Regulatory News
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Chapter 1 General Provisions
Article 1 The Provisions are formulated with a view of regulating importation filing, Customs declaration and port inspection for the importation of drugs and ensuring the quality of import drugs in accordance with the Drug Administration Law of the People’s Republic of China, Customs Law of the People’s Republic of China, Regulations for Implementation of the Drug Administration Law of the People’s Republic of China (hereinafter referred to as the Drug Administration Law, Customs Law and Regulations for Implementation of the Drug Administration Law) and relevant laws and regulations.
Article 2 The Provisions are applicable to importation filing, customs declaration, port inspection and import of drugs.
Article 3 Drugs shall be imported via the ports where drug importation is permitted by the State Council.
Article 4 "Importation filing" mentioned in the Provisions refers to the process by which an importer applies for a Drug Import Note to the drug regulatory department of the place where the port permitted for importation is located (hereinafter referred to as the “port drug administration”. The importation filing of narcotic and psychotropic drugs refers to the process by which an importer applies to the port drug administration for a Notice for Port Inspection of Import Drugs.
Port inspection mentioned in the Provisions refers to the inspection of import drugs arrived at a port, which is conducted by a drug testing institution designated by the State Food and Drug Administration (hereinafter referred to as the “port drug testing institution”) in accordance with the law.
Article 5 Only after obtaining an Import Drug License (or Pharmaceutical Product License) or an Import Drug Approval issued by the State Food and Drug Administration, can an importer go through formalities of importation filing and port inspection.
For importation of narcotic and psychotropic drugs, an Import License for narcotic and psychotropic drugs issued by the State Food and Drug Administration must be obtained.
Article 6 An importer shall file a declaration with the Customs in the presence of a Drug Import Note. The Customs shall handle the customs declaration procedures for the import drug based on the Drug Import Note issued by a port drug administration.
The Customs shall handle the customs declaration procedures for a import narcotic and psychotropic drug based on the Import License for narcotic and psychotropic drugs issued by the State Food and Drug Administration.
Article 7 The State Food and Drug Administration shall formulate, amend and publish the catalogue of import drugs jointly with the General Administration of Customs.
Chapter 2 Importation Filing
Article 8 The port drug administrations are responsible for drug importation filing. The importation filing undertaken by port drug administrations shall be under the leadership of the State Food and Drug Administration. Their specific responsibilities include:
(1) Accepting applications for importation filing and examining relevant materials;
(2) Handling matters with respect to importation filing or rejection of importation filing;
(3) Contacting the Customs to handle matters with respect to importation filing ;
(4) Notifying the port drug testing institute to conduct port inspection of import drugs;
(5) Addressing problems arising from importation filing and port inspection ;
(6) Other matters specified by the State Food and Drug Administration.
Article 9 The applicant for inspection shall be an independent legal entity holding a Drug Supply Certificate. A drug manufacturer must hold a Drug Manufacturing Certificate to import drug substances and intermediate preparations (including preparations to be repackaged within China) for its own use.
Article 10 An import drug with any of the following circumstances must be confirmed in compliance with specifications after inspection by a port drug testing institute before undergoing the importation filing procedure. For an import drug found not in compliance with specifications, the port drug administration shall not approve its importation filing.
(1) A biological product specified by the State Food and Drug Administration;
(2) A drug sold in China for the first time;
(3) Other drugs specified by the State Council.
Article 11 Where a purchase contract is signed, the importer shall select a port of delivery from the ports permitted for drug importation. A drug specified in any of the circumstances prescribed in Article 10 of the Provisions must be imported via ports that are specially approved by the State for drug importation.
Article 12 An application for (drug) importation filing shall be submitted to the port drug administration of the port of delivery and inspection shall be carried out by the port drug testing institute responsible for testing drugs imported form this port.
Article 13 To apply for importation filing, an applicant shall fill in a Application Form for Inspection of Import Drugs and provide the original of the Import Drug License [or Pharmaceutical Product License (formal edition or its counterpart)]. To import a narcotic or psychotropic drug, the applicant shall provide the original of the Import License for the narcotic and psychotropic drug and submit materials relating to the import drug in duplicate to the local port drug administration.
(1) Copy of the Import Drug License [or Pharmaceutical Product License (formal edition or its counterpart)]; copy of the Import License for narcotic and psychotropic drugs;
(2) Copies of the Drug Supply Certificate and Corporate Business License of the applicant;
(3) Copies of the Certificate of Origin;
(4) Copies of the purchase contract;
(5) Copies of the packing list, bill of lading and freight invoice;
(6) Copies of the certificate of analysis for the release of the drug by the manufacturer;
(7) Prototypes of the drug insert sheet, package and label (except for a drug substance or an intermediate preparation);
(8) For a biological product subjected to lot release as required by the State Food and Drug Administration, a summary manufacturing protocol as well as the original of the lot release certificate issued by the drug regulatory authority of the country or region of origin shall be provided;
(9) For a drug other than those specified in Article 10 of the Provisions, copies of the latest Import Drug Testing Report and Drug Import Note shall be submitted.
