Chapter I
GENERAL PROVISIONS
Article 1. Scope
1. This Decree deals with administrative violations, penalties, fines, remedial measures against each violation, the power to impose penalties, fines imposed by each authorized title holder and the power to record administrative violations in medical sector.
2. Administrative violations in medical sector prescribed herein are wrongful acts committed by organizations and individuals that contravene regulations on state management of medical sector but do not constitute criminal offences and are punishable by administrative penalties, including:
a) Violations against regulations on preventive healthcare, and HIV/AIDS prevention and control;
b) Violations against regulations on medical examination and treatment;
c) Violations against regulations on pharmacy and cosmetics;
d) Violations against regulations on medical devices;
dd) Violations against regulations on health insurance;
e) Violations against regulations on population.
3. Other administrative violations in medical sector which are not prescribed herein shall be penalized in accordance with the Decrees in which they are mentioned.
4. When detecting the violations in Point c Clause 3 Article 7, Point e Clause 5, Point b Clause 6 Article 38, Points a, b Clause 7 Article 44, Clause 6 Article 48, Point a Clause 2 Article 52, Clause 3 Article 53, Point a Clause 1 Article 54, Point c Clause 4 Article 56, Point d Clause 5, Clause 7 Article 57, Clause 7 Article 58, Clause 7 Article 59, Point a Clause 4 Article 60, Point c Clause 5 Article 67, Clause 3 Article 68, Point b Clause 2 Article 70, Points a, b Clause 3 Article 73, Clause 4 Article 80, Points d, dd, e, g, h Clause 2 Article 85, Points d, dd, e, g, h, i Clause 2 Article 86 or the repeating of the violations in Points a, b Clause, 3 Article 7, Clause 9 Article 15, Clause 6 Article 40, Point a Clause 6 Article 44, Point b Clause 5 Article 67 and Clauses 2, 3 Article 80 hereof, the competent persons who are handling such cases shall transfer the case files to competent criminal proceedings agencies for initiating criminal prosecution in accordance with the provisions in Clauses 1, 2 and 4 Article 62 of the Law on penalties for administrative violations. If the relevant criminal proceedings agency decides not to institute criminal proceedings in accordance with the provisions of the Criminal Procedure Code, the case file shall be returned to the person competent to impose penalties who has transferred it to the criminal proceedings agency as prescribed in Clause 3 Article 62 of the Law on penalties for administrative violations for imposing administrative penalties in accordance with the provisions hereof.
Article 2. Regulated entities
1. Vietnamese and foreign organizations and individuals (hereinafter referred to as “entities”) that commit administrative violations in the medical sector, persons competent to make records of violations, those competent to impose penalties and other relevant entities.
2. Organizations that are the entities incurring penalties as prescribed herein include:
a) Economic organizations that are duly established under the Law on enterprises, including: Sole proprietorships, joint-stock companies, limited liability companies, partnerships and their affiliates (including branches and representative offices);
b) Co-operatives and cooperative unions that are duly established under the Law on co-operatives;
c) Organizations that are duly established under the Law on investment or the Law on commerce, including: Domestic and foreign investors (except individual investors) and foreign-invested economic organizations; representative offices and branches of foreign traders in Vietnam; representative offices of foreign trade promotion organizations in Vietnam;
d) Social organizations, socio-political organizations, socio-political-professional organizations, and socio-professional organizations;
dd) Public service providers, people’s armed forces and agencies of the Communist Party of Vietnam;
e) Regulatory authorities committing the violations which are not related to their assigned management tasks;
g) Artels;
h) Other organizations as prescribed by law.
3. Household businesses, family businesses, domestic and foreign individual investors shall be liable to the same penalties as those imposed upon individuals for committing the administrative violations prescribed herein.
Article 3. Penalties and remedial measures
1. Primary penalties:
a) Warning;
b) Fines.
