Decree No. 6/CP On detailing certain Articles of the Ordinance on Private Medical and Pharmaceutical Practice

DECREE OF THE GOVERNMENT

Regarding certain provisions of the Private Medical and Pharmaceutical Practice Ordinance

THE GOVERNMENT

Pursuant to the Government Organization Law dated September 30, 1992;

Based on the Private Medical and Pharmaceutical Practice Ordinance dated September 30, 1993;

At the proposal of the Minister of Health;

DECREE:

Article 1. This Decree specifies certain Articles of the Private Medical and Pharmaceutical Practice Ordinance.

Article 2. Individuals meeting the criteria and conditions stipulated in the Private Medical and Pharmaceutical Practice Ordinance shall be granted certificates of qualification and conditions for establishing private medical and pharmaceutical practice facilities by the Ministry of Health or the Provincial Health Department, irrespective of their place of permanent residence registration.

Article 3. Foreign organizations and individuals, and overseas Vietnamese practicing private medical and pharmaceutical services within Vietnam must comply with the regulations set forth in the Private Medical and Pharmaceutical Practice Ordinance and other relevant laws.

Article 4. Foreign organizations and individuals, and overseas Vietnamese may invest in the pharmaceutical, medical examination, and treatment sectors in Vietnam under the forms of investment prescribed in Article 4 of the Law on Foreign Investment in Vietnam.

Article 5. The conditions for the Ministry of Health to issue certificates of qualification and conditions for establishing private medical and pharmaceutical practice facilities for foreign organizations and individuals, and overseas Vietnamese are as follows:

1. There is a need and they can meet the demand for medical examinations and treatments of the people and foreigners in Vietnam.

2. They have adequate conditions regarding location, modern medical equipment, high-level technical expertise, and other necessary conditions as specified by the Ministry of Health.

3. The individual applying for practice must meet the qualifications stipulated in the Private Medical and Pharmaceutical Practice Ordinance; if practicing pharmacy, they must hold a bachelor's degree in pharmacy and have five years of practical experience, and if practicing medicine, they must hold a bachelor's degree in medicine and have five years of practical experience.

Article 6. Documents and procedures for requesting certificates of qualification and conditions for establishing private medical and pharmaceutical practice facilities for foreign organizations and individuals, and overseas Vietnamese:

1. Application documents for certificates issued according to point b, Clause 1, Article 24 and point b, Clause 1, Article 25 of the Private Medical and Pharmaceutical Practice Ordinance.

2. Procedures for requesting:

a) Foreign organizations and individuals, and overseas Vietnamese requesting certificates must submit application documents to the Ministry of Health.

b) Within ninety days from the date of receipt of complete documents, the Ministry of Health will issue the certificate or refuse issuance and provide reasons for refusal.

Article 7. After twelve months from the date of issuance of the certificate, private medical and pharmaceutical practice facilities of foreign organizations and individuals, and overseas Vietnamese that fail to fully meet the conditions specified in the certificate or do not commence operations will have their certificates revoked by the Ministry of Health.

Article 8.

1. Certificates of qualification and conditions for establishing private medical and pharmaceutical practice facilities are valid for three years from the date of issuance. For certificates of qualification and conditions for establishing private hospitals, private enterprises, and private pharmaceutical trading companies, they are valid for five years from the date of issuance.

2. When the validity period specified in Clause 1 of this Article expires, the individual applying for private medical and pharmaceutical practice must apply to the authority issuing the certificate for renewal.

Article 9. Private medical and pharmaceutical practice facilities must reapply for new certificates in the following cases:

1. The holder of the certificate ceases to practice and transfers the facility to another person.

2. Change in the form of practice organization.

3. Splitting or merging.

4. Changing the practice location outside the province or centrally governed city; in case of changing the practice location within the province or centrally governed city, the private medical and pharmaceutical practice facility must report to the authority issuing the certificate for review and issuance of a new certificate.

Article 10. In the following cases, the authority issuing certificates of qualification and conditions for establishing private medical and pharmaceutical practice facilities will revoke the certificates:

1. Upon discovering that the certificate holder does not meet the qualifications stipulated in Articles 6, 7, and 8 of the Private Medical and Pharmaceutical Practice Ordinance; the practice facility does not meet the conditions specified in the certificate.

2. The certificate holder violates any of the provisions in Articles 15, 16, 18, 19, and 21 of the Private Medical and Pharmaceutical Practice Ordinance or seriously violates other provisions of this Ordinance.

3. The private medical and pharmaceutical practice facility is declared bankrupt or dissolved.

Article 11.

1. Procedures for requesting establishment licenses and business registration certificates for private medical and pharmaceutical enterprises must comply with the Law on Private Enterprises, the Law on Joint Stock Companies, and Decrees No. 221-HĐBT and No. 222-HĐBT dated July 23, 1991 of the Council of Ministers (now the Government), which specify certain provisions of the Law on Private Enterprises and the Law on Joint Stock Companies.

2. Procedures for requesting business operation licenses for private medical and pharmaceutical practice facilities operated by individuals and small groups with capital below the statutory minimum must comply with Decree No. 66-HĐBT dated March 2, 1992 of the Council of Ministers concerning individuals and small groups with capital below the statutory minimum as specified in Decree No. 221-HĐBT dated July 23, 1991.

Article 12.

1. Organizations and individuals requesting certificates of qualification and conditions for establishing private medical and pharmaceutical practice facilities must pay the assessment fee.

2. The Ministry of Health and the Ministry of Finance shall specify the amount of the fee, its management, and usage.

Article 13.

1. Private family planning service facilities may only perform technical services such as menstrual regulation, intrauterine device insertion, and male sterilization without surgery.

2. Strictly prohibited are abortion, female sterilization, and termination of contraceptive effects such as IUD removal, tubal recanalization, or vasovasostomy for those who have been sterilized at private family planning service facilities.

Article 14.

1. Content of advertisements for medical examinations and treatments must be approved by the provincial or centrally governed city health department; mass media outlets may advertise only upon obtaining approval from the health department.

2. Advertising of medicines must comply with the regulations of the Ministry of Health.

Article 15.

1. All private medical and pharmaceutical practice facilities must display prices.

2. For certain types of medical examinations and treatments, the Ministry of Health sets price ranges for private medical practice facilities to follow.

Article 16. Private medical and pharmaceutical practices are responsible for coordinating with local health authorities in preventing and combating sexually transmitted diseases, drug addiction, AIDS, and other infectious diseases that may pose a threat to society.

Article 17. The Minister of Health shall perform the state management function over private medical and pharmaceutical practices and issue guiding documents to implement this Ordinance and Decree according to their authority or in collaboration with relevant ministries to strictly and uniformly manage private medical and pharmaceutical practices nationwide.

Article 18This Decree takes effect from the date of signature. Previous regulations that conflict with the provisions of this Decree are abolished.

Article 19. The Minister of Health, ministers, heads of ministerial-level agencies, heads of government-affiliated agencies, and chairpersons of provincial and centrally-administered city People's Committees are responsible for implementing this Decree./.