Where a drug manufacturer imports a drug substance or an intermediate preparation for its own production, it shall provide copies of the Drug Manufacturing Certificate and Corporate Business License in replacement of what are required in Item (2) when applying for importation filing.
For an import drug transited via other countries or regions, all the purchase contracts, packing lists, bills of lading and freight invoices for transport from the place of origin to various transit places shall be submitted at the same time.
The copies above shall be affixed with the official seal of the importer.
Article 14 After receiving an Application Form for Inspection of Import Drugs and relevant materials, the port drug administration shall examine them according to the following procedures:
(1) Checking the integrity and authenticity of the materials submitted item by item;
(2) Checking the authenticity of the original of the Import Drug License [or Pharmaceutical Product License (formal edition or counterpart)] or original of the Import License for narcotic and psychotropic drugs;
(3) If no error is found, returning the original of the Import Drug License [or Pharmaceutical Product License (formal edition or counterpart)] or original of the Import License for narcotic and psychotropic drugs to the applicant for inspection and complete relevant importation filing procedures the same day.
Article 15 For a drug specified in the circumstances prescribed in Article 10 of the Provisions, after verifying all the materials to be correct, the port drug administration shall send a Notice for Port Inspection of Import Drugs along with a set of materials specified in Article 13 of the Provisions to the port drug testing institute responsible for inspection, and at the same time, send a Notice for Sampling of Import Drugs to the Customs. Administrative provisions on entering in an area under Customs supervision for sampling a drug for port drug testing shall be separately formulated by the State Food and Drug Administration and General Administration of Customs.
The port drug testing institute shall take samples at the location specified in the Notice for Port Inspection of Import Drugs, conduct quality test and submit the test result to the local port drug administration. For a drug in compliance with relevant specifications, importation filing shall be approved and a Drug Import Note shall be issued by the port drug administration; for a drug not in compliance with specifications, the filing shall be denied and a Notice for Rejection of Drug Importation Filing shall be issued by the port drug administration.
Article 16 For a drug other than those specified in Article 10 of the Provisions, after verifying all the materials to be correct, the port drug administration shall approve the importation filing and issue a Drug Import Note. Meanwhile, it shall send a Notice for Port Inspection of Import Drugs to the port drug testing institute (responsible for testing) along with a set of materials specified in Article 13 of the Provisions.
For a narcotic or psychotropic drug, after verifying all the materials to be correct, the port drug administration shall send a Notice for Port Inspection of Import Drugs to the port drug testing institute responsible for the testing along with a set of materials specified in Article 13 of the Provisions. The Import Drug Note is not required.
The port drug testing institute shall take samples at the location specified in the Notice for Port Inspection of Import Drugs, conduct quality test and submit the test result to the port drug administration. A drug not in compliance with specifications shall be handled by the port drug administration according to the Drug Administration Law and relevant regulations.
Article 17 For a drug in any of the following circumstances, importation filing shall not be approved and a Notice of Rejection of Drug Importation Filing shall be issued by the port drug administration; for a narcotic and psychotropic drug, the port drug administration shall not issue the Notice for Port Inspection of Import Drugs.
(1) Where the Original of the Import Drug License [or Pharmaceutical Product License (formal edition or counterpart)] or original of the Import License for a narcotic and psychotropic drug cannot be provided;
(2) Where the Import Drug License (or Pharmaceutical Product License) or the Import License for a narcotic and psychotropic drug has expired at the time of applying for importation filing;
(3) Where the drug has less than 12 months of shelf life left at the time applying for importation filing. (A drug with a shelf life of less than 12 months shall have no less than 6 months of shelf life left at the time of applying for importation filing);
(4) Where the actual place of production indicated in the certificate of origin is inconsistent with the place of production indicated in the Import Drug License (or Pharmaceutical Product License) or the Certificate of Origin issued by a regional international organization does not indicate the place of production specified in the Import Drug License (or Pharmaceutical Product License);
(5) Where the importer does not have a Drug Supply Certificate (a drug manufacturer shall have a Drug Manufacturing Certificate) and Corporate Business License;
(6) Where package and label of the import drug arriving at the port are inconsistent with those prescribed by the State Food and Drug Administration;
(7) Where the pharmaceutical preparation has no Chinese insert sheet or the Chinese insert sheet is inconsistent with the approved one;
(8) Where the importation is handled by a port which is not approved by the State Council for drug importation or the port of delivery is not within jurisdiction of the port drug administration;
(9) Where a valid biological product lot release certificate issued by the drug regulatory authority of the country or region of origin is not provided for a biological product subjected to lot release by the State Food and Drug Administration;
(10) Where relevant documents and bills are forged or falsified;
(11) Where the Import Drug License (or Pharmaceutical Product License) has been cancelled;
(12) Where the port drug testing institute refuses to sample a drug specified in Article 10 of the Provisions according to the requirements of Article 25 of the Provisions;
(13) Where a drug specified in Article 10 of the Provisions are confirmed not in compliance with specifications after port inspection;
(14) Other cases of inconformity with China's relevant regulations for drug administration.
