Anabolic agents and peptide hormones, import and export management (Interim) (Board Order No. 25)
July 28, 2006 release
"Anabolic agents and peptide hormones, import and export management (Provisional)" After the State Food and Drug Administration, General Administration of Customs, the State Sports General Administration considered by now to the State Food and Drug Administration Bureau that the order number release. The Measures September 1, 2006 shall come into force.
State Food and Drug Administration Republic of China General Administration of Customs
Secretary: Shao Mingli Director: Mu Xinsheng
State Sport General Administration
Secretary: Liu Peng
July 28, 2006
Anabolic agents and peptide hormones, import and export management (Interim)
First to regulate anabolic agents and peptide hormones import and export management, according to the "Drug Administration Law of the People's Republic", "PRC Customs Law," "Anti-Doping Code" and other laws and administrative regulations, development of this approach.
Article 2 The State of anabolic agents and peptide hormones, the management of import and export permit.
Article imports of anabolic agents and peptide hormones, the importers should give the State Food and Drug Administration to apply.
Article imported for medical use of anabolic agents and peptide hormones, the importer shall submit the following information:
(A) Application Form for import of medicines;
(B) a copy of the purchase contract or order;
(C) "Import Drug License" (or "Pharmaceutical Product License") (original or copy) a copy;
(D) the importer of the "Drug Supply Certificate", "business license", "Import and Export Enterprise Qualification Certificate" (or "foreign trade operators Registration Form"), "Organization Code Certificate" copy; drug production Enterprise businesses need to import the intermediate bulk drugs and formulations (including formulations within the sub-packaging) should be submitted to the "drug production license", "business license", "Organization Code Certificate" copy;
(E) "Import Drug License" (or "Pharmaceutical Product License"), holders of such commission other companies to export their drugs, must provide the commission the export letter.
Copies should be stamped with the above types of seal imports.
Article for teaching and research needs of the imports of anabolic agents and peptide hormones, the importers shall submit the following information:
(A) Application Form for import of medicines;
(B) a copy of the purchase contract or order;
(C) the legal qualification of the units for domestic use documents, the number of drug use and the use of units of measurement based on the legitimate use and management issued a letter of guarantee of the drug;
(D) the approval of the appropriate documents or relevant scientific research department of the approval documents;
(E) accept the use of units of the principal-agent imports, need to provide a copy of the agency agreement and import unit "business license", "Import and Export Enterprise Qualification Certificate" (or "foreign trade operators Registration Form"), "Organization Code Certificate" copy.
Copies should be stamped with the above types of seal imports.
Article domestic enterprises entrusted by foreign enterprises to accept the need to import the production of anabolic agents and peptide hormones, in addition to submit the first paragraph of Article 5 (a), paragraph (c), (e) of the information required, should also provide has provinces, autonomous regions and municipalities (food) drug administration departments for the record documents.
Copies should be stamped with the above types of seal imports.
Article 7 The State Food and Drug Administration received an application and import the information, shall be 15 working days to decide whether to agree to import; for consent to import, and given drugs "import permit"; do not agree to import should give reasons in writing.
Article VIII with import of units issued by the State Food and Drug Administration drug "import permit" to allow the import of medicines port customs declaration, customs with drugs "import permit" clearance. Imports of anabolic agents and peptide hormones do not need a "Drug Import Note."
Article IX imported for medical use of anabolic agents and peptide hormones (including the first sale in China), the importers shall import formalities are completed, the timely completion of "a single inspection of imported drugs," to the "Import Drug License" (or "Pharmaceutical Product License") Original (original or copy), drug "import permit" the original, to the import port (food) drug administration departments to submit the following information in duplicate, the application for "notified port inspection of imported drugs book ":
(A) "Import Drug License" (or "Pharmaceutical Product License") (original or copy) and drugs "import permit" copy;
(B) the importer of the "drug production license" or "Drug License" a copy of "business license" copies;
(C) a copy of the certificate of origin;
(D) of the purchase contract;
(E) packing list, Bill of Lading and freight invoice;
(F) a copy of the factory inspection report;
(G) instructions and pharmaceutical packaging, labeling pattern (except for bulk drugs and formulations intermediates).
Copies should be stamped with the above types of seal imports.
