China intends to the import of medicinal materials can be carried out on the spot inspection of over unfccc

China proposed regulations: on the import production site outside the examination – Beijing, Beijing, September 23, according to the State Council Legislative Affairs Office website news, imported materials management approach by the State Food and Drug Administration drafted "(Revised Draft) for public comment today". Provisions of the revised draft, medicine must allow the import of pharmaceuticals from the port or to allow the importation of medicines at the border port or border crossings import; the provincial food and drug administration department according to the needs, can check on the overseas import medicine production site. The revised draft stipulates that herbal medicines must be imported from the port to allow the import of crude drugs or permit the border crossings. The frontier ports that permit the import of medicinal materials can only be imported from the countries or regions adjacent to the port. On the application and approval of imported materials, revised version of the regulations, the applicant shall be imported materials, Chinese domestic made "drug production license" or "drug license" of the Chinese medicine production enterprises or pharmaceutical enterprises. The scope of operation of a pharmaceutical trading enterprise shall contain Chinese herbal medicine or traditional Chinese medicine. The State Food and drug administration shall authorize the provincial food and drug administration departments at or at the frontier ports to carry out import examination and approval for the first time the import of medicinal materials. The food and drug inspection authorities at the provincial level at the port or frontier port shall, within 30 days after receipt of the samples and relevant materials, complete the inspection of the samples. In the aspect of imported materials declaration and port inspection, the revised draft regulations, where the current version contains Chinese Pharmacopoeia varieties, the inspection standards shall implement the current version of the standard China Pharmacopoeia; China current version is not recorded in the Pharmacopoeia varieties, the inspection standards should be implemented import medicine standards; Chinese Pharmacopoeia edition, current import medicine standards were not received the varieties, the inspection standards shall implement the ministerial standard and other national standards of medicinal herbs.   the test does not meet the prescribed standards of imported materials, port or border food and drug supervision and administration department shall immediately take compulsory administrative measures to seal up and detain in receipt of the inspection report. In terms of supervision and management, the revised draft clearly, the provincial food and drug administration at the port or border crossings, according to the needs of the import of raw materials can be carried out on the spot inspection of overseas. Imported materials listed in the circulation of the food and drug inspection institutions shall be the port or border crossings where the provincial food and drug inspection agencies or the State Food and drug administration to determine the sampling inspection, inspection qualified rear can be traded. At the same time, the revised draft also provides that the need to strictly enforce the provisions of the relevant provisions of the import of drug traceability management. In addition, the revised draft also stipulates that the packaging of imported medicinal materials must be suitable for the quality requirements of imported medicinal materials, convenient storage, transportation and import inspection. In each package, must indicate the name, document number, medicine Chinese origin, marks number, name of enterprise, the exporter name, port of destination, weight and date processing packaging etc.. In addition to the above, the revised draft also stipulates that the applicant to bribery and other improper means to obtain the "import" or "customs clearance of imported crude drugs." drugs, food and drug supervision and administration department shall revoke the "import" or "drug of crude drugs.相关的主题文章: