Criteria for voting for the title "Vietnamese Medicine Star" for the second time in 2023 in Vietnam

Criteria for voting for the title "Vietnamese Medicine Star" for the second time in 2023 in Vietnam (Internet image)

Regarding this issue, LawNet would like to answer as follows:

1. General criteria for drug manufacturing enterprises in Vietnam

Enterprises participating in the Program must be enterprises with drug factories in Vietnam that have been granted a certificate of eligibility for pharmaceutical business by the Ministry of Health and meet the following criteria:

- Comply with legal regulations on business, investment, labor, land, construction, bidding, environmental protection, labor safety, social insurance, and health insurance for workers.

- Organize production and business to be stable and developed.

- Fully comply with financial obligations, taxes, and other state budget revenues according to the provisions of law.

- Ensure stable life and employment for workers.

- Strictly comply with legal regulations on the production, storage, distribution, and trading of pharmaceuticals according to good practice standards (GPs).

- Strictly comply with other provisions of the law related to the production and business activities of enterprises and entrepreneurs.

- Have an operating period of 5 years or more since the competent authority decided to establish the enterprise and granted business registration.

- Implement well-written policies and laws related to employees.

- Perform well the work of social order, security, and safety; fully participate in movements launched by the locality where the enterprise is located.

(Article 4 of rhe Regulations issued together with Decision 3981/QD-BYT 2023)

2. General criteria for domestically produced medicinal products

Drug products participating in the Program must be granted a Certificate of Circulation Registration in Vietnam by the Ministry of Health, be manufactured at a drug factory in Vietnam, and meet the following requirements:

- A medicinal product that plays a key role in the production and business strategy of the owned company, contributing a large proportion to the annual revenue and profit of the enterprise.

- Be a medicinal product with a long period of circulation and development, proven safety and effectiveness when used, and an important contribution to public health care; quality assurance; do not affect consumer health; and prices are announced according to regulations.

- Be a medicinal product that is deployed for business in compliance with the provisions of the law on the production, storage, distribution, and trading of pharmaceuticals according to good practice standards (GPs).

- Be a product that is deployed for business in accordance with other relevant legal regulations.

(Article 5 of the Regulations issued together with LawNet answers as follows: 1. General criteria for drug manufacturing enterprises Enterprises participating in the Program must be enterprises with drug factories in Vietnam that have been granted a certificate of eligibility for pharmaceutical business by the Ministry of Health and meet the following criteria: - Comply with legal regulations on business, investment, labor, land, construction, bidding, environmental protection, labor safety, social insurance, and health insurance for workers. - Organize production and business to be stable and developed. - Fully comply with financial obligations, taxes, and other state budget revenues according to the provisions of law. - Ensure stable life and employment for workers. - Strictly comply with legal regulations on the production, storage, distribution, and trading of pharmaceuticals according to good practice standards (GPs). - Strictly comply with other provisions of the law related to the production and business activities of enterprises and entrepreneurs. - Have an operating period of 5 years or more since the competent authority decided to establish the enterprise and granted business registration. - Implement well-written policies and laws related to employees. - Perform well the work of social order, security, and safety; fully participate in movements launched by the locality where the enterprise is located. (Article 4 Regulations issued together with Decision 3981/QD-BYT 2023) 2. General criteria for domestically produced medicinal products Drug products participating in the Program must be granted a Certificate of Circulation Registration in Vietnam by the Ministry of Health, be manufactured at a drug factory in Vietnam, and meet the following requirements: - A medicinal product that plays a key role in the production and business strategy of the owned company, contributing a large proportion to the annual revenue and profit of the enterprise. - Be a medicinal product with a long period of circulation and development, proven safety and effectiveness when used, and an important contribution to public health care; quality assurance; do not affect consumer health; and prices are announced according to regulations. - Be a medicinal product that is deployed for business in compliance with the provisions of the law on the production, storage, distribution, and trading of pharmaceuticals according to good practice standards (GPs). - Be a product that is deployed for business in accordance with other relevant legal regulations. (Article 5 Regulations issued together with Decision 3981/QD-BYT 2023) 3. Specific criteria for voting for Medicine Manufacturing Enterprises and Medicine Products to win the title of "Vietnamese Medicine Star" Specific criteria for voting for Enterprises producing drugs and medicinal products to win the title of "Vietnamese Drug Star" based on the set of criteria for selecting enterprises manufacturing drugs and medicinal products to win the title of "Vietnamese Drug Star" for the second time in 2023 in Appendix I of the Regulations issued with Decision 3981/QD-BYT 2023. 4. In case of considering stopping the evaluation and revoking the title "Star of Vietnamese medicine" According to Article 10 of the Regulations issued together with Decision 3981/QD-BYT 2023, the case of considering stopping the evaluation and revoking the title "Vietnamese Medicine Star" is as follows: - The Voting Council will stop evaluating titles in the following cases: + Enterprises were found to be dishonest in declaring their registration documents to participate in the Program. + During the voting period, stop evaluating and voting for businesses whose complaints and denunciations have been accepted according to the provisions of law or have opinions about violations at enterprises of inspection agencies or are in the process of investigation. - The Voting Council will report to the Ministry of Health to consider and revoke the title after being voted in the following cases: + After receiving the title, the business/product is determined to have fraudulently registered for voting. + After receiving the title, the business/product violates the provisions of law during the voting period, leading to criminal prosecution and withdrawal of product circulation registration number. Nguyen Ngoc Que Anh">Decision 3981/QD-BYT 2023)

