Pursuant to the law on organization of the Government of 25 December 2001;
Pharmaceutical Law base on June 14, 2005;
Commercial Law base on June 14, 2005;
Pursuant to the law of product quality, the goods on November 21, 2007;
Basing the Ordinance handling administrative violations on 02 July 2002 and Ordinance amendments and supplements to some articles of the Ordinance on handling administrative violations on 02 Apr 2008;
Pursuant to Decree No. 128/2008/ND-CP on December 16, 2008 detailing the implementation of a number of articles of the Ordinance on handling administrative violations in 2002 and Ordinance amending and supplementing some articles of the Ordinance on handling administrative violations in 2008;
Considering the recommendation of the Minister of health, DECREE chapter I GENERAL PROVISIONS article 1. Scope 1. This Decree provisions on violations, the form and the level of punishment, remedial measures, jurisdiction and procedure for sanctioning of administrative violations regarding drugs, cosmetics and medical equipment.
2. The administrative violations of drugs, cosmetics and medical equipment includes: a) the violation of the regulations on the production, trading, information, drug ads;
b) infringe regulations on the production, trading, information, advertising products;
c) infringe regulations on the production, trading, information, medical equipment ads.
Article 2. Application object 1. Personally, the organization acts intentionally or unintentionally violating the administration of drugs, cosmetics and medical equipment specified in chapter II of this Decree, which is not a crime.
Do not apply sanction administrative violations with regard to the violations of the provisions of this decree by officers, public servants, officers performed while on duty, the duty assigned. The processing for their violations are made according to the provisions of the law on public servants.
2. Individuals, foreign organizations active on the territory of Vietnam have administrative violations regarding drugs, cosmetics and medical equipment specified in chapter II of this Decree, except in the case of international treaties to which the Socialist Republic of Vietnam is a member have other regulations made under international treaties.
Article 3. Explanation of terms 1. Cosmetic products is a substance or preparations used to contact with the external parts of the human body (skin, hair nails, hair system, nails, lips and external genital organs) or with the teeth and mouth lining the main purpose is to clean, do, change the appearance , form, adjusting body odor, body guard or holding the body in good condition.
2. medical equipment is the type of equipment, tools, supplies and health (implants, consumables), chemical, biological Diagnostics (comes with medical equipment), specialized transportation service for health care operations, protect and improve the health of the people.
Article 4. Apply the provisions of the law on sanctioning administrative violations 1. The administrative violations related to customers; intellectual property infringement; breach of the stabilized price, exclusive links on price, in violation of the rules on subsidies, without transportation, supporting measures to implement the policy on reviews and other administrative violations regarding drugs, cosmetics and medical equipment not specified in this Decree shall apply in accordance with the law on sanctioning administrative violations in the field of management of the State concerned.
2. The violations halted receiving, consider: drug registration documents, registration records of foreign companies active on the drug in Vietnam; application of the good practices in the field of medicine; import profile yet has the registration number; registration profile information, advertising drugs, cosmetics; announcement cosmetic products; profile seminar registration, event organizers introducing cosmetic and other governance measures shall apply according to the regulations of the Ministry of health.
3. Principle of sanction; handle minor administrative violations; extenuating or aggravating; time and duration of sanctions; the time limit is considered to be not yet sanctioned; calculation of time limits, time limits; determining the authority sanctioning administrative violations; set the minutes of administrative violations; decision sanctioning administrative violations; procedure for fines, currency lodging fine; procedures for confiscating and handling exhibits, means of administrative violations; Executive decision sanctioning administrative violations, the fine decision postponement, coercive enforcement of the decision sanctioning administrative violations and transferred the decision sanctioning administrative violations regarding drugs, cosmetics and medical equipment to enforce are made according to the provisions of the law on the handling of administrative violations and Decree No. 128/2008/ND-CP on December 16 2008 detailing the implementation of a number of articles of the Ordinance on handling administrative violations in 2002 and Ordinance amending and supplementing some articles of the Ordinance on handling administrative violations in 2008 (hereinafter referred to as the Decree No. 128/2008/ND-CP).
Article 5. The sanctions 1. For each administrative violations regarding drugs, cosmetics and medical equipment, the individual, the organization suffered a breach in the sanctions: a) caution;
b) fines: maximum fine Level in sanctioning administrative violations regarding drugs, cosmetics and medical equipment is 40,000,000 (forty million).
2. Depending on the nature and extent of the violation, individual, organization, administrative violations can be applied one or the additional sanctions: a) deprived of the right to use the qualified certificate, business license to operate about smoking and smoking materials in Vietnam , export and import permit smoking, practice of Pharmacy has no time limit or time limit, import licenses of medical equipment;
b) confiscated exhibits, the means used to administrative violations.
3. In addition to the sanctions provided for in the paragraph 1 and paragraph 2 of this Article, personal, organizational administrative violations can be applied one or more of the following remedial measures: a) forced the cancellation of or reports, provide accurate information, product advertising;
b) changed or forced to apologize publicly on the mass media;
c) enforce the right professional regulations of the Ministry of health regulation;
d) Forced to overcome the consequences caused by the defective products;
DD procedure) forced grant back practice, qualified certificates, business certificates of good practice (GP), active license about smoking and smoking materials in Vietnam;
e) Forced recovery, recycling or destruction for medications, cosmetics, products that are not medicines or medical equipment violation; forced withdrawal, destruction of the materials, the means of infringement, unless is seized to do t, physical evidence for subsequent processing;
g) Withdraw the registration number for the smoking within the registration number validity due to violating regulations on specialization;
h) withdrawal of receiving the votes announced cosmetic products;
I) Withdraw the registration number issued to cosmetics;
k) Forced to resubmit the entire amount or difference has been made by the violation;
l) Forced back or taken out of the territory of Vietnam.
4. Sanctions are applied independently or accompanied by sanctions, additional remedial measures. The additional sanctions are only applied to the main sanctions attached.
