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Laws & Regulations - Drugs - Provisions for Import Crude Drugs (Trial)
Provisions for Import Crude Drugs (Trial)
 
2012/3/20 14:19:26¡¡Source: ¡¡Hits:

Provisions for Import Crude Drugs (Trial)
Chapter I General Provisions
Article 1 The Provisions is formulated to strengthen the supervision of import crude drugs and ensure their quality in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as ¡°Drug Administration Law¡±) and the Regulations for the Implementation of Drug Administration Law of the People's Republic of China (hereinafter referred to as ¡°Regulations for the Implementation of Drug Administration Law¡±) and provisions of relevant laws and regulations.
Article 2 The Provisions is applicable to application and approval, record filing, port inspection and supervision of import crude drugs.
Application and Approval of Import Crude Drugs refers to the procedure in which the State Food and Drug Administration, in accordance with the application, legal procedures and requirements, conducts technical evaluation and administrative examine on the crude drugs that are produced outside the territory of the People¡¯s Republic of China and intended to be marketed and used within the territory, and determines whether or not to allow their import.
An applicant for crude drug importation shall be a drug manufacturer or drug distributor who has obtained a Drug Manufacturing Certificate or a Drug Supply Certificate and is located within the territory of the People¡¯s Republic of China.
Article 3 The State Food and Drug Administration shall be responsible for the examination and approval of importation of crude drugs and shall supervise the procedures of filing and port inspection.
The (food and) drug administrations of provinces, autonomous regions and municipalities directly under the Central Government shall supervise import crude drugs in accordance with law.
The (food and) drug administration of a place where a port permitted for importation of drugs or a frontier port permitted for importation of crude drugs is located (hereinafter referred to as ¡°Port¡± or ¡°Frontier Port¡± (Food and) Drug Administration),  shall be responsible for putting import crude drugs on record, organizing port inspection, and exercising supervision and control.
The National Institute for the Control of Pharmaceutical and Biological Products shall be responsible for sample testing of crude drugs that are imported for the first time and verification of their quality specifications.
The drug testing institutions designated by the State Food and Drug Administration shall be responsible for port inspection of import crude drugs.
Article 4 Crude drugs must be imported from the ports where the entry of import drugs is allowed or the frontier ports where the entry of import crude drugs is allowed. At the frontier ports where the entry of import crude drugs is allowed, only the crude drugs produced in the countries and regions adjacent to such ports may be imported.
Chapter II Application and Approval
Section I General Rules
Article 5 The State Food and Drug Administration shall publicize the items required in an application dossier and sample texts of relevant application documents at the place where applications for importing crude drugs are accepted.
Article 6 When applying for importation of a crude drug, an applicant shall, as required, submit true, standard and complete data describing actual conditions and shall be accountable for the authenticity of the content of the application dossier.
Article 7 Where there is an error in the application dossier that can be corrected on the spot, on-the-spot correction shall be allowed.
Article 8  Where an application dossier is incomplete or not complied with laws, an one-off notification on the content to be supplemented or corrected shall be given to the applicant on the spot or within five working days by the State Food and Drug Administration ; where the notification to the applicant is not issued within the timeline, the application is deemed as accepted upon the date the dossier is received. Where an application is not accepted, the reasons shall be given in written form.
Article 9 In the examination process, where the State Food and Drug Administration finds that some materials are necessary to be supplemented, it shall make a request once and for all. The applicant shall, within four months after receiving a notice to supplement materials, submit required materials, and the examination timeline shall be extended by 20 days upon the original timeline; where the supplementary materials are not submitted within the specified timeline, the examination shall be terminated. Where the supplementary materials cannot be submitted within the specified timeline due to force majeure, the applicant shall make a written application, with reasons, to the State Food and Drug Administration. The State Food and Drug Administration shall give its opinions on how to handle the matter within 20 days.
Article 10 Where an application for importing a crude drug is examined in accordance with law and confirmed in conformity with the requirements, the State Food and Drug Administration shall approve it within the specified timeline and send to the applicant the approval documents for the importation of the crude drug within 10 days; where an application is found not in conformity with the requirements, the applicant shall be notified of the result with reasons in written form within the specified timeline, and its right to apply for a re-examination or administrative reconsideration or to bring an administrative lawsuit shall also be told.
Article 11 Where other party's vital interests are found directly involved in an application item during the examination on an application for importing a crude drug, the State Food and Drug Administration shall inform the interested party of the matter. The applicant and the interested party may submit written opinions to state their cases and defend themselves or request for a hearing in accordance with law.
Article 12 The State Food and Drug Administration shall publish the procedures of accepting and examining the applications for crude drug importation, as well as relevant information about approved import crude drugs on its official website.
Section II Application and Approval of Crude Drug Importation
Article 13 Applications for crude drug importation include first-entry application and non-first-entry application. A first-entry application consists of first-entry application for importing a crude drug with an official standard and one without an official standard.
Article 14 To apply for importing a crude drug, an applicant shall fill in an Application Form for Crude Drug Importation as required and submit relevant materials to the State Food and Drug Administration.
Article 15 The State Food and Drug Administration shall make a preliminary review to see if the dossier submitted is standard and complete, and issue a notice of acceptance or non-acceptance within five days after receiving the application dossier.
Article 16 After a first-entry application for an import crude drug is accepted, the applicant shall immediately submit testing samples and relevant materials to the National Institute for the Control of Pharmaceutical and Biological Products.
Article 17 After receiving samples and relevant materials, the National Institute for the Control of Pharmaceutical and Biological Products shall complete sample testing within 30 days in respect of a first-entry application for an import crude drug with an official standard, or shall complete verification of quality specifications and sample testing within 60 days in respect of a first-entry application for an import crude drug without an official standard. The test reports and verification opinions shall be submitted to the State Food and Drug Administration.
Article 18 The State Food and Drug Administration shall complete its technical review and administrative examination on a crude drug within 40 days after receiving the test report and verification opinions from the National Institute for the Control of Pharmaceutical and Biological Products. Where the requirements are met, an Import Crude Drug Approval shall be issued; where the requirements are not met, a Notice of Examination Conclusion shall be issued with reasons.
Article 19 The State Food and Drug Administration shall complete its technical review and administrative examination on a crude drug within 30 days after accepting a non-first-entry application for an import crude drug. Where the requirements are met, an Import Crude Drug Approval shall be issued; where the requirements are not met, a N

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