material or financial benefits in any form to manipulate physicians and medicine users in prescribing or using medicine;

d/ Taking advantage of physicians' disease prevention and treatment guidance or medicine usage in press articles or radio or television broadcasts to advertise medicines;

e/ Acting as medicine representatives without medicine representative cards;

f/ Failing to report and explain medicine information and advertisement violations and take remedial measures at the request of state management agencies.

5. Additional sanctioning forms:

a/ Deprivation of the right to use practice certificates, certificates of eligibility for medicine trading or licenses for medicines and medicine materials-related activities in Vietnam for between 3 and 6 months, for the violations specified in Clause 3 of this Article which are committed for three times or more within 12 months;

b/ Deprivation of the right to use practice certificates, certificates of eligibility for medicine trading or licenses for medicines and medicine materials-related activities in Vietnam for between 6 and 12 months, for the violations specified in Clause 4 of this Article which are committed for three times or more within 12 months.

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a/ Forcible strict compliance with law, for the violations specified in Clause 1, and at Point c, Clause 4 of this Article;

b/ Forcible reporting on or provision of accurate medicine information, for the violations specified at Points c and d, Clause 3, and Point f, Clause 4 of this Article;

c/ Forcible cancellation and correction of medicine information or advertisements, for the violations specified at Points a, b and d, Clause 3, and Points a, b and d, Clause 4 of this Article;

d/ Forcible destruction of all documents and means used for violations, for the violations specified in Clauses 2, 3 and 4 of this Article.

Article 14. Violations of regulations on medicine packages and labels (including use instruction inserts)

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

a/ Labeling medicines with contents and forms other than those indicated in approved files, except the contents specified in Clause 2 of this Article;

b/ Changing medicine packages or labels without written consent of the Ministry of Health;

c/ Trading in medicines with changed packages or labels as indicated in approved files.

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3. Additional sanctioning forms:

Deprivation of the right to use certificates of eligibility for medicine trading of medicine trading establishments for an indefinite time, or deprivation of the right to use licenses for medicines and medicine materials-related activities in Vietnam of medicine supply establishments for an indefinite time, for the violations specified in Clause 2 of this Article.

4. Remedial measures:

a/ Forcible strict compliance with law, for the violations specified in Clause 1 of this Article;

b/ Forcible destruction of all infringing medicines, for the violations specified in Clause 2 of this Article.

Article 15. Violations of regulations on habit-forming medicines, psychotropic medicines and medicinal precursors

1. A fine of between VND 5,000,000 and 10,000,000 shall be imposed for prescribing, dispensing or using habit-forming medicines, psychotropic medicines and medicinal precursors in contravention of regulations of the Ministry of Health.

2. A fine of between VND 20,000,000 and 30,000,000 shall be imposed for one of the following violations:

a/ Buying or selling habit-forming medicines, psychotropic medicines and medicinal precursors without approved plans;

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c/ Transporting, forwarding or packaging these medicines and precursors in contravention of regulations;

d/ Destroying these medicines in contravention of regulations;

e/ Failing to fully record or keep documents, files and books related to habit-forming medicines, psychotropic medicines and medicinal precursors;

f/ Exporting or importing habit-forming medicines, psychotropic medicines and medicinal precursors without permits of competent state agencies and not through prescribed border gates.

3. A fine of between VND 10,000,000 and 20,000,000 shall be imposed on retail establishments or a fine of between VND 30,000,000 and 40,000,000 on wholesale establishments selling habit-forming medicines, psychotropic medicines and medicinal precursors to ineligible buyers or to establishments without the function of trading in them under regulations.

4. Additional sanctioning forms:

a/ Deprivation of the right to use certificates of eligibility for medicine trading for between 6 and 12 months, for the violations specified in Clauses 2 and 3 of this Article which are committed twice or more within 12 months;

b/ Deprivation of the right to use certificates of eligibility for medicine trading for an indefinite time, for the violations specified in Clauses 2 and 3 of this Article which are committed for three times or more within 12 months.

