Application form for Imported Drug Supplementary Registretion 进口药品补充申请表格.docx

State Food and Drug AdministrationDrug Supplementary RegistrationApplication –for ForeignApplicantsEntry Number:Acceptance No:StatementWe guarantee: This application complies with laws and regulations such as Drug Administration Law of The People’s Republic of China, Implementing Regulation of the Drug Administration Law of The People’s Republic of China, and Drug Registration Regulation;②The content of application form, the submitted information and the samples are true andlegal, without infringing any other’s rights. Any methods and data is results of research and the drug tests conducted on the drugs; The accompanied electronic version is in perfect accordance with the printed version.We will take all the legal consequences of any false statements.Other StatementItemsin Particular That:Application Items1The Application for: Import registration2 Drug category: 3 whether OTC or not : 4 Status of the initial registration:5 Registration category:〇Supplemental applications to be approved by SFDA:□Application for Drug Approval Number of a new drug by the NewDrug Certificate holder of the drug.□Use of the name of the Trade Name of drugs.□Additional indications or functions of TCM or natural drug, or theindication approved in China for chemical drug or biologicalproducts.□Change in the usage or dosage of the drugs, or the group of patientto use the drug, but without change in route of administration.□Change of strength of drugs□Change of the supplementive in the formula of the drugs, wherethere is a medial requirement for it.□A change in the drug manufacture technology and process affectingdrug quality.□Amendment of drug registration standards.□ Substitute or removal of the drug material listed in formula ofNational Drug Standards as toxic or endangered.□Change of the immediate packing material or container of the importdrugs, domestic injection, ophthalmologic, spray, powder Aerosol,Inhaler and Spray. Use of new immediate packing material orcontainer.□