Chapter VII
PREVENTION AND CONTROL OF COMMUNICABLE DISEASES
Article 14. Annulment to some Articles on prevention and control of communicable diseases
1. Annul the following Articles of the Government's Decree No. 103/2016/ND-CP dated July 01, 2016 on biosafety in laboratories:
a. Article 2.
b. Clause 1d, Article 4.
c. Clause 1a, 1c, 1d, 1dd and 1e of Article 5.s
d. Clause 2b and 2c, Article 5.
dd. Clause 3b and 3d, Article 5.
e. Clause 4b, 4c, 4dd, 4e and 4g, Article 5.
g. Clause 2c, Article 6.
h. Clause 4b, Article 6.
Clause 1dd, Article 7.
k. Clause 2c, Article 7.
l. Article 8.
m. Clause 1d, 1e, 1h, Article 11.
n. Clause 4b, Article 11.
2. Annul the following Articles of the Government’s Decree No. 104/2016/ND-CP dated July 01, 2016 on vaccination:
a. Clause 1c, Article 8.
b. Clause 1b, 1c, 1d, 1dd and 1e, Article 9.
c. Clause 2b and 2d, Article 9.
d. Clause 1b, Article 10.
3. Annul Circular No. 43/2011/TT-BYT dated December 05, 2011 of the Ministry of Health on management of infectious specimens.
Article 15. Amendments to some Articles on prevention and control of communicable diseases
1. Amendments to some Articles of the Government’s Decree No. 103/2016/ND-CP dated July 01, 2016 on biosafety in laboratories:
Clause 1d, Article 4 is amended as follows:
“d. If the testing facilities specified in points a, b, c of this Clause have the equipment for storing the specimens and satisfy the regulations on standard practice, they are allowed to store, retain, use, research, exchange and dispose blood specimens, serum specimens, urine samples, fecal samples, secretion specimens and other specimens from human bodies which may or may not spread communicable diseases, as well as other micro-organisms specimens which may cause communicable diseases for people.”
b. Clause 1b, Article 5 is amended as follows:
“b. Emergency eye wash kits and first aid kits.”
c. Clause 1, Article 9 is amended as follows:
“1. Level I, level II and level III biosafety-testing facilities must comply with the requirements for facilities, equipment, employees and practices; restoration, maintenance and calibration of testing equipment and supervision of practices in the laboratory."
d. Clause 1, Article 10 is amended as follows:
“1. The Minister of Health shall conduct inspections, issue, re-issue or revoke the Certificates of Satisfaction of Biosafety Standards for level III biosafety-testing facilities (hereinafter referred to as "Certificate of Biosafety”), excluding testing facilities under the management of the Ministry of National Defense.
dd. Clause 1b, Article 11 is amended as follows:
“b. A list of employees, using form No. 03 in Appendix hereto.”
e. Clause 2c and 2dd, Article 11 are amended as follows:
“c. A report on changes in employees (if any)."
“dd. A report on changes to facilities.”
g. Clause 1, Article 17 is amended as follows:
“1. The Ministry of Health shall conduct regular or irregular inspections of testing facilities which have obtained the Certificate of biosafety of level III and the testing facilities which have declared themselves that they satisfy the biosafety standards of level I or level II nationwide.”
h. Clause 2, Article 19 is amended as follows:
“2. Annually, the level III biosafety laboratories must organize rehearsal of prevention and remedy for biosafety incidents according to the regulations of the Minister of Health.”
Clause 4, Article 20 is amended as follows:
“4. If an incident happening in a biosafety laboratory of level II and level III is spread widely, seriously influence the population communities or national security, the handling and remedy for such incident must comply with the provisions in section 2, Chapter IV of the Law on Prevention and Control of Communicable Diseases."
