Jiangsu Province issued the”Administrative Measures for the Operation and Use of Formula Foods for Special Medical Purposes in Jiangsu Province (Trial)”
By: Date: 2021-01-01 Categories: chinesefood Tags: ,
   On December 29, 2020, the Provincial Market Supervision Bureau, the Provincial Health Commission and the Provincial Medical Security Bureau jointly issued the”Administrative Measures for the Operation and Use of Formulas for Special Medical Purposes in Jiangsu Province (Trial)” (hereinafter referred to as the”Measures”), This is the first provincial-level regulatory document for the supervision of the operation and use of formula foods for special medical purposes jointly issued by multiple departments in the country. The”Measures” will be officially implemented on February 1, 2021.
   There are six chapters in the”Measures”, 38 articles:General rules, basic requirements, requirements for the use of medical institutions, requirements for the operation of network entities, requirements for operation of other places and supplementary rules, focusing on three aspects:

  01

   clarified the division of labor and responsibilities of the supervision departments for the operation and use of formula foods for special medical purposes.
   The”Measures” clarify that the market supervision department is responsible for the supervision and management of the business links of the special medical formula food operators. The administrative department of health and health shall instruct medical institutions to supervise the deployment and use of formula food for special medical purposes. The medical security department shall standardize designated medical institutions to do a good job in the management of the procurement and cost settlement of formula foods for special medical purposes paid by the basic medical insurance fund.
  02

   emphasized the principle of admission and prohibition of formula foods for special medical purposes.
   The”Measures” stipulate that operators of formula foods for special medical purposes shall obtain a food business license, and the permitted business items shall specify”formula foods for special medical purposes”. Specific nutritional formula foods in formula foods for special medical purposes shall be sold to consumers through medical institutions or pharmaceutical retail enterprises. The operator prohibits false and exaggerated publicity and deceives and misleads consumers. It is strictly forbidden to sell or use without national registration approval, expressly or imply that it can be used to meet the special needs of food restriction, digestion and absorption disorders, metabolic disorders or specific diseases for people with special nutrients or diet. Food.
  03

   clarifies the positioning of formula foods for special medical purposes in medical institutions.
   The”Measures” propose to encourage medical institutions to actively develop the clinical application of formula foods for special medical purposes. Encourage medical institutions to incorporate the use of formula foods for special medical purposes into the medical institution’s information system, and connect with subsystems such as prescriptions, medical orders, charges, and warehouse management to achieve standardized management throughout the use process. Medical institutions can refer to the management model of medicines to code and charge the registered and approved formulas for special medical purposes, so as to facilitate the centralized and standardized management of charging related links such as the purchase, warehousing, issuance, and outbound sales of formula foods for special medical purposes.
  The promulgation of the”Measures” marks the achievement of landmark results in the high-quality supervision of formula foods for special medical purposes in our province. In the next step, the three departments will continue to jointly promote the development and clinical application of formula foods for special medical purposes in our province, and contribute Jiangsu experience to the supervision and management of formula foods for special medical purposes.
   Jiangsu Province Special Medical Purpose Formula Food
  Management Measures for Operation and Use (Trial)
  Chapter One General Provisions
  Article 1 In order to strengthen the quality management of special medical formula food business, regulate the business behavior of special medical formula food, and ensure food safety, in accordance with the”Food Safety Law of the People’s Republic of China” and”The Implementation Regulations of the Food Safety Law of the People’s Republic of China””Regulations for the Registration of Formulas for Special Medical Purposes” and other laws, regulations and rules, formulate these measures.
  Article 2 The formula food for special medical purposes mentioned in these Measures refers to the formula foods that have been registered by the national market supervision and administration department and can be marketed in the country to meet the needs of people with restricted eating, digestion and absorption disorders, metabolic disorders or specific diseases. Special dietary needs, specially processed and formulated formulas, including formulas for special medical purposes for infants from 0 months to 12 months of age and formulas for special medical purposes for people over 1 year old. These measures are not applicable to the nutritious meals prepared by medical institutions for patients.