Chapter II ADMINISTRATIVE VIOLATIONS REGARDING drugs, COSMETICS and medical EQUIPMENT, FORMS and FINES section 1 ADMINISTRATIVE VIOLATIONS OF PRODUCTION, business, information, advertising, FORMS and FINES article 6. Violation of the regulations on business conditions and the use of practice certificate, certificate of eligible drug business; Active license about smoking and smoking materials in Vietnam 1. A fine from 5,000,000 to copper copper 3,000,000 for drug retail premises or from the same 5,000,000 to 8,000,000 contract for wholesale base, base maintenance service, the basis of drug testing service; foreign companies operate about smoking and smoking materials in Vietnam do one of the following behaviors: a) the professional manager is absent but not perform the delegated or elected replacement as prescribed by law;
b) production, wholesale, retail, service maintenance, drug testing services do not have the certificates of good practice according to the agenda of the Ministry of health or the good practice certificate validity period has expired without the suggested procedure again as prescribed by the Ministry of health;
c) drug business certificate of practice period has expired without the suggested procedure again as specified;
d) business or provide medication when the certificate of eligible drug business or operating licenses on medicines and raw materials for making the drug in Vietnam have expiry potency without the procedures suggested again as specified;
DD) business or provide medication when the certificate of practice or the certificate of eligible drug business or operating licenses on medicines and raw materials for making the drug in Vietnam were State regulators revoked or be deprived of the right to use under the provisions of the law;
e) drug business establishments do not have signs or signage with content not in accordance with the regulations;
g) drug business establishments do not perform open books or media to track the purchase and sale of drugs, the drug prescribed.
2. A fine of 5,000,000 VND to 10,000,000 VND retail establishments or from copper to copper 20,000,000 10,000,000 for wholesale base, base service maintenance, facility service tested drugs, foreign companies operate about smoking and smoking materials in Vietnam do one of the following behaviors : a) drug business does not have a certificate of practice;
b) drug business without the certificate of eligible drug business or providing unlicensed drugs activity on smoking and smoking materials in Vietnam;
c) forge, rent, lend or give personally, others rent, borrow, practice certificate certificate of eligible drug business, professional qualifications or licenses the operation of drugs and drug ingredients in Vietnam;
d) incorrect drug business address given in the certificate of eligible drug business;
drug trading correct) with business forms, business scope has recorded on the certificate of eligible drug business or provide incorrect medication with the active range indicated on the activity licence of the drug and drug materials in Vietnam.
3. additional sanctions: a) deprived of the right to use a certificate of practice within a period of 3 months for acts specified in point a paragraph 1 of this article;
b) deprived of the right to use the qualified certificate, business license to operate about smoking and smoking materials in Vietnam, a certificate of practice within a period from 6 months to 12 months for acts specified in points c, d and DD item 2 of this Article.
4. remedial measures: a) enforce the right in accordance with the law with regard to the behaviour defined in point a, e, f and g of paragraph 1, points a, b, d and DD item 2 of this Article;
b procedure) forced grant back practising certificate, the certificate of eligible drug business, good practice certificate, license to operate about smoking and smoking materials in Vietnam for acts specified in points b, c, d paragraph 1 of this article;
c) forced the withdrawal for cases of forgery of certificates of practice, the certificate of eligible drug business or relevant professional qualifications specified in point c of paragraph 2 of this Article.
Article 7. Violating regulations on drug registration 1. A fine from 5,000,000 to copper copper 3,000,000 for one of the following behaviors: a) does not make the request of competent State agencies about drug-related reports in the process of circulating the text without explanation of reasons;
b) Not enough archive records and drug registration records provided to the State agency authorized when required;
c) drug registration facility to coordinate with production facilities, facility to import the drug from the market withdrawal of the medication does not guarantee the quality, safety, as requested by the governing body or by the automatic detection facility.
2. A fine of up to 20,000,000 15,000,000 VND VND for one of the following behaviors: a) inform the competent authority of the Vietnam drug cases have been registered and withdrawn stopped circulation in the country of origin or the country concerned for reasons of safety, efficacy and quality of drugs;
b) providing records, information and data relating to technical records include records of quality standards, method of production, the stability that is not based on empirical research, the basis, the actual production of production facilities or drug registration facility;
c) filing by not registered drug research facilities or in production of drug registration records;
d) provides the data, profile, information on safety, effects and effectiveness of drugs that do not have the documents, scientific evidence to prove it.
3. additional sanctions: a) deprived of the right to use the certificate of eligible drug business or operating licenses on medicines and raw materials for making the drug in Vietnam within a period from 6 months to 12 months for acts specified in point c of paragraph 1 of this article from 2 times over.
b) deprived of the right to use the certificate of eligible drug business or operating licenses on medicines and raw materials for making the drug in Vietnam no time limit for the acts specified in paragraph 2 of this Article from 2 times over.
4. remedial measures: a) enforce the provisions of the law for the acts specified in paragraph 1 of this article;
b) Withdraw the registration number and the forced destruction of the entire smoking violation for the acts specified in paragraph 2 of this Article.
Article 8. Violation of regulations on the production of drugs 1. A fine from 5,000,000 VND to 10,000,000 VND for one of the following behaviors: a) the production of the drug does not ensure sufficient hygiene conditions as stipulated by the Ministry of health;
b) production of the drug without reporting to the competent State agencies when there is a change in the level of small change (according to the regulations of the Ministry of health) than the drug registration records or produces incorrect address stated in the registration records of medication;
c) drug production facilities do not have professional personnel to meet the requirements of drug quality control and management of medicines;
d) drug manufacturing facility does not keep the form prescribed medications;
DD) drug manufacturing facility does not save registered drug production record in the correct profile is registered with the competent State agencies;
e) drug manufacturing facility does not comply with the rules on the production of Oriental medicine, the drug from medicinal herbs prescribed by the Ministry of health;
g) produced and introduced the use of drugs, not standard quality level 3 according to regulations on drug quality management in the Ministry of health.
