According to the Decree, applications for GMP Certificate renewal no longer require environmental impact assessment (EIA) reports approved by the environmental authorities.
Particularly, an application for GMP Certificate renewal includes the original copies of the following documents:
- An application form for GMP re-inspection;
- 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;
- A report on remedies for shortcomings in the previous inspection;
- A report on trainings at the facility;
- A list of available equipment at the facility;
- A list of products being manufactured;
- A list of standard operating procedures;
- A latest minutes of self-inspection and evaluation of the facility (within 3 months) in terms of GMP application.
*GMP: Good Manufacturing Practice means rules, regulations and guidelines on requirements for manufacturing drugs in order to ensure that these drugs meet quality standards.
Decree No. 80/2022/ND-CP comes into force from October 13, 2022.
>> CLICK HERE TO READ THE ARTICLE IN VIETNAMES
Above are the summary and notification of new documents for customers of THU VIEN PHAP LUAT. For more information, please send an email to info@thuvienphapluat.vn.
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