The production permit management draft of health food is released (the full story)

The production permit management draft of health food is released (the full story)
Www.chinanews.com electricity, for strengthen the intersection of health food and the intersection of production permit and management, 20 day, national the intersection of food and medicines supervise administration bureau announce in official site their September 20 <>Full story, solicit the opinion of various circles of society publicly. The following are draft full texts of opinions: Production permit management of health food (draft Article 1 of general provisions of chapter one, in order to standardize the production permit management of health food, according to " safety law of the People's Republic of China food ", provisions about laws and regulations such as " administrative licensing law of the People's Republic of China ", " safety law implementing regulations of the People's Republic of China food ",etc., make this method. Application that this method is suitable for of article 2 in production permit of domestic health food of the People's Republic of China, examining and approving and supervising and managing. National food medicines of article 3 supervise the management that the administration bureau is in charge of production permit of national health food. Food pharmaceuticals administration department of province, autonomous region and municipality directly under the Central Government (hereafter referred to as the provincial food pharmaceuticals administration department) Responsible for the production permit management of health food in this administrative division. The fourth enterprise has not obtained the production permit of health food, can't be engaged in health food production the activity. The provincial food pharmaceuticals administration department of article 5 should accord with the laws and regulations while implementing the production permit of health food, authority, range, terms and procedure with normal and fixed rule, follow the openness, justice and fairness, principle convenient for people. The intersection of article 6 and any unit and individual to behavior of violating this method, have the right, supervise administration bureau or provincial the intersection of food and the intersection of pharmaceuticals administration and department report to national the intersection of food and medicines, national food medicines should verify, deal with to supervise the administration bureau or provincial food pharmaceuticals administration department in time. National food medicines of article 7 should set up and amplify the manufacturing enterprise of health food and permit the management system of information to supervise administration bureau and provincial food pharmaceuticals administration department, announce the production permit relevant information of health food in time. Chapter two is applied for and examined and approved Apply for the enterprises of production permit of health food (hereafter referred to as and apply for enterprises) in article 8 ,Should have " domestic health food products registration certificate " obtained in accordance with the law, accord with the fixed primary condition that " the health food produces the norm well ": (1) Have original adjuvants in conformity with health food variety, quantity produced in ~s places of dealing with and processing, packing, storing etc., keep the environment of this place neat, and keep the distance that stipulate with poisonous, harmful place and other pollution sources; (2) Have production equipment or facility in conformity with health food variety, quantity produced, there is corresponding disinfection, change one's clothes, apparatus or facilities such as washing hands and face, daylighting, illumination, ventilation, antiseptic, dustproof, fly-proof, the protection against rodents, the protection against insects, washing and dealing with the waste water, preserving the rubbish and offal,etc.; (3) Have rational device layout and technological process in conformity with health food variety, quantity produced, prevent original adjuvants, intermediate goods and finished product cross contamination, prevent the finished product from being exposed to toxicant, filth; (4) Employees should be trained through the food production knowledge of health care, are familiar with the operational procedure, the health status accords with relevant requirements. The production persons in charge, persons in charge of quality safety of enterprises should be familiar with the relevant regulation of health food, have academic certificates at or above the junior college level or the above title for technical personnel of the intermediate of relevant specialities, and have health care food production or experience of management of the quality safety of more than 5 years. It can be to the technical staff that the health food carried on quality control and quality inspection produced that there enterprises; (5) Health management systems such as training, employee's health examination, health file with assurance health care food security in conformity with health food variety, quantity produced,etc., purchase and check management systems of food security such as recording, delivery inspection record, original adjuvants confirmation, production process,etc.; Laws and regulations and national industrial policy have other requirements on producing the health food, should accord with this requirement. Article 9 it applies for enterprises to be should to produce the intersection of place and provincial food pharmaceuticals administration department of site, file an application, and submit the following materials: (1) Production permit application form of health food; (2) The business license copy or enterprise name which the administrative department for industry and commerce provides checks and approves the notice in advance; (3) Apply for to enterprise's legal representative (the person in charge of enterprises) I.D. copy; (4) Produce the legal documentary evidence that used of field; (5) Produce the place, surrounding environment picture, production factory general layout (auxiliary fields such as including the workshop, test field so and warehouse related to producing,etc.) ; (6) Plane figure of the workshop (including locker room, toilet, stream of people, logistics passway, air brake,etc., indicate people, the intersection of thing and flow into and the intersection of air and the intersection of cleanliness and grade, air cleaning system blow, answer the wind, air exhaust level layout drawing, level layout drawing of the technological equipment) ; The drawing needs to indicate the true size; (7) Plan to produce the variety and " domestic health food products registration certificate " copy, quality criteria or products technical requirement, label manual sample manuscript; (8) Plan to produce the prescription (main raw materials) of dosage form and variety , process chart; (9) Main production equipment and examining the instrument list; (10) Production management, management system catalogue of quality; (11) Quality survey report up to the standards of three sets of continuous samples; (12) The test organization with qualification provides examining reports such as air cleanliness in a last year, water quality,etc.; (13) Resume, education or professional title certificate copy for producing management and quality control person in charge, technical staff's registration form; (14) Apply for to enterprise's legal representative (the person in charge of enterprises) Ones that handle production permit of health food, should show their original papers of I.D.; The agent handled production permit of health food, should offer and apply for to enterprise's legal representative (the person in charge of enterprises) The letter of authority provided and I.D. copies of both sides of commission, and show agent's I.D. original paper and is verified; (15) Other materials that contribute to permitting being examined. Processes such as the pre-processing of raw materials, drawing,etc. need to trust other enterprises to finish, should refer the the intersection of craft and explanation, the intersection of intermediate goods and quality criteria to and store, transport, require, commission the legal documentary evidence that produced of enterprises. It should be responsible for their integrality of application material, authenticity to apply for enterprises. After the provincial food pharmaceuticals administration department of article 10 receives the application materials, should examine the form to regulation, integrality of applying for materials within 5 days, and make it Decision accepted. The provincial food pharmaceuticals administration department of article 11 should deal with separately applying for the permission application that enterprises put forward according to the following situations: ? ? One) Ones that apply for the item and does not need to obtain production permit of health food in accordance with the law, should tell immediately that refuse to accept; (2) Apply for the item in accordance with the law not belonging to limits of functions and powers of this department, should make the decision to will not be accepted immediately, and tell that applies for enterprises to apply for to relevant administrative organs; (3) What the application material can be corrected on the spot while existing is wrong, should allow to apply for enterprises to correct on the spot, applying for enterprises should confirm in correcting the stamped signature of the content; (4) The application material is not complete or does not accords with the legal and formal one, should at one time tell that it needs to mend all positive materials to apply for enterprises on the spot or within 5 workdays, the one that does not tell on the expiration of the time limit is accepting from the day of receiving application material; (5) Not yet complete or does not accord with the legal and formal one after the application material is added and corrected, the provincial food pharmaceuticals administration department can demand to continue adding and correcting. Without good reason, exceed 2 months and does not submit and add and correct the material from the day of telling and adding and correcting requiring, deemed to give up applying; (6) Applying for the item belongs to the limits of functions and powers of this department, the application material is complete and according with the legal form, or submit and all add and correct the material as requested, should accept. The provincial food pharmaceuticals administration department of article 12 should organize examining technology in applying for the materials in 20 days from the day of accepting, verify live. Accord with primary condition and relevant requirement that " the health food produces the norm well ", to " production licence of health food " of applying for enterprises and issuing, and send within 10 days; To requirement not in accordance with regulation, will not make the decision of the administrative licensing and give reasons in writing, tell and apply for enterprises at the same time and enjoy and apply for revision trial, administrative reconsideration or right to bring administrative litigation in accordance with the law. Applied for enterprises and put forward and recalled the application in writing before the production permit of health food determine to make in article 13, the provincial food pharmaceuticals administration department should stop examining according to their applications, unless return the application material, but apply for enterprises and file the false material to apply to permitting. Set up adjoining page in article 14 " production licence of health food ". " the style for producing the licence " of health food is supervised the administration bureau making in unison by national food medicines. The serial number form of " production licence of health food " is: Province (autonomous region, municipality directly under the Central Government) Abbreviated as + eat and strong in growing +4 titles of an emperor's reign and +4 serial numbers of card word. The article 15 " production licence of health food " should state licence serial number, enterprise's name, legal representative (the person in charge of enterprises) clearly , registered address, production address, health food dosage form, organ issuing the licence, date, term of validity of issuing licence,etc. project produced. Relevant information that mark out the health food variety name produced in the adjoining page, the certificate alters. Raw materials pre-processing, the intersection of person who draw and process trust whom other enterprise finish, should mark out, commission the intersection of enterprise and name and item of trusting in adjoining page. The production licence validity of 16th health food is 5 years. The article 17 " production licence of health food " can't be transferred, alter, lend, profiteering, hiring out. The manufacturing enterprise of 18th health food should be producing the obvious position in the place and is " production licence of health food " is hung or put. The same health care food production place of article 19, only permit to apply for a " production licence of health food ", can't apply for repeatedly. The same the intersection of health food and manufacturing enterprise in different to produce place, engaged in health food production activity, should apply for " production licence of health food " separately. The food production place of the 20th health care can't be used for producing medicines and waiting for the other products that may influence the quality safety of health food. Manufacturing enterprise should organize producing the health food according to the variety that " production licence of health food " state clearly, the health food that produces beyond the scope of variety is