"Import medicines management (tentative)"
2006-02-01

State Food and Drug Administration Order No. 22

"Import medicines management (tentative)" on October 21, 2005 by the State Food and Drug Administration Bureau of Finance Council, is hereby promulgated, February 1, 2006 shall come into force.

Secretary: Shao Mingli

November 24, 2005

Imports of medicines management (tentative)

Chapter I General Provisions

In order to strengthen supervision and management of imported medicines, to ensure the quality of imported medicines, according to "Drug Administration Law," "Implementation Regulations of the PRC Drug Administration Law" (hereinafter referred to as the "Drug Administration Law", "implementing regulations") and related laws and regulations, development of this approach.

The second application and approval of imported medicines, registration, inspection and supervision of port management, application of this approach.

Imported medicinal application and approval, the State Food and Drug Administration based on the applicant's application, in accordance with legal procedures and requirements of overseas production to be sold in China use herbal medicine for technical review and administrative review, and make it agree with the import decision.

Imported medicine applicants, should be made in China "Drug Production License" or "Drug License" or the drug manufacturer pharmaceutical enterprises.

Article responsible for the State Food and Drug Administration approval of imported medicines, and registration, port inspection and supervision and management of such work.

Provinces, autonomous regions and municipalities (food) and Drug Administration shall conduct supervision and management of imported medicines.

Port to allow imports of drugs or border crossings to allow import of medicinal location (food) and Drug Administration (hereinafter referred to as ports or border crossings (food) and Drug Administration) is responsible for the import of medicines registration, the organization and supervise the inspection port.

Pharmaceutical and Biological Products, China is responsible for testing samples of the first import of medicines, quality standards review and so on.

State Food and Drug Administration to determine the drug testing institution responsible for the inspection of imported medicines port.

Article IV medicine must be approved by the State Department to allow drug importation ports or border crossings to allow imports of imported medicines. Border crossings to allow imports of medicines, only to import the ports around the country or region produced medicines.

Chapter II Application and Approval

Section I General Provisions

The state Food and Drug Administration shall place public notice accepting applications for importing medicinal claims data application demonstration projects and related text.

Article 6 The applicant shall apply the provisions of herbs imported a complete specification of the material presented accurately reflect the true situation, and the substance of their claims data responsible for the authenticity.

Article information submitted by the applicant to declare the existence of errors can be corrected on the spot, it shall allow the applicant on the spot corrections.

Article VIII of the information submitted by the applicant are not complete, does not meet the statutory form, the State Food and Drug Administration on the spot or within five days inform the applicant needs a correction of the entire contents, fails to do so, the date of receipt of declarations play is accepted. Inadmissible, it shall give reasons in writing.

Article IX in the review process, the State Food and Drug Administration requires additional information that should be made one.

The applicant shall receive notice of the additional information submitted within four months to meet the requirements of the additional information in the original time of its review on the basis of the review period extended for another 20 days; according to the specified time limit to submit additional information, to back the trial. Due to force majeure, can not submit additional information within the time limit, and must be the State Food and Drug Administration to submit a written application and the reasons.

State Food and Drug Administration should be made within 20 days of handling.

Article by the law review of applications for importing medicines that meet the requirements, the State Food and Drug Administration should approve the decision made within the prescribed time limit, and served on the applicant within 10 days of imports of medicines approved documents; that does not meet the requirements, shall inform the applicant in writing within the prescribed time limit, state the reasons and inform the applicant of the right to apply for review, administrative reconsideration or bring an administrative lawsuit.

Article 11 The State Food and Drug Administration in the import of herbs found in the application review process to apply directly related to matters of significant interest to others, it shall notify the interested parties. The applicant and interested parties may submit written comments to statements and representations, or to request a hearing according to law.

Article 12 The State Food and Drug Administration should set up a government in its announcement on the website accepting applications for medicine imports, the review process and has approved the import of medicines information.

Section II and approval of applications for importing medicines

Article XIII of the first import of medicinal herbs, including applications for importing the first time the import of medicinal applications and applications. Application, including the first import of medicinal herbs has been the legal standard to apply and can not be the first import first import of standard medicinal applications.

Article 14 When applying medicine imports, the applicant shall be subject to fill out "Application Form for import medicines," the State Food and Drug Administration to submit the relevant information.

Article 15 The State Food and Drug Administration, after receiving claims data, should be declared within five days of normative data, review the form of integrity, and issued a notice to accept or not accept.

Article XVI received the first imports of medicinal application, the applicant shall promptly test samples and related information submitted to the China pharmaceutical and biological products.

Article XVII Chinese medicines and biological products where the test samples and relevant information received after the statutory standards for medicinal herbs have been the first imports of the application should be completed within 30 days of test samples, the standard medicine can not be the first of applications, should be quality standards within 60 days to complete review and sample testing, and inspection reports and review of comments submitted to the State Food and Drug Administration.

