Decision No. 7248/QD-BYT dated December 8, 2016 announcing administrative procedures amended and supplemented under the Government’s Decree 103/2016/ND-CP providing for biosafety in laboratories

DECISION

ANNOUNCING ADMINISTRATIVE PROCEDURES AMENDED AND SUPPLEMENTED UNDER THE GOVERNMENT’S DECREE NO. 103/2016/ND-CP DATED JULY 1, 2016 PROVIDING FOR BIOSAFETY IN LABORATORIES

MINISTER OF HEALTH

Pursuant to the Decree No.63/2012/NAAD-CP dated August 31, 2012 regulating functions, duty, powers and organizational structure of the Ministry of Health;

Pursuant to the Government’s Decree No.63/2010/ND-CP dated June 8, 2010 on the control of administrative procedures and the Government’s Decree No. 48/2013/ND-CP dated May 14, 2013 on modification and supplementation of some articles of the Decree related to the control of administrative procedures;

At the request of the Director of Preventive Medicine Department and the Director of Legal Department of the Ministry of Health,

HEREBY DECIDES

Article 1.Enclose herewith 04 sets of administrative procedures under the control of the Ministry of Health which are amended and supplemented by the Decree No. 103/2016/ND-CP dated July 1, 2016 regulating biosafety in laboratories (Appendix I  enclosed herein)

...

...

...

Article 3.This Decision takes effect from the signature day.

Article 4.Chief of the Ministry Office, Heads of Departments, Inspectorate Department, General Departments, Health Department of provinces and central-affiliated cities and Ministry-controlled units shall be responsible for implementing this Decision.

PP. MINISTER
DEPUTY MINISTER




Nguyen Thanh Long

APPENDIX I

ADMINISTRATIVE PROCEDURES UNDER THE MANAGEMENT OF THE MINISTRY OF HEALTH
(Enclosed with the Decision No. 7248/QD-BYT dated December 8, 2016 of the Minister of Health)

Part I

...

...

...

No.

Description

Field

Implementing authority

Note

Administrative Procedures of central authorities

1

Issuing testing facilities with the certificate of biosafety level III and IV under the power of the Ministry of Health

Preventive Medicine

...

...

...

Administrative procedure announced by the Decree No.103/2016/ND-CP

2

Granting testing facilities renewal of the certificate of biosafety level III and IV which has already expired under the power of the Ministry of Health

Preventive Medicine

Department of Preventive Medicine, Ministry of Health

Administrative procedure announced by the Decree No.103/2016/ND-CP

3

Granting testing facilities replacement of the certificate of biosafety level III, IV which has been damaged or lost under the power of the Ministry of Health

Preventive Medicine

...

...

...

Administrative procedure announced by the Decree No.103/2016/ND-CP

4

Granting testing facilities reissue of the certificate of biosafety level III and IV on which testing facility’s name is changed under the power of the Ministry of Health

Preventive Medicine

Department of Preventive Medicine, Ministry of Health

Administrative procedure announced by the Decree No.103/2016/ND-CP

APPENDIX II

LIST OF ADMINISTRATIVE PROCEDURES ANNULLED UNDER THE MANAGEMENT OF THE MINISTRY OF HEALTH
(Enclosed with the Decision No. 7248/QD-BYT dated December 2016 of the Minister of Health)

...

...

...

Description

Implementing authority

Note

Administrative procedures of central authorities

1

B-BYT-245083-TT

Issuing testing facilities with the certificate of biosafety level III and IV.

Department of Preventive Medicine

...

...

...

2

B-BYT-245126-TT

Granting testing facilities renewal of the certificate of biosafety level III and IV which has already expired

Department of Preventive Medicine

3

B-BYT-245321 - TT

Granting testing facilities replacement of the certificate of biosafety level III, IV which has been damaged or lost.

Department of Preventive Medicine

4

...

...

...

Granting testing facilities reissue of the certificate of biosafety level III and IV on which testing facility’s name is changed.

Department of Preventive Medicine

II. Administrative procedures of local authorities

5

B-BYT-245327-TT - TT

Issuing testing facilities with the certificate of biosafety level I

Health Department

...

...

...

B-BYT-245331-TT - TT

Issuing testing facilities with the certificate of biosafety level II

Health Department

7

B-BYT-245332-TT - TT

Granting testing facilities renewal of the certificate of biosafety level I and II which has already expired

Health Department

8

B-BYT-245333-TT - TT

...

...

...

Health Department

9

B-BYT-245334-TT - TT

Granting testing facilities reissue of the certificate of biosafety level III and IV on which testing facility’s name is changed.

Health Department

Part II

SPECIFIC CONTENTS OF EACH SET OF ADMINISTRATIVE PROCEDURES UNDER THE MANAGEMENT OF THE MINISTRY OF HEALTH

1 – Procedure

...