  Article 3 These Measures are applicable to the operation supervision and quality management of formula foods for special medical purposes in the administrative area of ​​Jiangsu Province. For those only engaged in the storage and transportation of formula foods for special medical purposes, the relevant process quality control requirements of these Measures shall apply.
  Article 4 The business entities of formula foods for special medical purposes include food sales operators (including network operators), pharmaceutical retail companies and medical institutions that use formula foods for special medical purposes, etc., hereinafter collectively referred to as operators of formula foods for special medical purposes .
  Article 5 Operators of formula foods for special medical purposes shall obtain a food business license, and the permitted business items shall specify”formula foods for special medical purposes”.
  Specific full-nutrition formula foods in formula foods for special medical purposes shall be sold to consumers through medical institutions or pharmaceutical retail companies. Medical institutions and pharmaceutical retail enterprises that only sell specific full-nutrition formula foods in formula foods for special medical purposes do not need to obtain a food business license, but they shall comply with the requirements of these Measures on the management and management of formula foods for special medical purposes.
  Article 6 Operators of formula foods for special medical purposes shall adopt effective quality control measures in the procurement, storage, sales and use of formula foods for special medical purposes to ensure food safety.
   Special medical formula food operators shall establish a food safety traceability system, and truthfully record and keep information on the purchase inspection and product sales of formula foods for special medical purposes in accordance with the Food Safety Law, Food Safety Law Implementation Regulations and other laws and regulations, Ensure traceability.
  Article 7 Operators of formula foods for special medical purposes are strictly prohibited from selling or using formula foods that have not been approved by the state, expressly or impliedly, can be used to meet the dietary restrictions, digestive and absorption disorders, metabolic disorders, or special diseases for people with specific nutrients or diets. Need food.
  Article 8 Operators of formula foods for special medical purposes shall adhere to honesty and trustworthiness, operate in accordance with the law, and prohibit false propaganda and deceit and mislead. Regulatory departments should strengthen credit supervision and restraint, encourage operators of formula food for special medical purposes to operate in good faith, and create a business order and environment for safe consumption.
  Chapter Two Basic Requirements
  Article 9 The market supervision department is responsible for the supervision and management of the business links of the special medical formula food operators.
  Article 10 Operators of formula foods for special medical purposes shall be equipped with full-time or part-time food safety management personnel. Food safety management personnel shall be trained in food safety laws, regulations, standards, nutrition, pharmacy and other relevant professional knowledge, and pass the assessment.
  Article 11 Operators of formula foods for special medical purposes shall inspect the licensing qualifications, product registration certificates, product qualification inspection reports, inspection and quarantine certificates of imported products, etc. of suppliers and manufacturers of formula foods for special medical purposes , Check whether the contents of the food labels and instructions are consistent with the registered labels and instructions, truthfully record the product name, specification, quantity, production date or batch number, shelf life, purchase date and supplier name, address, contact information, etc., and save the relevant Voucher records. The retention period of records and vouchers shall not be less than 6 months after the expiration of the product warranty period.
  Article 12 Operators of formula foods for special medical purposes shall carry out transportation, storage and display in accordance with the warning signs, warning instructions or precautions on the labels of formula foods for special medical purposes. For formula foods for special medical purposes that require temperature and humidity control, operators of formula foods for special medical purposes shall be able to meet the temperature and humidity requirements for product storage and sales.
  Article 13 Operators of formula foods for special medical purposes shall set up special areas or counters (shelves) for the storage, display and sale of formula foods for special medical purposes, and shall not be mixed and sold with other commodities such as general foods and medicines . The sales area or the counter (shelves) should be set up in a prominent position, indicating:”Special medical formula food sales area (or counter)”, the reminder is white on a green background (black), and the size should be such that consumers Eye-catching identification.