Article 18 The State Food and Drug Administration by the Chinese Pharmaceutical and Biological Products, review inspection reports and views should be within 40 days to complete the technical review and administrative review. Meet the requirements, issued a "medicine imported documents of approval"; do not meet the requirements, the issue of a "review of informed opinion pieces", and the reasons.

Article 19 The State Food and Drug Administration accepted the first time, imports of non-medicinal application, shall within 30 days to complete the technical review and administrative review. Meet the requirements, issued a "medicine imported documents of approval"; do not meet the requirements, the issue of a "review of informed opinion pieces", and the reasons.

Article 20 The State Food and Drug Administration as needed, medicines can be imported to inspect the production site.

Twenty-one "imported medicines approval documents" sub-documents of approval and several one-time use of effective approval documents. Valid documents issued is valid for one year, repeated use of documents relating to a period of 2 years.

"Imported medicines approval documents" Number format: State ingredients into the word reign +4 +4 bits bit sequence number.

Article 22 The State Food and Drug Administration for the import of endangered species of medicinal herbs or the first of applications, approval documents issued by a one-time effective.

Article 23 Change "imported medicines approval documents" in the applicant's name and port of arrival, the applicant should give the State Food and Drug Administration to ask a supplementary application, and submit the relevant information.

Supplement the original application the applicant should be "imported herbs documents of approval," the holder.

Article 24 The State Food and Drug Administration received a supplemental application, it shall apply within five days of normative data, review the form of integrity, and issued a notice to accept or not accept.

Article 25 The State Food and Drug Administration received a supplemental application should be completed within 20 days after the administrative review. Meet the requirements, issued a "supplementary imports of medicinal applications for approval documents"; for non-compliance, the issue of a "review of informed opinion pieces", and the reasons.

Article 26 "Supplementary Application herbs imported documents of approval" of the original approval documents with the same expiration date.

Article 27 The applicant of the State Food and Drug Administration made the decision not have objections to the approval, the approval can not be received within 10 days from the date of notification of the State Food and Drug Administration to submit a written application for review and explain the review reasons.

Review is limited to matters of the original application and the original declarations.

Article 28 The State Food and Drug Administration, after receiving the application for review, shall review the matter in accordance with the original application review timelines and requirements, and make a review of the decision. The decision not to revoke the approval, the applicant presented the corresponding "Import documents of approval medicinal" or "complementary medicine apply for import approval document"; maintain the original decision, the State Food and Drug Administration application for review will not be accepted again.

Article 29 to review the need for inspection or quality review sample, the sample should be tested according to the original time frame for review or quality standards and requirements.

Chapter registration

Article 30 The applicant made "medicine imported documents of approval", the should be from the "imported medicines approval documents," the organization stated in the arrival port medicine imports.

Organized medicine imports, the applicant shall submit port or border port (food) and Drug Administration registration, fill out the "import medicine inspection list" and submit the relevant information.

第 三十一条 ports or border crossings (food) should Drug Administration registration data integrity, and authenticity for regulatory review, and to review the decision the same day. Meet the requirements, issued a "Drug Import Note" to recover the one-time effective approval documents; the same time to the State Food and Drug Administration issued a drug testing institution established by "imported medicines port inspection notice", along with a registration information. Do not meet the requirements and issue a "notice of registration shall not be imported ingredients", and the reasons.

Article 32 shall not apply for registration of imported medicines, the applicant shall be returned. Can not be returned, the port or border port (food) and Drug Administration in accordance with relevant provisions of the supervision process.

Chapter IV port inspection and supervision

Article 33 The State Food and Drug Administration to determine the drug testing agencies receive a "notice of imported medicines port inspection" shall, within 2 days, according to "import medicines sampling requirement" to provided on-site inventory locations sampled. Sampling site, the applicant shall provide the original certificate of origin ingredients.

Article 34 The State Food and Drug Administration to determine the drug testing institution shall, according to port or border port (food) and Drug Administration to provide the registration information on medicinal herbs and the original certificate of origin to verify the actual arrival. Meet the requirements, to sample, fill out the "import medicines sampling records" in the "Drug Import Note" marked "has been sampled" the words, and affix the official seal of sampling units; do not meet the requirements, no sample and 2 days will be "imported medicines are not sampling notice" to submit port or border port where (food) and Drug Administration.

Ports or border crossings (food) and Drug Administration received "sample of imported medicines will not notice", shall have been imported to take all the medicine seizure, seizure of administrative enforcement measures, and make a decision within 7 days.

Article 35 The State Food and Drug Administration to determine the drug testing institution shall, within 20 days after completion of sampling inspection, issued by the "imported medicine inspection report", submitted to the local ports or border crossings (food) and Drug Administration, and notify the applicant; unable to complete the inspection by the prescribed time limit, it should be the port or border port (food) and Drug Administration reports, and notify the applicant.