regarded as the production without licences. Chapter four is altered, extended, reissued and cancelled Article 21 has already been obtained" the enterprises producing the licence " of health food are producing the address and newly building, reconstructing, extending or increasing and producing dosage form originally ", should be at the request of article 9 of this method, the provincial food pharmaceuticals administration department that the newspaper issues licence originally applies for the alteration. Qualified, authorize the new " production licence of health food ". Have already made " newly-built enterprise's changes address producing the licence " of health food, according to procedure and requirement which the manufacturing enterprise of health food runs in this method, file an application to the provincial food pharmaceuticals administration department in the site. Qualified, authorize the new " production licence of health food ". Article 22 has already been obtained" the enterprises producing the licence " of health food need increasing and producing variety or alteration raw materials pre-processing within the range of production that has already been sanctioned ", manufacturing enterprise of drawing etc., should relevant regulations of article 9 refer the corresponding material to according to method this, and the provincial food pharmaceuticals administration department that issues licence originally in newspaper applies for the alteration. Qualified, mark out the alteration content in the adjoining page of original " production licence of health food ". Registered the item in alteration name, legal representative, registered address of enterprise,etc. of " production licence of health food " of manufacturing enterprise of 23rd health food, should file an application to the provincial food pharmaceuticals administration department that issues licence originally in 30 days after the administrative department for industry and commerce check and approve to alter, and submit the following materials: (1) The production licence of health food alters the application form; (2) The administrative department for industry and commerce checks and approves the business license of the alteration or checks and approves to alter the notice copy; (3) Production licence copy of health food. After the alteration of the article 24 " production licence of health food ", the provincial food pharmaceuticals administration department issuing licence originally should record content and time of the alteration in the adjoining page of " production licence of health food ", retract the original " production licence of health food ", the term of validity does not change in " production licence of health food " after the alteration. Article 25 " the intersection of health food and production licence " term of validity apply for enterprise, plan, continue, produce expire, should put forward to provincial food pharmaceuticals administration department issuing licence originally and extend the application before the term of validity expire for 30 days. Overdue to file an application, according to applying for " production licence of health food " to handle newly. Article 26 applied to extend " production licence of health food ", should offer the following materials: (1) " production licence of health food " extends the application form; (2) Copy of original " production licence of health food "; (3) The working condition permitted originally changes Or unchanged explanation material; (4) Other materials which the provincial food pharmaceuticals administration department stipulates. Article 27 issues licence after the department accepts " production licence of health food " to extend and apply originally, whether should change to production facility, procedure, main technical staff of overall arrangement,etc. permitting originally especially, whether and accord with " the health food produces the norm well " primary condition and relevant requirement,etc. stipulate that verifies. Permit extending, issue the new " production licence of health food ", the card number of the original " production licence of health food " does not change. Retract the original " production licence of health food ". The article 28 " production licence of health food " is altered, extended, should apply to be handled with relevant procedures of examination and approval according to this method. Applied to reissue " production licence of health food " in article 29, applying for enterprises should put forward the written application to food pharmaceuticals administration departments at all levels issuing licence originally and give reasons. Lose, apply, reissue, should refer original paper that loss declare that publish at the the intersection of province and grades of newspapers and periodicals that issue publicly the above to, and file an application after from day when publish on 20 days; Because damage was applied to reissue, should return the original paper of " production licence of health food ". Qualified, according to checking and approving to reissue " production licence of health food " within 10 days after accepting and reissueing the application in item originally, the production licence number, term of validity do not change, and mark out and reissue the reason and reissue date in the adjoining page. Article 30 has one of the following situations, the organ issuing the licence should cancel " production licence of health food " in accordance with the law: (1) " production licence of health food " the term of validity expires and has not applied to extend, or extend and apply not to be sanctioned; (2) Manufacturing enterprise stopped the health food in accordance with the law; (3) " production licence of health food " is cancelled or revoked in accordance with the law; (4) Manufacturing enterprise applied to cancel the health food voluntarily; (5) " other situations for producing the licence " of health food that should be cancelled in accordance with the law. The article 31 " production licence of health food " is cancelled, the persons who hold the card originally should return " production licence of health food " to issuing licence originally in the provincial food pharmaceuticals administration department in time. Provincial the intersection of food and the intersection of pharmaceuticals administration and department should finish, cancel " the intersection of health food and for producing the licence " relevant registration in time. Chapter five entrusts article 32 of the production management and is approved by provincial food pharmaceuticals administration department in the site, the manufacturing enterprise of health food with working condition can accept a commission and produce the health food. The 33rd agent enterprise, to trusting the quality safety for producing health food to be responsible for; Being commissioned in enterprises should guarantee it produces to accord with " the health food produces the norm