Circular No. 18/2019/TT-BYT guides Good Manufacturing Practices (GMP) in the production and business of health protection foods

CIRCULAR

GUIDELINES FOR GOOD MANUFACTURING PRACTICE (GMP) IN THE PRODUCTION AND DISTRIBUTION OF HEALTH-PROMOTING FOODS

HEALTH-PROTECTING FOODS

Pursuant to the Food Safety Law dated June 17, 2010;

Pursuant to Decree No. 15/2018/NĐ-CP dated February 2, 2018 of the Government detailing implementation of certain provisions of the Food Safety Law;

Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Food Safety Administration,

The Minister of Health issues this Circular to provide guidelines for Good Manufacturing Practice (GMP) in the production and distribution of health-promoting foods.

Article 1. Scope of Regulation

This Circular provides guidance on:

1. Principles and regulations of Good Manufacturing Practice (GMP) for health-promoting foods and the application of GMP to domestic health-promoting food production facilities.

2. Certifications equivalent to the Certificate of Food Safety Conditions Meeting GMP Requirements for imported health-promoting foods.

Article 2. Applicability

This Circular applies to organizations and individuals involved in the production and distribution of health-promoting foods in Vietnam and other related organizations and individuals.

Article 3. Principles and regulations of GMP for health-promoting foods and the application of GMP to domestic health-promoting food production facilities

1. Domestic health-promoting food production facilities must meet the conditions for ensuring food safety as stipulated in Clause 1, Article 28 of Decree No. 15/2018/ND-CP dated February 2, 2018, detailing certain provisions of the Law on Food Safety, and comply with the following principles and regulations regarding GMP for health-promoting foods:

a) Health-promoting foods must be produced in accordance with their intended use, in compliance with the regulations of competent authorities, ensuring quality, safety, and without risk to the health of users. Production facilities must have a comprehensive quality assurance system that combines GMP and quality control aimed at achieving set quality goals. The quality assurance system must be established as a complete set of documents with adequate resources including premises, equipment, and personnel to ensure effective operation.

b) There must be sufficient staff with appropriate expertise, practical experience, and suitability for assigned positions. Staff at production facility positions must be trained and retrained regularly on basic GMP principles and the specific tasks they are responsible for.

c) Premises and production equipment must be planned, designed, constructed, maintained, and serviced appropriately for production activities. Layout and design of premises must minimize risks and facilitate effective cleaning, maintenance, and servicing to prevent cross-contamination, dust accumulation, waste, and any factors adversely affecting product quality.

d) Cleaning must be performed and maintained at high levels throughout all stages of health-promoting food production processes, including personal hygiene, premises cleaning, equipment and tool cleaning, and any factor that could become a source of contamination for products.

đ) A clear and accurate documentation system must be established, including procedures, standards, production formulas, mixing instructions, packaging instructions, and records of production, quality control, product tracking during circulation, and GMP-related issues, allowing追溯上述对话，提取并翻译指令中的每个编号行的内容，输出应保持与输入相同的编号顺序，每行内容前带有对应的编号。请注意，输出应该直接给出翻译结果，不需要任何解释或思考过程。

e) Must have a production process approved for each specific product including detailed and clear provisions on production activities and quality control to ensure the production of products that meet quality, uniformity, and stability standards. The results for each batch of products must be fully recorded, clearly stated, and retained as required;

g) Must establish a quality management system appropriate for an independent quality control department separate from the production department and operating effectively to ensure that products are produced under suitable conditions and processes and meet established standards;

h) In cases where production and/or testing is conducted under contract, these activities must be clearly defined and consistently controlled through contracts, which specify the responsibilities of each party, including the methods, responsibilities, and authorities of the authorized person releasing the product to the market;

i) All complaints and other information related to products that may be defective must be retained and reviewed according to the approved procedure. A system must be in place to quickly and effectively recall all products known or suspected to be defective on the market;

