Health Product Business License
Inter Area has applied for various Chinese license qualifications for many years of business experience. It has a number of experience in substantive certification. From the industrial and commercial registration, the Chinese license qualification certificate, the application for follow-up accounting services, Inter Area provides one-stop service for companies and provides professionals. Consultation, in order to enable investors to truly operate in the local area, and to be able to take care of the various business issues in the local area, so that investors can rest assured that investment, focus on business market development.
Table of Contents
- Introduction and Function of Health Supplement Business License
- What is " Health Supplement "?
- "Health Supplements Business License" application conditions
- Which companies need to apply?
- Documents to be submitted for application for health food registration
Introduction and Function of Health Supplement Business License
The Health Supplement Business License is a valid license issued by the Municipal Food and Drug Administration to strengthen the supervision and management of health foods and ensure the quality of health foods in accordance with the relevant provisions of the Food Sanitation Law of the People's Republic of China. Within a certain period of time, health care drugs will be gradually incorporated into health foods or medicines according to the corresponding standards, and the health medicine business licenses will no longer be issued separately. The Health Supplement Business License is a legal certificate for the operation of a health care product with pharmacological effects or a business or individual that manages health food and is also a legal guarantee for the normal operation of these business enterprises.
What is " Health Supplement "?
Health Supplement can also be called a dietary supplement or healthy food, meaning that it is insufficiently supplemented or added to the lack of meaning.
Health supplements are foods that claim to have specific health functions or are supplemented with vitamins and minerals. They are suitable for consumption by specific people, have the function of regulating the body, are not for the purpose of treating diseases and do not cause any acute or chronic harm to the human body.
On February 26, 2016, the State Food and Drug Administration issued the “Administrative Measures for the Registration and Recording of Health Foods”, which will take effect on July 1, 2016. The State Food and Drug Administration is responsible for the registration and management of health foods, as well as the first-time import of health foods that are supplemented with vitamins, minerals and other nutrients, and supervises the supervision of the registration of health foods undertaken by the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government.
According to the "Administrative Measures for Health Foods" promulgated by the former Ministry of Health, the foods that have obtained the "Health Food Approval Certificate" are permitted to use the health food mark specified by the Ministry of Health. The mark is sky blue, hat-shaped, and the industry is commonly known as the "blue hat."
"Health Supplements License" application conditions
Enterprises or units engaged in health supplement business activities must obtain the Health Care Supplement Business License in accordance with the law, and their enterprises or units must meet the following conditions before they can apply.
- Article 27 of the Food Safety Law of the People's Republic of China.
- Management system with guaranteed health and quality of health foods.
- The place for sales is away from pollutants such as manure fields and garbage dumps.
- Sanitary facilities such as lighting, ventilation, smoke exhaust, fly-proof, rodent-proof, dust-proof, insect-proof, sewage treatment, etc.
- Employees pass the health check; patients with viral hepatitis A and hepatitis E virus are not allowed to engage in health food business positions.
- It has the operation and storage area suitable for the scale of operation; the goods are stored off the wall and classified.
Which companies need to apply
With the increasingly standardized market economy, the legal system and the health food supervision system are becoming more and more complete. For enterprises that want to engage in the health food business, there is no health food business license. Inter Area has the expertise to help customers, simplify the approval process, avoid cumbersome processes, and save time and cost for the business. Here are some of the companies that need to apply for a health food business license.
- A company engaged in the management of healthy foods.
- A company engaged in the management of health care drugs.
- A company engaged in the management of health care cosmetics.
- A company engaged in the management of health care products.
Documents to be submitted for application for health food registration
- Application Form for Health Supplements Registration, and Legal Responsibility for Applicants Responsible for the Authenticity of Application Materials.
- Registered applicant's certificate.
- Product development report, including R&D personnel, R&D time, development process, verification data above the pilot scale, demonstration materials and product safety, health function, quality controllability report and related scientific basis, and product technical requirements.
- Product formula materials, including the name and dosage of raw materials and auxiliary materials, production process, quality standards, and, if necessary, the basis for the use of raw materials, the description of the parts of use, the certificate of inspection, the report of variety identification, etc.
- Product production process materials, including production process flow diagrams and descriptions, key process control points and instructions.
- Safety and health function evaluation materials, including the safety of raw materials and products outside the catalog, health care function test evaluation materials, food consumption evaluation materials; efficacy ingredients or iconic ingredients, hygiene, stability, strain identification, strain virulence Wait for the test report. In addition to this, there are test reports for stimulants and illicit drug ingredients.
- Types, names and related standards of packaging materials that are in direct contact with healthy foods.
- Product label, manual sample; search name for the generic name in the product name and the registered drug name.
- Provide 3 minimum sales package samples.
- Other materials related to product registration review.