2. Amend Article 36 of the Government's Decree No. 89/2018/ND-CP dated June 25, 2018 providing guidelines for implementation of the Law on Prevention and Control of Communicable Diseases regarding border health quarantine, as follows:
“1. The health quarantine officer shall collect:
a. The Declaration of biological products, tissues and human body organs which are imported for the purpose of prevention, research, diagnosis and treatment of diseases.
b. The Ministry of Health’s declaration and license for import of blood specimens, serum specimens, urine samples, fecal samples, secretion specimens and other specimens from human bodies which may or may not spread communicable diseases, as well as other micro-organisms specimens which may cause communicable diseases for people. These specimens and samples are imported for the purpose of prevention, research, diagnosis and treatment of diseases.
2. The application for import shall contain:
a. An application form for the import license, using form No. 25 in Appendix hereto.
b. A copy of the written approval from a competent agency which allows the execution of the research project or topic. Such approval must still be effective. Or a copy of the approved outline or approved document of the project, or a copy of an effective agreement, or related documents on the import of specimens between domestic and foreign facilities.
c. A copy of the self-declaration about the ability to satisfy the biosafety standards. Such declaration is made by the biosafety laboratory level I and II. Or a copy of the Certificate of Biosafety-Testing Facility from the biosafety laboratory level III.
3. Procedures for issuance of the import license:
a. The applicant shall send 01 application in person or by post to the Ministry of Health.
b. If the application is deemed satisfactory, the Ministry of Health shall issue the import license within 15 working days from the date on which the application is received.
c. If the application is deemed unsatisfactory, within 10 days from the date on which the application is received, the Ministry of Health shall send a written notification to the applicant to request for additional documents.
d. Within 30 days from the date on which the written notification from the Ministry of Health is received, the applicant shall provide additional documents as required. If the aforesaid period ends and the applicant does not provide additional documents, it shall re-apply for the import license.
dd. If the additional documents are deemed unsatisfactory, the Ministry of Health shall send a written notification to the applicant as specified in point c of this clause. If the additional documents are deemed satisfactory, the Ministry of Health shall issue the import license according to point b of this clause.”
3. Amend some articles of the Government’s Decree No. 104/2016/ND-CP dated July 01, 2016 on vaccination:
a. Clause 1d, Article 8 is amended as follows:
“d. There must be equipment for monitoring temperature of vaccines throughout the transport, storage and handling of products. Temperatures shall be recorded during transport and delivery. Storage temperatures shall be checked and recorded at least twice a day.”
b. Clause 1a, Article 9 is amended as follows:
“a. The vaccination area must be protected from rain and sunlight. Also, it must be airtight and airy and be arranged according to a flow pattern, including: welcoming patients, providing them guidance and counsel, performing screening tests, giving vaccination, monitoring and handling responses of post-vaccination."
c. Clause 3b, Article 9 is amended as follows:
"b. Health workers participating in vaccination must be trained in vaccination. Health workers performing screening tests, providing counsel, monitoring and handling responses of post-vaccination must have medical office assistant’s degrees or higher; health workers giving vaccination must have associate degrees in medicine or nursing (midwife) or higher.“
d. Clause 1c, Article 10 is amended as follows:
“c. It has adequate insulated containers and anti-shock kits according to the regulations of the Minister of Health.”
dd. Clause 2b, Article 10 is amended as follows:
“b. Facilities must be arranged according to a flow pattern, including: welcoming patients, providing them guidance and counsel, performing screening tests, giving vaccination, monitoring and handling responses of post-vaccination."
e. Clause 2c, Article 10 is amended as follows:
“c. Equipment: Have insulated containers and anti-shock kits according to the regulations of the Minister of Health.”
g. Clause 2d, Article 10 is amended as follows:
“d. Personnel: Have at least 02 health workers who satisfy the requirements specified in Clause 3b, Article 9 hereof.”
h. Clause 2, Article 11 is amended as follows:
“2. Within 03 working days from the date on which the declaration is received, the Department of Health shall post the information about the name, address and head of the clinic on its website (the declaration date is determined according to the date stamp)."
Tìm kiếm
Nghị định 155/2018/NĐ-CP (Bản Pdf)
Nghị định 155/2018/NĐ-CP (Bản Word)
