Conditions for being licensed to manufacture traditional medicines in Vietnam
Nowadays, herbal medicines are becoming more and more popular and perfect in terms of production, as well as maximizing the effects of health care and treatment for patients. Therefore, enterprises producing traditional medicines need to improve their research and production processes to meet standards, ensure quality and safety in treatment.
The production activities of traditional medicines are strictly managed by the Ministry of Health, in order to manage the quality of output drugs to meet standards. To operate in the field of trading and manufacturing drugs, businesses need a license to manufacture drugs from herbal ingredients.
Relevant legal documents in the production of traditional medicines:
Pharmacy Law 2016.
Decree 54/2016/ND-CP detailing the pharmaceutical law.
Decree 155/2018/ND-CP amending and supplementing Decree 54/2016/ND-CP
Circular 35/2018/TT-BYT providing guidance on good manufacturing practices for drugs and medicinal ingredients.
Enterprises need to meet the following conditions to be licensed to manufacture drugs from herbal ingredients:
Conditions for factories and standard infrastructure: In which: production workshops, laboratories, drug storage warehouses, input materials, auxiliary equipment, production and testing equipment assessment of drug quality and effectiveness, management system, professional and technical documents, production personnel, etc. need to meet regulations on good manufacturing practice for drugs and medicinal ingredients, according to Circular 35/2018 /TT-BYT.
Personnel conditions: The subject is the person in charge of the specialty of pharmaceutical production and the person in charge of the quality of the output drugs. Requirements need to have a certificate of professional diploma in pharmacy, along with 2 years of working experience at a pharmacy facility, in the same position. The person in charge of expertise and the person in charge of the quality of drugs from herbal ingredients may be 1.
Procedures for applying for a license to manufacture drugs from herbal ingredients include:
An application for a certificate of eligibility to manufacture traditional pharmaceutical drugs, made according to the form.
Certificate of diploma of the person in charge of expertise and quality of the drug – the original.
Certificate of business registration/certificate of investment in the production of traditional medicines.
Certificate of Good Manufacturing Practice GMP.
Papers and technical documents relevant to drug production and trading conditions.
The application must be submitted to the Department of Health, where the factory producing traditional medicines is located. The local Department of Health will set up a team to inspect and assess the conditions of the production facility.
Conditions for obtaining a certificate of good manufacturing practice
Good manufacturing practice GMP is an important standard and conditions for licensing the production of drugs from herbal ingredients. Enterprises need to meet GMP-WHO or GMP-EU standards of good manufacturing practice for traditional medicines.
Enterprises producing traditional medicines need to meet the following conditions to be granted a certificate of good manufacturing practice meeting GMP standards:

• Professionally trained personnel in the production of traditional medicines. At the same time, they are equipped with protective gear, meeting health requirements and not infectious diseases.
• Production equipment, workshops, storage warehouses, up to standards
• Standardized production process: production operations, material handling requirements, recipes, product standards...
  Product quality testing – sample testing.
• Quality control: products, semi-components, raw materials, suppliers...
• Standard handling of invalid products, reflect customers.
• Professional documents, research and production of traditional medicines, management of implementation records...

The certificate of good manufacturing practice GMP for traditional medicines is an important first step for all enterprises producing drugs and functional foods. Enterprises fully understand the principles and management scope to invest in production systems, factories, human resources, good production processes, etc. to ensure safe and effective output of medicinal products.
In addition, the certificate of good manufacturing practice will be a ticket for the enterprise's drug products to access projects, hospital pharmacies or international markets more easily.
source:  https://phongsachgmp.vn/dieu-kien-san-xuat-thuoc-dong-duoc-tai-viet-nam/