Administrative measures for precursor chemicals in medicine
(March 18, 2010 the Ministry of Health announced as of May 1, 2010, 72nd) Chapter I General provisions
First to strengthen drug precursor chemicals management category to prevent diversion into illicit channels, in accordance with the regulation of precursor chemicals (hereinafter referred to as the regulations), these measures are formulated.
Drug precursor chemicals in section refers to the regulations set forth in the lysergic acid, ephedrine and other substances, list of varieties see annex 1 to this approach.
Approved by the State Council to adjust classification and varieties of precursor chemicals involving precursor chemicals in medicine, the State food and Drug Administration should be adjusted and made public in a timely manner.
Third drug precursor chemicals in such production, management, purchase and supervision procedures apply.
Fourth head of the State food and Drug Administration national drug precursor chemicals in such production, management, purchase and other aspects of regulatory work.
Local food and drug supervision and administration at or above the county level responsible for the administration of precursor chemicals in medicine production, management, purchase and other aspects of regulatory work.
Chapter II production and business license
Fifth production of precursor chemicals, drug class, shall, in accordance with the Ordinance and these rules require the drug precursor chemicals category production and operation license.
In the production of drug precursor chemicals that are varieties of drugs, should also be in accordance with the pharmaceutical administration law and related provisions, drug approval.
The sixth drug-producing enterprises to apply for production of drug precursor chemicals, shall comply with the conditions provided for in the seventh of the to the local food and drug regulatory agency of provinces, autonomous regions and municipalities to apply, submit the following information:
(A) drug precursor chemical production category application form (see annex 2);
(B) the drug manufacturing license, certification of good manufacturing practices certificate and copy of business license;
(C) enterprises and drug precursor chemicals management organization chart (indicate responsibilities and relationships of various departments, Department heads);
(D) reflect the current condition of the surrounding environment, the General layout, storage layout, quality inspection place floor plans, drug precursor chemical production sites in category layout (State drug precursor chemicals in such an appropriate security management facilities);
(E) drug precursor chemical safety category system file directory;
(F) set up TV monitoring facilities in key areas of description and proof of alarm and public security organs;
(G) the legal representative of the enterprise, business leaders and technology, managers have the knowledge of drug precursor chemicals-related instructions materials;
(H) the legal representative of the enterprise and related staff in drug-free criminal record certificate;
(I) the production can only be used as pharmaceutical intermediates and drug precursor chemicals category, should also provide the legal description and other relevant information. Seventh provinces, autonomous regions and municipalities directly under the food and drug supervision and Administration Department shall from the date of receipt of the application within the 5th, to review the information and decide whether or not to accept. Accepted, finished in 30th spot checks, checks the results together with the enterprise reporting data submitted to the State food and drug administration.
State food and Drug Administration should be finished in 30th substantive review of compliance, be granted the drug precursor chemical production category of permit (hereinafter referred to as the production of license documents, see annex 3), indicate the license production of drug precursor chemicals category name; no permission, and shall state the reasons in writing. Article eighth drug manufacturers after receiving the permit, should be to the local provinces, autonomous regions and municipalities directly under the food and Drug Administration change the scope of pharmaceutical production license production applications.
The provinces, autonomous regions and municipal food and drug supervision and management departments should be on the basis of the production permit, in the production of the original scope of the pharmaceuticals production license marked "precursor chemicals in medicine"; in the copy of the production range marked "precursor chemicals in medicine", the bracketed annotations and drug precursor chemicals in category names. Nineth precursor chemicals in medicine production enterprises to apply for renewal of the pharmaceuticals production license, provinces, autonomous regions and municipal food and drug supervision and Management Department subject to review in accordance with the measures for the supervision and administration of drug production, but also for enterprises of drug precursor chemicals production conditions and to review the safety management.
To meet the requirements of, and continues through the renewal of the pharmaceutical production license tagging pharmaceutical precursor chemicals category scope and variety name; does not meet the provisions of the State food and drug administration.
