Legal consultancy on biotechnology in Vietnam

Biotechnology is a high-tech field with many applications in many areas of life. In Vietnam, biotechnology is one of the four technological directions that the Communist Party and the State are orienting for long-term development. In the goal by 2030 set by the Politburo in Resolution 36-NQ/TW in 2023, it is clearly stated: “Biotechnology enterprises increase by 50% in investment scale and growth scale”, leading to an increasing demand for legal advice on biotechnology. In the article below, Viet An Law will provide customers with legal consultancy on biotechnology in Vietnam.

What is biotechnology in Vietnam?

Biotechnology is the study and application of living organisms combined with technical processes and equipment to create products and produce on an industrial scale biological products to serve human interests, while developing the socio-economy and protecting the environment.

Biotechnology includes 7 fields:

• Fermentation technology;
• Cell technology;
• Enzyme technology;
• Nuclear transfer and embryo transfer technology;
• Environmental treatment biotechnology;
• Gene technology;
• Medical and pharmaceutical biotechnology.

Consulting on establishing a biotechnology company in Vietnam

Establishment conditions

When establishing a company, it is necessary to note some conditions pursuant to the Law on Enterprise 2020 such as:

Organizations and individuals have the right to establish

• Individual: The founder must have full capacity for civil acts and not be in the group of subjects prohibited from establishing an enterprise under the provisions of law.
• Organization: Any organization with legal status can participate in establishing a company, except for state agencies and units using the state budget.

Name

The company name must comply with legal regulations and must not be identical or confusing with the names of other enterprises. The company name includes the type of enterprise and the proper name.

Address of headquarter

The company’s headquarters address must be clearly stated, including house number, alley, street, district, and city. This location must be legal and ensure that it does not violate land use regulations.

Facilities

• Facilities play a key role for biotechnology companies. This is the factor that determines production capacity, research, and product development.
• The company needs to ensure that it has sufficient space, infrastructure and equipment suitable for its field of operation such as: laboratories, cold storage, biological safety cabinets, analytical equipment, production machinery, etc.
• These facilities must meet biosafety and environmental hygiene standards as prescribed by the regulatory agency. This is a mandatory condition for the company to be granted a biosafety certificate.
• In addition to initial investment, the company needs to allocate financial resources to maintain and upgrade facilities to ensure stable operations and enhance competitiveness.

Enterprise type

Depending on the number of investors, total investment capital, and capital mobilization needs, business entities can choose one of the popular company models today such as:

• Establish a private enterprise;
• Establish a single-member limited liability company;
• Establish a multiple-member limited liability company;
• Establish a joint stock company;
• Establish an FDI company;
• Establish a testing center;
• Establish a high-tech biological research center.

Charter capital

When registering an enterprise, depending on the business line, the regulations on minimum capital to establish a company will be different. If it is a normal business line, there is no regulation on the required minimum charter capital. However, if it is a business line that requires legal capital, there must be a minimum charter capital level in accordance with the provisions of the law.

Some biotechnology business lines

• Experimental biological research: Research on genetics, microbiology, biomedicine, and pharmacy at institutes and research centers of Ministries, branches, and universities.
• Product development, pharmaceuticals, functional foods, biotechnology products.
• Testing at hospitals, preventive health centers, and patient clinics.
• Laboratory for analysis, testing, and quality management of central tests, pharmaceuticals and functional foods, biotechnology products, and private blood DNA testing.

Dossier of biotechnology business establishment

When using the services of Viet An Law, customers will be supported in preparing documents to carry out procedures for establishing a biotechnology company in accordance with the law and drafting the Enterprise Registration Application as required. Accordingly, customers need to provide the following documents to complete the application:

• List of company members or shareholders (if it is a multiple-member limited liability company, a partnership, or a joint stock company);
• A valid copy of one of the following identification documents: Citizen Identification Card, Identity Card, Passport, or other legal personal identification of individual members;
• Authorization letter; Citizen ID card, Identity card, Passport, or other legal personal identification of the authorized representative of the organizational member;
• Decision on capital contribution for members who are organizations;
• Power of Attorney for Viet An Law (in case of choosing the company’s services).

Procedures for establishing a biotechnology business Company

After preparing all the information documents, the procedures for establishing a biotechnology company are as follows:

Step 1: Submit the enterprise establishment application to the Department of Planning and Investment where the head office is located.

Step 2: Receive the Enterprise Registration Certificate of a Biotechnology Company and publish the business registration content

Step 3: Carry out the following procedures to establish a biotechnology company, including procedures for obtaining a Business License (if necessary).

Consulting on sub-licenses in the field of biotechnology in Vietnam

A mandatory condition to be allowed to operate in the field of biotechnology is that the organization must be granted a Certificate of Biosafety Eligibility from the Ministry of Health (Department of Preventive Medicine) or a specialized management agency.

Application for Certificate of Biosafety Eligibility

• Application for new biosafety certificate according to Form No. 02 in the Appendix issued with Decree No. 103/2016/ND-CP;
• Plan to prevent and handle biosafety incidents;
• Personnel declaration;
• Equipment declaration;
• Ground plan of the testing facility, including testing area; window and door system; electrical system; water supply and drainage system; arrangement of fire and explosion prevention and fighting equipment;
• Maintenance and repair reports for testing equipment for testing facilities operating before Decree No. 103/2016/ND-CP takes effect.

Procedures for requesting a Certificate of Biosafety Eligibility

Step 1: The facility requesting a biosafety certificate submits a dossier to the Ministry of Health (Department of Preventive Medicine) according to Form No. 02 in the Appendix issued with Decree No. 103/2016/ND-CP regulating biosafety assurance in laboratories, amended and supplemented by Decree 155/2018/ND-CP.

Step 2: The competent authority issues a receipt of the application. Within 10 days from the date of receipt of the application, the competent authority shall appraise the application.

Step 3: In case the dossier is incomplete, within 05 working days from the date the dossier is appraised, the competent authority shall notify in writing the facility requesting the certificate to complete the dossier. The facility requesting the certificate must supplement and amend in accordance with the contents stated in the document and send it to the competent authority.

Step 4: In case the dossier is complete, the competent authority must conduct an assessment at the testing facility within 10 days from the date the dossier is assessed.

• In case the testing facility fully meets the conditions according to the assessment record, the competent authority shall report to the Minister of Health to issue a Certificate of Biosafety Eligibility within 07 working days from the date of assessment at the testing facility.
• In case the testing facility does not fully meet the conditions according to the assessment record, the standing unit must notify in writing the facility requesting the certificate within 07 working days from the date of assessment at the testing facility.

Note: Depending on the field of operation and products and services, the company needs to be granted other certificates and licenses such as:

• Certificate of Free Sale (CFS) for export products.
• License to circulate drugs, vaccines, and medical biological products issued by the Ministry of Health.
• GMP (Good Manufacturing Practice) certification for pharmaceutical and cosmetic manufacturing facilities.
• ISO, GLP (Good Laboratory Practice) certification for research and development activities.

The above is a legal consultancy on biotechnology in Vietnam. If you have any related questions or need advice on legal regulations, please contact Viet An Law for the best support!