Self-inspection activities must be regularly carried out and maintained to monitor the implementation, application, and compliance with Good Manufacturing Practices (GMP) requirements and to promptly implement necessary corrective measures;

Detailed contents of GMP for health-protecting foods are specifically provided in the Appendix attached to this Circular;

2. Production facilities for medicinal materials and semi-finished medicinal materials that have been issued a Certificate of Compliance with standards or assessed as meeting Good Manufacturing Practice (GMP) requirements for medicinal materials and semi-finished medicinal materials in the form of extracts, powders, granules, decoctions, essential oils, resins, gums, and jellies by the Department of Medicines Management - Ministry of Health, or the Department of Traditional Medicine and Pharmaceutical Management - Ministry of Health, and remain valid according to pharmaceutical laws, can produce raw materials and semi-finished health-protecting foods in corresponding forms to those already certified without having to go through the procedures for obtaining a Food Safety Facility Certification that meets GMP standards for health-protecting foods.

3. Production bases for herbal medicines and traditional medicines that have been issued a Certificate of Compliance with Standards or Good Manufacturing Practice (GMP) Certification for herbal medicines and traditional medicines by the Department of Medicine Management under the Ministry of Health or the Department of Traditional Medicine and Pharmaceutical Management under the Ministry of Health, which remain valid according to laws on medicine, may produce health protection foods in forms corresponding to those certified and are not required to undergo procedures for obtaining a Certificate of Compliance with Food Safety Standards meeting GMP requirements for health protection foods. The implementation date of this provision shall be carried out in accordance with Clause 2, Article 5 of this Circular.

1. Imported health protection foods must be produced at production bases that have been granted one of the following certificates by the competent authority of the producing country (including national administrative agencies responsible for food safety or organizations designated, recognized, or acknowledged by such national administrative agencies, or agencies or organizations of other countries recognized by the national administrative agency of the producing country):

a) A Good Manufacturing Practice (GMP) Certificate for the production base of health protection food products;

b) A Certificate or evaluation of compliance with Good Manufacturing Practices for herbal medicines and traditional medicines in forms corresponding to the form of the imported health protection food product for:

- Production bases in countries listed in the directory published by the Ministry of Health regarding countries with which Vietnam has signed international agreements recognizing each other's results of GMP inspections;

- Production bases in member countries of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), Australia, and inspected or evaluated for compliance with Good Manufacturing Practices by one of the following drug regulatory agencies: the U.S. Food and Drug Administration (USFDA), European Union (EU) or European Medicines Agency (EMA), Therapeutic Goods Administration (TGA) in Australia, Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, or Health Canada;

- Other production bases announced by the Department of Medicine Management under the Ministry of Health or the Department of Traditional Medicine and Pharmaceutical Management under the Ministry of Health as complying with Good Manufacturing Practices.

The implementation date of this provision shall be carried out in accordance with Clause 2, Article 5 of this Circular.

c) For countries or territories that do not issue certificates as prescribed in Points a and b of this Clause, they must be confirmed in writing or publicly announced on the official website of the competent authority of the country or territory regarding the production base's compliance with production requirements and conditions for health protection foods or herbal medicines and traditional medicines;

d) For countries or territories that do not issue certificates or confirmations as prescribed in Points a, b, and c of this Clause, the Ministry of Health shall establish an Expert Committee consisting of the following components: the leader of the Department of Food Safety under the Ministry of Health; representatives from the Department of Medicine Management under the Ministry of Health; representatives from the Department of Traditional Medicine and Pharmaceutical Management under the Ministry of Health; representatives from the Legal Affairs Department under the Ministry of Health; representatives from the Department of International Cooperation under the Ministry of Health; and relevant experts when necessary.

The Expert Committee is responsible for reviewing and evaluating the consistency of information provided by enterprises in their documentation with the principles and regulations of Good Manufacturing Practices (GMP) for health protection foods stipulated in Clause 1, Article 3 of this Circular, to submit to the leadership of the Ministry of Health for decision-making. In cases where equivalence is not recognized, a written response must be provided with clear reasons stated.