  Article 14 Operators of formula foods for special medical purposes engaged in wholesale business shall establish a sales record system to truthfully record the name, specification, quantity, production date or production batch number, shelf life, and date of sale of formula foods for wholesale special medical purposes. And the name, address, and contact information of the buyer. The storage period of relevant sales records and vouchers shall not be less than 6 months after the product warranty expires.
  Article 15 Operators of formula foods for special medical purposes shall establish a system for disposing of unqualified foods, regularly check stocks and shelf-displayed formulas for special medical purposes, and promptly clean up damaged, deteriorated or expired products that cannot guarantee product safety Nutritionally adequate products.
  Article 16 Operators of formula foods for special medical purposes shall establish a product recall record system. For formula foods for special medical purposes that need to be recalled, operators of formula foods for special medical purposes shall immediately stop selling them, and adopt a notice or announcement. Inform relevant producers and operators of formula foods for special medical purposes to stop production and sales, and consumers to stop eating, and report to local regulatory authorities.
  Article 17 Advertisements for formula foods for special medical purposes shall be reviewed by the advertising review agency, and the content shall be subject to the product registration certificate, product label and manual, and clearly indicate the applicable population,”not suitable for use by non-target groups”” Please use it under the guidance of a doctor or clinical nutritionist.”
  Chapter Three Requirements for the Use of Medical Institutions
  Article 18 The administrative department of health shall instruct medical institutions to supervise the preparation and use of formula foods for special medical purposes.
  The medical security department shall standardize designated medical institutions to do a good job in the management of the procurement and cost settlement of formula foods for special medical purposes paid by the basic medical insurance fund.
  Article 19 Encourage medical institutions to actively carry out the clinical application of formula foods for special medical purposes, and establish and improve the selection, procurement, storage, deployment, clinical application and evaluation of formula foods for special medical purposes in accordance with relevant laws, regulations and technical specifications. Management System.
  Article 20 Medical institutions that use formula foods for special medical purposes shall set up relevant warehouses, manage them in accordance with the storage, deployment system and prescription review system, and keep complete daily/monthly records of outbound, inbound, and inventory And credentials.
   Encourage medical institutions to incorporate the use of formula foods for special medical purposes into the information system of medical institutions, and connect with subsystems such as prescriptions, doctor orders, charges, and warehouse management to achieve standardized management throughout the use process.
  Article 21 Medical institutions shall strengthen the review and inspection of purchases in accordance with these Measures, and strictly prohibit the purchase and use of foods that have not been registered by the state, expressly or impliedly have the characteristics and uses of formula foods for special medical purposes, and ensure that the products are legal and compliant.
   Article 22 Practicing physicians or dietitians in medical institutions that use formula foods for special medical purposes are responsible for reviewing and evaluating the suitability of formula foods for special medical purposes for clinical application, and guiding patients to select and use formula foods for special medical purposes.
  Medical institutions shall train and evaluate practicing physicians and dietitians who use formula foods for special medical purposes. Only after passing the examination can formulate food prescriptions for special medical purposes. Training and assessment content should include:
   (1)”Food Safety Law”,”Food Safety Law Implementation Regulations” and other relevant laws, regulations, rules, national food safety standards and normative documents;
   (2) Clinical application and management system of formula food for special medical purposes;
   (3) Nutritional characteristics and precautions for use of formula foods commonly used for special medical purposes;
   (4) Prevention and treatment of malnutrition.
  Article 23 Medical institutions shall regulate the charge management of formula foods for special medical purposes, and may refer to the management model of drugs, and charge the registered and approved formula foods for special medical purposes to facilitate the purchase of formula foods for special medical purposes. Centralized and standardized management of charging-related links such as warehousing, issuance and outbound sales.
   Article 24 Medical institutions that need to make temporary preparations of formula foods for special medical purposes shall be completed in a preparation operation room with sanitary and disinfection conditions to ensure that the preparation process is pollution-free.