2. A fine of 20,000,000 30,000,000 VND to Board for one of the following behaviors for each medicinal product: a) produce the drug without reporting to the competent State agencies when there are changes in the levels of major changes and other changes (as defined by the Ministry of health) than the drug registration records or produces incorrect medication with drug registration records be appraised by State administration authorities, except for point b paragraph 1 of this article and the other acts stipulated in article 14 of this Protocol;
b) Not recovered the drug does not guarantee the quality, safety, as requested by the governing body or by the base auto detect;
c) produce the products are not smoking on drug manufacturing lines;
d) produced and introduced the use of drugs, not standard quality level 2 according to the regulations on drug quality management in the Ministry of health;
DD) manufacture of smoking when the registration number has been introduced to the market, except in special cases are the Ministry of health allowed.
3. A fine of 30,000,000 VND to 40,000,000 Council for one of the following behaviors for each medicinal product: a drug manufacturing) registration number of the competent health authorities to take out of circulation on the market, except for smoking, smoking weight according to the menu at the base hospital, Oriental medicine healing , medicinal drugs and lamina;
b) using raw materials as drugs expired or raw materials is not the purpose used to produce drugs for human or material is the active ingredient has been the World Health Organization or agency recommendations are not safe to use for people to produce the drug;
c) uses material does not clarify the source, origin, material not examined the quality, substandard materials to manufacture quality drugs;
d) produced and introduced the use of drugs, not standard quality level 1 under the regulations on drug quality management in the Ministry of health;
DD) manufacture of smoking (base address) has not been granted the certificate of eligible drug business (manufacturing type).
4. additional sanctions: a) deprived of the right to use the certificate of eligible drug business in term from 3 months to 6 months for acts specified in point a, b, c, e and g of paragraph 1 of this article;
b) deprived of the right to use the certificate of eligible drug trading deadline for the acts specified in clause 2 3 of this.
5. remedial measures: a) the Forced withdrawal, destruction of the whole smoking or not smoking products do perform acts specified at points a, e and g of paragraph 1 and paragraph 2, 3 this;
b) Withdraw the registration number for the smoking within the registration number validity due to perform acts specified at points a, b and d of paragraph 2, points b, c, d and DD paragraph 3 of this article.
Article 9. Violation of the regulation on wholesale, retail of drugs 1. Warning or fine from 500,000 to 1,000,000 VND VND for one of the following behaviors: a) to drugs retail prescription without doctor's menu; pharmaceutical retail fuel processing does not guarantee quality;
b) who sold drugs or involved selling the drugs had no criminal history or records but not full as specified.
2. A fine of 5,000,000 3,000,000 Dong to Dong for one of the following behaviors: a) do not sell the drug indicated for the treatment of a physician or are replaced according to the provisions in point c of paragraph 1 article 27 Drug Laws but not the consent of the buyer;
b) wholesale, retail facility smoking no invoice or voucher is valid;
c) wholesale of medication in these places is not the basis of the legal drug sale.
3. A fine from 5,000,000 to 7,000,000 copper contract for one of the following behaviors: a) is not made or does not report results of drug withdrawal at the request of the competent State agencies;
b) wholesale of pharmaceutical took over processing does not guarantee the quality according to the prescribed standards;
c) retail sale of medicines not standard quality or expired medication use;
d) no separate mixing rooms with retail establishments have concocted medicines according to the menu;
DD) no warehouses for preservation of retail drug establishments have to register the repository preservation;
e) trafficking in drugs use in the national program or the drug were paid health insurance or drug trafficking aid regulations not be sold, humanitarian aid medications, drugs import Africa trade.
4. A fine from 10,000,000 to 15,000,000 VND VND for one of the following behaviors: a) substandard drug wholesalers quality or expired medication use;
b) trafficking had recovered or not proceed to revoke the drug at the request of the competent State agencies;
c) trafficking or introduced widely on drug markets are in the testing phase, the clinical evaluation or monitoring medication dispensing under application used within the House or treatment facility;
d) drug promotion rules of law, taking advantage of a monopoly in the business of drugs illegal to profit;
DD) trafficking in banned import list, clinical trial drugs, the drug has not yet been allowed to circulate, drug samples used to register.
5. A fine from copper to double the 15,000,000 on the value of the whole of the drug obtained according to the sale price of the business but not too same 40,000,000 for the trafficking behavior of unknown origin, smuggled drugs, smoking is not allowed to circulate in the market.
6. additional sanctions: a) deprived of the right to use the certificate of practice, the certificate of eligible drug business in term from 3 months to 6 months for acts specified in point b of paragraph 2 and point a of paragraph 3 of this article;
b) deprived of the right to use the certificate of practice, the certificate of eligible drug trading within a period from 6 months to 12 months for acts specified in points d, e and e account 3, points a, b, d and paragraph 4, paragraph 5 of this Article;
c) confiscated all of the drug due to perform acts specified in points b and c of paragraph 3, clause 4 and clause 5 of this Article.
7. remedial measures: a) Forced to resubmit the entire proceeds due to perform acts specified in point e, paragraph 3 clause 4 and clause 5 of this Article;
b) enforce rules of law for acts specified in point d and paragraph 3 of this article.
Article 10. Violation of the regulations on the export, import and export of drugs 1. A fine fellow to fellow 30,000,000 20,000,000 words for one of the following behaviors: a) the import of the drug has not yet been allowed to circulate the Ministry of health;
b) importing drugs after producing countries announced bans circulating on the market;
c) imported the drugs no longer raw packaging of origin such as registered or licensed importer's Ministry of health (commercial or of smoking);
d) imported drugs are limited in use do not meet the rules of limit for taking rest when Vietnam port which has not allowed the Ministry of health;
DD) import, export the list banning the import, export or import, export of vires;
e) import, export expired drugs use;
g) import facility don't withdraw or revoke the drug coordination does not guarantee the quality, safety, as requested by the governing body or by the automatic detection facility.