Article 18 The importer shall return import drugs that are not approved for importation filing. Drugs that cannot be shipped back shall be transferred by the Customs to the port drug administration for disposal.
Article 19 Importation of drugs for urgent clinical needs, donated drugs, and samples or reference drugs for new drug research and drug registration must be approved by the State Food and Drug Administration. The importation filing procedure shall be handled based on the Import Drug Approval issued by the State Food and Drug Administration in accordance with requirements of Article 16 of the Provisions.
Chapter 3 Port Inspection
Article 20 The port drug testing institutes shall be designated by the State Food and Drug Administration according to the need for port inspection of import drugs. Responsibilities of the port drug testing institutes include:
(1) Carrying out on-site verification for shipment arrived at the port;
(2) Checking originals of the certificate of analysis for the release of drugs by the manufacturer and Certificate of Origin;
(3) Taking samples according to required rules;
(4) Carrying out port inspection for import drugs;
(5) Carrying out retesting on drugs with testing results in dispute;
(6) Others defined by the State Food and Drug Administration.
Article 21 The National Institute for the Control of Pharmaceutical and Biological Products is responsible for directing and coordinating port inspection of import drugs. Standard substances and reference standards shall be evaluated and calibrated by the National Institute for the Control of Pharmaceutical and Biological Products.
Article 22 The port drug testing institute shall test import drugs according to registration specifications specified in the Import Drug License (or Pharmaceutical Product License).
Article 23 Within 2 days after receiving a Notice for Port Inspection of Import Drugs, the port drug testing institute shall contact the importer and arrive at the specified storage location to carry out on-site sampling according to the Rules for Sampling of Import Drugs.
The importer shall provide originals of the certificate of analysis for the release of the drug by the manufacturer and Certificate of Origin before sampling.
To take sample in an area under Customs supervision, the port drug testing institute shall discuss sampling arrangement with the Customs and obtain customs’ agreement. The importer and the Customs staff shall be present together at the time of sampling.
Article 24 During on-site sampling, the port drug testing institute shall not neglect to verify the actual arrival status of the import drug, and shall make sampling record and fill out the Import Drug Sampling Record.
For a drug other than those specified in Article 10 of the Provisions, after sampling, the port drug testing institute shall mark the word “sampled” and stamp the official seal of the sampling institute on the original Drug Import Note held by the importer.
For a narcotic and psychotropic drug, after sampling, the port drug testing institute shall mark the word “sampled” and stamp the official seal of the sampling institute on the original Import License held by the importer.
Article 25 For an import drug prescribed in any of the following circumstances, the port drug testing institute shall refuse the sampling.
(1) Originals of the certificate of analysis for the release of the drug by the manufacturer and Certificate of Origin are not provided or the originals provided are inconsistent with copies provided at the time of applying for importation filing;
(2) The shipping mark is inconsistent with documents;
(3) Batch number or quantity of the import drug is inconsistent with documents;
(4) Package and label of the import drug are inconsistent with documents;
(5) Other cases of inconformity with the State laws, rules and regulations for drug administration.
For a drug, of which sampling is refused, the port drug testing institute shall send the Import Drug Sampling Record to the port drug administration within two days.
Article 26 The port drug testing institute shall timely test the samples taken, complete testing within 20 days after sampling, and issue the Import Drug Testing Report. Where the testing cannot be completed within the timeline for a particular product or under special circumstances, the port drug testing institute may appropriately extend the time limit for testing and notify the importer and port drug administration.
The test conclusion of “in compliance with specifications” or “not in compliance with specifications” shall be clearly indicated in the Import Drug Testing Report.
Where a biological product subject to lot release as specified by the State Food and Drug Administration is confirmed in compliance with specifications after testing, and meeting the requirements after review, a biological product lot release certificate shall be issued at the same time.
Article 27 For an import drug confirmed in compliance with specifications after testing, the port drug testing institute shall send the Import Drug Testing Report to the local drug regulatory administration and the importer.