...

...

Implementing sequences

Step 1. The testing facility applying for the certificate of conformance to biosafety requirements (hereinafter referred to as applicant) sends their documents to the Ministry of Health (Department of Preventive Medicine)

Step 2. Competent authority hands out the receipt of application documents by completing the Form No. 06 in the Appendix to the Decree No. 103/2016/ND-CP dated July 1, 2016. Within 10 (ten) days of receipt of the application, the competent authority proceeds to verify submitted documents.

Step 3. In case the required documents are not full, within 05 (five) working days from the date the documents are verified, the competent authority informs the applicant in writing to submit a complete application. The applicant needs to supplement and amend their application as informed and send the amended and supplemented application back to the competent authority.

Step 4. In case the required documents are full, the competent authority must pay an inspection visit to the testing facility’s workplace within 10 (ten) days from the date the documents are verified.

In case the applicant meets all the conditions as stated in the inspection report, the competent authority reports to the Minister of Health to issue the Certificate of biosafety within 07 (seven) working days according to the Form No. 07 in the Appendix to the Decree No. 103/2016/ND-CP dated July 1, 2016, from the date of the inspection visit.

In case the applicant has not yet met all the conditions as stated in the inspection report, the competent authority must inform the applicant in writing within 07 (seven) working days from the date of the inspection visit.

Implementing method

...

...

...

Apply by post or directly

Components and quantity of application documents

Components of application documents:

- Application form for issue of certificate of biosafety according to the Form No. 02 in the Appendix to the Decree No.103/2016/ND-CP dated July 1, 2016.

- List of personnel compiled according to the Form No. 03 in the Appendix to the Decree No.103/2016/ND-CP dated July 1, 2016 and personal profile of each staff member, including: authenticated copies of recruitment decision or Labor contract and diplomas, degrees and certificates of employees working at the testing facility.

- Inventory of equipment compiled using the Form No. 04 in the Appendix to the Decree No.103/2016/ND-CP dated July 1, 2016.

- Floor plan of the testing facility, including: testing area; windows and door systems; power systems; water supply and drainage systems; layout of fire and explosion protection equipment.

- Authenticated copies of documents proving that the testing facility is established and operated in compliance with law.

...

...

...

 Testing facilities that have been currently in operation since earlier than the effective date of the Decree No. 103/2016 / ND-CP dated July 1, 2016 must ensure that their wastewater test results meet the national environmental standards before discharge into the common wastewater storage pond.

- Reports on care and maintenance of testing equipment of testing facilities that have been currently in operation since earlier than the effective date of the Decree No. 103/2016 / ND-CP dated July 1, 2016.

- Designs and descriptions of quality specifications of materials employed in designs of equipment used in the air system.

- Biosafety emergency preparedness and response plan.  

II. Quantity of application documents: 01 set.

Processing duration

17 working days of receipt of the complete and valid application

Subjects of the administrative procedures

...

...

...

State or privately-owned testing facilities

Implementing authorities

Department of Preventive Medicine

Results obtained from implementation of this administrative procedure

Certificate of conformance of the testing facility to biosafety level III, IV

Fee

...

...

...

Name of the application or declaration form (attached thereto)

1. Form No. 1: The application form for the certificate of conformance to biosafety standards.

2. Form No. 2: List of laboratory personnel.

3. Form No. 3: Inventory of laboratory equipment.

Requirements of administrative procedures

Article 7. Requirements for conformance of a testing facility to biosafety level III

The testing areas must meet following conditions:

...

...

...

a) There are laboratory rooms and buffer rooms

b) Conditions regulated in point a, point b, and point d clause 1 of Article 6 of Decree No. 103/2016/ND-CP are met; c) These rooms are separated from  the others of the testing facility;

dd) The laboratory must be airtight to ensure the sterilization;

dd) Doors and windows must be made from fireproof and load-bearing materials;

e) Door systems of testing areas must ensure that, in normal conditions, doors of buffer rooms or of testing areas can only be open one at a time.

g) Testing rooms have transparent glass walls or surveillance equipment from outside observing the inside of testing areas;

h) The air system must be designed according to the one-way flow principle; the air coming out of the testing area must pass through a high-performance air filter;

i) There is an alarm system that rings when the pressure inside testing areas does not meet the standards; the pressure of testing areas is always lower than the pressure outside under normal working conditions;

k) The frequency of air exchange of the testing areas should be at least 6 times/hour;

...

...

...

m) There is shower and wash equipment in case of emergency occurring at testing areas;

n) Laboratory rooms have two-way communications and warning systems.

2. Equipment requirements:

a) Laboratory equipment are subject to requirements set forth in point a and point b, clause 2 of Article 5 of Decree No. 103/2016/ND-CP;

b) There are level-II or higher-level biosafety cabinets;

c) There are infectious medical waste sterilizers or disinfectants placed in the testing areas;

d) There is personal protective equipment suitable for testing techniques implemented at the testing area satisfying biosafety level III.