3. Specific criteria for voting for Medicine Manufacturing Enterprises and Medicine Products to win the title of "Vietnamese Medicine Star"

Specific criteria for voting for Enterprises producing drugs and medicinal products to win the title of "Vietnamese Drug Star" based on the set of criteria for selecting enterprises manufacturing drugs and medicinal products to win the title of "Vietnamese Drug Star" for the second time in 2023 in Appendix I of the Regulations issued with LawNet answers as follows: 1. General criteria for drug manufacturing enterprises Enterprises participating in the Program must be enterprises with drug factories in Vietnam that have been granted a certificate of eligibility for pharmaceutical business by the Ministry of Health and meet the following criteria: - Comply with legal regulations on business, investment, labor, land, construction, bidding, environmental protection, labor safety, social insurance, and health insurance for workers. - Organize production and business to be stable and developed. - Fully comply with financial obligations, taxes, and other state budget revenues according to the provisions of law. - Ensure stable life and employment for workers. - Strictly comply with legal regulations on the production, storage, distribution, and trading of pharmaceuticals according to good practice standards (GPs). - Strictly comply with other provisions of the law related to the production and business activities of enterprises and entrepreneurs. - Have an operating period of 5 years or more since the competent authority decided to establish the enterprise and granted business registration. - Implement well-written policies and laws related to employees. - Perform well the work of social order, security, and safety; fully participate in movements launched by the locality where the enterprise is located. (Article 4 Regulations issued together with Decision 3981/QD-BYT 2023) 2. General criteria for domestically produced medicinal products Drug products participating in the Program must be granted a Certificate of Circulation Registration in Vietnam by the Ministry of Health, be manufactured at a drug factory in Vietnam, and meet the following requirements: - A medicinal product that plays a key role in the production and business strategy of the owned company, contributing a large proportion to the annual revenue and profit of the enterprise. - Be a medicinal product with a long period of circulation and development, proven safety and effectiveness when used, and an important contribution to public health care; quality assurance; do not affect consumer health; and prices are announced according to regulations. - Be a medicinal product that is deployed for business in compliance with the provisions of the law on the production, storage, distribution, and trading of pharmaceuticals according to good practice standards (GPs). - Be a product that is deployed for business in accordance with other relevant legal regulations. (Article 5 Regulations issued together with Decision 3981/QD-BYT 2023) 3. Specific criteria for voting for Medicine Manufacturing Enterprises and Medicine Products to win the title of "Vietnamese Medicine Star" Specific criteria for voting for Enterprises producing drugs and medicinal products to win the title of "Vietnamese Drug Star" based on the set of criteria for selecting enterprises manufacturing drugs and medicinal products to win the title of "Vietnamese Drug Star" for the second time in 2023 in Appendix I of the Regulations issued with Decision 3981/QD-BYT 2023. 4. In case of considering stopping the evaluation and revoking the title "Star of Vietnamese medicine" According to Article 10 of the Regulations issued together with Decision 3981/QD-BYT 2023, the case of considering stopping the evaluation and revoking the title "Vietnamese Medicine Star" is as follows: - The Voting Council will stop evaluating titles in the following cases: + Enterprises were found to be dishonest in declaring their registration documents to participate in the Program. + During the voting period, stop evaluating and voting for businesses whose complaints and denunciations have been accepted according to the provisions of law or have opinions about violations at enterprises of inspection agencies or are in the process of investigation. - The Voting Council will report to the Ministry of Health to consider and revoke the title after being voted in the following cases: + After receiving the title, the business/product is determined to have fraudulently registered for voting. + After receiving the title, the business/product violates the provisions of law during the voting period, leading to criminal prosecution and withdrawal of product circulation registration number. Nguyen Ngoc Que Anh">Decision 3981/QD-BYT 2023.