For an import drug confirmed not in compliance with specifications after testing, the port drug testing institute shall timely send the Import Drug Testing Report to the local port drug administration and other port drug testing institutes, and meanwhile submit the report to the State Food and Drug Administration and National Institute for the Control of Pharmaceutical and Biological Products.
Article 28 Testing samples of an import drug shall be kept until the expiration of its shelf life. Retaining samples difficult to be kept can be retained for a certain period of time according to the actual situation. The retaining samples involved in claims or returned test articles shall be kept until the case is concluded. The samples beyond retention period shall be disposed of and recorded by the port drug testing institute.
Article 29 Where the importer holds a different opinion with the test result, a retesting application can be submitted either to the original port drug testing institute or directly to the National Institute for the Control of Pharmaceutical and Biological Products within seven days from the date of receiving the result. Application for retesting of a biological product shall be filed directly with the National Institute for the Control of Pharmaceutical and Biological Products.
The port drug testing institute shall timely notify the port drug administration after accepting a retesting application, and shall give its retesting conclusion, notify the port drug administration and other port drug testing institutes of the conclusion and submit the conclusion to the State Food and Drug Administration and the National Institute for the Control of Pharmaceutical and Biological Product within 10 days from acceptance of the retesting application.
Chapter 4 Supervision and Administration
Article 30 For a drug that the port drug testing institute refuses to sample in accordance with requirements of Article 25 of the Provisions, but the Customs clearance procedure has been completed, the port drug administration shall take administrative enforcement measures to seal and seize all of the drug already imported.
Article 31 Where a drug other than those specified in Article 10 of the Provisions is found to be not in compliance with specifications after testing by the port drug testing institute, within two days after receiving the Import Drug Testing Report, the importer shall report details about distribution and use of all of the import drug to the port drug administration.
After receiving the Import Drug Testing Report, the local port drug administration shall timely take enforcement measures to seal and seize all of the drug and make an administrative decision within seven days. Where a retesting application is filed, an administrative decision must be made within 15 days from the delivery date of the testing report. Relevant information shall be timely reported to the State Food and Drug Administration. Meanwhile, drug regulatory administrations of all provinces, autonomous regions and municipalities directly under the Central Government and other port drug administrations shall be notified.
Article 32 Where a retesting application is not submitted within the specified timeline or the retesting result remains as not in compliance with specifications, the port drug administration shall make an administrative decision according to the Drug Administration Law and relevant regulations. Relevant information shall be timely reported to the State Food and Drug Administration. Meanwhile, drug regulatory administrations of all provinces, autonomous regions and municipalities directly under the Central Government and other port drug administrations shall be notified.
Where the drug is confirmed in compliance with specifications after testing, the port drug administration shall lift enforcement measures of sealing up and seizure, and report the result of the case to the State Food and Drug Administration. Meanwhile, it shall notify drug regulatory administrations of all provinces, autonomous regions and municipalities directly under the Central Government and other port drug administrations of the result.
Article 33 Other problems found in drug importation filing shall be handled by the port drug administration according to the Drug Administration Law and relevant regulations.
Article 34 Where a domestic drug manufacturer, distributor and medical institution purchases an import drug, the supplier shall provide the following materials at the same time.
(1) Copies of the Import Drug License (or Pharmaceutical Product License) and Import Drug Approval;
(2) A copy of the Import Drug Testing Report or of the Drug Import Note marked with “sampled” and affixed with the official seal.
For a biological product subject to lot release as specified by the State Food and Drug Administration, the biological product lot release certificate issued by the port drug testing institution shall be provided at the same time.
For an import narcotic and psychotropic drug, copies of the Import Drug License (or Pharmaceutical Product License), the Import License and the Import Drug Testing Report shall be provided at the same time.
The copies above shall be affixed with the official seal of the supplier.
Article 35 The port drug administration and port drug testing institute shall establish a strict management system for materials involved in importation filing and port testing and be accountable for confidentiality of the materials submitted by the importer.
Article 36 A port drug administration or port drug testing institute that violates relevant requirements of the Provisions for importation filing and port inspection shall be criticized, criticized in a circulated notice and, in serious cases, deprived of its qualifications for importation filing and port inspection, by the State Food and Drug Administration.
Article 37 Violation of relevant customs-related requirements of the Provisions shall be handled by the Customs according to the Customs Law and Detailed Rules for Implementation of Administrative Punishment under the Customs Law of the People’s Republic of China.
Chapter 5 Supplementary Provisions
Article 38 Importers mentioned in the Provisions include traders, recipients and applicants for inspection.
The “traders” refers to enterprises or institutions within China who sign and enforce import & export contracts with overseas partners.
