Decree No. 80/2022/ND-CP amends and supplements some articles of Decree No. 35/2016/ND-CP dated May 15, 2016, of the Government detailing certain provisions of the Law on Animal Health.

DECREE

Amending and supplementing certain Articles of Decree No. 35/2016/NĐ-CP dated May 15, 2016 of the Government detailing certain provisions of the Law on Animal Health
The Government promulgates this Decree amending and supplementing certain Articles of Decree No. 35/2016/NĐ-CP dated May 15, 2016 of the Government detailing certain provisions of the Law on Animal Health.
detailing certain Articles of the Animal Health Law

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Pursuant to the Law on Organization of the Government dated June 19, 2015; the Law Amending and Supplementing Certain Provisions of the Law on Organization of the Government and the Law on Organization of Local Administration dated November 22, 2019;

Pursuant to the Law on Veterinary Medicine dated June 19, 2015;

At the proposal of the Minister of Agriculture and Rural Development;

The Government issues a Decree amending and supplementing certain Clauses of Decree No. 35/2016/NĐ-CP dated May 15, 2016, detailing certain Articles of the Animal Health Law.

Article 1. Amending and supplementing certain Articles of Decree No. 35/2016/NĐ-CP dated May 15, 2016 of the Government detailing certain provisions of the Law on Animal Health

1. Amending and supplementing Point a Clause 2 Article 14 as follows:

"a) Organizations and individuals submit one set of registration dossier for the issuance of the Good Manufacturing Practice (GMP) Certificate to the Department of Animal Health via one of the following methods: online, through postal service, or in person. Within ten days from the date of receiving the registration dossier, the Department of Animal Health shall review the dossier or issue a document requesting amendments or supplements if the dossier does not meet the requirements;"

2. Amending and supplementing Clause 1 of Article 15 as follows:

"1. Organizations and individuals submit one set of registration dossier for extending the validity period of the GMP Certificate to the Department of Animal Health via one of the following methods: online, through postal service, or in person. The dossier includes the original copies of the following documents:

a) Application for re-inspection of GMP;

b) Report on activities and changes at the facility over the past five years implementing GMP; information on measures taken by the facility to protect the environment in accordance with the law;

c) Report on rectifying deficiencies identified during the previous inspection;

d) Report on training and education conducted by the facility;

đ) List of existing equipment at the facility;

e) List of products currently being manufactured;

g) List of standard operating procedures;

h) Minutes of self-inspection and evaluation conducted by the facility in the most recent self-inspection period (within three months) regarding the implementation of GMP."

3. Amending and supplementing Clause 1 of Article 16 as follows:

"1. Dossier, procedure, and process for issuing a new GMP Certificate in cases of loss, error, damage; or change of information related to the registering organization:

a) Organizations and individuals submit one set of application dossier for a new GMP Certificate to the Department of Animal Health via one of the following methods: online, through postal service, or in person. The dossier includes: the original copy of the application for a new certificate and the original or certified true copy or stamped copy of the enterprise's documents: documents proving the content of the change in case of change of information related to the registering organization; the previously issued GMP Certificate, except in cases of loss;

b) In cases where the dossier is incomplete or invalid, within three working days from the date of receipt of the dossier, the Department of Animal Health shall issue a document guiding organizations and individuals to complete the dossier;

c) Within five working days from the date of receipt of a valid dossier, the Department of Animal Health shall issue a new GMP Certificate or issue a document explaining the reasons for non-issuance."

Article 2. Abolishing and changing certain Points and Clauses of Decree No. 35/2016/NĐ-CP dated May 15, 2016 of the Government detailing certain provisions of the Law on Animal Health

1. Abolishing Point b and Point k of Clause 1 of Article 14.

2. Replacing the phrase "The registration dossier for GMP inspection must have a cover page and table of contents, arranged in the correct sequence according to the table of contents, with clear separation between sections" with the phrase "The dossier includes the original copies of the documents specified in Points a, c, d, đ, e, g, and i of Clause 1 of this Article; the original or certified true copy or stamped copy of the enterprise's documents specified in Point h of Clause 1 of this Article. The registration dossier for GMP inspection must have a cover page and table of contents, arranged in the correct sequence according to the table of contents, with clear separation between sections" in Clause 1 of Article 14.

Article 3. Effectiveness

This Decree takes effect from the date of issuance.

Article 4. Transitional Provisions

For dossiers received before the effective date of this Decree, they shall be processed in accordance with the provisions of Decree No. 35/2016/NĐ-CP dated May 15, 2016 of the Government detailing certain provisions of the Law on Animal Health.

Article 5. Responsibilities for Implementation

Ministers, Heads of ministerial-level agencies, Heads of agencies under the Government, Chairpersons of provincial People's Committees directly under the central government, organizations, and individuals concerned are responsible for implementing this Decree.