The State food and Drug Administration received from provinces, autonomous regions and municipalities directly under the food and Drug Administration report, does not meet the requirements of enterprise's cancellation of its production permit, and notify the local provinces, autonomous regions, municipalities directly under the food and Drug Administration to remove the enterprise the drug production licenses in the range of drug precursor chemical production category.
Article tenth class of precursor chemicals manufacturers no longer produce precursor chemicals in medicine, you should stop production and operation for cancellation within 3 months after the relevant licensing procedures.
Drug class of precursor chemicals are not produced by the manufacturer for 1 year, shall report in writing where food and drug regulatory agency of provinces, autonomous regions and municipalities; needs a resumption of production, should be the local provinces, autonomous regions and municipalities directly under the food and drug supervision and Management Department of the production conditions and safety management of on-site inspections.
11th drug precursor chemical production industry category changes the address scope, variety, should renew bid for the production of license documents.
Drug precursor chemical production enterprise change category name, legal representative of the person, the local provinces, autonomous regions and municipalities directly under the food and drug supervision and Administration Department for the pharmaceutical production license change, submitted to the State food and drug administration records.
Article 12th class of precursor chemicals and medicine preparations may not authorize the production of precursor chemicals.
Pharmaceutical producing enterprises shall not accept offshore vendor delegate processing drug precursor chemicals and products containing precursor chemicals in drug classes; special situations need to be processed, to be approved by the State food and drug administration.
13th drug precursor chemicals category business license, the State food and Drug Administration commissioned province, autonomous region, or municipality directly under the food and drug supervision and Administration Department.
Drug precursor chemicals in such preparations and a small Pack of ephedrine into narcotic sales channel management, only by narcotic drugs a national wholesale enterprises and regional wholesale distribution enterprises shall not retail.
Implementation of management of drug approval number, into the drug class drug precursor chemicals management.
14th pharmaceutical trading enterprises to apply for drugs type of drug precursor chemicals, should be consistent with the regulations stipulated in the Nineth of conditions to the local food and drug regulatory agency of provinces, autonomous regions and municipalities to apply, submit the following information:
(A) drug class drug precursor chemicals management application form (see annex 4);
(B) the narcotic drugs and psychotropic substances designated management qualification or second psychotropic drug marketing status of the drug business license, drug quality control standard certificate and copy of business license;
(C) enterprises and drug precursor chemicals management organization chart (indicate responsibilities and relationships of various departments, Department heads);
(D) reflect the current condition of the surrounding environment, general layout, storage floor plan (State drug precursor chemicals in such an appropriate security management facilities);
(E) drug precursor chemical safety category system file directory;
(F) set up TV monitoring facilities in key areas of description and proof of alarm and public security organs;
(G) the legal representative of the enterprise, business leaders and marketing, managers have the knowledge of drug precursor chemicals-related instructions materials;
(H) the legal representative of the enterprise and related staff without proof of drug-related crimes recorded. 15th of provinces, autonomous regions and municipalities directly under the food and drug supervision and Administration Department shall from the date of receipt of the application within the 5th, to review the information and decide whether or not to accept.
Accepted, finished in 30th spot checks and reviews, in conformity with the provisions and scope of business in the pharmaceutical business license marked "precursor chemicals in medicine", and report to the State food and Drug Administration for record; no permission, and shall state the reasons in writing.
Chapter III purchased license 16th State licensing system for pharmaceutical precursor chemicals purchase category.
Purchases of drug precursor chemicals, should go through the classes in the drug purchase and use of precursor chemicals (hereinafter referred to as the purchase and use of), but except in the case provided for in article 21st of this approach.
The purchase and use of uniformly printed by the State food and Drug Administration (styles, see annex 5), valid for 3 months.
