Ministry Of Health, The General Administration Of Customs On The Decision To Amend The Drug Import Regulations

Original Language Title: 卫生部、海关总署关于修改《药品进口管理办法》的决定

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Read the untranslated law here: http://www.chinalaw.gov.cn/article/fgkd/xfg/gwybmgz/201210/20121000377272.shtml

Ministry of health, the General Administration of customs on the decision to amend the drug import regulations (August 24, 2012 Ministry of health, and Customs makes 86th, announced since announced of day up purposes) for implement implementation People's Republic of China administrative forced method, according to State on implement implementation straddling People's Republic of China administrative forced method of notification (country sent (2011) 25th,) requirements, on food drug regulatory Council, and customs Yu August 18, 2003 announced of drug imports management approach for following modified: a, and will 17th article 14th items modified for: " Pharmaceutical supervisory and administrative departments have other evidence that imported drugs may harm human health. "The second article of the 25th, the fifth is amended as:" the pharmaceutical supervisory and administrative departments have other evidence that imported drugs may harm human health.

” This decision shall come into force as of the date of.

    Drug import regulations in accordance with this decision be revised and republished.

    Appendix: administrative measures for the import of drugs 2012 (revised) (August 18, 2003 food and drug supervision Bureau, the General Administration of Customs released 4th order of August 24, 2012 Ministry of health, the General Administration of customs, the 86th published come into force on the date of promulgation of the Ministry of health, the General Administration of customs on decision to modify the administrative measures for the import of drugs Amendment)

    Chapter I General provisions

    First to standardize the drug importation record keeping, customs declaration and port inspection work, guarantee the quality of imported drugs, according to the People's Republic of China medicine management law, the People's Republic of China Customs law and the People's Republic of China pharmaceutical administration law implementing regulations (hereinafter referred to as the Pharmaceutical Affairs Act, the Customs Act, the implementation of the pharmaceutical Administration Law Ordinance) and the provisions of relevant laws and regulations, these measures are formulated.

    Second drug import record keeping, customs declaration and port inspection and import procedures apply.

    Article medicines must be imported through ports which are approved by the State Council to allow drug imports. Article fourth filing mentioned in these measures refers to imported units to allow drug imports port local drug regulatory authorities (hereinafter referred to as the port Drug Administration) to apply to the process of customs clearance of imported drugs.

Narcotic and psychotropic drugs for import record keeping, refers to the importer to the port Drug Administration to apply for the notification of inspection of imported drugs.

    Port inspection mentioned in these measures refers to countries identified by the food and drug administration and drug control agency (hereinafter referred to as the port drug inspection Institute) on arrival at the port of import drug law implementation inspection work.

Fifth imported drugs shall be issued by the State food and Drug Administration made the imported drug registration certificate (or certificate of registered pharmaceutical products), or the imported drugs after approval, for import record keeping and port inspection procedures.

    Import of narcotic drugs, psychotropic drugs, must also be issued by the State food and drug administration of narcotic and psychotropic drugs of the import permit.

Drug import holders a sixth importer customs form to the customs declaration, Customs port Drug Administration issued by the customs clearance of imported drugs, and go through the formalities of Customs Declaration and examination of imported drug.

    Import of narcotic drugs, psychotropic drugs, and Customs issued by the State food and drug administration of narcotic and psychotropic drugs go through the formalities of Customs Declaration and examination of the import permit.  

    Article seventh State food and drug administration, in conjunction with the General Administration of customs develop, revise, publish list of imported drugs.

    Chapter II import record keeping Article eighth port drug administration responsible for drug import record keeping work.

Borne by the port drug administration import record keeping by the State food and Drug Administration's leadership, its specific responsibilities include:

(A) the applications for import record keeping, reviewing import record keeping materials;

(B) the formalities for import record keeping or not matters related to import record keeping;

(C) contact customs in connection with matters relating to import record keeping;

(D) notify the port drug inspection offices to implement port inspection of imported drugs;

(E) problems found in import record keeping and port inspection supervision;

    (Vi) other matters prescribed by the State food and drug administration. Nineth Inspection Unit should be holding the drug business of independent legal entities.

