APPLICATION FOR REGISTRATION OF CIRCULATION OF PROBIOTICS

Probiotics are products containing live microorganisms for the purpose of improving human and animal health. The registration of a license to circulate biological products is essential and mandatory for organizations and individuals trading and importing biological products in order to create safety for humans and animals. In this article, Doanh Tri will make an attempt to answer about the application for registration of circulation of probiotics.
I. Legal basis
- Circular 19/2010/TT-BTNMT providing the registration of bio-product marketing for waste treatment in Vietnam

II. General provisions
1.What are probiotics?
These are preparations that are prepared and extracted from ingredients available in nature such as seaweed, seaweed, garlic, chili, etc., which are very safe, friendly to humans and the environment.
In aquaculture, using probiotics (also known as probiotics) for the purpose of improving the environment (water and pond bottom), increasing animal health, increasing the ability to absorb food, etc. increases productivity and output.
The biological products produced in service of Agricultural cultivation that we may often encounter such as Bio-fertilizers, biological pesticides for cultivation; biological padding, microbial bran for livestock; Supplements with beneficial bacteria for water sources, microbial feeds for aquaculture, etc.

2. Biological products must be registered for a list/permit for circulation:
- Domestically produced or imported biological products are not included in the List of biological products for waste treatment in Vietnam.
- Probiotics are listed in the List of biological products for waste treatment in Vietnam, but there are changes in the composition or content of active ingredients in the probiotics, affecting the treatment efficiency and safety. for human and animal health.
III. Procedures for applying for a license to circulate biological products
1. Dossier for registration of a license to circulate biological products
- A written request for registration of circulation of biological products;
- Copy of Business Registration Certificate or equivalent, certified by the organization or individual;
- Process for the production of biological products;
- The results of testing or analyzing the quality of biological products of the unit having the domestic or foreign accrediting function;
- Summary of the introduction of probiotics according to the form specified in Appendix 2 to this Circular and relevant documents: Ingredients - Properties, effectiveness, instructions for use, preservation - Safety for human and biological health – Documentation of the origin of microbial strains for microbial preparations;
- Minutes of evaluation of the Scientific Council at the management level for biological products are the results of scientific research projects;
- Results of testing or testing of biological products (if any);
- The label, the form of the official packaging to be circulated together with instructions for the preservation and use of biological products and warnings about risks to human health and organisms;
- Patent protection title or commitment not to violate the regulations on intellectual property for domestically produced products;
- Detailed testing plan, including the following main contents: testing content, time, location, and testing agency for biological products without recognized testing results.

2. Registration process
Within 05 working days from the date of receipt of the dossier, the Vietnam Environment Administration shall consider the completeness and validity of the dossier. In case the dossier is incomplete or invalid, a written notice must be sent to the registrant organization or individual for correction and supplementation.
Within 10 working days after finishing the consideration of the completeness and validity of the dossier, for biological products without testing results, the Vietnam Environment Administration shall notify in writing of supervision and inspection program according to the contents of detailed testing plans of organizations and individuals that have registered for circulation of biological products.
Within 20 working days from the date of receipt of a complete dossier, according to the provisions of Clause 2 of this Article or the results of testing of preparations specified in Clause 3 of this Article, the Vietnam Environment Administration shall establish and organize a meeting to The specialized scientific council evaluates the application for registration of circulation of biological products (hereinafter referred to as the Council for short).
For biological products that have been granted a certificate of circulation, organizations and individuals wishing to continue trading or importing biological products are responsible for notifying the name and quantity of biological products to the relevant authorities. Vietnam Environment Administration, Ministry of Natural Resources and Environment at least 15 working days before the circulation time. Within 5 working days from the date of receipt of the notice of the organization or individual, the Vietnam Environment Administration shall reply in writing to the organization or individual. Organizations and individuals are only allowed to circulate with the approval of the Vietnam Environment Administration.

The above information is about the "Application for registration of circulation of probiotics" For more information and advice on this issue, please contact Doanh Tri Law Firm directly via:

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