Article 17th of the purchase and use of the application range:
(A) the approved drug class of precursor chemicals used in drug production and drug production enterprises;
(B) the use of precursor chemicals in medicine teaching and research units;
(C) with the drug precursor chemicals category qualified drug-handling enterprises;
(D) access to medications such export licenses exports of precursor chemicals enterprises;
(E) by the Ministry of agriculture in conjunction with the State food and Drug Administration issued a veterinary veterinary drug manufacturers of the production plan of ephedrine hydrochloride injection.
Drug precursor chemical production industry category use drugs type of drug precursor chemicals used in drug production, according to provisions of the purchase and use of these measures.
18th article purchase drug class easy business HIV chemicals should meet Ordinance 14th article provides, to location province, and autonomous regions, and municipalities food drug supervision management sector or province, and autonomous regions food drug supervision management sector determine and announced of set district of city level food drug supervision management sector proposed application, filled purchase drug class easy business HIV chemicals application table (see annex 6), submitted corresponding information (see annex 7). 19th district of the municipal food and drug supervision and Administration Department shall from the date of receipt of the application within the 5th, to review the information and decide whether or not to accept. Accept, if necessary, organize on-site inspections, inspection results together with the enterprise reporting information submitted within the 5th provincial and State food and drug administration.
Province and autonomous region food and drug supervision and Administration Department shall complete the review within the 5th, in conformity with the provisions issued to the purchase and use of; no permission, and shall state the reasons in writing.
Food and drug regulatory agency of provinces, autonomous regions and municipalities directly admissible, it should be completed in the 10th from the date of receipt of the application for review and the necessary on-site inspections, compliance, issue of the purchase and use for; not to permit and shall state the reasons in writing.
The provinces, autonomous regions and municipalities directly under the approval of the food and Drug Administration issued prior to the purchase and use of, public security organs should be requested to assist the verification of related content police verification not counting of time spent within this period. 20th only within the validity period of the purchase and use for one use. The purchase and use of shall not be lent or transferred.
Purchases of drug precursor chemicals must be used when the purchase and use for original, copy, faxed copy shall not be used.
21st in line with one of the following circumstances, exemptions apply for the purchase and use of:
(A) medical institutions with narcotic, psychotropic drug purchase and use signature card purchases of drug precursor chemicals, preparations and a small Pack of ephedrine;
(B) the narcotic drugs a national wholesaler, allocating regional wholesale enterprises of narcotic buy small packages of ephedrine and a single purchase of 60,000 tablets of ephedrine tablets, injections of up to 15,000;
(C) according to the provisions for pharmaceutical precursor chemicals category standard and reference substance;
(D) drug precursor chemical production industry category with precursor chemicals export permit for drug export drug precursor chemicals category.
Fourth chapter marketing management
22nd precursor chemicals in medicine production enterprises shall medicine raw materials sales of precursor chemicals to make the purchase and use of drug manufacturers, drug-handling enterprises and foreign trade companies. Article 23rd drug precursor chemicals business enterprise should be in category medicine raw materials sales of precursor chemicals to the provinces, autonomous regions and municipalities within the administrative area of the purchase and use of the unit.
Drug precursor chemicals in such enterprises between the purchase and sale of drugs type of drug precursor chemicals.
24th teaching and research unit only available with the purchase and use for from narcotic drugs a national wholesale enterprises, regional wholesalers and drug precursor chemicals in such enterprises buy precursor chemicals in medicine. 25th of precursor chemicals in medicine production enterprises should be drug precursor chemical preparations and small packages sell ephedrine to narcotic drugs a national wholesale business. Narcotic drugs a national wholesale, regional wholesale enterprises shall, in accordance with the narcotic and psychotropic drugs under Chapter III of the regulation of channel sales and drug precursor chemicals in such preparations of ephedrine and small packaging.
Narcotic culture-wholesale business and selling drugs between classes of precursor chemical preparations and a small Pack of ephedrine.
Narcotic culture wholesale enterprises for special needs such as medical need prescription drug precursor chemicals in such preparations shall be after transfers transfers within the 2nd situation report the provinces, autonomous regions and municipalities directly under the food and Drug Administration for record.