    Pharmaceutical manufacturers import raw materials required for drugs and intermediate preparations (including local preparations for package), you should hold the drug manufacturing license. Article tenth following cases of imported drugs, must be approved by the port drug inspection offices inspection in accordance with standard requirements, formalities for import record keeping procedures.

Not meeting the prescribed standards, the port drug administration no import record keeping:

(A) biological products under the State food and drug administration;

(B) drugs sold in China for the first time;

    (C) other drugs prescribed by the State Council. The 11th article Import when you sign a purchase contract, to allow drug imports CIF cargo port of choice.

    Which medicines the tenth provisions of these measures must be approved by the national special ports that allow drug importation.

    12th for import record keeping, should apply to the goods CIF port drug administration and port drug inspection Office responsible for the port drug inspection test.

13th article handle imports record, reported inspection units should fill in imports drug reported inspection single, holding imports drug registered card (or medicine products registered card) (original or copy) original, imports anesthesia drug, and spirit drug also should holding anesthesia drug, and spirit drug imports allowed card original, to location port drug supervision authority submitted by imports varieties of about information a type two copies:

(A) the imported drug registration certificate (or certificate of pharmaceutical product registration) (original or copy) to copy of narcotic and psychotropic drugs in copies of the import permit;

(B) the inspection by the drug business license and copy of the business license;

(C) the copy of the certificate of origin;

(D) copies of purchase contract;

(E) the packing list, copy of the air waybill and freight invoice;

(Vi) copies of factory inspection report;

(VII) drug instructions and packaging and labelling design (API and intermediate preparations);

(H) the provisions issued by the State food and Drug Administration Biologics, you need to provide production test summary, and producers or regions of lot release certificate issued by regulatory authorities;

(I) the tenth provided drugs other than these measures, recent drug import inspection report shall be submitted with a copy of the customs clearance of imported drugs.

Pharmaceutical producing enterprises can import produce the necessary APIs and pharmaceutical intermediates for import record keeping, (b) information should be submitted to the drug manufacturing license with a copy of the business license.

Imported drugs going through other countries or regions, need to submit both from the point of origin to the re-export to all purchase contracts, packing lists, tracking and shipping invoice.

    Copies of these types of seals shall be affixed to imported units.

14th port Drug Administration received the inspection of imported drugs and related information, be reviewed according to the following program requirements:

(A) item by item to verify the reported information is complete, true;

(B) the inspection of imported drugs registration certificate (or certificate of pharmaceutical product registration) (original or copy) original or narcotic drugs, psychotropic drugs in the original import permit for authenticity;

    (C) the review is correct, the imported drug registration certificate (or certificate of pharmaceutical product registration) (original or copy) original or narcotic drugs, psychotropic drugs in the original import permit, returned to the inspection and related procedures completed in time for import record keeping on that day. 15th article tenth of the drugs in these measures, the port drug administration review after all the information is correct, it shall inspect the port drug inspection Office has issued the notice of inspection of imported drugs, 13th provided a copy of these measures and to issue the notification of the sampling of imported drugs.

Sites sampled on the port drug inspection offices enter the customs supervision regulations formulated by the State food and drug administration and the General Administration of customs. Port drug inspection Office in accordance with the provisions of the notice of inspection of imported drugs sampling locations, taking test samples, inspection and the inspection result to the local port drug administration.

    Inspection in accordance with prescribed standards, granted for import record keeping, issued by the port drug administration import drugs tongguan Dan; do not meet the requirements of the standard, no import record keeping by the port Drug Administration issued no notice of filing in the drug. 16th article tenth drugs other than herein, the port drug administration review after all the information is correct, granted for import record keeping, issued of the customs clearance of imported drugs.

And to inspect the port drug inspection Office has issued the notice of inspection of imported drugs, 13th provided a copy of these measures.