Article port (food) drug administration departments received "a single inspection of imported drugs," and related information, the review is correct, the "Import Drug License" (or "Pharmaceutical Product License") (original or copy) the original, drugs "import permit" returned the original importer, and shall be responsible for inspection on the same day to the port of Drug Control issued a "Notice of port inspection of imported drugs," with the information specified in Article 9 a.
Port Drug received "notice of imported drugs test ports" shall, within two working days and contact the importer, to the inventory sample locations, sampling is completed, it should be in the drug "import permit" First United original the back of the state "has been sampled" the words, and affix the official seal of the sampling unit.
Article XI for teaching and research needs of the import of protein assimilation preparations and peptide hormones as well as domestic enterprises and foreign enterprises to import commissioned the production of anabolic agents and peptide hormones, to be exempt.
Article XII of the following circumstances, the port (food) drug regulatory department shall promptly report to the State Food and Drug Administration:
(A) port (food) drug regulatory department under the "Drug Import Regulations" (State Food and Drug Administration, General Administration of Customs No. 4) Article 17 provides that no payment "notice of port inspection of imported drugs." a;
(B) port for Drug Control under the "Measures for the Administration of Drug Import" Article 25, not sampled.
Port (food) drug administration departments in line with the preceding paragraph and has imported all the drugs should be taken to attachment, seizure of administrative enforcement measures, and in the seizure, detention within seven days from the date of the decision to approve the return shipment, notify the importer in accordance with with the provisions of anabolic agents and peptide hormones pharmaceutical export procedures "export permit" will import all the drugs returned to the original exporter.
Importer receives grant returned within 10 days from the date of the decision is not clear that the answer or not returned, and has been seizure, seizure of drugs by the port (food) drug administration to supervise the destruction.
Article XIII of the import of protein assimilation preparations and peptide hormones by the port for Drug testing does not meet the standard requirements, the import unit shall receive the "Import Drug Report 'after 2 days, the entire flow of imported drugs, the use of detailed situation, report to the local port (food) drug administration.
Port (food) drug administration departments received "Import Drug Report", shall promptly be taken of all drugs seized or detained compulsory administrative measures, and whether made within 7 days of filing of the decision.
Importer is not made within the prescribed time or re-inspection is still the standard by re-inspection requirements, port (food) drug administration should be allowed to send back the decision, notify the importer in accordance with the provisions of anabolic agents and peptide export procedures hormone drugs "export permit" will import all the drugs returned to the original exporting country. Importer receives grant returned within 10 days from the date of the decision is not clear that the answer or not returned, the port (food) drug administration to supervise the destruction.
After retesting the standard requirements, port (food) drug regulatory departments shall lift the seizure, seizure of administrative enforcement measures.
Port (food) drug administration department shall in accordance with this paragraph, 3 and 4 regulations in time to report the State Food and Drug Administration, and notice the provinces, autonomous regions and municipalities (food) drug administration and other port (food) drug administration.
Article XIV of domestic pharmaceutical manufacturers, enterprises and medical institutions purchase imports of anabolic agents and peptide hormones, the supply unit should provide "Import Drug License" (or "Pharmaceutical Product License") copies of drugs "import permit "copy and" Drug Import Inspection Report, "a copy, and copies of the above types of units available on the official seal affixed.
Article XV exports of anabolic agents and peptide hormones, the exporter shall provide the provinces, autonomous regions and municipalities (food) drug administration department for approval, submit the following information:
(A) Drug export application form;
(B) the importing country or region of the medicines regulatory agencies to provide the original import permit (or a notarized copy and the text).
Importing countries or regions, such as anabolic agents and peptide hormones have not yet implemented the import licensing system, to provide the importing country's drug regulatory agencies such products imported without import permits issued by the documents (original), and the following documents a:
1. Importing country or region's drug regulatory authority to provide consent to import the drug's original documents (or notarized copies and text);
(2) legal qualification of the importer of the drug use of documents and legal documents the original (or notarized copies and text);
(C) the contract or purchase order copies (self-export production enterprises);
(D) copy of export contract or order;
(E) export drugs such as domestic pharmaceutical manufacturers approved the production of varieties, to provide the pharmaceutical manufacturers' drug production license "," business license "and a copy of drug approval documents;
Export drugs such as domestic enterprises overseas enterprises commissioned the production of varieties, have been required to provide the provinces, autonomous regions and municipalities (food) drug administration departments for the record copies of supporting documents;
(F) export business, "business license", "Import and Export Enterprise Qualification Certificate" (or "foreign trade operators Registration Form"), "Organization Code Certificate" copy.