Article 26th class of precursor chemicals to prohibit the use of cash or in-kind transactions.
27th of precursor chemicals in medicine production enterprises, Enterprise sale of drug precursor chemicals shall establish the purchaser files one by one.
Purchase for non-medical institutions, archives should at least include:
(A) the purchaser of the pharmaceuticals production license, drug trading license, copy of business license and other qualification documents;
(B) the purchaser's legal representative, in charge of precursor chemicals in medicine head, procurement staff names and contact information;
(C) the legal representative power of Attorney originals and copies of identity documents for procurement staff;
(D) the allocation of the purchase and use of narcotic drugs or original;
(E) sales records and verification records.
Purchaser for medical institutions, record should include the medical institutions of narcotic, psychotropic drugs purchased with a copy of the signature card and sales records.
28th of precursor chemicals in medicine production enterprises, Enterprise sale of drug precursor chemicals, are supposed to check identification and related to buy permits for procurement staff, flawless before the sale, and saves the records of verification.
Shipments shall strictly perform the review system, carefully check the physical and drug sales out Bill is consistent with, and to ensure that precursor chemicals in medicine served on the purchaser of the pharmaceuticals production license or business address contained in the drug, medicine or medical institutions.
During the process of verification, delivery, delivery of suspicious circumstances, should immediately stop selling, and to the local food and drug supervision and management departments and public security authorities.
Article 29th drug precursor chemicals in such business enterprises, purchased units in accordance with the enshrined in the purchase and use for the use of precursor chemicals in medicine, not for resale trade export Enterprise purchases of drug precursor chemicals shall not be sold. Purchase medicine needs to be returned to the original supplier of precursor chemicals should be separately reported their original suppliers and local provinces, autonomous regions and municipalities directly under the food and Drug Administration for record.
Indigenous supplier upon receipt of the return, should give its location and site of the original units of provinces, autonomous regions and municipalities directly under the food and Drug Administration report.
The fifth chapter safety management
30th of precursor chemicals in medicine production enterprises, trading companies, the use of precursor chemicals in drug class drug manufacturers and teaching and research unit should be equipped with security management of drug precursor chemicals safety facilities, building layer upon layer of accountability and drug precursor chemicals management system category.
31st of precursor chemicals in medicine production enterprises, trading enterprises and use of precursor chemicals in drug class drug manufacturers should set up a special library or to set up an independent library in a medicine warehouse (counter) store and drug precursor chemicals category.
Narcotic drugs a national wholesale enterprises, regional wholesale enterprises in the narcotic drugs and psychotropic zone established in the store and drug precursor chemicals category.
Teaching and research units should set up a special counter stores and drug precursor chemicals category.
Banks should be equipped with anti-theft devices, counters you should use safe and counters should be introduced for double double lock management.
Precursor chemicals in medicine production enterprises, trading enterprises and use of precursor chemicals in drug class drug manufacturers, its key production, storage sites should be set up TV monitoring facilities, alarm device is installed and networked with the public security organs. 32nd of precursor chemicals in medicine production enterprises, trading enterprises and use of precursor chemicals in drug class drug manufacturers and drug precursor chemicals category-specific books should be established.
Private records retention period should be from the drug class of precursor chemicals from the date of the expiration of not less than 2 years.
Drug precursor chemical production industry category export drug precursor chemicals category, must be contained in dedicated books, and retained an export licence and the corresponding documentation for future reference.
Drug precursor chemicals in storage category should double check, double check, so the AC line. 33rd precursor chemicals in medicine was stolen, robbed, lost or other diversion into illicit channels, flat shall immediately report to the local police and the local food and drug supervision and administration at or above the county level.
Received a report of the food and Drug Administration should escalate, and cooperate with the public security organs investigated and dealt with.