The “recipients” refers to consignees or cargo owners specified in the purchase contract and freight invoice.
The “applicants” refers to actual owners or domestic distributors of the import drug, responsible for handling procedures for importation filing and port inspection.
The recipient and applicant can be the same one.
Article 39 For drugs entering bonded warehouses, bonded areas and export processing zones from abroad, import formalities such as importation filing and port inspection shall be exempted and the Customs shall implement supervision according to relevant regulations; for drugs leaving or entering China from bonded warehouses, export supervised warehouses, bonded areas and export processing zones, formalities such as importation filing and port inspection shall be handled according to relevant requirements of the Provisions.
For drug substances and crude drugs approved to be imported for processing trade, import formalities such as importation filing and port inspection shall be exempted. The drug substances and finished products made from them are forbidden to be sold in the domestic market. Those cannot be exported due to special circumstances shall be transferred to the local drug regulatory administration for disposal in accordance with relevant regulations, and shall be cancelled after verification by the Customs.
Small amounts of drugs carried by individuals entering or leaving the country for their own use shall be limited to an amount appropriate for personal use and subject to supervision and control by the Customs.
Article 40 To import drug substances that are not yet included in the catalogue of import drugs, the applicant shall go through importation filing formalities at the port drug administration in accordance with relevant requirements of the Provisions.
Article 41 Provisions on filing and port inspection for importation of crude drugs shall be formulated separately by the State Food and Drug Administration.
Article 42 To import narcotic and psychotropic drugs, the applicant shall apply for the Import License in the presence of the Import Drug License (or Pharmaceutical Product License) and in accordance with relevant regulations of the State Council for administration of narcotic and psychotropic drugs.
Article 43 Narcotic and psychotropic drugs specified in the Provisions are those for clinical use. The import of narcotic and psychotropic drugs for research, teaching and veterinary use shall be conducted in accordance with relevant regulations of the State Council for administration of narcotic and psychotropic drugs.
Article 44 The State Food and Drug Administration and the General Administration of Customs are responsible for the interpretation of the Provisions.
Article 45 These Provisions shall go into effect as of January 1, 2004. The Provisions for Import Drugs enforced on May 1, 1999 shall be annulled therefrom.
Rules for Sampling of Import Drugs
1. These rules are hereby formulated with a view to improving the management of sampling of import drugs and ensuring that sampling for port testing is representative and scientific and testing results are accurate.
2. Sampling of an import drug shall be carried out by a port drug testing institute undertaking testing of the drug. The applicant for testing shall be responsible for preparing tools and site needed for the sampling as well as matters such as moving, stack shifting, opening and package restoration.
3. Under one contract, only when the drug name, country of origin, manufacturer, package, batch number, dosage form, specification, shipping mark and contract number are all identical, can the drug be sampled as of the same batch; a drug imported under the same contract but arrives at different times shall be sampled at different times as well.
4. For sampling of an import pharmaceutical preparation to be repackaged within China, the importer shall provide the Import Drug License for the large package and approval document for repackaging of the import drug. Sampling is carried out according to the strength and quantity after repackaging and with reference to provisions for sampling of corresponding preparations.
5. Sampling size
Except specially regulated or required, sampling size is usually three times of the quantity needed for the test. Apart from those kept for future reference, remaining samples after test shall be returned to the applicant.
6. Sampling method
(1) Drug substances
1. For package unit above 10 kilograms
Less than 10 units, 1 sample ; 11 to 50 units, 1 more sample for every other 10 units, and the remaining less than 10 units, considered as 10 units; 51 to 100 units, 1 more sample for every other 20 units, and the remaining less than 20 units, considered as 20 units; more than 101 units, 1 more sample for every other 50 units, and the remaining less than 50 units, considered as 50 units; more than 1001 packing units, 1 more sample for every other 100 units, and the remaining less than 100 units , considered as 100 units;
2. For package unit between 5 to 10 kilograms (inclusive of 5 kilograms), 1 sample taken for every 100 kilograms, the remaining less than 100 kilograms, considered as 100 kilograms;
3. For package unit between 1 to 5 kilograms (inclusive of 1 kilogram), 1 sample taken for every 50 kilograms, the remaining less than 50 kilograms, considered as 50 kilograms;
4. For drug package unit less than 1 kilogram, 1 sample taken for every 20 kilograms, the remaining less than 20 kilograms, considered as 20 kilograms (samples shall be taken from original packages).
(2) Injections
1. Small volume injections
Less than 20 thousand (inclusive of 20 thousand) vials (ampoules ), 1 sample taken; less than 50 thousand (inclusive of 50 thousand) vials (ampoules ), 2 samples; less than 100 thousand (inclusive of 100 thousand) vials (ampoules ), 3 samples; more than 100 thousand vials (ampoules ), 1 more sample for every other 100 thousand vials (ampoules ), less than 100 thousand vials (ampoules ) , considered 100 thousand vials (ampoules ).
2. Large volume infusions
For the volume of each infusion package unit between 100 and 1000 (inclusive of 1000) ml, 1 sample taken for every 10 thousand bottles, less than 10 thousand bottles, considered as 10 thousand bottles. For the the volume of each bottle of injection (including dialysis) more than 1000 ml, 1 sample for every 5000 bottles (bags), less than 5000 bottles, considered as 5000 bottles.
(3) Other types of preparations
1 sample for every 20 thousand boxes (bottles); less than 20 thousand boxes (bottles), considered as 20 thousand boxes (bottles).
7. Sampling requirements
(1) Before opening a package for samples, checking the outer package, shipping mark or contract number, product name and quantity against application materials for testing. After opening the package, checking the product name, manufacturer’s name and batch number on small packages, not neglecting to check the integrity and cleanliness of the packages and whether there are water stains, mold and rot or other contamination. If some packages are found deteriorated, re-sampling and testing shall be conducted.
(2) After opening a drug substance package, taking samples from different positions until the total amount reaches the sample size, then pouring the drug substance into the sample flask and mixing well.
(3) After sampling, sealing the opened package and marking the sample size and sampling date on the package.
8. Sampling Cautions
(1) The sampling environment shall be clean and sanitary, sampling tools must be clean and dry, conforming to requirements for sampled drugs.
(2) Caution shall be taken to avoid deterioration of drugs in sampling caused by contamination, moisture absorption, efflorescence and oxidation. Samples taken shall be quickly put in a closed container (plastic bag, iron tank or ground glass stoppered bottle).
(3) Liquid samples shall be shaken even before sampling. For those containing crystals, given that the quality is not affected, the crystals shall be dissolved before sampling.
(4) For sampling of toxic, corrosive and explosive drugs, relevant protective measures shall be taken, the samples shall be moved with cautions, vibration shall be avoided, and the sign “dangerous goods” shall be put on the sample flask.
(5) Metal sampling tools shall not be used for corrosive drugs.
(6) For sampling of drugs that tend to be deteriorated when exposed to light, cautions shall be taken to avoid light exposure when sampling. The sample shall be put in a colored flask, and when necessary, a black paper cover shall be attached to the flask.
(7)For a drug substance that is subject to sterility test, pyrogen test and microbial limit test or has to undergo vacuum treatment and be filled with nitrogen, sampling shall be conduct in accordance with aseptic operation methods or special requirements.
(8) Sampling shall be conducted by technical staff (more than two) who have received specialized training and concerning staff of applicant for inspection shall be present on the spot.
(9) Where the sampling method and sample size need to be appropriately changed in view of abnormalities of quality and package of the goods received, the port drug testing institute shall confer with the applicant on changing the method so that representative samples can be taken. Change of the sampling method shall be recorded in the Import Drug Sampling Record.
Drug Import Note
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____________________Customs: In accordance with relevant requirements of the Provisions for Drug Importation, the following drug has been approved for importation filing. Please complete the Customs clearance procedures. Drug name (Chinese/English): _____________________________ Trade name (Chinese/English): _________________________________ Consignee: _________________________________________________ Applicant for inspection: ______________________________________ HS commodity code: ____________Bill of lading No.:______________ ┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈ Contract number/shipping mark: _______________Port of entry: _____________ Drug manufacturer: _______________Origin: _____________________ Dosage Form: ___________________Strength:___________________ Import Drug License/Approval No.:______ Package type:________ Batch number: ______________________________________ ,Import Quantity ______________Value of import drug:________________ Sampling institute:______________________________ _____________________ Remark: The note is valid within 15 days from the date it is issued. Re-application shall be submitted after the expiration of the note. Port drug administration Specified stamp for drug importation filing MM/DD/YYYY |
Note: the certificate is uniformly printed by the State Food and Drug Administration and served in quadruplicate. The first sheet is archived, the second sent to the Customs, the third to the importer and the fourth to the port drug testing institute.
