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PROCEDURES FOR REGISTRATION OF BIO - PRODUCTS IN 2021

Subjects who want to circulate biological products must follow all processes outlined in the State's regulations on biological product circulation. Customers will have a better understanding of the method for applying for a license to circulate biological products by reading the following article, which was revised in 2021.

Legal basis:
- The Pharmacy Law of 2016.

1. What are probiotics and how do you use them?
Probiotics (also known as biological pharmaceuticals) are drugs made from biologically derived substances or mixes of macromolecules, such as blood and blood derivatives, using biological technologies or procedures. Humans are similar.

Antibiotics, biologically generated chemicals with low molecular weight that may be separated as pure substances, and in vitro diagnostic biological products are not considered probiotics.
2. An application for a Certificate of Free Sale of Biological Products contains the following:

- An application for a Certificate of Drug Registration is included in the administrative dossier;

- A certified authentic copy of a foreign drug-trading establishment's License for Firm of a Representative Office, or a valid Certificate of Eligibility for Pharmacy Business, for a drug-trading establishment in Vietnam;

- For still-valid imported pharmaceuticals, the original or a certified true copy of the pharmaceutical product certificate;

- Drug and medicinal ingredient sample labels, as well as drug information and other documentation related to drug trading and circulation;

- Technical documents demonstrating that the medicine meets the necessary parameters;

- For reference biological agents, more clinical records demonstrating safety and efficacy are required;

- There must be more records confirming the similarity in quality, safety, and effectiveness of identical biological goods when compared to control biological products;
- A sample of the drug's real label circulating in the host nation or the reference country for imported medications.

3. Competence and time limit for issuing certificates of drug registration

- The Minister of Health shall issue a certificate of drug registration based on the dossier's appraisal and the Advisory Council's advice for the issuance of the certificate of drug registration.

- The time limit for granting a certificate of drug registration is 12 months from the date of receipt of a complete application for a certificate of drug registration or 12 months from the date of receipt of a complete application for new drugs or reference drugs, bioproducts, and biosimilar products that have been clinically proven to be safe and effective.

The above information is about the " Procedures for registration of bio-products in 2021". For more information and advice on this issue, please contact Doanh Tri Law Firm directly via:

Hotline: (+84) 911.233.955 - (024) 6293 8326

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