Supervision and administration of the sixth chapter
34th local food and drug supervision and administration at or above the county level shall be responsible for the administrative area of precursor chemicals in medicine production enterprises, business enterprises, the use of drug precursor chemicals for drug production enterprises and units of teaching and research supervision and inspection. 35th food and drug supervision and Administration Department shall establish supervision and inspection of enterprises within their respective administrative areas system and check the file. Supervision shall at least include the safety management of drug precursor chemicals in such flows, sales, usage, and more; archives should be comprehensive and detailed supervision and inspection of enterprises, shall have an on-site inspection of records.
After each inspection shall in writing inform the check result check unit needs rectification should make rectification and reform period, and implement follow-up inspections.
Article 36th food and drug supervision and management departments of precursor chemicals in medicine production, management, purchase activity when conducting supervision and inspection, law to check out live, read, and copy the information, recording the situation, seizing evidence related to the materials and items, if necessary, you can temporarily seized the premises.
Inspected unit and its staff shall coordinate with the food and drug administration supervision and inspection, provide relevant information and materials and articles shall not refuse or conceal.
37th food and drug supervision and management departments should be drug precursor chemicals in a class license, revoked or cancelled informed promptly of any public security authorities and industrial and commercial administrative departments.
Food and Drug Administration received from the industrial and commercial administration departments regarding precursor chemicals in medicine production enterprises, trading enterprises business license revoked or cancellation of registration after the briefing should be timely write-off and drug precursor chemicals in such license. 38th article drug class easy business HIV chemicals production enterprise, and business enterprise should Yu monthly 10th Qian, to location County food drug supervision management sector, and police organ and the China anesthesia drug Association submitted last month drug class easy business HIV chemicals production, and business and inventory situation; annual March 31 Qian to location County food drug supervision management sector, and police organ and the China anesthesia drug Association submitted Shang annual drug class easy business HIV chemicals production, and business and inventory situation.
Food and drug supervision and management departments should be on the summary report in a timely manner level food and drug supervision and administration departments.
Precursor chemicals in medicine production enterprises, trading enterprises shall, in accordance with the food and Drug Administration drug developed by electronic monitoring of implementation requirements, electronic supervision network into drugs in a timely manner, and submitted through the network and drug precursor chemicals in such production, management and inventory. 39th precursor chemicals in medicine production enterprises, trading companies, the use of precursor chemicals in drug class drug manufacturers and teaching and research units, expired, damaged, drug precursor chemicals category shall register, and to the local food and drug supervision and administration at or above the county authority for destruction.
Food and drug supervision and Administration Department shall from the date of receipt of the application within the 5th to the scene to supervise the destruction.
40th article of the administrative licensing law of the 69th article, second paragraph, of provinces, autonomous regions and municipalities directly under the food and drug administration or State food and drug administration shall be revoked in accordance with the measures of the license.
The seventh chapter legal liability
41st precursor chemicals in medicine production enterprises, trading companies, use drugs type of drug precursor chemicals production, teaching and research unit, not complying with the provisions of the safety management system, food and drug supervision and administration departments at or above the county level in accordance with the regulations of the 40th article first provides for punishment.
42nd precursor chemicals in medicine production enterprises export drug precursor chemicals, according to stipulations in the special books contained or were not retained as required export permission, the appropriate documentation for future reference, by the food and drug administration departments at or above the county level in accordance with the regulations of the 40th article provides for punishment of the fourth.
43rd under any of the following circumstances, food and drug supervision and administration departments at or above the county level shall give it a warning, rectification, may be of less than 10,000 yuan and 30,000 yuan fines:
(A) drug precursor chemical production enterprise for production category provides more than 1 year is not reported, or without a seat of provinces, autonomous regions, municipalities directly under the food and Drug Administration site inspections that resumed production;
(B) precursor chemicals in medicine production enterprises, trading enterprises and selling drugs not according to stipulations such precursor chemicals;
(C) regional narcotic prescription drug wholesale businesses due to special circumstances such precursor chemicals in accordance with stipulations for the record;
(D) return of precursor chemicals drug class, purchase units, delivery units not complying with the provisions of the record, reported.