3.  Personnel requirements:

a) Quantity of employees: there must be at least 02 laboratory technicians and 01 laboratory equipment engineers. Laboratory technicians must hold educational degrees or certificates in the testing technique that they are assigned to implement; laboratory equipment engineers must have educational certificates in equipment operation activities performed in the testing areas;

...

...

...

c) Laboratory technicians, laboratory equipment engineers and biosafety personnel must be trained in level-III or higher-level biosafety.

4. Requirements concerning laboratory practice regulations:

a) Laboratory practice regulations must be subject to clause 4 of Article 6 of this Decree;

b) There must be an antiseptic process for materials, tools, equipment and infectious substances before being carried out of the testing areas;

c) There is an antiseptic process enforced at the testing areas;

d) There is an emergency response process in effect at the testing areas;

dd) Biosafety emergency preparedness and response plan is available.

Article 8. Requirements for conformance of a testing facility to biosafety level IV

1. Infrastructure requirements:

...

...

...

b) There are changing rooms between buffer rooms and testing areas;

c) There is an uncirculated air ventilation system specially designed for level-III biosafety cabinets;

d) There is an independent air supply for protective clothes that can ensure 100% of air supply in case of biosafety emergencies;

dd) Separation, safety and security for such infrastructure are ensured;

e) There must be transport boxes to carry the infectious materials in and out of the testing areas;

g) Air coming in and out of the testing areas must flow through high-performance air filters.

2.  Equipment requirements:

a) Laboratory equipment must be subject to requirements set out in point a and point b clause 2 Article 5 of the Decree No. 103/2016/ND-CP;

b) There are level-III or higher-level biosafety cabinets;

...

...

...

d) There is personal protective equipment suitable for types of testing techniques done at the testing facility of biosafety level IV.

3. Personnel requirements:

a) Personnel must be subject to requirements set forth in point a and point b, clause 3 of Article 7 of Decree No. 103/2016/ND-CP must be observed;

b) Laboratory technicians, laboratory equipment engineers and biosafety personnel must be trained in biosafety level IV.

4. Requirements concerning laboratory practice regulations:

a) There are regulations as per clause 4 of Article 7 of the Decree No.103/2016/ND-CP;

b) There is the process of moving laboratory materials and instruments in and out of the testing areas by means of transport boxes or double-door circular autoclaves;

c) There is the process of protection of testing areas;

Legal bases for this administrative procedure

...

...

...

1. Law No. 03/2007/QH12 dated November 21, 2007 on prevention of contagious diseases.

2. Investment Law No.67/2014/QH13 dated November 26, 2014.

4. Circular No. 03/2013/TT-BTC of January 8, 2013 prescribing the fee for assessment of conditional commercial business; the fee for assessment of conformity with medical and pharmaceutical practicing standards; the fee for grant of license to import and export medical equipment and pharmaceutical products; the fee for eligibility for medical practicing certificate; the fee for granting license to healthcare establishments; Effective date is on March 01, 2013.

SPECIMEN OF THE APPLICATION FORM FOR CERTIFICATE OF CONFORMANCE TO BIOSAFETY STANDARDS.

….……..^[1]…………

SOCIAL REPUBLIC OF VIETNAM
Independence – Freedom - Happiness
---------------

...

...

...

APPLICATION FOR BIOSAFETY CERTIFICATE

To: ...............................^[3].......................

Name of the testing facility: ........................................................................................

Testing laboratory: .............................................................................................................

Address: .................................................................^[4].........................................................

Telephone: ...................................................... Email (if any): ...........................................

Pursuant to the Decree No.103/2016/TT-BYT dated July 1, 2016 regulating biosafety in laboratories; After satisfying requirements concerning infrastructure, equipment, human resources, and regulations on practices of documents involved in the application for the biosafety certificate,

We would like the designated certification agency to verify and process our application, and issue the certificate of biosafety level...^[6]… (please see attached documents)

We undertake to observe all regulations on laboratory biosafety and shall be held legally liable for our operations.

...

...

...

Testing facility’s head
(Signature and seal)

_______________

¹ Testing facility’s name

² Place name

³ Name of the agency issuing the certificate of biosafety

⁴ Detailed address of testing facility

LIST OF LABORATORY PERSONNEL

...

...

...

Full name

Title

Specialization

 Assigned task

1

...

...

...

3

...

...

...

…

...

...

...

TESTING FACILITY’S REPRESENTATIVE
(Signature and seal)

INVENTORY OF LABORATORY EQUIPMENT

No.

Equipment description

Model of device

Maker

Made in

...

...

...

Condition

Maintenance/calibration

Note

1

...

...

...

2

...

...

...

3

...

