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GOVERNMENT OF VIETNAM
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
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No. 80/2022/ND-CP
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Hanoi, October 13, 2022
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DECREE
Amendments to certain
articles of Decree No. 35/2016/ND-CP dated May 15, 2016 of the Government of
Vietnam elaborating certain Articles of the Law on Veterinary medicine
Pursuant to the
Law on Governmental Organization dated June 19, 2015; Law on amendments to the
Law on Governmental Organization and the Law on Local Government Organization
dated November 22, 2019;
Pursuant to the
Law on Veterinary Medicine dated June 19, 2015;
At the request of
the Minister of Agriculture and Rural Development;
The Government of
Vietnam promulgates a Decree on amendments to certain Articles of Decree No.
35/2016/ND-CP dated May 15, 2016 of the Government of Vietnam elaborating
certain Articles of the Law on Veterinary Medicine.
Article 1.
Amendments to certain Articles of Decree No. 35/2016/ND-CP dated May 15, 2016
of the Government of Vietnam elaborating certain Articles of the Law on
Veterinary Medicine
1.
Amendments to Point a Clause 2 Article
14:
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2.
Amendments to Clause 1 Article 15:
“1. Entities shall
send 01 application for GMP Certificate renewal to the Department of Animal
Health via online media, by post or in person. The application includes the
original copies of the following documents:
a) An application
form for GMP re-inspection;
b) A report on
operations and changes of the facility in 05-year application of GMP;
Description of information on the facility that has prepared environmental
protection measures as prescribed by laws;
c) A report on
remedies for shortcomings in the previous inspection;
d) A report on
trainings of the facility;
dd) A list of
available equipment of the facility;
e) A list of
products being manufactured;
g) A list of
standard operating procedures;
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3.
Amendments to Clause 1 Article 16:
“1. Application and
procedures for GMP certificate renewal in case of loss, damage or wrong
information; changes in information related to the applicant:
“a) The entity shall
send 01 application for GMP Certificate renewal to the Department of Animal
Health via online media, by post or in person. The application includes an
original copy of the application form for renewal and original copy or a
certified true copy or a copy bearing a certification seal of the facility of
the documentary evidence of changes in information related to the applicant or
the issued GMP Certificate, except for Certificate lost;
b) Within 03 working
days after receiving the application, the Department of Animal Health shall
send a written instruction for completing the inadequate application to the
entity (if any);
c) Within 05 working
days after receiving the adequate application, the Department of Animal Health
shall renew the GMP Certificate or send a written reply with clear explanation
in case of rejection."
Article 2.
Annulments and changes of certain points and clauses of Decree No.
35/2016/ND-CP dated May 15, 2016 of the Government of Vietnam elaborating
certain Articles of the Law on Veterinary Medicine
1. Annulment of
points b and k clause 1 Article 14.
2. Replacement of
the phrase “Hồ sơ đăng ký kiểm tra GMP phải có trang bìa và mục lục, được sắp
xếp theo đúng trình tự của mục lục, có phân cách giữa các phần” (“the
application for GMP inspection must include a cover page and a table of
contents, arranged in the correct order of the table of contents, with a
separation between sections”) to the phrase “Hồ sơ gồm bản chính tài liệu quy
định tại các điểm a, c, d, đ, e, g và i khoản 1 Điều này; bản chính hoặc bản
sao có chứng thực hoặc bản sao có đóng dấu xác nhận của Doanh nghiệp tài liệu
quy định tại điểm h khoản 1 Điều này. Hồ sơ đăng ký kiểm tra GMP phải có
trang bìa và mục lục, được sắp xếp theo đúng trình tự của mục lục, có phân cách
giữa các phần” (“An application consists of an original copy specified at
Points a, c, d, dd, e, g and i, Clause 1 of this Article; an original or a
certified true copy or a copy bearing a certification seal of the facility of
the documents specified at Point h, Clause 1 of this Article. The application
for GMP inspection must have a cover page and a table of contents, arranged in
the order of the table of contents, with a separation between sections” in
clause 1 of Article 14.
Article 3. Entry
into force
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Article 4.
Transitional regulations
Applications
received before the date on which this Decree takes effect shall comply with
regulations in Decree No. 35/2016/NĐ-CP dated May 15, 2016 of the Government
elaborating certain Articles of the Law on Veterinary Medicine.
Article 5.
Responsibility for implementation
Ministers, Heads of
ministerial agencies, Heads of Governmental agencies, Presidents of the
People's Committees of provinces and central-affiliated cities, relevant
organizations and individuals are responsible for implementation of this
Decree.
ON BEHALF OF. GOVERNMENT OF VIETNAM
PP. PRIME MISNISTER
DEPUTY PRIME MINISTER
Le Van Thanh