Notice for Port Inspection of Import Drugs
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______________ drug testing institute: The following import drug has arrived at the port. In accordance with relevant requirements of the Provisions for Drug Importation, please carry out inspection and sampling at storage place, and conduct quality test of the drug. Drug name (Chinese/English): _____________________________ Trade name (Chinese/English): _________________________________ Consignee: _________________________________________________ Applicant for inspection: ______________________________________ HS Commodity Code: ___________Bill of lading No.: __________ Contract number/shipping mark: _____________Port of entry: _______________ Drug manufacturer: __________________Origin:___________________ Dosage Form: ___________________Strength: ____________________ Import Drug License /Approval No.: _______Package type: _______ Batch number: _______________________________________ Import Quantity ______________Value of import drug: _______________ Name/address of the storage place:______________________________ Contact person: ______________________TEL: _________________ Port drug administration Specified stamp for drug importation filing MM/DD/YYYY |
Note: the notice is uniformly printed by the State Food and Drug Administration and served in triplicate. The first sheet is archived, the second sent to the importer and the third to the drug testing institute responsible for testing.
Application Form for Inspection of Import Drugs
HS Commodity Code: First-entry product: Yes□ No□
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Drug name |
Chinese: |
Trade name |
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English: |
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Dosage Form |
Strength |
Package size |
Expiration Date/Shelf life |
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Import drug license No. |
Contract number/shipping mark |
Specifications |
Claim period |
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Quantity |
Value |
Batch number/number of packages: |
Bill of lading No. |
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Port (place) of delivery |
Date of delivery |
Transport (Voyage/flight No.) |
Responsible Customs |
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Port (place) of destination |
Date of arrival |
Storage place |
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Manufacturer |
Country |
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Consignor |
Country |
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Consignee |
Name |
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Address |
(Official seal) MM/DD/YYYY | |||||||||||||
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Contact person |
TEL |
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Applicant for inspection |
Name |
Drug Supply Certificate or Drug Manufacturing Certificate No. |
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Address |
(Official seal) MM/DD/YYYY | |||||||||||||
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Contact person |
TEL |
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Attached materials |
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(Please see “Notes” on the Back) Made by the State Food and Drug Administration
Notes
1. This form is to be completed by the applicant for inspection and served in duplicate. One sheet is archived by the port drug administration; the other sheet is sent to the port drug testing institute. The applicant for inspection and consignee shall affix their seals on the specified “stamp” area.
2. "First-entry products” refers to drugs specified in Article 10 of the Provisions for Drug Importation.
3. For import drugs transited via other countries or regions, all the purchase contracts, packing lists, bills of lading and freight invoices for transport from the place of origin to each transit place shall be submitted at the same time.
4. “Specifications” means the specifications and its number specified in the Import Drug License or Pharmaceutical Product License.
5. “Quantity” refers to the total quantity of product with the package size specified in the Import Drug License or Pharmaceutical Product License as the basic unit, such as bottle, box and kilogram.
6. For drugs specified in Article 41 of the Drug Administration Law, the "storage place” refers to the specific location of the Customs supervised warehouse; storage places of other drugs are the specific locations of the warehouses in which the drugs are to be stored after completing Customs procedures and their names and addresses shall be indicated.
7. For the item “attached materials", the number of each material specified by the Provisions for Drug Importation shall be indicated.
8. Please attach a separate sheet if space is insufficient.
Notice for Sampling of Import Drugs
No.:
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________________________Customs: In accordance with relevant requirements of the Provisions for Drug Importation, the following import drug shall be subject to quality test before customs declaration, please assist the port drug testing institute to carry out inspection and sampling. Drug name (Chinese/English): ____________________________ Trade name (Chinese/English): _________________________________ Consignee: _________________________________________________ Applicant for inspection: ______________________________________ HS commodity code : __________Bill of lading No.: __________ ┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈ Contract number/shipping mark: _______________Port of entry: _____________ Drug manufacturer: _______________Origin______________________ Dosage Form: ____________________Strength____________________ Import Drug License/Approval No.: ________Package type: ______ Batch number: _______________________________________ Import Quantity_________________Value of import drug: _______________ Sampling institute: ___________________________________________________ Port drug administration Specified stamp for drug importation filing MM/DD/YYYY |
Note: the notice is uniformly printed by the State Food and Drug Administration and served in quadruplicate. The first sheet is archived, the second sent to the Customs, the third to the importer and the fourth to the port drug testing institute.
Notice of Rejection of Drug Importation Filing
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_______________Customs: The following drug does not meet requirements for importation filing of the Provisions for Drug Importation. Please handle it according to relevant provisions. Drug name(Chinese/English): ____________________________ Trade name (Chinese/English): _________________________________ Consignee: _________________________________________________ Applicant for inspection: ___________________________________ HS commodity code: ___________Bill of lading No.: ________ ┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈┈ Contract number/shipping mark: _____________Port of entry: _____________ Drug manufacturer: __________________Origin__________________ Dosage Form: __________________Strength_____________________ Import Drug License/Approval No.: ________Package type: ______ Batch number: _______________________________________ Import Quantity ________________Value of import drug: _______________ Problems found: __________________________________________________ ___________________________________________________ ___________________________________________________ Port drug administration |
Note: the notice is uniformly printed by the State Food and Drug Administration and served in quadruplicate. The first sheet is archived, the second sent to the Customs, the third to the importer and the fourth to the port drug testing institute.