...

...

…

...

...

...

TESTING FACILITY’S REPRESENTATIVE
(Signature and seal)

..........¹...........
---------

SOCIAL REPUBLIC OF VIETNAM
Independence – Freedom - Happiness
---------------

Quantity of files.:        /PTN-.....²....

....... ³......, date (dd/mm/yyyy)….

APPLICATION ACKNOWLEDGEMENT

...

...

...

Name of the receiving unit: ...........................................................................................................

Address: ⁴............................................................................................................

Telephone: ...........................................................................................................

Certification type: Issue □                                     Re-issue □

Has received the application for issue, renewal or reissue of the certificate of biosafety, including the following documents:

1.

Application for issue, renewal or reissue of certificates

□

2.

...

...

...

□

3.

List of laboratory personnel.

□

4.

Inventory of laboratory equipment.

□

5.

Floor plan of the testing facility

...

...

...

6.

Documents evidencing establishment and operation of facility of the testing facility.

□

7.

Diagram of the wastewater treatment system

□

8.

 Wastewater test results

□

...

...

...

Description of quality specifications of materials employed in each design of door and window

□

10.

Description of quality specifications of materials employed in each design of equipment used in the power and water system.

□

11.

The design of the system of chemical treatment of liquid wastes and the test result that meets national technical environmental standards

□

12.

...

...

...

□

13.

Report on changes (in case of reissue)

□

Receipt of supplemented application for the:...time

date (dd/mm/yyyy)……

Signature

Receipt of supplemented application for the:...time

...

...

...

Signature

Receipt of supplemented application for the:...time

 date (dd/mm/yyyy)……

Signature

...

...

...

Recipient of the application

(Signature, title and full name)

_______________

Name of the agency issuing the certificate of biosafety.

Abbreviated name of the agency issuing the certificate of biosafety.

Place name

Detailed address of the testing facility

...

...

...

 Granting testing facilities renewal of the certificate of biosafety level III and IV under the power of the Ministry of Health

Implementing sequence

Step 1. The testing facility applying for the certificate of conformance to biosafety requirements (hereinafter referred to as applicant) sends their documents to the Ministry of Health (Department of Preventive Medicine)

After receiving valid application for certificates renewal, reissue, the authority hands out the receipt of application documents by completing the Form No. 06 in the Appendix to the Decree No. 103/2016/ND-CP dated July 1, 2016

Step 3. Within 10 (ten) days of receipt of the application, the competent authority completes the verification of the submitted documents and also checks the previous verification of the previous application for the certificate of conformance to biosafety standards.

Step 4. In case the application is not complete, within 05 (five) working days from the date the documents are verified, the competent authority informs the applicant in writing to facilities requesting certificates to submit a complete application.  The applicant needs to supplement and amend their application as informed and send the amended and supplemented application back to the competent authority.

Where necessary, within 10 (ten) days from the date the documents are verified, the competent authority pays an inspection visit to the testing facility’s workplace.

In case the application is sufficient and there is no inspection visit to the applicant’s workplace, the competent authority reissues the Certificate of biosafety according to the Form No. 07 in the Appendix to the Decree No. 103/2016/ND-CP dated July 1, 2016 within 10 (ten) days since the date the application is verified.

...

...

...

Apply by post or directly

Components and quantity of application documents

I. Components of application documents:

-  Application form for issue of certificate of biosafety according to the Form No. 05 in the Appendix to the Decree No. 103/2016/ND-CP dated July 1, 2016.

- Copies of the issued certificate of biosafety;

- Reports on changes of relevant personnel (if any) along with the List of personnel according to the Form No. 03 in the Appendix to the Decree No. 103/2016/ND-CP dated July 1, 2016 and personal profile of each staff member, including: authenticated copies of recruitment decision or Labor contract and diplomas, degrees and certificates of employees working at the testing facility.

- Reports on changes of relevant equipment: clearly state names of equipment, quantity and condition of supplemented or replaced equipment as prescribed in the Form No. 04 in the Appendix to this Decree No. 103/2016/ND-CP dated July 1, 2016

...

...

...

- Reports on biosafety emergencies occurred in the past (if any) The content of reports must state clearly the time of emergencies, emergency levels and biosafety emergency response and mitigation methods.

II. Quantity of application: 01 set.

Processing duration

10 working days of receipt of the complete and valid application

 Subjects of the administrative procedures

State or privately-owned testing facilities

 Implementing authorities

...

...

...

Department of Preventive Medicine

 Results obtained from implementation of this administrative procedure

Certificates of testing facilities for qualifying the biosafety standards level III, IV

Fee

NA

Type of form, declaration (attached right after this procedure)

...

...

...

