Chapter I General provisions article registered for the standard formula foods for special medical purposes, strengthening management, ensure the safety quality formula foods for special medical purposes, in accordance with the People's Republic of China food safety law and other laws and regulations, these measures are formulated.

Article People's Republic of China territory of production and sale and registration of the imported formula foods for special medical purposes, these measures shall apply.

Registered article formula foods for special medical purposes, refers to the State food and drug administration according to the application, in accordance with the procedures and requirements as provided herein, the formula foods for special medical purposes the product formulation, manufacturing process, labels, brochures, and product safety and nutritional adequacy review and special medicine uses clinical effects, and decide whether or not to grant the registration process.

Part IV registration formula foods for special medical purposes should be guided by science, principles of openness, fairness and justice.

Fifth, the State food and Drug Administration is responsible for the registration of formula foods for special medical purposes.

The State food and drug administration of administrative organization (hereinafter referred to as the Organization) is responsible for the registration application accepted formula foods for special medical purposes.

The State food and drug administration food review agencies (hereinafter referred to as the review bodies) responsible for registration review of formula foods for special medical purposes.

State food and Drug Administration approved inspection bodies (hereinafter referred to as the verification agency) is responsible for registering formula foods for special medical purposes during the review of field verification work.

Sixth the State food and Drug Administration set up by the food and nutrition, clinical medicine, food safety, food processing and other experts in the field of database registration review of formula foods for special medical purposes.

Article seventh State food and Drug Administration should strengthen information construction and raise the level of registration information management formula foods for special medical purposes.

Section I of chapter II registration application and accept the eighth applicant formula foods for special medical purposes (hereinafter the applicant) should be to be in the country of production and sale of formula foods for special medical purposes manufacturers and intends to export to the country outside of formula foods for special medical purposes manufacturers.

Applicants should has and by production special medical uses formula food phase adapted of development, and production capacity, established special medical uses formula food development institutions, equipped with full-time of products development personnel, and food security management personnel and food security professional technicians, according to good production specification requirements established and by production food phase adapted of production quality management system, has according to special medical uses formula food national standards provides of all project by batch test of capacity.

Research and development institutions should be food-related senior professional title or appropriate professional competence of staff. Nineth article application special medical uses formula food registered, should to national food drug supervision management General submitted following material: (a) special medical uses formula food registered applications; (ii) products development report and products formula design and according to; (three) production process information; (four) products standard requirements; (five) products label, and manual sample; (six) test samples test report; (seven) development, and production and test capacity proved material; (eight) other showed that products security, and

Nutritional adequacy, and special medical purposes effect of material.

Application-specific nutritional food, shall also submit the report.

The applicant should be responsible for the authenticity of the application materials. Tenth article accepted institutions on applicants proposed of special medical uses formula food registered application, should according to following situation respectively made processing: (a) application matters law not need for registered of, should rates told applicants not accepted; (ii) application matters law not belongs to national food drug supervision management general terms range of, should rates made not accepted of decided, and told applicants to about administrative organ application; (three) application material exists can spot corrections of errors of, should allows application people spot corrections

; (Four) application material not complete or not meet statutory form of, should spot or in 5 a days within once told applicants need correction of all content, late not told of, since received application material of day up that for accepted; (five) application matters belongs to national food drug supervision management general terms range, application material complete, and meet statutory form, or applicants according to requirements submitted all correction application material of, should accepted registered application.　　

Accepting institutions to accept or not to accept applications for registration should be stamped with the State food and Drug Administration issued administrative permission to accept special and date in written form.

The second section reviews and decided to 11th review bodies shall review the application materials, and organization to the applicants as needed for on-site verification, sampling the test sample testing, on-site verification of clinical trials and experts on professional issues.

12th review of verification bodies shall, upon receiving the bodies completed within 20 working days from the date of notification to the applicant's research and development, production, testing, and so on-site verification, and provide the verification report.

Verification body shall notify the applicant the local provincial food and drug supervision and management departments participate in the on-site verification, the provincial food and drug supervision and management departments should send personnel to participate in the on-site verification.