44th of precursor chemicals in medicine production enterprises, trading companies, the use of precursor chemicals in drug class drug manufacturers and teaching and research unit, refused to accept the supervision and inspection of the food and drug regulatory agency, food and drug supervision and administration departments at or above the county level shall, in accordance with the regulations stipulated in the 42nd of penalties.
Article 45th by the public security organs, administrative departments for industry and commerce in accordance with the regulations of the decision on administrative penalty made the 38th article, the food and drug supervision and Management Department of the administrative penalty within 3 years from the date of the decision not to accept its precursor chemicals in medicine production, management, purchase a license application.
46th, staff of the food and drug administration in the management of precursor chemicals in medicine should be permitted without permission, which permission should not permit, as well as other acts of abuse of power, negligence, malpractice, shall be given administrative sanctions constitutes a crime, criminal responsibility shall be investigated according to law.
The eighth chapter supplementary articles
47th applicants apply for administrative licensing items in accordance with these regulations, shall be responsible for the authenticity of the data, copy of the data should be stamped with the seal of the applicant.
Small Pack of ephedrine in 48th article of the rules means designated by the State food and Drug Administration for teaching, scientific research and medical institution prepared formulations use ephedrine API for a specific package.
49th of ephedrine hydrochloride for veterinary drug manufacturers to buy raw materials and animal production and management of ephedrine hydrochloride injection, supervision and management, in accordance with the regulations of the Ministry of agriculture and the State food and drug administration. 50th these measures come into force on May 1, 2010.
Former State food and Drug Administration on June 26, 1999, issued by the management of ephedrine (trial) be repealed simultaneously.
Annexes: 1. list of precursor chemicals in medicine
2. drug precursor chemical production category application form
3. precursor chemicals in medicine production permit
4. drug class drug precursor chemicals business application form
5. precursor chemicals in medicine purchase and use
6. purchases of drug precursor chemicals application form
7. purchases of drug precursor chemicals information requirements annex 1: list of precursor chemicals in medicine
1. lysergic acid
2. ergotamine
3. ergometrine
4. ephedrine, pseudoephedrine, racemic ephedrine, norephedrine, methyl ephedrine, ephedra extract, ephedra extract ephedrine powder material
Introductions:
First, the salts of the substances listed, including possible.
Two precursor chemicals including active pharmaceutical ingredients, drug class and its preparations.
Annex 2: drug precursor chemical production category application form
┌───────┬──────────────────────────┐
│ 申请企业名称 │ │
├───────┼──────────────┬──┬────────┤
│ 注册地址 │ │邮编│ │
├───────┼──────────────┼──┼────────┤
│ 生产地址 │ │邮编│ │
├───────┼──────────────┼──┼────────┤
│企业法定代表人│ │电话│ │
├───────┼──────────────┼──┼────────┤
│ 联系人 │ │电话│ │
├───────┼─────────┬────┼──┴────────┤
│ 药品生产 │ │ GMP │ │
│ 许可证编号 │ │证书编号│ │
├───────┼─────────┴────┴───────────┤
│ 品名 │ │
├───────┼─────────┬────┬───────────┤