Article 36 of the inspection do not meet the standard requirements of the import of medicines, ports or border crossings (food) and Drug Administration shall, after receiving the inspection report immediately to attachment, seizure of administrative enforcement measures, and make the decision within 7 days ; on the application for re-inspection, the conclusion must be issued from the re-inspection within 15 days from the date of the decision made by the executive. While the report of the province, autonomous regions and municipalities (food) and Drug Administration. The applicant shall receive two days after the inspection report to the local ports or border crossings (food) and Drug Administration in writing all imports of medicines in circulation, the use of details.

Article 37 The applicant disagrees with the results of the test, you can press the "Drug Administration Law," Article 67 apply for retesting. Drug testing agency to receive an application for re-inspection, shall report to port or border port (food) and Drug Administration, and re-inspection within 20 days after receiving an application to re-inspection conclusions, the report port or border port (food) and Drug Administration and notify the applicant.

Article 38 The re-inspection within the standard of imported medicines, ports or border crossings (food) and Drug Administration re-inspection findings should be received immediately after the lifting of seizure, seizure of administrative enforcement measures, and reports of the province, autonomous regions and municipalities (food) and Drug Administration.

Article 39 does not apply within the specified time for re-inspection or retesting after the import is still within the standard of medicine, ports or border crossings (food) and Drug Administration shall make the decision, take appropriate measures, the report provinces, autonomous regions and municipalities (food) and Drug Administration.

Article 40 for the first time in the sales of imported herbs before use, must be approved by the State Food and Drug Administration drug testing agencies to determine the sampling, inspection and approval before marketing use.

Article 41 test does not meet the standard requirements, but have been in circulation to the port or border port of the province, autonomous regions and municipalities (food) drug administration outside the jurisdiction of imported medicines, port or border of the province, autonomous regions and municipalities ( food) and Drug Administration shall be timely informed of the medicine into the area of ​​the provinces, autonomous regions and municipalities (food) and Drug Administration. Medicine into the area of ​​the provinces, autonomous regions and municipalities (food) and Drug Administration shall take appropriate measures.

Article 42 The import of medicinal herbs imported packaging must be suitable for the quality requirements, to facilitate storage, transport and import inspection. In each package must contain the name of Chinese medicine, approval document number, place of origin, top marks to apply for business name, the name of the exporter, arrival port, processing, packaging, weight and date.

Chapter V Legal Liability

Article 43 of "Administrative Licensing Law," the circumstances specified in Article 69, the State Food and Drug Administration based on the request of interested party or ex officio, may revoke the approval documents for the import of medicines.

Article 44 The import of medicines in the approval, registration and port inspection process, one of the following circumstances, in accordance with "Administrative Licensing Law" Article 72, Article 73, Article 74 and Article 75 provides treatment:

(A) meet the statutory conditions for the import of medicinal applications inadmissible;

(B) not accept the import declaration places publicity medicine information project;

(C) acceptance, the review process, not to inform the applicant to fulfill legal obligations;

(D) claims data submitted by the applicant are not complete, does not meet the statutory form, not a correction of the applicant must inform all the content;

(E) instructions will not be accepted or not according to reason is not approved;

(F) do not meet with the provisions of an application for approval of import of medicines beyond the statutory authority to make decisions or approve the decision;

(Vii) comply with the provisions of the imported medicines will not make a decision on approval or application of this method is not approved within the prescribed period to make the decision;

(H) without charges or not in accordance with the statutory items and standards of charges;

(Ix) ask for or accept property or seek other interests.

Article 45 applicants did not disclose relevant information or providing false materials and sample applications for the import of medicines, the State Food and Drug Administration for the application not be accepted or not approved, the applicant be given a warning, the application will not be accepted within one year person's application for import of medicines.

Article 46 The applicant provided false certificates, documents, samples or by other fraudulent means to obtain the "approval documents imported medicines," the State Food and Drug Administration should revoke the "imported medicines approval documents" within five years will not be accepted its application for medicine imports and impose a fine of 30,000 yuan yuan.

Applicants to bribery and other improper means to obtain "imported medicines approval documents", the State Food and Drug Administration should revoke the "imported medicines approval documents," medicine imported within three years of its application will not be accepted.

Article 47 The State Food and Drug Administration drug testing institution established in assuming port inspection, the inspection reports or issuing a false charge inspection fees illegal, according to "Drug Administration Law," Article 87, Article 96 regulations .

Chapter VI Supplementary Provisions

Article 48 of the Regulations of the work period are working days, excluding legal holidays.

First import of medicine, is the first origin of imports from outside of a medicine.

Medicine has been the legal standard, is already the national drug standards or provinces, autonomous regions and municipalities standard medicinal herbs.

Can not set the standard medicine, refers to non-national drug standards or provinces, autonomous regions and municipalities medicine standards, but in our approved prescription medicine containing herbs.

Article 49 These Measures shall be February 1, 2006 onwards.

Implementation of these measures before the release of provisions for the import of medicines, inconsistent with this approach, since the date of implementation of these measures to stop the implementation.

  

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