Article 13th review body should be entrusted with the statutory qualification of food inspection institutions to conduct sampling inspection.

Inspection bodies shall be entrusted to completed within 30 working days from the date of sampling inspection.

14th verification bodies shall, upon receiving the review bodies within 40 working days from the date of notification to complete the clinical test of authenticity, completeness, accuracy of on-site verification and issue a verification report.

15th review body can be from formula foods for special medical purposes registered reviewers selected library experts, the review demonstrates the problems encountered in the process, and the formation of expert opinion.

Article 16th review body shall, within 60 working days from the date of receipt of accepted materials, based on its verification report, inspection reports, and expert advice to complete technical review process, the review and conclusion. Correction process requires the applicant for the review material, review bodies should be told to correct everything at once. The applicant shall make correction within 6 months of a material.

Time correction material does not count in the review period.

Special circumstances need to extend review time, agreed by the heads of review agencies, can be extended by 30 days, extend the decision shall promptly inform the applicant in writing.

17th review body finds that the application materials, science, security, reasonable, viable and production quality control, technical requirements and testing methods for scientific, reasonable, it shall submit a proposal to be registered. Recommendations of the review body shall be rejected for registration, shall send to the applicant written notice of the intention to refuse to register. Of objection to the notice of the applicant shall, within 20 working days of receipt of the notification the review agencies submit written applications for review and explain the grounds for reexamination.

Review is limited to the contents of the original application and the application materials. The review authority shall accept the application for review made within 30 working days from the date of decision.

Recommendations of the change shall be rejected for registration and shall notify the applicant in writing.

18th the State food and drug administration shall, within 20 working days from the date of acceptance of the application for registration formula foods for special medical purposes the decision whether or not to grant registration.

On-site verification, sampling inspection and review required not included in the review and registration decisions within the time limit.

For the applications for registration of imported formula foods for special medical purposes should be based on the actual situation of overseas manufacturers to determine on-site verification and sampling time outside.

19th article national food drug supervision management General made granted registered decided of, accepted institutions since decided of day up 10 a days within issued, and served special medical uses formula food registered certificate; made not registered decided of, should description reason, accepted institutions since decided of day up 10 a days within issued special medical uses formula food not registered decided, and told applicants enjoys law application administrative reconsideration or filed administrative litigation of right.

Formula foods for special medical purposes registration certificate is valid for a period of 5 years.

20th formula foods for special medical purposes registration certificate and annex shall contain the following particulars: (a) the name, (ii) the business name, address, (iii) the registration number and the term of validity; (d) the product categories (v) product formulations; (vi) production and (VII) the product labels and instructions.

Format of the registration number for formula foods for special medical purposes: food TY+4-year + 4-bit sequence number, where TY represents the formula foods for special medical purposes.

Section III changes with continuous registration article 21st need to change the formula foods for special medical purposes a certificate of registration of the applicant and of the matters set out in the annex, should make changes to the State food and drug administration application for registration, and submit the following materials: (a) the application for registration changes formula foods for special medical purposes, (ii) change of registration certificate and proof of the matters set out in the annex.

22nd applicant product formulation, manufacturing process changes that may affect product safety and nutritional adequacy, and special medical purposes effect of matter, the State food and Drug Administration should conduct a substantive review, and completed within the period stipulated in this article 18th registration changes.

Changed business name, address of the applicant's name will not affect the safety and nutritional adequacy, and special medical purposes effect of matter, State food and drug administration shall verify, within 10 working days from the date of acceptance of the decision whether or not to grant registration changes.

23rd State food and Drug Administration granted change registration and issue to the applicant a certificate of registration, the original registration number the same and does not change the validity period of the certificate; refuse to approve the change registration application, refuse to change registration decisions should be made.

24th article special medical uses formula food registered certificate validity expires, need continues to production or imports of, should in validity expires 6 months Qian, to national food drug supervision management General proposed continued registered application, and submitted following material: (a) special medical uses formula food continued registered applications; (ii) special medical uses formula food quality security management situation; (three) special medical uses formula food quality management system self-examination report; (four) special medical uses formula food track evaluation situation. 25th State food and drug administration under the substantive review of the need for renewal of registration, and completed within the period stipulated in this article 18th continued registration.