well " and bear corresponding legal liability. The 34th agent enterprise should possess the following conditions: (1) Legal enterprise legal person who registered within the border; (2) Hold " domestic health food products registration certificate "; (3) Have person in charge of quality in conformity with quality control of the products; (4) Have storage condition in conformity with product management; (5) Set up corresponding production and follow, confirm quality management system of handing over, examining, delivery of cargo from storage, selling, retrieving, complaining and dealing with,etc. and record. Article 35 is commissioned in enterprises and should possess the following terms: (1) Hold and trust and produce the products " production licence of health food " of the same dosage forms; (2) Have, produce, trust ability and terms of health food in the whole course from raw materials to products; (3) Have and trust the products original adjuvants, intermediate goods, test ability that finished quality criteria test demand to meet; (4) Have complete management system of quality of production of products that can be traced back to; (5) Producing the field, apparatus and other conditions should meet the requirement producing the variety and total amount in the same period. Apply for and entrust and produce the health food in article 36, agent enterprise and site of should commission enterprise together to commission enterprising provincial the intersection of food and the intersection of pharmaceuticals administration and department file following the intersection of application and materials: (1) The health food is trusted the application form of production; (2) Consignment that enterprises signed with commissioning of agent enterprise, including basic important document, technological process and original adjuvants, intermediate goods, finished quality criteria of contract,etc.; (3) The plane figures of management place and storage place of agent enterprise; (4) Product quality management system file of agent enterprise; (5) Apply, trust " the domestic the intersection of health food and the intersection of products and registration certificate " and the intersection of enterprise and business license or legal documentary evidence copy of registration of agent enterprise to produce products; (6) Commissioned " production licences of health food ", business license copies of enterprises; (7) Trust the labels, catalogues (sample manuscript) which produce the health food ,Should indicate the agent enterprise and be commissioned enterprise's name, address and commissioned enterprise's health food production licence number; (8) Agent enterprise, commissioning the letter of commitment of quality safety of the enterprise products; (9) Across what the Provincial Party committee holds, the agent enterprise should offer site department's examination reports of pharmaceuticals administration of provincial food. Provincial food pharmaceuticals administration department should finish examining article 37 in 20 days after accepting, if necessary, and commissioned in the production scene of enterprises and check to the agent enterprise. Qualified, should sanction, and authorize the health food and entrust the document of production approval to the agent enterprise, content of marking out the unit name, address of agent enterprise and trusting and producing the name of product of the health food, authentication code, trusting time limit etc., increase and entrust the health food name produced in adjoining page of " production licence of health food " that is commissioned in enterprises at the same time. Ones that refuse to sanction, should request in writing to enterprises, and explain the reason. Hold production across the Provincial Party committee, commissioned in the provincial food pharmaceuticals administration department of enterprise site should check the result makes a copy for the provincial food pharmaceuticals administration department of site of agent enterprise. Article 38 trusts time limit to be year shortest, can't exceed the validity when is commissioned the production licence that enterprises hold at most. Trust time limit to keep the same with contract term. The 39th agent enterprise can't entrust within the same time limit two and production of the above enterprise of the same product. Different products trusted different enterprises to produce, should apply according to the regulation separately. Stop, trust, produce in trusting time limit, should commission enterprise, put forward the written application together by agent enterprise, commissioned in the provincial food pharmaceuticals administration department of the enterprise site and can abrogate and entrust the document of production approval, has not elapsed one years in indentured period, not in one year Must apply for this variety and entrust production again. Chapter six should strengthen the prison implementing production permit of health food to the provincial food pharmaceuticals administration department to supervise the administration bureau while supervising and inspecting national food medicines of article 40 Superintend and direct, check, find, violate regulation, implement the intersection of health food and production permit, should order, correct or correct directly within a definite time period. Article 41 has one of the following situations, do the provincial food medicines making the decision to permit make sure that manage? Yu one vomits Yang A � Yi is called fragrant Sweet-smelling burnt Fei pierces the clock �� and carries waste � Dong =Does �� claim to fly in ��� sulphone �� workshop Ran �� of Chinese herbaceous peony and raise �� well? (1) Surmount the permission decision that the legal functions and powers are made; (2) Violate the permission decision that the due course of law is made; (3) Apply for enterprises and obtain permitting with the improper means of cheating, bribing etc.; (4) Forge, alter, lend " production licence of health food " or sanction the file; (5) Other situations that should be cancelled. The article 42 " production licence of health food " is cancelled, pharmaceuticals administration department should take over, register the food in time, and announce, request in writing to the administrative department for industry and commerce at the same time. Article 43 violated relevant laws and regulations in implementing the administrative licensing that this method stipulates, deal with according to relevant laws and regulations. The time limit of implementation administrative licensing that this method stipulates of article 44 of supplementary provisions of chapter seven is calculated with workday, do not include legal festivals or holidays. Article 45 way this is supervise the administration bureau responsible for explaining by national the intersection of food and medicines. Originally method of article 46 enters into force on 2011 date.

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