For narcotic drugs, psychotropic substances, the port drug administration review after all the information is correct should be only to inspect the port drug inspection Office has issued the notice of inspection of imported drugs, 13th provided a copy of these measures, without the customs clearance of imported drugs. Port drug inspection Office shall be provided for in the notice of inspection of imported drugs sampling site sampling, quality control and the inspection result to the local port drug administration.

    For not meeting the standards of drugs, by the port drug administration in accordance with the drug administration law and relevant regulations.

Article 17th imported drugs, one of the following circumstances, no import record keeping by the port Drug Administration issued no notice of filing in the drug; for narcotic drugs, psychotropic substances, the port drug administration shall not be issued the notice of inspection of imported drugs:

(A) do not provide the imported drug registration certificate (or certificate of pharmaceutical product registration) (original or copy), and the approval of imported drugs or narcotic, psychotropic drugs of the original import permit;
(B) when the formalities for import record keeping, the imported drug registration certificate (or certificate of registered pharmaceutical products), or narcotic, psychotropic drugs of the import permit has expired;

(C) when the formalities for import record keeping, drug the validity period is less than 12 months.

(About the drug itself will expire within 12 months, when the import record keeping, the validity period shall not be less than 6 months);

(D) the certificate of origin is marked by the actual production and the imported drug registration certificate (or certificate of registered pharmaceutical products) provided does not match the origin, or certificate of origin issued by regional international organizations did not have the imported drug registration certificate (or certificate of pharmaceutical product registration) provides origin;

(E) the importer without a drug license (manufacturers shall obtain the drug manufacturing license) and the enterprise license;

(F) the CIF of packing, labels, inconsistent with the provisions of the State food and drug administration;

(VII) no manual or instructions in Chinese drug preparation not consistent with the approved specifications;

(H) is not approved by the State Council to allow drug imports port organization imported, or goods to a bank not belonging to the local port drug administration jurisdiction;

(I) the lot release of biological products under the State food and Drug Administration did not provide effective producers or regions the Biologics lot release certificate issued by drug regulatory authorities;

(J) the forged or altered documents and instruments;

(11) the imported drug registration certificate (or certificate of pharmaceutical product registration) has been revoked;

(12) article tenth of the drugs in these measures, the port drug inspection Office under the provisions of the article 25th no sampling;

(13) article tenth of the drugs in these measures, port inspection does not meet the prescribed standards;

    (14) the pharmaceutical supervisory and administrative departments have other evidence that imported drugs may harm human health. Article 18th no import record keeping imported drugs, the import entity shall be shipped back.

    Unable to return, the port drug administration supervision by the customs. 

    Article 19th clinical urgent need of drugs, donations of medicines, drug research and drug samples or controlled drugs required for registration, it must be approved by the State food and Drug Administration approved and issued by the State food and Drug Administration's drug import documents, in accordance with the provisions of the present article 16th, formalities for import record keeping procedures.

    Chapter III inspection 20th port drug inspection by the State food and Drug Administration on import customs inspection of medicine needs to be determined.

Port drug inspection Office's responsibilities include:

(A) conduct verification over the landed goods;

(B) verify the factory inspection report and the original certificate of origin;

(C) in accordance with the provisions of the sample;

(D) to implement port inspection of imported drugs;

(E) on results of inspection re-inspection of dissent;

    (Vi) other matters prescribed by the State food and drug administration. Article 21st of pharmaceutical and biological products are responsible for the inspection of imported drugs of guidance and coordination.

    Required for customs inspection standards and the control of pharmaceutical and biological products is responsible for auditing, calibration.

    22nd the port drug inspection Office shall in accordance with the imported drug registration certificate (or certificate of pharmaceutical product registration) shall record the registration standards test on imported drugs.

Article 23rd port drug inspection Office after receipt of the notice of the inspection of imported drugs, shall, within the 2nd contact importer, to provide stock location in accordance with the sampling provisions for on-site sampling of imported drugs.