The State Food and Drug Administration
进 口 药 品 批 件
Import Drugs Approval Notice
批 件 号：
Approval No.:
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药品通用名Generic Name(INN) |
药品商品名 |
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剂型 |
规格 |
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包装规格 Package Size |
进口数量 |
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生产厂 |
名称 |
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地址 |
产地 |
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公司 |
名称 |
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地址 |
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申请单位 |
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通关备案单位 |
检验标准 |
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批件效期 |
The approval document is valid until MM/DD/YYYY | |||||||
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记录 |
Stamp of the port drug testing institute for cancelation: Date: Actual import quantity and batch number: | |||||||
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备注 |
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(Please notice “Matters for Compliance” on the back)
MM/DD/YYYY
Matters for Compliance
1. This Notice is exclusively used for approval of import products such as donated drugs and samples for research. The applicant shall complete the importation the approved import quantity at one time within the valid period specified by the Notice. The Notice shall not be reused and will become invalid upon expiration.
2. With the original of the Notice and materials specified in “Remark" of the Notice, the applicant for inspection shall go through importation filing and port inspection procedures at the responsible port drug administration specified in the document in accordance with requirements of the Provisions for Drug Importation.
3. After verifying and recording the actual quantity of the products received, the port drug testing institute responsible for testing shall stamp the specified stamp for “cancellation” on the designated place of the original to write off the Notice.
4. Products designated as exempted from inspection in the Notice can be released without inspection.
5. The Notice is in duplicate. One copy is sent to the applicant; the other copy is archived.
6. The Notice shall be kept properly. It shall not be reissued in cases of any loss or damage.
Import Drug Sampling Record
Record No.: Sampling date: MM/DD/YYYY
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Drug name: Trade name： Import Drug License: Port Inspection Notice No.: ___________________________________________________________ 1. Record of conditions of storage place 1.1 Storage place: 1.2 Sampling place: 1.3 Storage conditions: ___________________________________________________________ 2. Record of package conditions 2.1 Whether the outer package is intact □; sealed □ (lead seal □; plastic seal □; adhesive paper □; others: 2.2 The outer package is: iron drum □; fiber drum □; aluminum can □; fiberboard carton □;wooden case □ kraft bag □; plastic woven bags □; others: 2.3 The inner package is: glass bottle □; paper box □; plastic bag □ others: ___________________________________________________________ 3. Record of checking the package label against Import Drug License: 3.1 Product name, specification, package size, shelf life, manufacturer and Import Drug License number are consistent with those on the Import Drug License; 3.2 Batch number, quantity and number of packages are the same as those specified at the time of applying for inspection; 3.3 Inconsistent items: (listed in details) ___________________________________________________________ 4. Record of sampling, including the number of the drum (carton, can, bag), batch number and quantity: ___________________________________________________________ 5 Sampling Conclusion: ___________________________________________________________ Sampling institute: drug testing institute Handled by: Applicant for inspection: Handled by: |
(Please see “Notes” on the Back) Printed by the State Food and Drug Administration.
Notes
1. The Record is in quadruplicate and filled out by the port drug testing institute. One copy is sent to the port drug administration responsible for customs clearance record, one copy is sent to the applicant for inspection and one copy is archived. For products to be sampled in the area under customs supervision, one copy shall be sent to the responsible customs after sampling is completed.
2. According to onsite inspection , put a tick “√” in “□” in the table to indicate a confirmation of such condition, otherwise put a cross “×”.
3. After completing the inspection, the port drug testing institute shall clearly indicate "compliance and sampled” or “non-compliance and unsampled " in the “sampling conclusion" item so that the port drug administration can properly handle importation filing matters in view of this.
4. After being filled out and verified to be correct by the port drug testing institute and applicant for inspection, this Record become effective upon being signed by handling persons of both parties.
××× Drug Testing Institute
Import Drug Testing Report
Report No.: Page , Total pages
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Chinese name of sample |
Sample No. |
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English name of sample |
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Manufacturer/Place of origin |
Batch number |
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Applicant for inspection |
Strength |
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Import Drug License |
Dosage form/Grade |
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Approval document No. |
Package Size |
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Contract No. |
Purpose of testing |
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Date of receipt |
Valid until |
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Sampling size |
Quantity declared |
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Basis for testing |
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Test items Specifications Test result | ||||
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Remarks |
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Conclusion |
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Person in charge |
Issuing date |
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