│ │原料药 □│ │ │
│ 类别 │单方制剂 □│ 剂型 │ │
│ │小包装麻黄素 □│ │ │
│ │其他 □│ │ │
├───────┴─────────┴────┴───────────┤ │申请理由： │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
├──────────────────────────────────┤
│ Inspection of food and Drug Administration site: │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│检查人签字： │
│ │
│ │
│ │
│ │
│ │
│ 年 月 日 │
│ │
├──────────────────────────────────┤
│审查意见： │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
¦ Food and drug regulatory agency of provinces, autonomous regions and municipalities sealed │
│ │
│ 年 月 日 │
└──────────────────────────────────┘
Annex 3: precursor chemicals in medicine production permit
受理号： 批件号：
┌──────┬────────────────────────────┐
│ │ │
│ 品名 │ │
│ │ │
├──────┼───────────────────┬──┬─────┤
│ 类别 │原料药 □ 单方制剂 □ │剂型│ │
│ │小包装麻黄素 □ 其他 □ │ │ │
├──────┼───────────────────┴──┴─────┤
│ │ │
│生产企业名称│ │
│ │ │
├──────┼────────────────────────────┤
│ │ │
│ 生产地址 │ │
│ │ │
├──────┼────────────────────────────┤
│ │ │
│ │ │
│ 审批结论 │ │
│ │ │
│ │ │
│ │ │
├──────┼────────────────────────────┤
│ │ │
│ 主送单位 │ │
│ │ │
├──────┼────────────────────────────┤
│ │ │
│ 抄送单位 │ │
│ │ │
├──────┼────────────────────────────┤
│ │ │
│ 说明 │ │
│ │ │
└──────┴────────────────────────────┘
Seal of the State food and drug administration
Year month day
Annex 4: drug precursor chemical raw materials management category application form
┌───────┬───────────────────────────┐
│ 申请企业名称 │ │
├───────┼───────────────┬──┬────────┤
│ 注册地址 │ │邮编│ │
├───────┼───────────────┼──┼────────┤
│ 仓库地址 │ │邮编│ │
├───────┼───────────────┼──┼────────┤
│企业法定代表人│ │电话│ │
├───────┼───────────────┼──┼────────┤
│ 联系人 │ │电话│ │
├───────┼──────────┬────┼──┴────────┤
│ 药品经营 │ │ GSP │ │
│ 许可证编号 │ │证书编号│ │
├───────┼──────────┴────┴───────────┤
│ 品名 │ │
├───────┴───────────────────────────┤
│申请理由： │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
├───────────────────────────────────┤
│ Inspection of food and Drug Administration site: │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│检查人签字： │
│ │
│ │
│ │
│ 年 月 日 │
│ │
├───────────────────────────────────┤
│审查意见： │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
¦ Food and drug regulatory agency of provinces, autonomous regions and municipalities sealed │
│ │
│ 年 月 日 │
└───────────────────────────────────┘
Annex 5: drug precursor chemicals category of purchase and use
Control no:
┌──────┬────────────────────────────┐
│购用单位名称│ │
├──────┼────────────────────────────┤
│供货单位名称│ │
├──────┼────────────────────────────┤
│ 购用品名 │ │
├──────┼────────────────────────────┤
│ │ Category API-preparations-small Pack of ephedrine-other-│
├──────┼─────────────┬───┬──────────┤
│ 规格 │ │ 剂型 │ │
├──────┼─────────────┴───┴──────────┤
│ 用途 │ │
├──────┼────────────────────────────┤
│ │ │ │ 购用数量 │ │
│ │ │
│ │ │
├──────┼────────────────────────────┤
│ 有效期 │ 自 年 月 日至 年 月 日│
└──────┴────────────────────────────┘
Drug regulatory agency of provinces, autonomous regions and municipalities directly under the food stamp
Year month day Note: 1. food and drug regulatory agency of provinces, autonomous regions and municipalities to fill out five copies, archiving a copy of supply units of provinces, autonomous regions and municipalities directly under the food and drug administration.
Purchase flat supply unit a copy of purchase and use for making local public security organs, retained a copy.
2. fill out when buying supplies to indicate salts, number and case State.
3. purchase units, delivery units retain the purchase and use for 3 years for reference.