2. additional sanctions: a) deprived of the right to use the license to import the drug in Vietnam within a period from 6 months to 12 months for acts specified in points c, d paragraph 1 of this article;
b) deprived of the right to use a certificate of practice; export licence, import drugs; certificate of eligible drug business; registration license about smoking Vietnam indefinitely for acts specified in points a, b, e, f and g of paragraph 1 of this article.
3. the remedial measures: withdrawal and force taken out of Vietnam territory or force appeared, the destruction for drugs or drug ingredients do perform acts specified in paragraph 1 of this article.
Article 11. Violation of the regulations on maintenance drugs 1. A fine from 500,000 to 1,000,000 copper copper retail establishments perform one of the following behaviors: a) retail drug does not meet the requirements of preserving the record on drug labels;
b) To each of the items is not the same with smoking.
2. A fine of 5,000,000 VND to 10,000,000 VND for one of the following behaviors: a) does not meet the GSP regulation of health service facility for the preservation of the drug;
b) does not meet the conditions of preservation in the process of preservation or transport the drugs wholesale establishments;
c) does not meet the requirements for conditions for preservation of vaccines and medical products during shipping, packaging, preservation and delivery of vaccines and medical products;
d) To each of the items is not the same with the drug wholesale drug establishments.
3. additional sanctions: deprived of the right to use the certificate of practice, the certificate of eligible drug business from 6 months to 12 months for acts specified in point a, b and c of paragraph 2 of this Article.
4. remedial measures: a) Forced the entire destruction of the drug do not ensure quality due to perform acts specified in point a of paragraph 1, points b, c and d of paragraph 2 of this Article;
b) Forced to comply with the provisions of the law for the acts specified in paragraph 1 and 2 of this Article.
Article 12. Violation of the rules on drug testing 1. A fine from 5,000,000 VND to 10,000,000 VND for one of the following behaviors: a) does not meet GLP regulations of the Ministry of health with respect to the basis of drug testing service;
b) does not comply with the rules of good practice in drug testing.
2. A fine from 10,000,000 VND to 20,000,000 Board for one of the following behaviors: a) Do about drug testing services without permission of the Ministry of health;
b) repairs, falsify or untrue data analysis;
c) using the model not by production or research facility included in drug registration records to make the sample tested.
3. additional sanctions: deprived of the right to use the certificate of eligible drug business from 6 months to 12 months for the acts specified in paragraph 2 of this Article.
4. remedial measures: Forcing the correct implementation of the provisions of the law for the acts specified in paragraph 1 and 2 of this Article.
Article 13. Violation of the regulations on drug advertising, information 1. Warning for the behaviour of people introduce drugs does not wear the card who introduced the drug when active.
2. A fine of 5,000,000 VND to 10,000,000 VND for one of the following behaviors: a) does not send the text of the notice with the Department of health when people introduce drugs operation in the province other than the province issued the card;
b) does not submit the text of the notice with the paper receipt and advertising content to the Health Department when drug ads on the radio, local television;
c) held a workshop to introduce the drug without filing registration held workshops to introduce the drug in State administration authorities or are within the review, resolve regulatory records.
3. A fine from 10,000,000 VND to 20,000,000 Board for one of the following behaviors: a) information, incorrect drug ads with the content already registered in the State Agency of competent jurisdiction; information, drug ads are within the review, addressed the prescribed records; information, drug ads by ad information document signed off value; information, drug ads without filing registration information, drug ads in State administration authorities (except not registered drug information);
b) advertising, information the drug has not yet been issued the registration number or the registration number expire, except not registered drug information and drug introduction workshop for medical officers;
c) Not tracking, timely reporting to the Ministry of health (pharmaceutical Management Bureau) and the National Center of drug information and monitoring of harmful reaction of the new information was discovered by smoking, harmful effects of smoking and the expression of the smoking quality deterioration due to business units;
d) provided information materials, incorrect drug ads.
4. A fine of 30,000,000 VND to 40,000,000 Council for one of the following behaviors: a prescription drug ad); vaccines, medical products used for prevention; non prescription drugs but are state management agencies have the authority to recommend in writing to use restricted or supervised use of a physician;
b) cosmetic ads, information, functional food and the products are not smoking with explicit content makes consumers think that product is smoking;
c) use physical or financial benefits in any form to affect drug users, physician to promote the prescription, the use of drugs;
d) advantage of form of physician guidelines for prevention, cure or medication with the manual of newspaper articles, radio programs, television to advertise smoking;
DD) Who introduced the drug works when not yet granted the card who introduced the drug;
e) No justification and implementation of corrective measures at the request of the State Agency when there are violations of information, drug ads.
5. additional sanctions: a) deprived of the right to use the certificate of practice, qualified certificate, business license to operate about smoking and smoking materials in Vietnam during the period from 3 months to 6 months for the acts specified in paragraph 3 of this article from 3 times or more within 12 months.
b) deprived of the right to use the certificate of practice, qualified certificate, business license to operate about smoking and smoking materials in Vietnam within a period from 6 months to 12 months for the acts specified in clause 4 of this from 3 times or more within 12 months.
6. remedial measures: a) enforce the provisions of the law for the acts specified in paragraph 1, point c of paragraph 4 of this Article;
b) Forcing reports, provide accurate information about smoking for acts specified in points c and d, paragraph 3, point e in paragraph 4 of this Article;
c) Forced cancellations and revised information, drug ads for acts specified in points a, b and d, paragraph 3, points a, b and d of paragraph 4 of this Article;
d) forced the destruction of the entire document, the media breached for the acts specified in paragraph 2, 3 and 4 of this Article.