5. Remedial measures:

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b/ Forcible strict compliance with law, for the violations specified at Points c, d and e, Clause 2 of this Article.

Article 16. Violations of regulations on scientific research, testing and clinical trial of medicines

1. A fine of between VND 5,000,000 and 10,000,000 shall be imposed for concealing or failing to provide adequate and truthful information on research and clinical trial of medicines to persons participating in such trial, the testing process and possible risks;

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

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

b/ Failing to report on the process and results of the clinical trial under regulations;

c/ Failing to comply with regulations on good practices in clinical trial of medicines.

3. A fine of between VND 30,000,000 and 40,000,000 shall be imposed for one of the following violations:

a/ Conducting clinical trial of medicines without permission of the Ministry of Health;

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c/ Using clinical trial medicines for other purposes;

d/ Forcing research subjects to try medicines;

e/ Distorting testing results of tested medicine samples.

4. Additional sanctioning form:

Deprivation of the right to use certificates of eligibility for medicine trading or certificates of attainment of the standard of medicine clinical trial good practice for between 6 and 12 months, for the violations specified in Clauses 2 and 3 of this Article.

5. Remedial measures:

Forcible strict compliance with law, for the violations specified in Clause 1, at Points b and c, Clause 2, and in Clause 3 of this Article.

Article 17. Violations of regulations on medicine price management

1. Violations of regulations on medicine price declaration:

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a/ Failing to declare or inadequately declaring medicine prices under regulations;

b/ Failing to adjust declared prices after receiving written opinions of the state management agency in charge of medicine prices;

c/ Selling medicines at prices higher than declared prices;

d/ Failing to notify customers of declared medicine prices.

2. Violations of regulations on posting up medicine prices:

A fine of between VND 5,000,000 and 10,000,000 shall be imposed for one of the following violations:

a/ Failing to post up or inadequately posting up prices of medicines displayed for sale or improperly posting up medicines;

b/ Selling medicines at prices higher than posted up prices.

3. Violations of regulations on retail returns or regulations on medicine prices applicable to hospital drugstores:

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4. Additional sanctioning form:

Deprivation of the right to use certificates of eligibility for medicine trading or licenses of foreign businesses for medicines and medicine materials-related activities in Vietnam for between 3 and 6 months, for the violations specified at Points a, c and d, Clause 1 and Point b, Clause 2 of this Article which are committed twice or more within 12 months after the detection of first-time violations.

5. Remedial measures:

a/ Forcible strict compliance with law, for the violations specified at Point a, Clause 1, Point a, Clause 2, and in Clause 3 of this Article;

b/ Forcible remittance of the whole margin amount earned from the commission of the violation specified at Point c, Clause 1 or Point b, Clause 2 of this Article.

Section 2: ADMINISTRATIVE VIOLATIONS IN COSMETIC MANUFACTURE, TRADING, INFORMATION AND ADVERTISEMENT, SANCTIONING FORMS AND LEVELS

Article 18. Violations of regulations on cosmetic trading

1. A fine of between VND 1,000,000 and 5,000,000 or between VND 5,000,000 and 10,000,000 shall be imposed in case the total value of the infringing goods lot is under VND 10,000,000 or VND 10,000,000 or more, respectively, calculated according to sale prices, on trading establishments other than organizations and individuals responsible for putting products in market circulation for one of the following violations:

a/ Trading in cosmetics with changed packages;

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c/ Trading in cosmetics after their expiry date;

d/ Trading in cosmetics for which cosmetic products have not yet been publicized;

e/ Trading in cosmetics containing in their ingredients a substance banned from use in cosmetics or of a content or concentration in excess of the permitted limit prescribed by current laws for substances subject to use content or concentration limits;

f/ Trading in cosmetics of inferior quality or unsafe for consumers;

g/ Trading in cosmetics subject to competent state management agencies' notices of recall for violations of law.