2. Form No.2: List of laboratory personnel.

3. Form No.3: Inventory of laboratory equipment.

 Requirements of administrative procedures

Article 7. Requirements for conformance of a testing facility to biosafety level III

 The testing areas must meet following conditions:

1. Infrastructure requirements:

a) There are laboratory rooms and buffer rooms;

b) Conditions regulated in point a, point b, and point d clause 1 of Article 6 of Decree No. 103/2016/ND-CP are met;

...

...

...

dd) The testing laboratory must be airtight to ensure the sterilization;

dd) Doors and windows must be made from fireproof and load-bearing materials;

e) Door systems of testing areas must ensure that, in normal conditions, doors of buffer rooms or of testing areas can only be open one at a time;

g) Testing rooms have transparent glass walls or surveillance equipment from outside observing the inside of testing areas;

h) The air system must be designed according to the one-way flow principle; the air coming out of the testing area must pass through a high-performance air filter;

i) There is an alarm system that rings when the pressure inside testing areas does not meet the standards; the pressure of testing areas is always lower than the pressure outside under normal working conditions;

k) The frequency of air exchange of the testing areas should be at least 6 times/hour;

l) The air supply system only works when the air exhaust system already operates; and it automatically stops when the exhaust system is stopped;

m) There is shower and wash equipment in case of emergency occurring at testing areas;

...

...

...

2. Equipment requirements:

a) Laboratory equipment are subject to requirements set forth in point a and point b, clause 2 of Article 5 of Decree No. 103/2016/ND-CP;

b) There are level-II or higher-level biosafety cabinets;

c) There is infectious medical waste sterilization equipment or disinfectants placed in the testing areas;

d) There is personal protective equipment suitable for testing techniques implemented at the testing area satisfying biosafety level III.

3.  Personnel requirements:

a) Quantity of employees: there must be at least 02 laboratory technicians and 01 laboratory equipment engineers. Laboratory technicians must hold educational degrees or certificates in the testing technique that they are assigned to implement; laboratory equipment engineers must hold educational certificates in operation of the testing areas;

b) Laboratory personnel must be subject to requirements set forth in point b clause 3, Article 5 of this Decree;

c) Laboratory technicians, equipment operation engineers and biosafety personnel must be trained in level-III and higher-level biosafety.

...

...

...

a) Laboratory practice regulations must be subject to clause 4, Article 6 of the Decree No.103/2016/ND-CP;

b) There must be an antiseptic process for materials, tools, equipment and infectious substances before being carried out of the testing areas;

c) There is an antiseptic process enforced at the testing areas;

d) There is an emergency response process in effect at the testing areas;

dd) Biosafety emergency preparedness and response plan is available.

Article 8. Requirements for conformance of a testing facility to biosafety level IV

1.  Infrastructure requirements:

a) Infrastructure must be subject to requirements laid down in point a, b, d, dd, e, g and h, clause 1 Article 7 of this Decree;

b) There are changing rooms between buffer rooms and testing areas;

...

...

...

d) There is an independent air supply for protective clothes that can ensure 100% of air supply in case of biosafety emergencies;

dd) Separation, safety and security for such infrastructure are ensured;

e) There must be transport boxes to carry the infectious materials in and out of the testing areas;

g) Air coming in and out of the testing areas must flow through high-performance air filters.

2. Equipment requirements:

a) Laboratory equipment must be subject to requirements set out in point a, point b clause 2 Article 5 of the Decree No.103/2016/ND-CP;

b) There are level-III or higher-level biosafety cabinets;

c) There are double-door circular autoclaves;

d) There is personal protective equipment suitable for testing techniques implemented at the testing facility satisfying biosafety level IV.

...

...

...

a) Laboratory personnel must be subject to requirements set out in point a and point b clause 3 of Article 7 of this Decree;

b) Laboratory technicians, laboratory equipment engineers and biosafety personnel must be trained in biosafety level IV.

4.  Requirements concerning laboratory practice regulations:

a) Laboratory practice regulations must be subject to clause 4, Article 7 of this Decree;

b) There is the process of moving materials and instruments in and out of the testing areas by means of transport boxes or double-door circular autoclaves;

c) There is the process of protection of testing areas;

 Legal bases for this administrative procedure

1. Law No. 03/2007/QH12 dated November 21, 2007 on prevention and control of contagious diseases.

...

...

...

3. Decree No. 103/2016/ND-CP dated July 1, 2016 providing for biosafety in testing laboratories.

4. Circular No. 03/2013/TT-BTC of January 8, 2013, prescribing the fee for assessment of conditional commercial business; the fee for assessment of conformity with medical and pharmaceutical practicing standards; the fee for grant of license to import and export medical equipment and pharmaceutical products; the fee for eligibility for medical practicing certificate; the fee for granting license to healthcare establishments. Effective date is on March 1, 2013

SPECIMEN OF THE APPLICATION FOR THE CERTIFICATE OF CONFORMANCE TO BIOSAFETY STANDARDS

….……..^[1]…………

SOCIAL REPUBLIC OF VIETNAM
Independence – Freedom - Happiness
---------------

No.:         /     

……^[2]…..,,date (dd/mm/yyyy)...