The export of various types of copy should be stamped seal.
Article XVI in accordance with the Article 12, Article XIII returned, and for drug "export permit" shall provide the following information:
(A) the exporter of the original application for return of proof of export unit material;
(B) drugs "import permit."
Article XVII provinces, autonomous regions and municipalities (food) drug administration departments received the application and export the information, shall be 15 working days to decide whether to agree to export; export of consent, given drugs "export permit "; do not agree to export, it shall give reasons in writing.
In accordance with the provisions of this Article 16 apply for drugs "export permit", the issuing authority should be in the drug "export permit," with the "original goods back" message.
Article 18 The export unit with provinces, autonomous regions and municipalities (food) drug administration issued by the drug "export permit" to the customs clearance. Customs with drugs "export permit" clearance.
Article 19 The import and export units in the customs clearance procedures should be more of a joint declaration submitted to the Customs for sign-off of the joint declaration. Customs with drugs "import permit", "Export permit" in the joint declaration on the affixed "examined stamp" back export units. Customs in accordance with the relevant provisions of the license fee charged.
1 month after completion of import and export, the import and export of the drug unit should be "import permit", "export permit," the first joint Customs declarations returned to the issuing authority signature.
After import and export permits to obtain drugs not associated import and export trade, import and export units in the permit shall be effective within one month after the expiration of the original permit returned to the issuing authority.
Diershitiao drugs "import permit" valid for one year. Drugs "Export permit" a period not exceeding 3 months (no multi-year validity period).
Drugs "import permit", "Export permit" implementation of "one license one customs", one-time use only within the validity period, the content may change the face cards. Delayed for some reason the import and export, import and export permit can take the original for an extension of replacement procedures.
Twenty-one drugs "import permit", "Export permit" any loss, import and export units should immediately report the loss to the original issuing authority in writing. Loss of the original issuing authority receives the report, notify the port customs. The original issuing authority verified no adverse consequences, be re-replacement.
Article 22 of the drugs "import permit", "Export permit" by the State Food and Drug Administration printed.
Article 23 The import and export of processing trade of anabolic agents and peptide hormones, drugs with Customs' import permit "," Export permit "for inspection and clearance procedures and regulate. Do not export because of special circumstances, the transfer of location of the goods (food) drug regulatory department according to regulations, the Customs shall evidence for the write-off procedures.
Article 24 bonded zones, export processing zones and other customs supervision and control sites and offshore and out of bonded and special customs surveillance areas, bonded out between regulatory sites of protein assimilation preparations and peptide hormones, immunity for drugs "import permit certificate "," export permit ", supervised by the Customs.
From bonded areas, export processing zones and other customs supervision and bonded into place within the territory outside the control of anabolic agents and peptide hormones, drugs should be handled "import permit."
From outside the territory into bonded zones, export processing zones and other customs supervision and monitoring of bonded premises of anabolic agents and peptide hormones, drugs should be handled "export permit."
Article 25 individuals for medical needs to carry or mail the entry and exit within a reasonable amount for personal use of anabolic agents and peptide hormones, customs authorities in accordance with health regulations with the prescription medical prescription to be clearance.
Article 26 except as otherwise provided in this way for the medical use of anabolic agents and peptide hormones imports, port inspection, supervision and management, etc., refer to "Measures for the Administration of Drug Import" on drug importation regulations.
Article 27 The term imported for medical use of anabolic agents and peptide hormones, is the import of protein assimilation preparations and peptide hormones, or intended to be used for production of formulations marketed in China.
Import unit: is made in accordance with the way the drug "import permit," stated on the importer.
Export unit: is made in accordance with the way the drug "export permit," stated on the export units.
Article 28 These Measures shall be September 1, 2006 shall come into force. State Food and Drug Administration September 30, 2004 "issued on anabolic agents and peptide hormones Import and Export Control" (State Food and Drug Safety [2004] No. 474) shall be repealed simultaneously.
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