Article 14. Violation of the regulations on the packaging, label medications (including drug manuals sheets) 1. A fine from 10,000,000 VND to 20,000,000 Board for one of the following behaviors: a) drug Labels with content, not the correct form as the approved profile, except the content prescribed in clause 2 of this Thing;
b) changed the packaging or the label smoking without Health Ministry agreed in writing;
c) drug business is no longer intact packaging or labeling the drug as approved profile.
2. A fine of 30,000,000 VND to 40,000,000 for the copper acts purged, deleted or corrected the content about the term used, specify, contraindications, dosage, features, uses on the label of the drug compared with the approved profile.
3. additional sanctions:
Deprived of the right to use the certificate of eligible drug business is not the deadline for business establishments, smoking or deprived of the right to use the license to operate on the drug and raw drug-making in Vietnam no time limit with respect to facilities provided by the drug performed acts specified in paragraph 2 of this Article.
4. remedial measures: a) enforce the provisions of the law for the acts specified in paragraph 1 of this article;
b) forced the destruction of the entire smoking violation for the acts specified in paragraph 2 of this Article.
Article 15. Violation of the regulations on smoking addictive, mental direction and precursor drugs used as medicines 1. A fine from 5,000,000 VND to 10,000,000 VND for the prescribed behavior, allocate, addictive drug use, mental direction and precursor drugs used are not properly regulated by the Ministry of health.
2. A fine of 20,000,000 30,000,000 VND to Board for one of the following behaviors: a) buy, sell addictive drugs, mental direction and drug precursors used in drug plan has been approved;
b) preservation, addictive medications, mental direction and precursor drugs used are not properly regulated by the Ministry of health;
c) shipping, delivery, improper packaging regulations;
d) Cancel the incorrect medication prescribed;
VND) notes, Not kept full of documents, records and books related to addictive drugs, mental direction and precursor drugs used as medicines;
e) import-export smoking addictive, mental direction and drug precursors without license of the authorized State bodies and not to the right gate.
3. A fine from 10,000,000 20,000,000 to copper copper retail establishments or a fine fellow to 30,000,000 VND 40,000,000 words for wholesale establishments performing the behavior of selling addictive drugs, mental direction and precursor drugs used do not use the right audience or base without addictive drugs business functions mental direction, drug and precursor used according to regulations.
4. additional sanctions: a) seizure certificate eligible drug business within 6 months to 12 months for the acts specified in clause 2, 3 this 2 times or more within 12 months;
b) deprived of the right to use the certificate of eligible drug business for the duration of the behavior specified in paragraphs 2 and 3 of this article 3 times or more within 12 months.
5. remedial measures: a) forced the recall and destruction of all of the drugs due to perform acts specified in point e clause 2 and clause 3 of this article;
b) enforce rules of law for acts specified in points c, d and DD item 2 of this Article.
Article 16. Violating the rules of scientific research, testing and clinical trials on drugs 1. A fine from 5,000,000 VND to 10,000,000 VND for concealed information or behavior do not provide sufficient information and honest about drug testing research on clinical drug trial participants, about the testing process and the risks that may occur;
2. A fine from 10,000,000 VND to 20,000,000 Board for one of the following behaviors: a) provide personal information to clinical trial without the consent of that person;
b) did not report on the process, the results of clinical trials as a rule;
c) does not comply with the prescribed good practice in clinical drug trials.
3. A fine of 30,000,000 VND to 40,000,000 Council for one of the following behaviors: a clinical drug Trial) without permission of the Ministry of health;
b) changes, additional content profile, outline of clinical drug research has been approved by the Ministry of health;
c) clinical trial drugs used in other purposes;
d) forced audience participation research tried smoking;
DD) falsifying test results for drug samples were tested.
4. additional sanctions: deprived of the right to use the certificate of eligible drug business, certificate of good practice standards for clinical drug trials within a period from 6 months to 12 months for the acts specified in paragraph 2 and paragraph 3 of this article.
5. remedial measures: Forcing the correct implementation of the provisions of the law for the acts specified in paragraph 1, points b and c of paragraph 2, paragraph 3 of this article.
Article 17. Violating regulations on management of drug prices 1. Violation on Declaration of drug price: 5,000,000 VND fine to 10,000,000 VND for one of the following behaviors: a) Not declare, Declaration not full reviews of prescribed medication;
b) Not to adjust prices after the Declaration of the opinion in writing of State administration on drug prices;
c) drug Sale drug prices higher than declared;
d) does not inform the customer reviews before opening.
2. Violation of the regulations on drug price listing: fines from 5,000,000 VND to 10,000,000 VND for one of the following behaviors: a) not listing or not listing the full price of the items sold are drugs or improper listing rules;
b) Sold higher drug prices.
3. Violation of rules on retail number increment or the regulation of drug prices for hospital pharmacies: a fine from 5,000,000 to 10,000,000 copper copper for sale behavior taller than the maximum retail numbers increment by the regulating authority bodies.
4. additional sanctions: deprived of the right to use the certificate of eligible drug business or permit the operation of foreign enterprises about smoking and smoking materials in Vietnam from 3 months to 6 months for acts specified in points a, c and d of paragraph 1 b, paragraph 2 of this Article from 2 times within 12 months from the date of detection of violations.
5. remedial measures: a) enforce the provisions of the law for acts specified in point a of paragraph 1, point a of paragraph 2 and paragraph 3 of this article;
b) Forced to resubmit the full amount of variances due to perform acts specified in point c of paragraph 1, point b of paragraph 2 of this Article.
