Interim Measures for the administration of contain

2022-07-25
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Measures for the administration of containers for drug packaging materials (Provisional)

Order No. 21 of the State Drug Administration

measures for the administration of containers for drug packaging materials (Provisional), which was deliberated and adopted by the board meeting of the State Drug Administration on March 17, 2000, is hereby promulgated and shall enter into force as of October 1, 2000. Director general: April 29th, 2000 chapter I General Provisions Article 1 These measures are formulated in accordance with the provisions of the drug administration law of the people's Republic of China in order to strengthen the supervision and administration of drug packaging materials and containers (hereinafter referred to as "drug packaging materials"), ensure the quality of drugs and ensure the safe, effective and convenient use of drugs. Article 2 Whoever produces or deals in drug packaging materials and uses drug packaging materials to package drugs shall comply with the provisions of these measures. Article 3 the State implements a product registration system for drug packaging materials. The State Drug Administration and the drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government shall be responsible for the registration and management of drug packaging materials in accordance with the principle of unified management and hierarchical responsibility. Chapter II Classification and standards Article 4 drug packaging products are divided into three categories: I, II and III. Class I drug packaging materials refer to the materials and containers for drug packaging that are in direct contact with drugs and used directly. Class II drug packaging materials refer to the materials and containers for drug packaging that are in direct contact with drugs but easy to clean. In the actual use process, they need to be cleaned and can be sterilized. Class III drug packaging materials refer to materials and containers for drug packaging other than class I and II that may directly affect the quality of drugs. The classified catalogue of drug packaging materials shall be formulated and published by the State Drug Administration. Article 5 drug packaging materials shall be produced according to the statutory standards, and those that do not meet the statutory standards shall not be produced, sold or used. Article 6 the national or industrial standards for drug packaging materials shall be prepared and revised by the SDA. Article 7 for drug packaging materials without national or industrial standards, the enterprise applying for product registration shall formulate enterprise standards. Article 8 the standards for drug packaging materials shall be implemented under the supervision of the drug regulatory department. Chapter III Registration Management Article 9 drug packaging materials can be produced only after they are registered by the drug regulatory department and obtain the registration certificate of drug packaging materials. Unregistered drug packaging materials shall not be produced, sold, operated or used. The registration certificate of drug packaging materials shall be valid for five years, and shall be renewed six months before the expiration. Article 10 the registration certificate of drug packaging materials shall not be forged, altered, leased or lent. Article 11 the production of class I drug packaging materials shall be approved and registered by the State Drug Administration, and a registration certificate of drug packaging materials shall be issued. The production of class II and III drug packaging materials shall be approved and registered by the drug regulatory department of the province, autonomous region or municipality directly under the central government, and a certificate of registration of drug packaging materials shall be issued. Article 12 after the implementation of the new standard for drug packaging materials, the manufacturer of drug packaging materials shall re apply to the original issuing authority for issuing the registration certificate for drug packaging materials. If the contents listed in the registration certificate of drug packaging materials are changed, the certificate holder shall apply to the original issuing authority for change or re registration within 30 days of the change. Article 13 the drug packaging materials imported for the first time (produced by foreign enterprises and Sino foreign joint ventures overseas) must obtain the registration certificate for imported drug packaging materials issued by the State Drug Administration, and can only be sold and used within the territory of the people's Republic of China after passing the inspection by the drug packaging materials testing institution authorized by the State Drug Administration. The registration certificate for imported drug packaging materials shall be valid for three years and shall be renewed six months before the expiration. Article 14 the class I registration certificate of drug packaging materials and the registration certificate of imported drug packaging materials registered and issued by the State Drug Administration, and the class II and III registration certificates of drug packaging materials registered and issued by the drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government are valid nationwide. This kind of plastic granulator equipment causes very serious environmental pollution. The registration certificate of drug packaging materials and the registration certificate of imported drug packaging materials shall be uniformly printed by the State Drug Administration. Article 15 for the use of imported drug packaging materials, they can be used only after the copy of the registration certificate of imported drug packaging materials issued by the State Drug Administration is affixed with the effective seal of the manufacturer of drug packaging materials, and the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where