Importers shall, before sampling, provide the factory inspection report and the original certificate of origin. Need access to the customs surveillance zone for sampling, the port drug inspection Office shall at the same time to contact Customs sampling, with the consent of the customs agreement.

    When sampling, importers and customs officers should be present.

Article 24th port drug inspection and sampling at the scene, it should be noted that verification of the actual delivery of the imported varieties, well sampling records and fill out the sampling of imported drugs record keeping form.

Tenth provided drugs other than these measures, after the sampling is completed, the port drug inspection offices shall be held by the importer of the original import drugs tongguan Dan indicated on the "sample" words, and shall affix its official seal.

    On narcotic drugs, psychotropic drugs, after the sampling is completed, it should be indicated in the import permit, the original "sample" words, and shall affix its official seal.

25th to imported drugs, one of the following circumstances, the port drug inspection and not sampling:

(A) does not provide the factory inspection report and the original certificate of origin, or provide the original and copy of the import declaration when filing is inconsistent;

(B) the shipping mark and documents are inconsistent;

(C) batch number or quantity of imported drugs and documents are inconsistent;

(D) the packaging and labelling of imported drugs and documents is inconsistent;

(E) the pharmaceutical supervisory and administrative departments have other evidence that imported drugs may harm human health.

    For drugs that are not sampled, the port drug inspection Office shall, within the 2nd, to record the sampling of imported drugs to the local port drug administration. 26th the port drug inspection Office shall promptly on the extraction of the samples tested and sampled in the 20th, perform inspection, issued the report on inspection of imported drugs.

Can't finish the examination in special variety or special situations, you can extend the testing period and notify the importer and the port drug administration.

The report on inspection of imported drugs should be clearly marked "meeting the prescribed standards" or "does not meet the standards" test results.

    Lot release of biological products under the State food and drug administration, port inspection in accordance with the standard requirements, audit compliance, and shall at the same time granting Biologics lot release certificate.

Article 27th test meeting the prescribed standards of imported drugs, the port drug inspection Office shall send a report of the inspection of imported drugs to seat the port drug administration and imported units.

    To test imported drugs not meeting the prescribed standards, the port drug inspection Office shall timely report of the inspection of imported drugs send port drug administrations and other port drug inspection Office, and submitted to the State food and drug administration and pharmaceutical and biological products. 28th article import drug test samples shall be kept until the expiration date. Easy storage of samples, according to the actual situation grasp to save time. Claim or return of seized goods samples shall be preserved until at the end of the case.

    Over shelf life samples, be dealt with by the port drug inspection offices and records. Article 29th importer disagrees with the results of testing, can be since the date of receiving the test results apply to the port drug inspection offices in the 7th reinspection or directly file an application for re-inspection to the pharmaceutical and biological products.

Biological products directly to the reinspection of pharmaceutical and biological products applied for. 

    The port drug inspection Office after accepting an application for re-inspection shall promptly notify the port drug administrations, and acceptance within 10th of the reinspection, to retest conclusion, notify the port drug administration and other port drug inspection Office, reported that the State food and drug administration and pharmaceutical and biological products.

    Supervision and administration of the fourth chapter

    30th port drug inspection Office under the provisions of the present article 25th no sampling drugs completes the customs clearance procedures, the port drug administration shall have to import all drugs seizure, seizure of compulsory administrative measures.

31st article tenth drugs other than herein, the port drug inspection offices inspection does not meet the prescribed standards, the import entity shall upon receipt of the report of the inspection of imported drugs in the 2nd, all imported drugs, using the details, reports local port drug administration. Local port drug administration after receiving a report of the inspection of imported drugs, shall take all the drugs in time to seal up or seize administrative coercive measures, and make a decision of administrative handling within the 7th. To file an application for re-inspection, must be from the date of inspection reports issued 15th make a decision of administrative handling within.

    The situation shall promptly report to the State food and drug administration, and notify each province, autonomous region, municipality directly under the food and drug administration and other port drug administrations. Article 32nd not within the time stipulated in the proposed retest or retest is still not meeting the prescribed standards, the port drug administration shall, according to the pharmaceutical administration law and relevant provisions of decision of administrative handling.