Fails to make a decision, considered to approve the extension.

26th State food and drug administration approve the extension register, issue to the applicant a certificate of registration, the original registration number does not change, the certificate is valid from the date of approval to recalculate without approving an extension of an application for registration, refuse to continue registration decisions should be made.

27th article has following case one of of, not continued registered: (a) registered people not in provides time within proposed continued registered application of; (ii) registered products continuous 12 months within in provincial above supervision sampling in the appeared 3 batch above not qualified of; (three) enterprise failed to keep registered Shi production, and test capacity of; (four) other not meet legal regulations and products security, and nutrition sufficient sex and special medical uses clinical effect requirements of case.

28th article change formula foods for special medical purposes and continue the registration process, this section is not specified, the relevant provisions of the applicable section of this chapter, in section II. 29th chapter III clinical trials clinical trials formula foods for specific nutritional needs, commissioned by the applicant meets the requirements of the clinical trial clinical trial reports issued by the Agency.

Clinical trial reports should include complete statistical analysis reports and data.

30th clinical trials should be in accordance with the formula foods for special medical purposes quality control of clinical trials.

Formula foods for special medical purposes quality control of clinical trials published by the State food and drug administration.

31st applicant organizations to carry out clinical trial, should be clearly acted and statistical units.

32nd applicant should be used in clinical trials of test samples and the quality control sample are responsible for the security.

Test samples used in clinical trials should be produced by the applicant and endorsed by the inspection, production conditions should be consistent with good manufacturing practice formula foods for special medical purposes.

Fourth chapter of labels and label of the 33rd formula foods for special medical purposes shall be in accordance with the laws, regulations and rules and regulations labeling of food safety standards.

34th formula foods for special medical purposes, labels and the content should be consistent, involving registered certificate of formula foods for special medical purposes shall be consistent with the certificate of registration and indicate the registration number.

Label all details in the covers, you can attach a separate statement.

35th formula foods for special medical purposes labels and instructions shall be true and accurate, clear, durable, eye-catching and easy to read. 36th special labels or instructions shall not contain false formula foods for medical purposes, shall not be involved in disease prevention and treatment.

Labels and instructions provided by the manufacturer on the content.

37th formula foods for special medical purposes the name should reflect the true properties of food, use the category name under the food safety standards or equivalent name.

Formula foods for special medical purposes of the 38th article labels, instructions shall be prominently marked in accordance with food safety standards the following: (a) under the guidance of the doctor and clinical nutritionist, please use, (ii) do not apply to non-target populations used; (c) of this product is prohibited from use in parenteral nutrition support and intravenously.

Fifth chapter, supervision and inspection of the 39th formula foods for special medical purposes production enterprises shall, in accordance with approved the registration of product formulation, production and other technical requirements to organize production, ensure safe formula foods for special medical purposes.

Formula foods for special medical purposes production enterprise applications for registration changes without prior permission should be strictly in accordance with the registration certificate has been approved and its annex containing the content organization, without changing the production conditions and requirements.

Formula foods for special medical purposes manufacturers made changes after approval an application for registration shall be strictly in accordance with the changed formula foods for special medical purposes specified in the annex to the certificate of registration and content production.

40th participation registration accepted formula foods for special medical purposes, technical reviews, on-site verification, sampling, testing, clinical trials and other work staff and experts, shall keep business secret obtained in the registration.

Applicants shall, in accordance with relevant regulations of the State of the application materials marked and indicated the trade secret in the basis.

41st article has following case one of of, national food drug supervision management general according to interest relationship people of requests or according to terms, can revoked special medical uses formula food registered: (a) staff abuse, and negligence made granted registered decided of; (ii) beyond statutory terms made granted registered decided of; (three) violation statutory program made granted registered decided of; (four) on not has application qualification or not meet statutory conditions of applicants granted registered of;

(E) where the food production licenses revoked and (vi) may revoke the registration of the other cases in accordance with law.