...

...

...

To: ...............................^[3].......................

 Name of the testing facility: .......................................................................................

Testing laboratory: .......................................................................................

Address: .............................................................^[4].......................................................

Telephone: ...................................................... Email (if any): .....................................

 Pursuant to the Decree No.103/2016/TT-BYT dated July 1, 2016 regulating biosafety in laboratories.  After satisfying requirements concerning infrastructure, equipment, human resources, and regulations on practices of documents involved in the application for the biosafety certificate level...^[5…

 We would like the designated certification agency to verify and process our application, and issue the certificate of biosafety level...^[6]…(please see attached documents)<

We undertake to observe all regulations on laboratory biosafety and shall be held legally liable for our operation.

...

...

...

 Testing facility’s head
(Signature and seal)

_______________

 ¹ Testing facility’s name

² Place name

³ Name of the agency issuing the certificate of biosafety;

⁴ Detailed address of the testing facility

^{5 6} Specify the level of biosafety on demand

 LIST OF LABORATORY PERSONNEL

...

...

...

Full name

Title

Specialization

 Assigned task

1

...

...

...

3

...

...

...

…

...

...

...

TESTING FACILITY’S REPRESENTATIVE
(Signature and seal)

 INVENTORY OF LABORATORY EQUIPMENT

No.

Equipment description

 Model of device

Manufacturer

 Made in

...

...

...

Condition

Maintenance/calibration

Note

1

...

...

...

2

...

...

...

3

...

...

...

…

...

...

...

 TESTING FACILITY’S REPRESENTATIVE
(Signature and seal)

..........⁵...........
---------

SOCIAL REPUBLIC OF VIETNAM
Independence – Freedom - Happiness
---------------

No.:        /PTN-.....⁶....

....... ⁷......, date (dd/mm/yyyy)......

 APPLICATION ACKNOWLEDGEMENT

...

...

...

Name of the receiving unit: ................................................................................................

Address: ⁸............................................................................................................................

Telephone: .......................................................................................................

Certification type: Issue □                           Reissue □

Has received the application for issuing or re-issuing the certificate of biosafety, including the following documents:

1.

Application for issue, renewal or reissue of certificates

□

2.

...

...

...

□

3.

List of laboratory personnel.

□

4.

Inventory of laboratory equipment.

□

5.

Floor plan of the testing facility

...

...

...

6.

Documents evidencing establishment and operation of facility of the testing facility.

□

7.

Diagram of the wastewater treatment system

□

8.

 Wastewater test results

□

...

...

...

Description of quality specifications of materials employed in each design of door and window

□

10.

Description of quality specifications of materials employed in each design of equipment used in the power and water system.

□

11.

The design of the system of chemical treatment of liquid wastes and the test result that meets national technical environmental standards

□

12.

...

...

...

□

13.

Report on changes (in case of reissue)

□

Receipt of supplemented application for the:...time

date (dd/mm/yyyy)……

Signature

Receipt of supplemented application for the:...time

...

...

...

Signature

Receipt of supplemented application for the:...time

 date (dd/mm/yyyy)……

Signature

...

...

...

Recipient of the application

(Signature, title and full name)

_______________

⁵ Name of the agency issuing the certificate of biosafety.

⁶ Abbreviated name of the agency issuing the certificate of biosafety.

⁷ Place name

⁸ Detailed address of the testing facility

...

...

...

Granting testing facilities replacement of the certificate of biosafety level III, IV which has been damaged or lost under the power of the Ministry of Health

Implementing sequences

Step 1. The testing facility applying for the certificate of conformance to biosafety requirements (hereinafter referred to as applicant) sends their documents to the Ministry of Health (Department of Preventive Medicine)

Step 2. After receiving valid application for certificates renewal, reissue, the authority hands out the receipt of application documents by completing the Form No. 06 in the Appendix to the Decree No. 103/2016/ND-CP dated July 1, 2016.

Step 3. Within 10 days from the date of receipt of the application, the competent authority issues the certificate.

Implementing methods

Apply by post or directly

...

...

...

I. Components of application documents:

-  Application form for issue of certificate of biosafety according to the Form No. 05 in the Appendix to the Decree No. 103/2016/ND-CP dated July 1, 2016.

II. Quantity of application: 01 set.

 Processing duration

10 working days of receipt of the complete full and valid application

Subjects of the administrative procedures

...

...

...

Implementing authorities

Department of Preventive Medicine

Results obtained from implementation of this administrative procedure

Certificates of testing facilities for qualifying the biosafety standards level III, IV

Fee

NA

...

...

...