2. A fine of between VND 10,000,000 and 20,000,000 shall be imposed on organizations or individuals responsible for putting products in market circulation for one of the following violations:

a/ Trading in cosmetics with product information files kept at businesses not up to requirements;

b/ Trading in cosmetics of inferior quality or unsafe for consumers;

c/ Trading in cosmetics with changed packages or information origin;

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3. A fine of between VND 20,000,000 and 30,000,000 shall be imposed on organizations and individuals responsible for putting products in market circulation for one of the following violations:

a/ Trading in cosmetics containing in their ingredients a substance banned from use in cosmetics or of a content or concentration in excess of the permitted limit prescribed by current laws for substances subject to use content or concentration limits;

b/ Trading in cosmetics without product information files as required;

c/ Trading in cosmetics with formulas inconsistent with their approved announcement files;

d/ Trading in cosmetics already banned by countries of manufacture from market circulation;

e/ Failing to recall cosmetics in violation of regulations at the request of competent state management agencies.

4. Remedial measures:

a/ Forcible recall and destruction of all cosmetics, for the violations specified in Clause 1, and at Points b, c and d, Clause 2, and Points a, c and d, Clause 3 of this Article;

b/ Revocation of numbers of receipt of cosmetic product announcement cards or cosmetic circulation registration numbers, for the violations specified at Point a, b, c or d, Clause 3 of this Article;

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Article 19. Violations of regulations on import of cosmetics

1. A fine of between VND 10,000,000 and 20,000,000 shall be imposed for importing cosmetics with changed packages or origin information.

2. A fine of between VND 20,000,000 and 30,000,000 shall be imposed for one of the following violations:

a/ Importing cosmetics containing in their ingredients a substance banned from use in cosmetics or of a content or concentration in excess of the permitted limit prescribed by current laws for substances subject to use content or concentration limits;

b/ Importing cosmetics already banned by countries of manufacture from market circulation.

3. Remedial measures:

a/ Forcible recall and destruction of all cosmetics, for the violations specified in Clauses 1 and 2 of this Article;

b/ Revocation of numbers of receipt of cosmetic product announcement cards or cosmetic circulation registration numbers, for the violations specified in Clause 2 of this Article.

Article 20. Violations of regulations on manufacture of cosmetics

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a/ Manufacturing cosmetics not pursuant to the "cosmetic good manufacturing practice" principles and standards of the Association of Southeast Asian Nations (CGMP-ASEAN) or equivalents recognized by the ASEAN's Cosmetic Council;

b/ Manufacturing cosmetics containing in their ingredients a substance banned from use in cosmetics or of a content or concentration in excess of the permitted limit prescribed by current laws for substances subject to use content or concentration limits, or manufacturing cosmetics of inferior quality or unsafe for consumers;

c/ Manufacturing cosmetics with formulas inconsistent with their announcement files.

2. Remedial measures:

a/ Forcible recall and destruction of all cosmetics, for the violations specified at Points b and c, Clause 1 of this Article;

b/ Revocation of numbers of receipt of cosmetic product announcement cards or cosmetic circulation registration numbers, for the violations specified at Points b and c, Clause 1 of this Article;

c/ Forcible strict compliance with law, for the violations specified at Point a, Clause 1 of this Article.

Article 21. Violations of regulations on announcement of cosmetics

1. A fine of between VND 30,000,000 and 40,000,000 shall be imposed for one of the following violations:

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b/ Putting cosmetic products in market circulation without announcing them, for domestic cosmetics manufacturers or importers of foreign cosmetics.

2. Remedial measures:

a/ Forcible recall and destruction of all cosmetics, for the violations specified in Clause 1 of this Article;

b/ Revocation of numbers of receipt of cosmetic product announcement cards or cosmetic circulation registration numbers, for the violations specified at Point b, Clause 1 of this Article.