Section 2 of the ADMINISTRATIVE VIOLATIONS OF PRODUCTION, business, information, advertising, PRODUCTS, FORMS and FINES Article 18. Violation of the regulations on cosmetics business 1. A fine from 1,000,000 to 5,000,000 đồng VND for the total value of the shipment violated under 10,000,000 5,000,000 fine copper or copper to copper for 10,000,000 total value of the shipment violated from 10,000,000 VND over sale prices for the base business is not held individuals responsible for putting the product into the market when doing one of the following behaviors: a) cosmetic business no longer intact packaging;
b) smuggled cosmetics business cosmetics, of unknown origin, origin;
c) overdue cosmetics business;
d) cosmetic business have not made announced cosmetic products;
cosmetic business) component chemicals used in cosmetics or exceeds the limit allowed for substances that limit the concentration, amount of use according to the current rules of law;
e) cosmetics business doesn't guarantee quality, not safe for use;
g) cosmetic business have been state management agencies have the authority to announce the recall due to violation of the provisions of the law.
2. A fine from 10,000,000 20,000,000 to copper copper for the Organization, the individual is responsible for bringing the product to market perform one of the following behaviors: a) has cosmetic business profile product information (.PIF) stored in the enterprise does not meet regulations;
b) cosmetics business doesn't guarantee quality, not safe for use;
c) cosmetic business no longer intact packaging, origin;
d) overdue cosmetics business user or too limited time as recommended by the manufacturer.
3. A fine fellow to fellow 30,000,000 20,000,000 words for the Organization, the individual is responsible for bringing the product to market perform one of the following behaviors: a) cosmetic business component chemicals used in cosmetics or exceeds the limit allowed for substances that limit the concentration use of content, according to the current rules of law;
b) cosmetic business no records of product information (PIF) under the regulations;
c) cosmetic business formula is not correct the record was announced;
d) cosmetic business has been producing countries announced bans the circulation on the market;
DD) does not make a withdrawal cosmetic regulatory violations at the request of the State Agency of competent jurisdiction.
4. remedial measures: a) forced the withdrawal and destruction of the entire cosmetics do perform acts specified in paragraph 1, points b, c and d of paragraph 2, points a, c and d of paragraph 3 of this article;
b) reception of a revocation vote announced cosmetic products or withdraw the registration number issued for cosmetics acts specified at points a, b, c and d of paragraph 3 of this article;
c) Required to comply with the provisions of the law with regard to the behaviour defined in art. 2, DD account 3 this.
Article 19. Violation of the regulations on imported products 1. A fine from 10,000,000 20,000,000 for copper to copper acts imported cosmetics are not intact packaging, origin.
2. A fine of 20,000,000 30,000,000 VND to Board for one of the following behaviors: a) the import of cosmetics containing ingredients banned substances used in cosmetics or exceeds the limit allowed for substances that limit the concentration, amount of use according to the current rules of law;
b) imported cosmetics have been producing countries announced bans circulating on the market.
3. the remedial measures: a) forced the withdrawal and destruction of the entire cosmetics do perform acts specified in clause 1 2 of this;
b) reception of a revocation vote announced cosmetic products or withdraw the registration number issued for cosmetics with the acts specified in paragraph 2 of this Article.
Article 20. Violation of the regulations on cosmetics production 1. A fine fellow to fellow 30,000,000 20,000,000 words for one of the following behaviors: a) cosmetics production did not comply with the principles, standards of "good manufacturing practice of cosmetic" of the Association of South-East Asian countries (ASEAN-CGMP) or equivalent products the ASEAN Council admit;
b) cosmetics production are composed of chemicals used in cosmetics or exceeds the limit allowed for substances that limit the concentration, amount of use according to the current rules of law or cosmetics production does not guarantee the quality, are not safe for use;
c) cosmetics production formula is not correct as published records.
2. remedial measures: a) forced the withdrawal and destruction of the entire cosmetics do perform acts specified in points b and c of paragraph 1 of this article;
b) reception of a revocation vote announced cosmetic products or withdraw the registration number issued for cosmetics with the acts specified in point b, c paragraph 1 of this article;
c) Required to comply with the provisions of the law with regard to the behaviour defined in art. 1 of this article.
Article 21. Violation of the regulations on cosmetics announced 1. A fine of 30,000,000 VND to 40,000,000 Council for one of the following behaviors: a) dishonest Declaration of content has committed in the vote published cosmetic product;
b) Not proceed with announced cosmetic products that have put the product out of circulation on the market for cosmetics manufacturers domestic production or manufacture cosmetics importers abroad.
2. remedial measures: a) forced the withdrawal and destruction of the entire cosmetics do perform acts specified in paragraph 1 of this article;
b) reception of a revocation vote announced cosmetic products or withdraw the registration number issued for cosmetics with the acts specified in point b of paragraph 1 of this article.
Article 22. Violation of the regulations on information, cosmetic ad 1. A fine from 5,000,000 VND to 10,000,000 VND for one of the following behaviors: a) improper cosmetics ads with ad registration documents have been approved by the governing body or is inconsistent with the documents proving the safety and efficacy of cosmetic products;
b) seminar, organized the event to introduce incorrect cosmetics with registered profile seminar, organized the event to introduce products that have been approved by the Administration;
c cosmetics ad) with the registered content off value or cosmetics ad when are reviewed within the time limit, resolve regulatory records;
d) organized the workshop, the event showcases cosmetics with registered content off the value; Organization of seminars, the event showcases beauty products when you are in the time limit for review, addressed the prescribed records;
cosmetics ad) was the Department of health in granting the receiver but when other local advertising that does not notify the local health department where the ad know;
e) held seminars, event introduced cosmetic has been the Health Department in granting the receiver but when there is a change in the timing and location of the formal organization without prior notice to the Health Department in the organization before you proceed.
2. A fine from 10,000,000 VND to 20,000,000 Board for one of the following behaviors: a) cosmetic ads when not yet State administration authorities of receiving the votes announced cosmetic products or have not filed registration documents cosmetic ads;
b) organized the workshop, the event showcases beauty products when not yet State administration authorities of receiving the votes announced cosmetic products or have not filed registration documents seminar, organized the event to introduce cosmetics;
c) information, advertising my products as drugs, make consumers think that product is smoking.
