What are the procedures for GMP Certificate renewal in Vietnam? When is GMP certificate revoked?
What are the procedures for issuance of GMP Certificates in Vietnam?
Pursuant to the provisions of Clause 1, Article 3 of Decree No. 35/2016/ND-CP defining Good Manufacturing Practice as follows:
Interpretation of terms
For the purposes of this Decree, these terms below shall be construed as follows:
1. Good Manufacturing Practice (GMP) means rules, regulations and guidelines on requirements for drug manufacturing to assure that the drug products meets quality standards.
The procedures for issuance of GMP Certificates in Vietnam are specified in Article 14 of Decree No. 35/2016/ND-CP (amended by Clause 1, Article 1 and Article 2 of Decree No. 80/2022/ND-CP) as follows:
Procedures for issuance of GMP Certificates for veterinary drugs
1. An application for issuance of a GMP Certificate for veterinary drugs (hereinafter referred to as GMP Certificate), including:
a) An application form for GMP inspection;
c) A chart of organization and personnel of the manufacturer;
d) Programs, training materials and evaluation of training results pertaining to GMP at the manufacturer;
dd) A list of manufacturing, storing and quality-inspecting equipment;
e) A list of standard operating procedures;
g) A list of products being manufactured or to be manufactured;
h) A report on environmental impact assessment approved by an environment authority;
i) A minutes of GMP self-inspection;
Each application for GMP inspection must have covers and index; its content must be sorted according to the order of the index with separation between parts.
2. Time limit for inspection:
a) Entities shall send 01 application for issuance of GMP Certificates to the Department of Animal Health via online media, by post or in person. Within 10 working days after receiving the application, the Department of Animal Health shall process it or send a written request for adjustment if the application does not meet the requirements;
b) Within 30 days from the day on which a satisfactory application is received, Department of Animal Health shall establish a GMP Inspectorate, and inform the inspection schedule for the manufacturer and undertake an inspection visit;
c) Within 10 days from the end date of the inspection, Department of Animal Health shall issue a GMP Certificate to a satisfactory manufacturer or provide explanation in writing to an unsatisfactory manufacturer.
3. The process of inspection:
a) Upon a GMP inspection visit, the manufacturer must provide diagrams, charts and brief data on its operation and the application works of GMP;
b) When a GMP inspection is performed, the entire operation in the manufacturer must being carried out;
c) The GMP Inspectorate shall inspect whether the entire operation of the manufacturer of veterinary drugs conforms to GMP, its registration dossiers and applicable specialized regulations.
4. Handling inspection results:
a) According to an inspection record, the Chief inspector shall request the Director of Department of Animal Health to issue a GMP Certificate of eligibility for GMP requirements;
b) Regarding a manufacturer satisfying GMP requirements along with some shortcomings which are remediable in a short time, the Inspectorate shall request it to remedy those shortcomings. Within 2 months from the date of inspection, such manufacturer shall remedy the shortcomings and send a written report to the Department of Animal Health. The Chief inspector shall consider requesting the Director of Department of Animal Health to issue a GMP Certificate to the satisfactory manufacturer;
c) Regarding to a manufacturer failing to satisfy GMP requirements, it must remedy its shortcomings. The manufacturer shall, upon the self-inspection revealing the satisfaction of GMP requirements, re-file an application for registration as prescribed.
5. The validity period of a GMP Certificate is 5 years. At least 3 months prior to the expiry date of a GMP Certificate, the holder wishing to continue its manufacturing of veterinary drugs shall apply for Certificate renewal. Any manufacturer holding a GMP Certificate is not required to apply for a Certificate of eligibility for manufacturing of veterinary drugs.
Thus, the procedures for issuance of GMP Certificates for veterinary drugs include the following steps: Preparation of application; Receipt and evaluation of application; Inspection; Handling inspection results.
What are the procedures for GMP Certificate renewal in Vietnam? When is GMP certificate revoked? (Image from the Internet)
What are the procedures for GMP Certificate renewal in Vietnam?
The procedures for GMP Certificate renewal are specified in Article 15 of Decree No. 35/2016/ND-CP (amended by Clause 2, Article 1 of Decree No. 80/2022/ND-CP) as follows:
Procedures for GMP Certificate renewal
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;
h) The latest minutes of self-inspection and evaluation of the facility (within 3 months) in terms of GMP application.
2. Time limit for processing, process of inspection, handling of inspection results and validity of GMP Certificates shall comply with Clause 2, Clause 3, Clause 4 and Clause 5 Article 14 of this Decree.
Thus, compared with the old regulations on the procedures for renewal of GMP Certificate for veterinary drugs in Decree No. 35/2016/ND-CP, the application for renewal of the GMP Certificate no longer requires an environmental impact assessment report approved by the state management agency in charge of the environment.
When is GMP certificate revoked?
Pursuant to the provisions of Clause 2, Article 16 of Decree No. 35/2016/ND-CP on the revocation of the GMP Certificate as follows:
Procedures for re-issuance or revocation of GMP Certificate
…
2. The Department of Animal Health shall revoke a GMP Certificate of a manufacturer of veterinary drugs in any of the following cases:
a) The GMP Certificate is erased or modified;
b) The manufacturer incurs administrative penalties for at least three times a year or incurs administrative penalties for 3 constant times for the same violation in the field of veterinary drug manufacturing;
c) The manufacturer no longer performs the manufacturing of veterinary drugs;
d) The manufacturer commits another violation that is regulated to have the Certificate of eligibility for manufacturing of veterinary drugs revoked.
The Minister of Agriculture and Rural development shall provide guidance on application for renewal, revocation, changes or amendments to GMP Certificate.
Thus, the GMP certificate of manufacturer of veterinary drugs will be revoked in the cases specified above.
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