2. Depending on the nature and severity of each administrative violation, the violating entity may face one or some of the following additional penalties:
a) Suspension of the following licenses or practicing certificates for a fixed period of 01-24 months, including: certificate of eligibility for pharmacy business, license for medical operations, certificate of satisfaction of level-3 biosafety standards, certificate of eligibility to provide HIV testing, certificate of eligibility to produce cosmetics, license to trade in alcoholic beverages, license to operate tissue bank, pharmacy practicing certificate and medical examination and treatment practicing certificate;
b) Confiscation of exhibits and instrumentalities used for committing administrative violations in medical sector;
c) Suspension of operations for a fixed period of 01 - 24 months;
d) Deportation.
3. In addition to the primary and additional penalties, the violating entity may, depending on the nature and severity of each administrative violation, be liable to one or some of the remedial measures specified in Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and the following remedial measures:
a) Enforced return of amounts of money collected against regulations of law. Any amounts of money which cannot be returned to payers shall be paid to state budget as prescribed by law;
b) Enforced implementation of cleaning, disinfection and sterilization measures and other measures for prevention and control of infectious diseases;
c) Enforced organization of medical isolation, implementation of coercive measures for medical isolation, health inspection and control;
d) Enforced implementation of measures for cleaning of clean water supply and distribution system;
dd) Enforced making of direct apologies to HIV-positive persons and their families and correction of information published on means of mass media at the place where the HIV patient is living within 03 days as prescribed by law, unless the HIV patient rejects public apologies;
e) Enforced receipt and burial or cremation of corpses or remains of HIV infected persons;
g) Enforced receipt of HIV-positive persons;
h) Enforced making of direct apologies to persons who are discriminated against, practitioners, and patients;
i) Enforced re-appointment to previous job positions;
k) Enforced provision of legitimate rights and benefits to HIV-infected employees;
l) Enforced cancellation of decisions to discipline or expel pupil or student for HIV infection;
m) Enforced payment of interests on different amounts due to false declarations or late payment of compulsory contributions; enforced making of payments due to evasion or commission of frauds in payment of compulsory contributions; enforced return of amounts of money which have been used against regulations;
n) Enforced payment of all costs of medical services;
o) Enforced return of entire different amounts. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;
p) Enforced reimbursement of amounts of money as compensation for damage suffered by health insurance purchasers (if any); enforced reimbursement of amounts of money as compensation for damage suffered by health facilities (if any). Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;
q) Enforced transfer of amounts of money involving in the violations to the dedicated account of the health insurance fund (if any);
r) Enforced removal of intrauterine devices and contraceptive implants;
s) Enforced revocation of practicing certificates, license for medical operations, license to import medical devices and medical face masks, certificate of eligibility for pharmacy business, certificate of free sale of domestically manufactured medical devices, certificate of registration of drugs/pharmaceutical starting materials, receipt number of cosmetic product declaration, acknowledgement of receipt of declaration dossier, certificate of registration of drugs/pharmaceutical starting materials, certificate of registration of type B, C, D medical devices.
Article 4. Fines
1. The maximum fine imposed for a violation against regulations on population is VND 30.000.000 if committed by an individual or VND 60.000.000 if committed by an organization.
2. The maximum fine imposed for a violation against regulations on preventive medicine and HIV/AIDS prevention and control is VND 50.000.000 if committed by an individual or VND 100.000.000 if committed by an organization.
3. The maximum fine imposed for a violation against regulations on health insurance is VND 75.000.000 if committed by an individual or VND 150.000.000 if committed by an organization.
4. The maximum fine imposed for a violation against regulations on medical examination and treatment, pharmacy, cosmetics or medical devices is VND 100.000.000 if committed by an individual or VND 200.000.000 if committed by an organization.
5. The fines prescribed in Chapter II hereof are imposed on violating individuals. The fine imposed on an organization is twice as much as that imposed on an individual for the same administrative violation.
6. Fines imposed by the competent officials prescribed in Chapter VIII hereof are incurred by violating individuals; a competent official who has the power to impose fines shall have the right to impose a fine twice as much as that imposed upon an individual upon a violating organization for the same administrative violation.
Tìm kiếm
Nghị định 117/2020/NĐ-CP (Bản Pdf)
Nghị định 117/2020/NĐ-CP (Bản Word)