This Circular guides the classification and management of drug-food products to ensure consumer health safety and facilitate businesses in registering, producing, and circulating these products.
Đối tượng áp dụng
[Provincial Health Departments; pharmaceutical and food production and trading units]
Các điểm cốt lõi
- Products with active ingredients at preventive and therapeutic dosages are considered drugs (Point 1.1, Article 1).
- Products containing vitamins and mineral salts exceeding recommended nutritional requirements for Vietnamese people are also considered drugs (Point 1.1, Article 1).
- If the manufacturer declares preventive and therapeutic effects like those of a drug, such products are considered drugs (Point 1.2, Article 1).
- Products not meeting the conditions specified in Point 1, Article 1 are considered food (Point 2, Article 1).
- Products classified as drugs must be registered, produced, and circulated in accordance with the laws on pharmaceuticals (Clause 1, Article II).
- Products classified as food must declare food quality standards in compliance with the laws on food (Clause 2, Article II).
🌐 Tác động xã hội từ văn bản này
- Facilitate businesses in registering, producing, and circulating products.
- Help consumers easily identify and use drug-food products correctly.
- Regulatory agencies have additional grounds to inspect and monitor product quality.
- Some businesses must adjust their registration, production, and circulation procedures according to the new guidelines.
❓ Câu hỏi thường gặp
Which products are considered drugs?
Products with active ingredients at preventive and therapeutic dosages or containing vitamins and mineral salts exceeding recommended nutritional requirements for Vietnamese people.
Which products are considered food?
Products not meeting the conditions specified in Point 1, Article 1 of this Circular.
What should production and trading units do when encountering difficulties in applying this Circular?
Units must report to the Ministry of Health (Vietnam National Pharmaceutical Administration, Food Safety and Quality Control Department) for support in resolving issues.
When does this Circular take effect?
This Circular takes effect fifteen days from the date of issuance.
Which Circular does this Circular replace?
This Circular replaces Circular No. 17/2000/TT-BYT guiding the registration of drug-food products as drugs.
Toàn văn
CIRCULAR
Guidelines for managing drug-food products
_________________________
A drug is a product derived from animals, plants, minerals, or organisms that is formulated for human use to prevent disease, treat illness, restore health, adjust bodily functions, alleviate symptoms, diagnose disease, recover or enhance health, numb a part or the entire body, affect the reproductive process, or alter body shape.
Currently, there are certain products abroad that are granted permission for circulation by drug and food regulatory agencies (FDA) as drug-food products (Food and Drug Interface Products). To unify management, facilitate businesses when registering or declaring quality, producing, circulating, and ensuring consumer health safety, the Ministry of Health provides guidance on classifying and assigning management of drug-food products as follows:
I. CLASSIFICATION OF DRUG-FOOD PRODUCTS
1. Drug-food products meeting all of the following conditions shall be considered drugs:
1.1 Contain active ingredients at concentrations and dosages effective for disease prevention and treatment. For products containing vitamins or mineral salts with daily concentrations and dosages exceeding the recommended dietary allowances (RDA - Recommended Daily Allowances) specified in the attached Circular.
1.2 The manufacturer declares the product has preventive or therapeutic effects like a pharmaceutical product (with efficacy, indications, dosages, contraindications as a type of drug).
2. Drug-food products not meeting the conditions stipulated in Point 1 above shall be considered food.
II. ASSIGNMENT OF MANAGEMENT
1. Products classified as drugs according to Point 1, Section I of this Circular must be registered, produced, and circulated in accordance with laws on pharmaceuticals and detailed guidance provided by the Vietnam National Medicines Administration.
2. Products classified as food according to Point 2, Section I of this Circular must declare food quality standards in accordance with laws on food and detailed guidance provided by the Vietnam Food Safety Quality Control Administration.
3. Products whose classification as drugs or food is unclear shall be jointly reviewed and resolved by the Vietnam National Medicines Administration, the Vietnam Food Safety Quality Control Administration, and the Traditional Medicine Department.
III. IMPLEMENTATION:
1. Provincial Departments of Health under central cities and health sectors are responsible for implementing, directing, managing, inspecting, and supervising pharmaceutical and food production and business units to comply with this Circular's provisions.
2. Pharmaceutical and food production and business units are responsible for complying with this Circular's provisions.
This Circular takes effect 15 days from its date of issuance and replaces Circular No. 17/2000/TT-BYT dated September 27, 2000, regarding guidelines for registering drug products in the form of drug-food products.
During implementation, if difficulties arise, units must report to the Ministry of Health (Vietnam National Medicines Administration, Vietnam Food Safety Quality Control Administration) for research and resolution.
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