Form No.1: The application form for the certificate of conformance to biosafety standards

Requirements of administrative procedures

NA

Legal bases for this administrative procedure

1. Law No. 03/2007/QH12 dated November 21, 2007 on prevention and control of contagious diseases.

2.  Investment Law No.67/2014/QH13 dated November 26, 2014.

...

...

...

4. Circular No. 03/2013/TT-BTC of January 8, 2013, prescribing the fee for assessment of conditional commercial business; the fee for assessment of conformity with medical and pharmaceutical practicing standards; the fee for grant of license to import and export medical equipment and pharmaceutical products; the fee for eligibility for medical practicing certificate; the fee for granting license to healthcare establishments. Effective date is on March 1, 2013

 SPECIMEN OF THE APPLICATION FOR THE CERTIFICATE OF CONFORMANCE TO BIOSAFETY STANDARDS

….……..^[1]…………

SOCIAL REPUBLIC OF VIETNAM
Independence – Freedom - Happiness
---------------

No.: :         /     

………^[2]…..,,date (dd/mm/yyyy)...

APPLICATION

...

...

...

To: ...............................^[3].......................

Name of testing facility: ...................................................................................

Address: .................................................................^[4]...........................................................

Telephone: ...................................................... Email (if any): .............................................

Certificate of biosafety No.: Date of issue: …………………………..…

Pursuant to the Decree No. 103/2016/TT-BYT dated July 1, 2016 providing for biosafety in testing laboratories.

Requests reissue of the certificate of biosafety due to:

Expiration:                                                                                            □

Damage:                                                                                              □

...

...

...

Change of name:                                                                                   □

We would like the designated certification agency to verify and process our application, and issue the certificate of biosafety level...^[6]…(please see attached documents)

 We undertake to observe all regulations on laboratory biosafety and shall be held legally liable for our operation.

 TESTING FACILITY’S HEAD
(Signature and seal)

_______________

 ¹ Testing facility’s name

² Place name

...

...

...

⁴ Detailed address of testing facility

^{5 6} Specify the level of biosafety on demand

..........⁹...........
---------

No.:     /PTN-.....¹⁰....

....... ¹¹......, date (dd/mm/yyyy)......

APPLICATION ACKNOWLEDGEMENT

...

...

...

Name of the receiving unit: .................................................................................................

Address: ⁸.............................................................................................................................

Telephone: .......................................................................................................

Certification type: Issue □                           Reissue □

Has received the application for issue or re-issue of the certificate of biosafety, including the following documents:

1.

Application for issue, renewal or reissue of certificates

□

2.

...

...

...

□

3.

List of laboratory personnel.

□

4.

Inventory of laboratory equipment.

□

5.

Floor plan of the testing facility

...

...

...

6.

Documents evidencing establishment and operation of facility of the testing facility.

□

7.

Diagram of the wastewater treatment system

□

8.

 Wastewater test results

□

...

...

...

Description of quality specifications of materials employed in each design of door and window

□

10.

Description of quality specifications of materials employed in each design of equipment used in the power and water system.

□

11.

The design of the system of chemical treatment of liquid wastes and the test result that meets national technical environmental standards

□

12.

...

...

...

□

13.

Report on changes (in case of reissue)

□

Receipt of supplemented application for the:...time

date (dd/mm/yyyy)……

Signature

Receipt of supplemented application for the:...time

...

...

...

Signature

Receipt of supplemented application for the:...time

 date (dd/mm/yyyy)……

Signature

...

...

...

Recipient of the application

(Sign, state the title and full name)

_______________

⁹ Name of the agency issuing the certificate of biosafety.

 Place name

¹² Detailed address of the testing facility

4- Procedures

...

...

...

Implementing sequence

Step 1. The testing facility applying for the certificate of conformance to biosafety requirements (hereinafter referred to as applicant) sends their documents to the Ministry of Health (Department of Preventive Medicine)

Step 2. After receiving valid application for certificates renewal, reissue, the authority hands out the receipt of application documents by completing the Form No. 06 in the Appendix to the Decree No. 103/2016/ND-CP dated July 1, 2016

Step 3. Within 10 (ten) days of receipt of the application, the competent authority completes the verification of the submitted documents and also checks the previous verification of the previous application for the certificate of conformance to biosafety standards.

Step 4. In case the application is not complete, within 05 (five) working days from the date the documents are verified, the competent authority informs the applicant in writing to facilities requesting certificates to submit a complete application. The applicant needs to supplement and amend their application as informed and send the amended and supplemented application back to the competent authority.

Where necessary, within 10 (ten) days from the date the documents are verified, the competent authority pays an inspection visit to the testing facility’s workplace.

In case the application is sufficient and there is no inspection visit to the applicant’s workplace, the competent authority reissues the Certificate of biosafety according to the Form No. 07 in the Appendix to the Decree No. 103/2016/ND-CP dated July 1, 2016 within 10 (ten) days since the date the application is verified.

