Chương III Thông tư 12/2015/TT-BYT: Hồ sơ, thủ tục cấp, cấp lại giấy phép hoạt động đối với cơ sở điều trị

Chapter III

DOCUMENTS, PROCEDURES FOR THE ISSUANCE/REISSUANCE OF OPERATING LICENSE TO TREATMENT FACILITIES

Article 9. Application for the issuance/reissuance of operating license to treatment facilities

1. An application for the issuance of a new operating license shall include:

a) An application form for operating license using the form in Appendix 1 enclosed with this Circular;

b) A certified true copy of the decision on the establishment granted by an authority body or a certified true copy of the certificate of business registration or a certified true copy of the certificate of investment;

c) A list of staff members of the treatment facility using the form in Appendix 2 enclosed herewith and enclose with a certified true copy of qualifications of each member;

d) The floor plan of the treatment facility;

dd) A list of equipment of the treatment facility using the form in Appendix 3 enclosed herewith.

2. The application for reissuance of operating license to the facility whose license is lost or damaged shall include:

a) An application from using the form in Appendix 1 enclosed with this Circular;

b) The original copy of the operating license that is damaged (if any);

c) The report on the operation in the latest 6 months up to the time the application is made.

3. The application for reissuance of operating license to the treatment facility that is relocated or have its operating license withdrawn shall include:

a) The papers specified in clause 1 of this Article;

b) The report on the operation over the latest 6 months up to the time the application is made.

Article 10. Procedures for the issuance/reissuance of operating licenses to treatment facilities

1. The application for issuance/reissuance of operating license shall be made in 01 set and sent to the Department of Health of provinces of the area where the facility is located.

2. Procedures for considering the issuance/reissuance of operating licenses to treatment facilities:

a) When the application is received, the Department of Health of provinces shall send the applicant facility the Document receipt using the form in Appendix 4 enclosed herewith;

b) Within 20 working days from the day on which the satisfactory application is received, the Director of the Department of Health of provinces shall conduct an appraisal to issue/reissue the operating license;

c) If the application is not satisfactory, within 10 working days from the day written on the Document receipt, the Department of Health of provinces shall send a written notification to the applicant for completion. The notification shall specify the contents and documents that are unconformable;

d) When the request is received, the applicant shall complete the application according to the notification and submit the application to the Department of Health of provinces. The date of receipt of the modified application shall be written on the Document receipt;

dd) If the application is still unsatisfactory after modification, the Department of Health of provinces shall send a written notification to the applicant for completion according to the provisions in Point c Clause 2 of this Article.

Article 11. Appraisal serving the issuance/reissuance of operating licenses to treatment facilities

The Director of the Department of Health of provinces shall establish an appraisal team to carry out the issuance/reissuance of operating licenses to treatment facilities including:

1. A representative of heads of the Department of health of provinces as Leader.

2. A representative of heads of HIV/AIDS centers of provinces as the standing Deputy leader.

3. A representative of heads of the Division in charge of managing the ORT of the Department of Health of provinces as the Deputy leader.

4. Representatives of Specialist Pharmaceutical Division of the Department of Health of provinces as Members.

5. Physicians with experience in ORT as Members.

6. Representatives of Police department as members.

7. Specialists of the Division in charge of managing the ORT of the Department of Health of provinces as the Secretary.

Article 12. Procedures for the issuance/reissuance of operating licenses to treatment facilities

1. The procedures for the issuance of operating licenses to treatment facilities or the reissuance of operating licenses to treatment facilities that are relocated or have operating license withdrawn:

a) Conduct appraisal of the legal record; inspect the conditions of material facilities, medical equipment, staff of the treatment facility;

b) Formulate appraisal record according to the form in Appendix 5 enclosed herewith. The record of appraisal of a treatment facility shall be made in 02 copies, 01 of which shall be retained at the Department of Health of provinces and the other shall be retained at the treatment facility undergoing appraisal;

c) Within 02 working days from the day of appraisal, the Appraisal team shall submit the Director of the Department of Health of provinces the appraisal record;

d) Within 03 working days from the day on which the appraisal record is received, the Director of Department of Health shall consider and give decision on the issuance/reissuance of operating license to the treatment facility. If the application is rejected, the applicant treatment facility shall be sent a writing containing the explanation.

2. Procedures for reissuance of operating license applicable to the treatment facility with the license being lost or damaged:

a) Within 05 working days from the day on which the application for the reissuance of the operating license is received (according to the to the date stamp on the dispatch sent by the Provincial Department of Health), the division in charge of managing the ORT of the Department of Health of provinces shall examine the appraisal documents according to which the operating license for such treatment facility is granted that are retained at the Department of Health;

b) Within 10 working days from the day on which the application for reissuance of operating license is received (according to the dated stamp on the dispatch sent by the Provincial Department of health), the Director of Department of Health of provinces shall consider and give decision on the reissuance of operating license. If the application is rejected, the applicant treatment facility shall be sent a writing containing the explanation.

Article 13. Management of operating licenses

1. A treatment facility shall be granted with only 1 operating license according to the form in Appendix 6 enclosed herewith.

2. A copy of the operating license and the application for issuance/reissuance of operating license shall be retained at the Department of Health of provinces.