Article 22. Violations of regulations on cosmetics information and advertisement

1. A fine of between VND 5,000,000 and 10,000,000 shall be imposed for one of the following violations:

a/ Advertising cosmetics in inconsistency with their advertisement registration files already approved by management agencies or at variance with documents proving the safety and efficacy of cosmetic products;

b/ Organizing a workshop or an event to introduce cosmetics different from files for registration of organization of such workshop or event already approved by management agencies;

c/ Advertising cosmetics with no-longer-valid registered contents or during the period of file examination and processing under regulations;

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e/ Advertising cosmetics, for which the provincial-level Health Department of a locality has granted a receipt paper, in another locality without notifying it to the provincial-level Health Department of such locality;

f/ Organizing a workshop or an event to introduce cosmetics for which the provincial-level Health Department of the host locality has granted a receipt paper, without notifying in advance changes in the official time and venue to this Health Department.

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

a/ Advertising cosmetics without numbers of receipt of cosmetic product announcement cards granted by competent state management agencies or without submitting cosmetic advertisement registration files;

b/ Organizing a workshop or an event to introduce cosmetics without numbers of receipt of cosmetic product announcement cards granted by competent state management agencies or submitting a file for registration of organization of such workshop or event;

c/ Providing cosmetics information or making cosmetics advertisements stating that cosmetics have effects like medicines, misleading consumers to confusingly take these cosmetics as medicines.

3. Remedial measure:

Forcible strict compliance with law, for the violations specified in Clauses 1 and 2 of this Article.

Article 23. Violations of regulations on labels of cosmetics

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a/ Manufacturing or trading in cosmetics with labels failing to meet current cosmetics labeling requirements;

b/ Manufacturing or trading in cosmetics with labels stating their effects and utilities at variance with their announced files.

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

a/ Imitating labels of other products already permitted for circulation;

b/ Indicating untruthfully the origin of goods on labels;

c/ Failing to indicate on labels names and addresses of organizations or individuals responsible for putting products in market circulations.

d/ Indicating on labels utilities and effects not true to inherent properties of products.

3. Remedial measures:

a/ Forcible recall and destruction of all cosmetics, for the violations specified at Points a, b and d, Clause 2 of this Article;

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c/ Forcible strict compliance with law, for the violations specified in Clause 1 and at Point c, Clause 2 of this Article.

Section 3: ADMINISTRATIVE VIOLATIONS IN MEDICAL EQUIPMENT MANUFACTURE, TRADING, INFORMATION AND ADVERTISEMENT, SANCTIONING FORMS AND LEVELS

Article 24. Violations of regulations on medical equipment trading conditions

1. A fine of between VND 5,000,000 and 10,000,000 shall be imposed for one of the following violations:

a/ Trading medical equipment without business registration certificates;

b/ Failing to build physical and technical foundations or have sufficient staffs for medical equipment manufacture and trading under the Ministry of Health's regulations;

c/ Failing to post up prices of medical equipment at medical equipment trading establishments;

d/ Selling medical equipment at prices higher than posted up prices.

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

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b/ Conducting trading activities beyond the registered trading scope.

3. Additional sanctioning form:

Confiscation of medical equipment, for the violations specified at Point a, Clause 2 of this Article.

4. Remedial measures:

a/ Forcible strict compliance with law, for the violations specified in Clause 1 of this Article;

b/ Forcible remittance of margin amounts earned from the violations specified at Point d, Clause 1 of this Article;

c/ Forcible recall of medical equipment traded beyond the registered trading scope, for the violations specified at Point b, Clause 2 of this Article.

Article 25. Violations of regulations on manufacture of medical equipment

1. A fine of between VND 5,000,000 and 10,000,000 shall be imposed for failing to promptly notify competent management agencies of changes in manufactured products, manufacturing establishments or persons in charge of manufacture.

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3. A fine of between VND 20,000,000 and 30,000,000 shall be imposed for manufacturing medical equipment not up to their announced quality standards.

