Decree No. 06-CP On detailing certain provisions of the Ordinance on Private Medical and Pharmaceutical Practice

DECREE

Regarding the elaboration of certain provisions in the Private Medical and Pharmaceutical Practice Ordinance

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 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 elaborates on 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 Services, irrespective of their place of permanent residence registration.

Article 3. - Foreign organizations and individuals, and Vietnamese citizens residing abroad practicing private medical and pharmaceutical services within Vietnam must comply with the provisions of the Private Medical and Pharmaceutical Practice Ordinance and other relevant laws.

Article 4. - Foreign organizations and individuals, and Vietnamese citizens residing abroad may invest in the pharmaceuticals, 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 consider issuing certificates of qualification and conditions for establishing private medical and pharmaceutical practice facilities for foreign organizations and individuals, and Vietnamese citizens residing abroad are as follows:

1. There is a need and they can meet the demand for medical examination and treatment for 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 applicant 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 applying for certificates of qualification and conditions for establishing private medical and pharmaceutical practice facilities for foreign organizations and individuals, and Vietnamese citizens residing abroad:

1. Application documents for certificate issuance as prescribed at point b, Clause 1, Article 24 and point b, Clause 1, Article 25 of the Private Medical and Pharmaceutical Practice Ordinance.

2. Application procedure:

a) Foreign organizations and individuals, and Vietnamese citizens residing abroad applying for 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, if private medical and pharmaceutical practice facilities of foreign organizations and individuals, and Vietnamese citizens residing abroad fail to fully meet the conditions stipulated in the certificate or do not commence operations, the Ministry of Health will revoke the issued certificate.

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 stipulated in this Clause expires, the applicant 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 certificate:

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 stipulated 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 applying for establishment licenses and business registration certificates for private medical and pharmaceutical enterprises must follow the provisions of the Law on Private Enterprises and the Law on Joint Stock Companies, Decree No. 221-HĐBT, and Decree No. 222-HĐBT dated July 23, 1991 of the Council of Ministers (now the Government) which elaborates on certain provisions of the Law on Private Enterprises and the Law on Joint Stock Companies.

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

Article 12.

1. Organizations and individuals applying for 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 ligation reversal, or vasectomy reversal for those who have undergone sterilization at private family planning service facilities.

Article 14.

1. Content of advertisements for medical examination and treatment must be approved by the provincial or centrally governed city health department; mass media outlets may only advertise when they have approval from the health department.

2. Advertising of medicines must comply with regulations set by 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 apply.

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