4. In case of considering stopping the evaluation and revoking the title "Vietnamese Medicine Star" in Vietnam

According to Article 10 of the Regulations issued together with LawNet answers as follows: 1. General criteria for drug manufacturing enterprises Enterprises participating in the Program must be enterprises with drug factories in Vietnam that have been granted a certificate of eligibility for pharmaceutical business by the Ministry of Health and meet the following criteria: - Comply with legal regulations on business, investment, labor, land, construction, bidding, environmental protection, labor safety, social insurance, and health insurance for workers. - Organize production and business to be stable and developed. - Fully comply with financial obligations, taxes, and other state budget revenues according to the provisions of law. - Ensure stable life and employment for workers. - Strictly comply with legal regulations on the production, storage, distribution, and trading of pharmaceuticals according to good practice standards (GPs). - Strictly comply with other provisions of the law related to the production and business activities of enterprises and entrepreneurs. - Have an operating period of 5 years or more since the competent authority decided to establish the enterprise and granted business registration. - Implement well-written policies and laws related to employees. - Perform well the work of social order, security, and safety; fully participate in movements launched by the locality where the enterprise is located. (Article 4 Regulations issued together with Decision 3981/QD-BYT 2023) 2. General criteria for domestically produced medicinal products Drug products participating in the Program must be granted a Certificate of Circulation Registration in Vietnam by the Ministry of Health, be manufactured at a drug factory in Vietnam, and meet the following requirements: - A medicinal product that plays a key role in the production and business strategy of the owned company, contributing a large proportion to the annual revenue and profit of the enterprise. - Be a medicinal product with a long period of circulation and development, proven safety and effectiveness when used, and an important contribution to public health care; quality assurance; do not affect consumer health; and prices are announced according to regulations. - Be a medicinal product that is deployed for business in compliance with the provisions of the law on the production, storage, distribution, and trading of pharmaceuticals according to good practice standards (GPs). - Be a product that is deployed for business in accordance with other relevant legal regulations. (Article 5 Regulations issued together with Decision 3981/QD-BYT 2023) 3. Specific criteria for voting for Medicine Manufacturing Enterprises and Medicine Products to win the title of "Vietnamese Medicine Star" Specific criteria for voting for Enterprises producing drugs and medicinal products to win the title of "Vietnamese Drug Star" based on the set of criteria for selecting enterprises manufacturing drugs and medicinal products to win the title of "Vietnamese Drug Star" for the second time in 2023 in Appendix I of the Regulations issued with Decision 3981/QD-BYT 2023. 4. In case of considering stopping the evaluation and revoking the title "Star of Vietnamese medicine" According to Article 10 of the Regulations issued together with Decision 3981/QD-BYT 2023, the case of considering stopping the evaluation and revoking the title "Vietnamese Medicine Star" is as follows: - The Voting Council will stop evaluating titles in the following cases: + Enterprises were found to be dishonest in declaring their registration documents to participate in the Program. + During the voting period, stop evaluating and voting for businesses whose complaints and denunciations have been accepted according to the provisions of law or have opinions about violations at enterprises of inspection agencies or are in the process of investigation. - The Voting Council will report to the Ministry of Health to consider and revoke the title after being voted in the following cases: + After receiving the title, the business/product is determined to have fraudulently registered for voting. + After receiving the title, the business/product violates the provisions of law during the voting period, leading to criminal prosecution and withdrawal of product circulation registration number. Nguyen Ngoc Que Anh">Decision 3981/QD-BYT 2023, the case of considering stopping the evaluation and revoking the title "Vietnamese Medicine Star" is as follows:

- The Voting Council will stop evaluating titles in the following cases:

+ Enterprises were found to be dishonest in declaring their registration documents to participate in the Program.

+ During the voting period, stop evaluating and voting for businesses whose complaints and denunciations have been accepted according to the provisions of law or have opinions about violations at enterprises of inspection agencies or are in the process of investigation.

- The Voting Council will report to the Ministry of Health to consider and revoke the title after being voted in the following cases:

+ After receiving the title, the business/product is determined to have fraudulently registered for voting.

+ After receiving the title, the business/product violates the provisions of law during the voting period, leading to criminal prosecution and withdrawal of product circulation registration number.

Nguyen Ngoc Que Anh

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