42nd article has following case one of of, national food drug supervision management General should law handle special medical uses formula food registered cancellation procedures: (a) enterprise application cancellation of; (ii) validity expires not continued of; (three) enterprise law terminated of; (four) registered law was revoked, and withdrawn, or registered certificate law was revoked of; (five) legal regulations provides should cancellation registered of other case.

Sixth chapter legal liability article 43rd applicant concealing facts or providing false information to apply for registration, the State food and Drug Administration not to accept or to refuse to register and give a warning in which the applicant may not apply again for registration within 1 year.

44th licensee to deception, bribery or other improper means to obtain a registration certificate by the State food and Drug Administration revoke the registration certificate and fines of between 10,000 yuan and 30,000 yuan in which the applicant may not apply again for registration within 3 years.

Article 45th forge, alter, resell, rent, lend, transfer of certificate of registration formula foods for special medical purposes, by the food and drug administration departments at or above the county level shall be ordered to correct, given a warning and fined a maximum of 10,000 yuan and in serious cases, fines of between 10,000 yuan and 30,000 yuan.

46th registrant change does not affect product safety and nutritional adequacy, and special medical purposes effect of matter, failing to apply, by the food and drug administration departments at or above the county level shall be ordered to correct and give a warning; it refuses, fines of between 10,000 yuan and 30,000 yuan.

Registrant's product formulation, manufacturing process changes, which affect product safety, nutritional adequacy and matters of special medicinal effect, does not apply for change, by the food and drug administration departments at or above the county level in accordance with the 124th article of food safety law punishment.

47th food and drug supervision and management departments and their staff to an applicant who does not meet the requirements for registration, or beyond the statutory authority for registration, in accordance with the food safety law, provisions of the 144th article.

Food and drug administration and its staff in the registration and approval process abuse, negligence, malpractice, according to 145th article to deal with the food safety law.

Seventh chapter schedule 48th article special medical uses formula food, is refers to for meet eating by limited, and Digest absorption obstacles, and metabolism disorder or specific disease state crowd on nutrients or dietary of special need, specifically processing preparation and into of formula food, including applies Yu 0月 age to December age of special medical uses baby formula food and applies Yu 1 age above crowd of special medical uses formula food.

49th article suitable for the age of 0月 months to December special medical purposes including lactose-free infant formula formula or low-lactose milk protein partially hydrolyzed formula, formula food, deep hydrolysis of milk protein amino acid formula, formula or premature birth or low birth weight baby formula, amino acid metabolism nutritional supplement formula and breast milk.

50th is applicable to people over the age of 1 formula foods for special medical purposes, including nutritional formula, specific nutrients in food, non-nutritional foods.

Total nutrient formula refers to can be used as a sole source of nutrition to meet the nutritional needs of the target population of formula foods for special medical purposes. Specific nutritional formula refers to as a single source of nutrition to meet the target group in a specific disease or medical condition nutritional demands of formula foods for special medical purposes. Common specific full nutrition formula food has: diabetes full nutrition formula food, respiratory disease full nutrition formula food, nephropathy full nutrition formula food, tumor full nutrition formula food, liver disease full nutrition formula food, muscle attenuation integrated levy full nutrition formula food, trauma, and infection, and surgery and the other should stress state full nutrition formula food, inflammatory sex intestinal disease full nutrition formula food, food protein allergy full nutrition formula food, difficult rule sex epilepsy full nutrition formula food, gastrointestinal road absorption obstacles, and pancreatic inflammatory full nutrition formula food,

Formula foods for fatty acid metabolism nutrition, obesity, reduced fat formula foods for total nutrition. Non-nutritional foods, is one that can meet the nutritional requirement of part of the target population formula foods for special medical purposes and not used as a single source of nutrition.

Common non-nutritional food: nutrient components (components, components of fat, carbohydrate components of protein), electrolyte formulation, thickening component formula liquid formulation and amino acid metabolism disorders.

51st medical institutions to prepare for the patient to eat nutritional meals do not apply these measures. 52nd these measures come into force on July 1, 2016.