applicationformforimporteddrugsupplementaryregistretion進口藥品補充申請表格(編輯修改稿)
2024-09-17 01:08 本頁面
【文章內(nèi)容簡介】 omestic drugs according to national drug standards or required by SFDA.□Supplementing and perfecting of the domestic drug safety part of the insert sheet.□Modification of design of packing and label of the domestic drugs according to the regulation.□Change of the packing specification of domestic drugs.□Change of manufacture location of domestic drugs□Change of appearance of the domestic drug without change of drug standards.□othersDrugs Information6 Generic Name: 7 Generic Name Source: 8 English / Latin name: 9 Chinese Phonetic Alphabet: 10 Chemical Name: 10 Trade Names: 11 Product category: 12 strength: 13 Other accepted or submitted preparation and Strength at the same time: 14 Packaging: immediate packing material: Packaging size: 15 Date of Expiration: 36 months16 Prescriptions (Including Prescription Volume): API/materials in TCM(Traditional Chinese medicine): Accessories: 17 Materials /Accessories SourceSerial NO.Materials /Accessories NameApproval No/Registration No/Accepted NoManufacturerImplementation StandardsVariation or notVariation approved status and approved institution1218 Chinese Medicinal Materials Standard: Serial NumberMaterials /Accessories NameWhether legal or not Standard referenceImplementation StandardsVariation or notVariation approved status and approved institution1219 Indications or Attending Functions: Indications category: Supplementary contents:20 Supplementary contents:21 Rational to propose this supplementary:22 Initial approved registration contents and relevant information: Initial acceptance No: Clinical Trial Approval No: Initial IDL No: Dr
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