4. A fine of between VND 30,000,000 and 40,000,000 shall be imposed for one of the following violations:

a/ Manufacturing medical equipment without certificates of eligibility for medical equipment manufacture;

b/ Manufacturing medical equipment without certificates of circulation registration or free sale for market circulation or export;

c/ Manufacturing medical equipment without having conducted clinical tests, or improperly conducting clinical tests on products subject to clinical tests.

5. Additional sanctioning form:

Deprivation of the right to use operation licenses for between 3 and 6 months, for the violations specified in Clause 3 and at Points b and c. Clause 4 of this Article.

6. Remedial measures:

a/ Forcible taking of the responsibility for remedying consequences caused by defective medical equipment, for the violations specified in Clause 2 of this Article;

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c/ Forcible strict compliance with law, for the violations specified in Clauses 3 and 4 of this Article.

Article 26. Violations of regulations on import of medical equipment and instruments

1. A fine of between VND 20,000,000 and 30,000,000 shall be imposed for one of the following violations:

a/ Importing medical equipment and instruments without import permits under the Ministry of Health's regulations;

b/ Importing medical equipment and instruments banned from circulation in their country of manufacture or in Vietnam or banned from use by the World Health Organization;

c/ Importing medical equipment and instruments which have not yet gone through clinical tests at some medical establishments under international practice or regulations on clinical tests in Vietnam;

d/ Importing medical equipment and instruments which have not yet gone through quality inspection at state testing or quality inspection agencies, for equipment subject to precision requirements and some other equipment specified by law;

e/ Importing medical equipment and instruments which are defective or ineffective in medical examination and treatment, causing harmful side effects to humans;

f/ Importing used medical equipment (for commercial purposes) other than those given as gifts or donations.

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a/ Deprivation of the right to use medical equipment import permits for an indefinite time, for the violations specified in Clause 1 of this Article;

b/ Confiscation of medical equipment and instruments, for the violations specified in Clause 1 of this Article.

3. Remedial measure:

Forcible strict compliance with law, for the violations specified at Point d, Clause 1 of this Article.

Article 27. Violations of regulations on medical equipment information and advertisement

1. A fine of between VND 5,000,000 and 10,000,000 shall be imposed for one of the following violations:

a/ Providing or making medical equipment information or advertisements at variance with registered files or failing to modify advertising contents as requested by competent health agencies; b/ Organizing a workshop or an event to introduce medical equipment without a registration file accepted by competent state management agencies.

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

a/ Making medical equipment advertise­ments not true to their utilities and effects;

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c/ Deliberately concealing or failing to give prompt warnings on dysfunctions or undesirable effects of medical equipment to management agencies or customers.

3. Remedial measure:

Forcible reporting on or provision of accurate information or making of public apologies or corrections in the mass media, for the violations specified at Point a, Clause 1, and in Clause 2 of this Article.

Chapter III

COMPETENCE AND PROCEDURES FOR SANCTIONING ADMINISTRATIVE VIOLATIONS

Article 28. Competence of chairpersons of People's Committees at all levels to sanction administrative violations

1. Chairpersons of People's Committees of communes, wards or townships may:

a/ Give cautions;

b/ Impose fines of up to VND 2,000,000;

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d/ Apply the remedial measures provided at Points a, b, c, d, f and j, Clause 3, Article 5 of this Decree.

2. Chairpersons of People's Committees of rural districts, urban districts or provincial cities may:

a/ Give cautions;

b/ Impose fines of up to VND 30,000,000;

c/ Apply the additional sanctioning forms under the law on handling of administrative violations;

d/ Apply the remedial measures provided at Points a, b, c, d, f and j, Clause 3, Article 5 of this Decree.

3. Chairpersons of People's Committees of provinces or centrally run cities may:

a/ Give cautions;

b/ Impose fines of up to VND 40,000,000;

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d/ Apply the remedial measures provided in Clause 3, Article 5 of this Decree.