   If medical institutions need to refill formula foods for special medical purposes, it should be completed in an independent enteral nutrition configuration room, which should be equipped with hand washing, disinfection, dressing, air disinfection, weighing, waste disposal, etc. Equipment and facilities, and establish corresponding operating procedures and sanitation management systems.
  Article 25 Medical institutions shall establish a health management system for post personnel. Those suffering from diseases that hinder food safety and other infectious diseases as prescribed by the health department of the State Council shall not engage in the preparation and feeding of formula foods for special medical purposes.
  Article 26 Medical institutions shall establish nutritional medical records for hospitalized patients who purchase formula foods for special medical purposes through medical institutions, and include them in electronic medical record management if possible.
   Article 27 Medical institutions shall establish an adverse reaction record system. Collect and record adverse reactions caused by eating methods, product characteristics, individual differences in consumers, etc., and timely feedback to manufacturers, market supervision departments and clinical nutrition quality control agencies in accordance with relevant regulations and procedures.
  Chapter 4 Operational Requirements of Network Entities
  Article 28 Network operators operating formula foods for special medical purposes shall have physical business premises or storage locations, and the physical business premises or storage premises must meet the requirements for the management of special medical-purpose formula foods specified in Chapter 2 of these Measures Claim.
  Article 29 Network operators shall publish business license information, food production and operation license information, or link identification of the above information in a prominent position on their homepage. The product sales page should also publicize the special medical formula food registration certificate in a prominent position and link to the corresponding data query page of the market supervision department website.
  Article 30 Network operators should mark the following warning words in a prominent position on the special medical-use formula sales page:Special medical-use formulas should be used under the guidance of doctors or clinical nutritionists, and are not suitable for use by non-target groups. It is forbidden to be used for parenteral nutrition support and intravenous injection.
  Article 31 Network operators’ promotion of special medical formula food product names, formulas, nutritional characteristics, applicable people, etc. should be consistent with the content of the product label, manual and product registration certificate, and must not contain false content or Involved in disease prevention and treatment functions.
  Article 32 Internet operators operating formula foods for special medical purposes shall keep the purchaser’s name, address, contact information, and the name of the purchased commodity, and other transaction record information, and the retention period shall not be less than three years from the date of completion of the transaction .
  Article 33 Providers of third-party online business platforms shall require network operators that apply to enter the platform to sell formula foods for special medical purposes to submit their subject registration, storage address, contact information, and specify”formula foods for special medical purposes” Real information such as the valid food business license of the company, establish registration files, and regularly check and update.
  Chapter 5 Operation Requirements for Other Places
  Article 34 Operators of centralized trading markets, counter lessors, and fair organizers shall review the business licenses of operators of formula foods for special medical purposes that enter the market in accordance with the law, and conduct regular inspections on their business environment and conditions. If the inspection finds illegal behavior, it shall be stopped in time and reported to the local market supervision department.
   Article 35 Those engaged in the storage, transportation or distribution of formula foods for special medical purposes shall store and transport formula foods for special medical purposes in accordance with the requirements of ensuring food safety, and truthfully record the names and addresses of the entrusting party and the consignee The storage period of records and contact information shall not be less than 2 years after storage and transportation.
  Chapter VI with additional rules
   Article 36 The medical institutions mentioned in these Measures refer to hospitals, health centers, nursing homes, maternal and child health institutions, and community health service centers that have obtained the”Medical Institution Practicing License” and are engaged in disease diagnosis and treatment activities in accordance with the law ( Stations), outpatient departments, clinics and other institutions.
   Article 37 This approach is interpreted by the Jiangsu Provincial Market Supervision Administration, the Jiangsu Provincial Health Commission and the Jiangsu Provincial Medical Security Bureau according to their respective duties. Where laws, regulations, rules and national food safety standards provide otherwise, those provisions shall prevail.
  Article 38 This method shall come into force on February 1, 2021.