Annex 6: application form for purchases of drug precursor chemicals,
┌─────┬─────────────────────────────┐
│ 申购单位 │ │
│ 名称 │ （盖章） │
├─────┼────────────────┬──┬─────────┤
│ 地址 │ │邮编│ │
├─────┼────────────────┼──┼─────────┤
│法定代表人│ │电话│ │
├─────┼────────────────┴──┴─────────┤
│身份证号码│ │
├─────┼────────────────┬──┬─────────┤
│ 经办人 │ │电话│ │
├─────┼────────────────┴──┴─────────┤
│身份证号码│ │
├─────┼───────────────────┬──┬──────┤
│ 申购品名 │ │规格│ │
├─────┼───────────────────┼──┼──────┤
│ 类别 │原料药 □ 单方制剂 □ │剂型│ │
│ │小包装麻黄素 □ 其他 □ │ │ │
├─────┼───────────────────┴──┴──────┤
│ 申购数量 │ │
├─────┼────────────────┬──┬─────────┤
│ 拟定供货 │ │电话│ │
│ 单位 │ │ │ │
├─────┴────────────────┴──┴─────────┤
│ Purpose and amount calculated on the basis of a detailed description of: │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
├───────────────────────────────────┤
¦ The food and drug administration review of the acceptance of the application: │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ 盖 章 │
│ │
│ 年 月 日 │
│ │
└───────────────────────────────────┘
Annex 7: purchases of drug precursor chemicals information request
┌───────────────┬────┬────┬────┬────┐
│ │ │ The requisitioning units type drug production and drug operation │ │ teaching and research of foreign trade export │
│ Information │ company │ │ │ │
├───────────────┼────┼────┼────┼────┤
│企业营业执照复印件 │ ＋ │ ＋ │ － │ ＋ │
├───────────────┼────┼────┼────┼────┤
│《药品生产许可证》复印件 │ ＋ │ － │ － │ － │
├───────────────┼────┼────┼────┼────┤
│《药品经营许可证》复印件 │ － │ ＋ │ － │ － │
├───────────────┼────┼────┼────┼────┤
Other copies of qualification documents │ │-│-│ │ + + │
├───────────────┼────┼────┼────┼────┤
│《药品生产质量管理规范》 │ ＋ │ － │ － │ － │
│认证证书复印件 │ │ │ │ │
├───────────────┼────┼────┼────┼────┤
│《药品经营质量管理规范》 │ － │ ＋ │ － │ － │
│认证证书复印件 │ │ │ │ │
├───────────────┼────┼────┼────┼────┤
│ Drug copies of approval documents │ +1 │-│-│ + │
├───────────────┼────┼────┼────┼────┤
│国内购货合同复印件 │ ＋2 │ ＋ │ － │ ＋ │
├───────────────┼────┼────┼────┼────┤
│ Last purchase tax invoice │ │ │ │ + + + +2 │
│复印件（首次购买的除外） │ │ │ │ │
├───────────────┼────┼────┼────┼────┤
│上次购买的使用、销售或 │ ＋ │ ＋ │ ＋ │ ＋ │
│出口情况（首次购买的除外） │ │ │ │ │
├───────────────┼────┼────┼────┼────┤
│用途证明材料 │ － │ － │ ＋ │ － │
├───────────────┼────┼────┼────┼────┤
│ Ensure that precursor chemicals in medicine │-│-│-│ + │
│用于合法用途的保证函 │ │ │ │ │
├───────────────┼────┼────┼────┼────┤
│本单位安全保管制度及 │ － │ － │ ＋ │ － │
│设施情况的说明材料 │ │ │ │ │
├───────────────┼────┼────┼────┼────┤
│加强安全管理的承诺书 │ ＋ │ ＋ │ ＋ │ ＋ │
├───────────────┼────┼────┼────┼────┤
│出口许可文件复印件 │ － │ － │ － │ ＋ │
├───────────────┼────┼────┼────┼────┤
│当提供的其他材料* │ － │ － │ ＋ │ － │
└───────────────┴────┴────┴────┴────┘ Notes: 1. "
+ "Must be submitted to the information;
2. "-" means the exempt information;
3. "+1", drug manufacturers have not yet obtained approval, submit materials for scientific research;
4. "+2" medicine manufacturers use precursor chemicals used in drug production are not submitted; 5. "*" by provinces, autonomous regions and municipalities directly under the food and drug administration regulations and published in advance.
