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Legal analysis: 1. Registration procedures must be carried out in the destination country of going abroad, which is different in each country, some countries need to re-do clinical trials, and some countries even need to re-do basic tests such as pharmacology and toxicology. 2. There are also some countries that require that the enterprises that produce the drug must also pass the certification to be eligible for export, of course, the items that require certification are different, some require EU certification, some FDA certification, WHO certification, and PQ certification.
3. Rewrite the packaging and instructions of all drugs, use the language of the export destination country, and conform to the relevant requirements of the export destination country.
Legal basis: Drug Administration Law of the People's Republic of ChinaArticle 27 For the first import of drugs, the importing unit must provide the instructions, quality standards, inspection methods and other relevant information and samples of the drugs, as well as the supporting documents approved by the exporting country (region) for production, and the import contract can only be signed with the approval of the health administrative department.
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1. Import filing. The importing entity shall apply to the Port Drug Administration for the Customs Clearance Form for Imported Drugs.
2. The imported hosiery unit shall declare to the customs with the "Customs Clearance Form for Imported Drugs", and the Customs shall handle the customs declaration and inspection procedures for imported drugs with the "Customs Clearance Form for Imported Drugs" issued by the Port Drug Administration.
The Port Drug Administration is responsible for the import filing of drugs. The import filing work undertaken by the Port Drug Administration is under the leadership of the State Food and Drug Administration, and its specific responsibilities include:
1) The morning car cover accepts the application for import filing and reviews the import filing materials;
2) Matters related to the handling of import filing or non-import filing;
3) Contact the Customs for matters related to import filing;
4) Notify the port drug inspection institute to carry out port inspection of imported drugs;
5) Supervise and deal with the problems found in the import filing and port inspection;
6) Other matters stipulated by the State Food and Drug Administration.
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Information required for customs declaration of imported drugs 1. Customs declaration process for imported drugs 1Import commodity inspection. The importing unit shall apply to the Port Drug Administration for the Customs Clearance Form for Imported Drugs.
2.The importing unit shall declare to the customs with the "Customs Clearance Form for Imported Drugs", and the customs shall declare the customs declaration and release of imported drugs with the "Customs Clearance Form for Imported Drugs" issued by the Port Drug Administration. Pharmaceuticals.
2. The import filing and inspection unit shall fill in the "Imported Drug Inspection Form", and need to provide all copies of the "Import Drug Registration Certificate", "Medical Product Registration Certificate", "Import Drug Approval Document", "Drug Business License", business license, certificate of origin, packing list, purchase contract, factory inspection report, drug morning liquid product instructions and packaging label style and seal 1Fill in the "Imported Drugs ** Form"; 2.Review the above.
After passing the examination, the port drug administration will issue the "Notice of Port Inspection of Imported Drugs" to the port drug inspection institute, and at the same time issue the "Notice of Sampling of Imported Drugs" to the customs; 3.After passing the sampling inspection, the sampling inspection shall be indicated on the customs clearance form; For imported drugs that have been re-exported by other countries or regions or regions, it is necessary to submit all purchase contracts, packing lists, bills of lading and freight from the place of origin to the land group of goods in each re-export at the same timeNote: The "Import Drug Registration Certificate" is the import unit's application to the national food and drug supervision and administration.
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