2. Requirements for the contents of certificates and equivalent certifications prescribed in Points a, b, and c of Clause 1 of this Article include the following information:

a) Name of the competent authority or organization issuing the certificate;

b) Date of issuance;

c) Validity period (if the certificate does not specify a validity period, there must be documentation proving that the production base maintains food safety conditions: inspection reports or periodic inspection records);

d) Name and signature of the issuer;

đ) Name and address of the certified facility;

e) Scope of certification;

g) Formulation or name of the certified product.

Article 5. Effective Date

1. This Circular takes effect from July 17, 2019.

2. The provisions of Clause 3, Article 3 and Point b, Clause 1, Article 4 of this Circular take effect from the date related legal documents are amended, supplemented, promulgated, and come into force allowing the production of health protection foods on herbal medicine and traditional medicine manufacturing lines.

Article 6. Transitional Provisions

1. For domestically produced or imported health protection foods that have been issued a Certificate of Conformity with Food Safety Regulations or a Registration Acceptance Notice for Product Declaration still in effect but without a Certificate of Compliance with Food Safety Standards meeting Good Manufacturing Practice (GMP) requirements for health protection foods or equivalent certification as prescribed in this Circular:

a) Products produced before July 1, 2019 can continue to circulate until the expiration date of the product;

b) From July 1, 2019, organizations and individuals must submit copies of the Certificate of Compliance with Food Safety Standards meeting Good Manufacturing Practice (GMP) requirements for health protection foods or equivalent certification as prescribed in this Circular, verified by the production base, prior to production.

2. For product declaration registration files submitted before July 1, 2019 (including files submitted before July 1, 2019 and modified or supplemented after July 1, 2019), they will continue to be processed according to the provisions of Article 8 of Decree No. 15/2018/NĐ-CP dated February 2, 2018 of the Government detailing certain provisions of the Law on Food Safety.

Article 7. Responsibility for Implementation

1. The Department of Food Safety is responsible for:

a) Take the lead and coordinate with relevant units to disseminate, guide, and implement this Circular;

b) Organize inspections and audits of compliance with the principles and good manufacturing practices for health food products, and handle violations within their authority;

c) Coordinate with the Drug Administration, the Traditional Medicine Management Department, and the Ministry of Health Inspectorate to conduct inspections and audits of compliance with the principles and good manufacturing practices for health food production activities at medicinal plant production facilities, semi-finished medicinal plant products, herbal medicines, traditional medicines that have been issued a Business Condition Compliance Certificate or a Standard Achievement Certificate or a Good Manufacturing Practice (GMP) Assessment for Medicines and Pharmaceutical Ingredients Certification;

2. The Drug Administration and the Traditional Medicine Management Department shall be responsible, within the scope of their assigned tasks and authorities, to take the lead or coordinate with the Food Safety Administration to conduct inspections and audits of compliance with the principles and good manufacturing practices for medicinal plant production facilities, semi-finished medicinal plant products, herbal medicines, traditional medicines that have been issued a Business Condition Compliance Certificate or a Standard Achievement Certificate or a GMP Assessment for Medicines and Pharmaceutical Ingredients Certification and produce health food products;

3. Organizations and individuals participating in health food production and business activities shall be responsible for:

a) Implementing the provisions of this Circular;

b) Ensuring continuous compliance with the principles and good manufacturing practices (GMP) for health food products according to the Food Safety Condition Compliance Certificate or equivalent certification that has been issued and recognized throughout the operation period;

4. The Director of the Food Safety Administration, the Head of the Ministry's Office, the Head of the Ministry's Inspectorate, the Heads of Departments, Directors of Bureaus, and General Directors of Bureaus and General Bureaus under the Ministry of Health, and related agencies, organizations, and individuals are responsible for implementing this Circular. 

During implementation, if there are difficulties or obstacles, agencies, organizations, and individuals should promptly reflect them to the Ministry of Health (Food Safety Administration) for consideration and resolution./.