Implementing methods

...

...

...

Apply by post or directly

Components and quantity of application documents

I. Components of application documents:

-  Application form for issue of certificate of biosafety according to the Form No. 05 in the Appendix to the Decree No. 103/2016/ND-CP dated July 1, 2016

- Issued certificate of biosafety qualification;

- Documents proving the change of name of the testing facility: Authenticated copies of decision of establishment of state medicine facility or authenticated copies of business license of privately-owned medical facility or the Investment certificate of medical facility with foreign investment capital.

II. Quantity of application: 01 set.

Processing duration

...

...

...

10 working days of receipt of the complete and valid application

Subjects of the administrative procedures

State or privately-owned testing facilities

Implementing authorities

Department of Preventive Medicine or agencies authorized by the Ministry of Health

Results obtained from implementation of this administrative procedure

...

...

...

Fee

NA

Name of application and declaration form (attached thereto)

Form No.1: The application form for the certificate of conformance to biosafety standards.

Requirements of administrative procedures

NA

...

...

...

1. Law No. 03/2007/QH12 dated November 21, 2007 on prevention of contagious diseases.

2.  Investment Law No.67/2014/QH13 dated November 26, 2014.

3. Decree No. 103/2016/ND-CP dated July 1, 2016 providing for biosafety in testing laboratories.

4. Circular No. 03/2013/TT-BTC of January 8, 2013, prescribing the fee for assessment of conditional commercial business; the fee for assessment of conformity with medical and pharmaceutical practicing standards; the fee for grant of license to import and export medical equipment and pharmaceutical products; the fee for eligibility for medical practicing certificate; the fee for granting license to healthcare establishments. Effective date is on March 1, 2013

SPECIMEN OF THE APPLICATION FOR THE CERTIFICATE OF CONFORMANCE TO BIOSAFETY STANDARDS

….……..^[1]…………

...

...

...

……^[2]…,date (dd/mm/yyyy)...

APPLICATION  FOR BIOSAFETY CERTIFICATE

To: ...............................^[3].......................

Name of the testing facility: .........................................................................................

Address: .................................................................^[4]............................................................

Telephone: ...................................................... Email (if any): ..............................................

Certificate of biosafety No.: …………………………..… Date of issue: ……………

Pursuant to the Decree No. 103/2016/TT-BYT dated July 1, 2016 providing for biosafety in testing laboratories.

...

...

...

Expiration:                                                                                                □

Damage:                                                                                             □

Loss:                                                                                                    □

Change of name:                                                                                  □

 We would like the designated certification agency to verify and process our application, and issue the certificate of biosafety level...^[6]…(please see attached documents)

 We undertake to observe all regulations on laboratory biosafety and shall be held legally liable for our operation.

 TESTING FACILITY’S HEAD
(Signature and seal)

...

...

...

 ¹ Testing facility’s name

² Place name

³ Name of the agency issuing the certificate of biosafety;

⁴ Detailed address of the testing facility

⁵ Specify the level of biosafety on demand

..........¹³...........
---------

SOCIAL REPUBLIC OF VIETNAM
Independence – Freedom - Happiness

No.:     /PTN-......

...

...

...

APPLICATION ACKNOWLEDGEMENT

Application for issue or re-issue of the certificate of biosafety;

Name of the receiving unit: .................................................................................................

Address: ⁸.............................................................................................................................

Telephone: .......................................................................................................

Certification type: Issue □                           Reissue □

Has received the application for issue or re-issue of the certificate of biosafety, including the following documents:

1.

...

...

...

□

2.

Authenticated copies of educational degrees or certificates

□

3.

List of laboratory personnel.

□

4.

Inventory of laboratory equipment.

...

...

...

5.

Floor plan of the testing facility

□

6.

Documents evidencing establishment and operation of facility of the testing facility.

□

7.

Diagram of the wastewater treatment system

□

...

...

...

 Wastewater test results

□

9.

Description of quality specifications of materials employed in each design of door and window

□

10.

Description of quality specifications of materials employed in each design of equipment used in the power and water system.

□

11.

...

...

...

□

12.

The design and description of quality specifications of materials employed in each design of equipment in the air ventilation system

□

13.

Report on changes (in case of reissue)

□

Receipt of supplemented application for the:...time

...

...

...

Signature

Receipt of supplemented application for the:...time

date (dd/mm/yyyy)……

Signature

Receipt of supplemented application for the:...time

date (dd/mm/yyyy)……

Signature

...

...

...

Recipient of the application

(Signature, title and full name)

_______________

¹³ Name of the agency issuing the certificate of biosafety.

¹⁴ Abbreviated name of the agency issuing the certificate of biosafety.

...

...

...

¹⁶ Detailed address of the testing facility