The situation shall promptly report to the State food and drug administration, and notify each province, autonomous region, municipality directly under the food and drug administration and other port drug administrations.

    Meeting the prescribed standards upon re-inspection, the port drug administration shall lift the seizure, seizure of compulsory administrative measures and will report to the State food and drug administration, and notify each province, autonomous region, municipality directly under the food and drug administration and other port drug administrations.

    Article 33rd other problems found in import record keeping, by the port drug administration in accordance with the drug administration law and relevant provisions to deal with it.

Article 34th China pharmaceutical producing enterprises, trading enterprises and medical institution purchases imported drugs, the supplier shall provide the following information:

(A) the imported drug registration certificate (or certificate of pharmaceutical product registration) copies of copies, of the imported drug approvals;

(B) the copy of the report of the inspection of imported drugs, or marked "sample" and stamped with the official seal of the copy of the import drugs tongguan Dan;

Lot release of biological products under the State food and drug administration, you need to provide lot release certificate issued by the port drug inspection Office.

Import of narcotic drugs, psychotropic drugs, should be also presented the imported drug registration certificate (or certificate of pharmaceutical product registration) of the copy of the import permit copies and copies of the report on inspection of imported drugs.

    These copies must be stamped with the supply unit.

    35th port drug administration and port drug inspection Office shall establish a strict import record keeping materials and port inspection information management system, and the importer reported information confidential.
Article 36th in violation of these regulations for import record keeping and port inspection provisions of the port drug administration and port drug inspection Office, the State food and drug administration, according to circumstances, criticism, criticism, serious to stop the import record keeping and port inspection qualification.

    37th in violation of the relevant provisions concerning the customs, the customs in accordance with the Customs Act and the People's Republic of China administrative penalty provisions of the rules for the implementation of the Customs Act.

    The fifth chapter by-laws

Importer in 38th article of the rules, including business unit, receiving and inspection units.

Entity is a foreign import and export trade contracts signed and implemented by domestic enterprises or units.

Receiving unit, refers to the purchase contract and shipping invoice the consignee or consignor set forth in.

Inspection Unit refers to the territory of the actual owner or distributor of imported drugs, and specifically responsible for the formalities for import record keeping and port inspection procedures.

    Receiving and inspection units for the same unit.

39th from abroad into bonded warehouses, bonded areas, export processing zone, medicines, exempted from import procedures such as formalities for import record keeping and port inspection, in accordance with the relevant provisions of regulation from the bonded warehouse, export supervised warehouse, bonded areas, export processing zone or area into the country's drugs, according to the relevant provisions of the measures for import record keeping and port inspection procedures. Approved processing trade imports of raw materials, raw material for medicine, exempt from formalities for import record keeping and port inspection, import procedures, prohibited to sell its raw materials and manufactured goods.

Unable to export due to special circumstances, transfer of local drug supervision and management departments in accordance with the regulations, the customs are cancelled.

    Inbound and outbound personnel carry personal use of small amounts of drugs, shall be limited to reasonable quantities for personal use and subject to customs control. 

    40th article import provisional API that are not included in the list of imported drugs shall be in compliance with the regulations, to the port drug administration formalities for import record keeping procedures.

    41st medicine import record keeping and port inspection provisions, shall be separately formulated by the State food and drug administration.

    The 42nd article import of narcotic drugs, psychotropic drugs with the imported drug registration certificate (or certificate of registered pharmaceutical products), according to the State Department narcotics, psychotropic drug management and the related regulations of the import permit.

    43rd article of the regulation of narcotic drugs, psychotropic drugs refers to clinical use, research, teaching, veterinary import of narcotic, psychotropic drugs, narcotic and psychotropic drugs under the State Council management and the related regulations.

    44th article this way interpreted by the State food and drug administration and the General Administration of customs. 45th article of the measures shall come into effect on January 1, 2004. With effect from May 1, 1999 drug import regulation repealed simultaneously.