Application for registration dossiers of bio-product marketing in Vietnam

Application for registration dossiers of bio-product marketing in Vietnam (Internet image)

1. What is bio-products for waste treatment?

According to Clause 1, Article 3 of Circular 19/2010/TT-BTNMT, bio-products for waste treatment means products of biological origin used to treat waste, which include microorganisms, enzymes and substances extracted from animals, plants and microorganisms, but do not include genetically modified organisms.

2. Application for registration dossiers of bio-product marketing in Vietnam

The application for registration dossiers of bio-product marketing is specified in Article 12 of Circular 19/2010/TT-BTNMT, specifically as follows:

- An application for registration of bio-product marketing made according to the form provided in Appendix 1 to Circular 19/2010/TT-BTNMT (not printed herein).

- Copy of the business registration certificate or equivalent certified by the organization or individual.

- Bio-product production process.

- Bio-product quality testing or analysis slip of a domestic or foreign unit with testing function.

- Brief introduction on the bio-product made according to the form provided in Appendix 2 to Circular 19/2010/TT-BTNMT and related documents:

+ Composition;

+ Properties, effects, use instructions, preservation:

+ Safety to the health of humans and living organisms;

+ Documents on the origin of the original microorganism species, for microorganism products.

- Evaluation record of the science council of the managing sector, for bio-products being scientific research findings.

- Trial or testing results of bio-products (if any).

- Official label and packaging applied for marketing together with the insert on instructions for use and preservation of bio-products and warnings on health of humans and living organisms.

- Patent or written commitment on not violating intellectual property regulations, for domestic bio-products applied for marketing registration, made according to the form provided in Appendix 3 to Circular 19/2010/TT-BTNMT; license for bio-product marketing granted by a competent authority of the country of manufacture, for imported bio-products.

- Detailed testing plan, covering testing contents, time, place and institution, for bio-products without recognized testing results.

3. Cases of withdrawal of certificates of bio-product marketing in Vietnam

Specifically, in Clause 1, Article 17 of Circular 19/2010/TT-BTNMT, a certificate of bio-product marketing is withdrawn when:

- It is granted at variance with regulations;

- There are changes in the composition of the bio-product;

- A competent agency certifies infringement upon industrial property rights over the registered bio-product;

- It expires.

4. Principles of bio-product marketing in Vietnam

The principles of bio-product marketing specified in Article 4 of Circular 19/2010/TT-BTNMT, specifically as follows:

- Organizations and individuals having bio-products shall register these products with competent agencies for consideration and grant of certificates of bio-product marketing before marketing and using them.

- Certificates of bio-product marketing shall be granted by competent state agencies based on testing results and conclusions of the Specialized Science Council for evaluation of registration dossiers of bio-product marketing.

- Organizations and individuals registering bio-product marketing shall pay charges and fees under current law

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