3. the remedial measures: Forcing the correct implementation of the provisions of the law for the acts specified in paragraph 1, item 2 of this Article.
Article 23. Violation of the regulations on cosmetic labels 1. A fine from 5,000,000 VND to 10,000,000 VND for one of the following behaviors: a) the production, trading cosmetics labeled does not meet the requirements for labeling of cosmetics according to the current regulations;
b) production, sales of cosmetics have labels stating features, the use of the product does not fit the profile was published.
2. A fine from 10,000,000 VND to 20,000,000 Board for one of the following behaviors: a) fake label of other products have been allowed to circulate;
b) false origin, record label of origin of goods;
c) the label does not record the name, address of the Organization, the individual is responsible for bringing the product to market;
d) record label features, uses distortions with the inherent nature of the product.
3. the remedial measures: a) forced the withdrawal and destruction of the entire cosmetics do perform acts specified at points a, b and d of paragraph 2 of this Article;
b) reception of a revocation vote announced cosmetic products or withdraw the registration number issued for cosmetics regulatory violations at points a, b and d of paragraph 2 of this Article;
c) Required to comply with the provisions of the law for the acts specified in paragraph 1, point c of paragraph 2 of this Article.
Section 3 of the ADMINISTRATIVE VIOLATIONS OF PRODUCTION, business, information, advertising, medical EQUIPMENT, FORMS and FINES article 24. Violation of the provisions of the business conditions of the medical equipment 1. A fine from 5,000,000 VND to 10,000,000 VND for one of the following behaviors: a) medical equipment business without business registration certificate;
b) infrastructure, engineering, personnel for the production and sales of medical equipment as prescribed by the Ministry of health;
c) business establishments medical equipment not listing price;
d) business establishments medical equipment higher selling prices.
2. A fine from 10,000,000 VND to 20,000,000 Board for one of the following behaviors: a) medical equipment business did not have the registration number in circulation; No import license of the Ministry of health or there is no clear proof of origin;
b) business range of business registration.
3. additional sanctions: seized medical equipment with respect to acts specified in point a of paragraph 2 of this.
4. remedial measures: a) enforce the provisions of the law for the acts specified in paragraph 1 of this article;
b) forced the return of the money disparity has been due to perform acts specified in point d of paragraph 1 of this article;
c) Forced to revoke the medical equipment business registration range for acts specified in point b of paragraph 2 of this Article.
Article 25. Violation of the regulations on medical equipment production 1. A fine from 5,000,000 VND to 10,000,000 VND for acts not timely notification to the competent authority when there are changes in production of items, production facilities, the main responsibility of the production.
2. A fine from 10,000,000 20,000,000 for copper to copper acts evade, not responsible for remedying the consequences of medical equipment products have caused the error.
3. A fine fellow to fellow 30,000,000 20,000,000 words for acts of medical equipment manufacturing non-standard, quality has announced.
4. A fine of 30,000,000 VND to 40,000,000 Council for one of the following behaviors: a) manufacture of medical equipment has no certificate of qualified medical equipment production;
b) producing medical equipment without a certificate of registration or certificate of circulation circulation (CFS) to circulate on the market or export;
c) medical equipment production not conducted clinical tests or clinical trials do not proceed properly with regard to clinical trials to product.
5. additional sanctions: deprived of the right to use the license to operate from 3 months to 6 months for the acts specified in paragraph 3, points b and c of paragraph 4 of this Article.
6. remedial measures: a) Compel the responsibility remedial due medical equipment products have caused errors for the acts specified in paragraph 2 of this Article;
b) forced the recall and destruction or recycling the entire medical equipment due to perform acts specified in clause 3, 4 this;
c) Required to comply with the provisions of the law for the acts specified in paragraphs 3 and 4 of this Article.
Article 26. Violation of the regulations on importing equipment, medical instruments 1. A fine fellow to fellow 30,000,000 20,000,000 words for one of the following behaviors: a) importing equipment, medical instrument import permit under the provisions of the Ministry of health;
b) imported into Vietnam, equipment and medical instruments are not allowed to circulate in the country of origin, all circulating in Vietnam or the World Health Organization banned circulation;
c) importing equipment, medical tools, not through clinical trials in a number of medical establishments according to international practices or legal provisions on clinical trials in Vietnam;
d) importing equipment, medical instruments were not inspected at testing agency or the State's quality control for precise equipment and some other devices as prescribed by law;
DD) imported the equipment, medical instruments are defective in quality, less effective in the treatment, cure cause harmful side effects for humans;
e) importing medical equipment used (with business purposes, not gift gifts).
2. additional sanctions: a) deprived of the right to use the license to import medical equipment no time limit for the acts specified in paragraph 1 of this article;
b) confiscating the devices, medical instruments for the acts specified in paragraph 1 of this article.
3. the remedial measures: enforce correct provisions of the law for acts specified in point d of paragraph 1 of this article.
Article 27. Violation of the regulations on information, advertising medical equipment 1. A fine from 5,000,000 VND to 10,000,000 VND for one of the following behaviors: a) the content, advertising, information, medical equipment is not properly registered profile or do not modify ad content at the request of the competent medical authorities;
b) organized the workshop, the event showcases medical equipment when not yet State regulators have the authority to receive the records.
2. A fine from 10,000,000 VND to 20,000,000 Board for one of the following behaviors: a) the promotion of medical equipment not properly with features, the effect of medical equipment;
b) ads about medical equipment when no votes registered profile receiving advertising by the competent health authorities or not allowed to circulate in Vietnam;
c) intentionally hide, not timely information to the authorities, the warning about the problem, unwanted effects of medical equipment products.
3. the remedial measures: Forcing reports, provide accurate information or apologize, publicly on the mass media with regard to the behaviour defined in art. 1, paragraph 2 of this Article.