they are located is filed. Article 16 to apply for registration of drug packaging materials, the following basic conditions shall be met: (1) the applicant must have a business license for enterprise legal person. (2) The drug packaging materials applied for registration shall meet the needs and development direction of China's drug packaging. The products that have been eliminated by the state or within a time limit shall not be registered. (3) Have the necessary conditions for quality assurance such as reasonable process, equipment, cleanliness requirements, inspection instruments, personnel and management system for the production of the product. (4) The production of class I drug packaging materials shall meet the same cleanliness conditions as the production of packaged drugs, and shall pass the inspection by the State Drug Administration or the testing institution designated by the drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government. Article 17 the registration of drug packaging materials shall be carried out in accordance with the following procedures: (1) three batches of products applied for registration shall be sampled according to the regulations, and the products shall meet the legal standards after being tested by the drug packaging materials quality inspection agency. (2) For the registration of class I drug packaging materials, the applicant enterprise shall fill in the "application for registration of containers for drug packaging materials" according to the requirements of the regulations, and submit it to the State Drug Administration for approval and issuance of the registration certificate of drug packaging materials after passing the preliminary examination by the drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government together with the required materials. (3) For the registration of class II and III drug packaging materials, the applicant enterprise shall fill in the "application form for material containers for drug packaging note 1. failure to put the original volume when clamping the jaws" according to the requirements, and submit it together with the required materials to the drug regulatory department of the province, autonomous region and municipality directly under the central government for approval and issuance of the drug packaging materials registration certificate, and at the same time, submit it to the State Drug Administration for filing. Article 18 the drug packaging materials first developed in China shall apply for the registration certificate of drug packaging materials according to the category after passing the review and approval organized by the State Drug Administration. Chapter IV Supervision and administration Article 19 The SDA and the drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government shall supervise and inspect the quality of drug packaging materials and their quality assurance system, and the inspection results shall be published. Article 20 the State Drug Administration and the drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government shall designate the drug packaging material quality inspection institutions, entrust them to undertake the inspection of product quality and quality assurance system, and issue inspection reports. Article 21 the National Drug Administration and the drug administration of provinces, autonomous regions and municipalities directly under the central government shall establish a manual or simple finite element model for drugs and loading methods to supervise, manage and guide the quality inspection institutions of drug packaging materials. Article 22 The State encourages the research, development, popularization and application of high-quality new drug packaging materials and their production technologies. The State Drug Administration announced the elimination of backward varieties of drug packaging materials. The drug packaging materials announced to be eliminated shall not be reproduced, sold, operated or used, and the registration certificate of drug packaging materials shall be cancelled. Chapter V Penalty Provisions Article 23 under any of the following circumstances, the drug regulatory department at or above the county level shall order it to make corrections and give a warning: (1) in violation of the provisions of Article 5 of these measures, it produces drug packaging materials that do not meet the statutory standards; (2) Using drug packaging materials without registration certificate of drug packaging materials in violation of Article 9 of these measures; (3) Using imported drug packaging materials in violation of the provisions of Article 15 of these measures without registration with the drug regulatory department of the province, autonomous region or municipality directly under the central government where they are located. Article 24 under any of the following circumstances, a fine of less than 30000 yuan shall be imposed: (1) in violation of the provisions of Article 9 of these measures, producing drug packaging materials without obtaining the registration certificate of drug packaging materials; (2) Operating unregistered drug packaging materials in violation of Article 9 of these measures; (3) Producing, selling, operating and using drug packaging materials that have been eliminated by the state in violation of the provisions of Article 22 of these measures; (4) Forging, altering, leasing or lending the registration certificate of drug packaging materials and the registration certificate of imported drug packaging materials in violation of Article 10 of these measures. Article 25 these Measures shall be interpreted by the State Drug Administration. Article 26 these Measures shall enter into force as of october1,2000, and the former Decree No. 10 of the State Pharmaceutical Administration (measures for the administration of the production of containers for pharmaceutical packaging materials) shall be repealed at the same time

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