Article 29. Competence of medical inspectors to sanction administrative violations

1. Medical inspectors on duty, within the ambit of their functions, may:

a/ Give cautions;

b/ Impose fines of up to VND 500,000;

c/ Confiscate material evidences, means and tools involved in violations and valued at up to VND 2,000,000;

d/ Apply the remedial measures provided at Points a, b, c, d, f and j, Clause 3, Article 5 of this Decree.

2. Chief inspectors of provincial-level Health Departments may:

a/ Give cautions;

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c/ Apply the additional sanctioning forms under the law on handling of administrative violations;

d/ Apply the remedial measures provided at Points a, b, c, d, f and j, Clause 3, Article 5 of this Decree.

3. The Chief Inspector of the Ministry of Health may:

a/ Give cautions;

b/ Impose fines of up to VND 40,000,000;

c/ Apply the additional sanctioning forms under the law on handling of administrative violations;

d/ Apply the remedial measures provided in Clause 3, Article 5 of this Decree.

4. Heads of agencies assigned to perform the specialized inspection function and persons assigned to perform specialized inspection tasks are competent to sanction administrative violations under the law on handling of administrative violations and relevant laws.

Article 30. Sanctioning competence of other agencies

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Article 31. Authorization and principles of determination of competence to sanction administrative violations related to medicines, cosmetics and medical equipment

1. The competence to sanction administrative violations related to medicines, cosmetics and medical equipment complies with Article 41 of the Ordinance on Handling of Administrative Violations.

2. The principles of determination of competence to sanction administrative violations related to medicines, cosmetics and medical equipment are those provided in Article 42 of the Ordinance on Handling of Administrative Violations.

Article 32. Procedures for sanctioning administrative violations related to medicines, cosmetics and medical equipment

1 .The order and procedures for sanctioning administrative violations related to medicines, cosmetics and medical equipment comply with the Ordinance on Handling of Administrative Violations and Decree No. 128/2008/ND-CP.

2. Documents related to the sanctioning of administrative violations related to medicines, cosmetics and medical equipment must be fully kept at sanctioning agencies. Minutes of sanctioning of administrative violations shall be made according to the forms currently in force.

3. Fined persons and organizations shall pay fines on time and at places indicated in sanctioning decisions, unless they have paid fines on the spot under Articles 54 and 58 of the Ordinance on Handling of Administrative Violations and received fine receipts.

4. When applying the sanctioning form of confiscation of material evidences and means, persons with sanctioning competence shall strictly comply with Articles 60 and 61 of the Ordinance on Handling of Administrative Violations and Decree No. 128/2008/ND-CP.

Article 33. Execution and enforcement of decisions on sanctioning of administrative violations related to medicines, cosmetics and medical equipment

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2. When applying measures to enforce decisions on sanctioning of administrative violations related to medicines, cosmetics or medical equipment, competent agencies and persons shall comply with the order and procedures for enforcement specified in Articles 66 and 67 of the Ordinance on Handling of Administrative Violation and regulations on enforcement of administrative violation sanctioning decisions.

Article 34. Forms of minutes and decisions on sanctioning of administrative violations related to medicines, cosmetics and medical equipment

To this Decree are appendices providing forms of minutes and decisions on sanctioning of administrative violations related to medicines, cosmetics and medical equipment (not printed herein).

Chapter IV

IMPLEMENTATION PROVISIONS

Article 35. Effect

This Decree takes effect on December 15, 2011.

To annul Articles 19 thru 24 and Articles 32 thru 44 of the Government's Decree No. 45/ 2005/ND-CP of April 6, 2005, on sanctioning of administrative violations in the health sector.

Article 36. Guiding and implementing responsibilities

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2. Ministers, heads of ministerial-level agencies, heads of government-attached agencies, chairpersons of People's Committees at all levels and related agencies, organizations and individuals shall implement this Decree.-

ON BEHALF OF THE GOVERNMENT
PRIME MINISTER




Nguyen Tan Dung