Chapter III JURISDICTION and PROCEDURE for SANCTIONING of ADMINISTRATIVE VIOLATIONS to article 28. The authority sanctioning administrative violations of the people's Committee Chairman granted 1. Chairman of people's Committee of the communes, wards and towns have the right: a) caution;
b) a fine of up to 2,000,000;
c) confiscated exhibits, media, tools valuable to 2,000,000 transgressions;
d) apply remedial measures specified in point a, b, c, d, e and k paragraph 3 article 5 of this Decree.
2. The Chairman of the district people's Committee, district, town, city in the province have the right to: a) caution;
b) a fine of up to 30,000,000 VND;
c) apply the additional sanctions as stipulated by the law on handling administrative violations;
d) apply remedial measures specified in point a, b, c, d, e and k paragraph 3 article 5 of this Decree.
3. The Chairman of the provincial people's Committee, central cities have the right to: a) caution;
b) fines up to 40,000,000;
c) apply the additional sanctions as stipulated by the law on handling administrative violations;
d) apply remedial measures prescribed in paragraph 3 article 5 of this Decree.
Article 29. The authority sanctioning administrative violations of medical inspector 1. When health inspectors are on duty in the scope of its functions has the right to: a) caution;
b) a fine of up to 500,000;
c) confiscated exhibits, media, tools valuable to 2,000,000 transgressions;
d) apply remedial measures specified in point a, b, c, d, e and k paragraph 3 article 5 of this Decree.
2. The Chief Inspector of the Department of health has the right: a) caution;
b) a fine of up to 30,000,000 VND;
c) apply the additional sanctions as stipulated by the law on handling administrative violations;
d) apply remedial measures specified in point a, b, c, d, e and k paragraph 3 article 5 of this Decree.
3. The Chief Inspector of the Ministry of health have the right to: a) caution;
b) fines up to 40,000,000;
c) apply the additional sanctions as stipulated by the law on handling administrative violations;
d) apply remedial measures prescribed in paragraph 3 article 5 of this Decree.
4. Heads perform functions assigned specialized inspectors, who carry out missions specialised inspection authority sanctioning administrative violations in accordance with the law on handling administrative violations and relevant legislation.
Article 30. The authority sanction of agencies other than those prescribed in article 28 and Article 29 of this Decree, others under the provisions of the Ordinance on handling administrative violations on 8 July 2002 and amended Ordinance, supplementing some articles of the Ordinance on handling administrative violations on 02 April 2008 (hereinafter referred to as the Ordinance treats vi administrative offences) of the function, the task that detected the administrative violations specified in this Decree in the fields or areas of management, has the right to sanction in accordance with the Ordinance on handling administrative violations.
Article 31. Authority and principles delineate the authority sanctioning administrative violations in the field of drugs, cosmetics and medical equipment 1. Authorised sanctioning administrative violations in the field of drugs, cosmetics and medical equipment are applied according to the provisions of article 41 of the Ordinance on handling administrative violations.
2. Principles for determining the jurisdiction of sanctioning administrative violations in the field of drugs, cosmetics and medical equipment are applied according to the provisions of article 42 of the Ordinance on handling administrative violations.
Article 32. Procedure for sanctioning of administrative violations in the field of drugs, cosmetics and medical equipment 1. Procedure, the order sanctioning administrative violations in the field of drugs, cosmetics and medical equipment made according to the provisions of the Ordinance on handling administrative violations and Decree No. 128/2008/ND-CP.
2. The documents concerning the sanctioning administrative violations in the field of drugs, cosmetics and medical equipment are kept fully in the Agency sanction. Minutes of administrative violations are established according to the model regulations.
3. Individuals, the Organization fined must pay fines on time and at the place stated in the decision to sanction unless filed spot fines under the provisions of article 54 and article 58 of the Ordinance on handling administrative violations and get receipts.
4. When granting confiscated exhibits, means of infringement, who has the authority to sanction the correct implementation of the provisions of article 60, article 61 of Ordinance on handling administrative violations and Decree No. 128/2008/ND-CP.
Article 33. Accept the decision and sanction coercive enforcement of the decision sanctioning administrative violations in the field of drugs, cosmetics and medical equipment 1. Personally, the organization sanctioned administrative violations in the field of drugs, cosmetics and medical equipment under this decree must strictly obey decided to sanction within 10 days from the date of delivery of the decision to sanction, unless the law otherwise. If the individual, the organization sanctioned the Executive decided voluntarily not to sanction coercive enforcement of the sanction decision as specified in article 66 of the Ordinance on handling administrative violations and the coercive regulations enforce the decision sanctioning administrative violations of the law.
2. When applying coercive measures to enforce the decision sanctioning administrative violations in the field of drugs, cosmetics and medical equipment, the Agency and the competent person must comply with the order, coercive procedures as specified in article 66 and article 67 of the Ordinance on handling administrative violations and the coercive enforcement of regulations decide sanction breach the administration of the law.
Article 34. Sample documents, sample decided to use in sanctioning administrative violations regarding drugs, cosmetics and medical equipment attached to this Decree's annex and decision thereon patterns used in sanctioning administrative violations regarding drugs, cosmetics and medical equipment.
Chapter IV the TERMS OF IMPLEMENTATION of Article 35. Effective enforcement of this Decree in effect enforced since December 15, 2011.
Removal of Articles 19, 20, 21, 22, 23, 24 and 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44 of Decree No. 45/2005/ND-CP dated April 6, 2005 of the Government regulation on sanctioning administrative violations in the field of health.
Article 36. Responsibilities and enforcement 1. The Minister of health is responsible for guiding the Organization, and examined the enforcement of this Decree.
2. Ministers, heads of ministerial agencies, heads of government agencies, the Chairman of the people's Committee and the agencies, organizations, individuals responsible for the implementation of this Decree.
