Decree 80/2022/ND-CP amending Decree 35/2016/ND-CP detailing Law on Animal Health

DECREE

Amending and supplementing a number of articles of the Government’s Decree No. 35/2016/ND-CP of May 15, 2016, detailing a number of articles of the Law on Animal Health^[1]

Pursuant to the June 19, 2015 Law on Organization of the Government; and the November 22, 2019 Law Amending and Supplementing a Number of Articles of the Law on Organization of the Government and the Law on Organization of Local Administration;

Pursuant to the June 19, 2015 Law on Animal Health;

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

The Government promulgates the Decree amending and supplementing a number of articles of the Government’s Decree No. 35/2016/ND-CP of May 15, 2016, detailing a number of articles of the Law on Animal Health.

Article 1. To amend and supplement a number of articles of the Government’s Decree No. 35/2016/ND-CP of May 15, 2016, detailing a number of articles of the Law on Animal Health

1. To amend and supplement Point a, Clause 2, Article 14 as follows:

“a/ An organization or individual shall send 1 (one) set of dossier of application for a GMP certificate online or by post or hand-deliver it to the Department of Animal Health. Within 10 days after receiving a dossier, the Department of Animal Health shall appraise it or request in writing the applicant to modify and supplement the dossier if it is unsatisfactory;”

2. To amend and supplement Clause 1, Article 15 as follows:

“1. An organization or individual shall send 1 (one) set of dossier of request for extension of a GMP certificate online or by post or hand-deliver it to the Department of Animal Health. A dossier must comprise the originals of the following documents:

a/ A request for GMP re-inspection;

b/ A report on operation and changes of the establishment in the last 5 years of GMP application; description of environmental protection measures taken by the establishment;

c/ A report on remediation of problems detected during the previous inspection;

d/ A report on coaching and training activities carried out by the establishment;

dd/ A list of existing equipment of the establishment;

e/ A list of commodities currently manufactured by the establishment;

g/ A list of standard operation processes;

h/ A written record of self-inspection and assessment by the establishment in the latest inspection (within the last 3 months) of GMP application.”

3. To amend and supplement Clause 1, Article 16 as follows:

“1. Dossier, order and procedures for re-grant of a GMP certificate in case it is lost, erroneous or damaged or there is a change in information about the registering organization:

a/ An organization or individual shall send 1 (one) set of dossier of request for re-grant of a GMP certificate online or by post or hand-deliver it to the Department of Animal Health. A dossier must comprise the original request for certificate re-grant; and the original or a certified copy or a copy bearing the enterprise’s certification seal of the following documents: document proving the changed information in case of a change in information about the registering organization; and the granted GMP certificate, unless it is lost;

b/ In case a dossier is incomplete or invalid, within 3 working days after receiving the dossier, the Department of Animal Health shall provide the organization or individual with written guidance for completing the dossier;

c/ Within 5 working days after receiving a complete and valid dossier, the Department of Animal Health shall re-grant the certificate, or reply in writing clearly stating the reason in case of refusal to re-grant the certificate.

Article 2. To annul or replace a number of points and clauses of the Government’s Decree No. 35/2016/ND-CP of May 15, 2016, detailing a number of articles of the Law on Animal Health

1. To annul Points b and k, Clause 1, Article 14.

2. To replace the phrase “A dossier of registration for GMP inspection must have cover pages and a table of contents, be arranged according to the sequence stated in the table of contents, and have a blank page between two adjoining sections” in Clause 1, Article 14 with the phrase “A dossier must comprise the original documents specified at Points a, c, d, dd, e, g and i, Clause 1 of this Article; the original or a certified copy or a copy bearing the enterprise’s certification seal of the document specified at Point h, Clause 1 of this Article. A dossier of registration for GMP inspection must have cover pages and a table of contents, be arranged according to the sequence stated in the table of contents, and have a blank page between two adjoining sections.”

Article 3. Effect

This Decree takes effect on the date of its signing. 

Article 4. Transitional provision

The dossiers received before the effective date of this Decree shall be processed in accordance with the Government’s Decree No. 35/2016/ND-CP of May 15, 2016, detailing a number of articles of the Law on Animal Health.

Article 5. Implementation responsibility

Ministers, heads of ministerial-level agencies, heads of government-attached agencies, chairpersons of provincial-level People’s Committees, and related organizations and individuals shall implement this Decree.-

On behalf of the Government
For the Prime Minister
Deputy Prime Minister
LE VAN THANH