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

State Food and Drug Administration Drug Supplementary Registration Application for Foreign Applicants Entry Number: Acceptance No:StatementWe guarantee: This application complies with laws and regulations such as Drug Administration Law of The Peoples Republic of China, Implementing Regulation of the Drug Administration Law of The Peoples Republic of China, and Drug Registration Regulation; The content of application form, the submitted information and the samples are true and legal, without infringing any others 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 Statement Items in Particular That:Application Items1The Application for: Import registration 2 Drug category: 3 whether OTC or not : 4 Status of the initial registration:5 Registration category:Supplemental applications to be approved by SFDA: Application for Drug Approval Number of a new drug by the New Drug 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 biological products. Change in the usage or dosage of the drugs, or the group of patient to 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, where there is a medial requirement for it. A change in the drug manufacture technology and process affecting drug quality. Amendment of drug registration standards. Substitute or removal of the drug material listed in formula of National Drug Standards as toxic or endangered.Change of the immediate packing material or container of the import drugs, domestic injection, ophthalmologic, spray, powder Aerosol, Inhaler and Spray. Use of new immediate packing material or container.Application for combined packing of drug.The transfer of new drug technology.Addition or amendment of items in insert sheet of TCM or natural drug, such as pharmacology and toxicology, clinical trial and Pharmacokinetic.A change in items within the import drug registration certificate, such as name of the drug, drug enterprise name, registered location, packing specification.Change of the location where the import drug is manufactured.Change of the location where the import drug is packed overseas.Repacking of import drugs in China.Change of the location where the raw material for import preparation is manufactured. Supplemental applications to be approved by PDA and be filed for record at SFDA, or directly be filed for record at SFDA: Change of the name of a domestic drug manufacturer.Internal change of the manufacture workshop of a domestic drug manufacturer. Change of immediate packing material or container (except for the item 10 as above) Change of valid period of domestic drugs Change of manufacture location of import drugs Change of appearance of the drug without change of drug standards. Amendment of insert sheet of the drugs according to national drug standards or required by SFDA. Supplementing and perfecting of the drug safety part of the insert sheet. Modification of design of packing and label of the drugs according to the regulation.Change of the agent for import drug registration.OthersSupplemental applications to be filed for record at PDA: Amendment of insert sheet of the domestic 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 drugsChange 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: Drug specification No.:Relevant Conditions23 Patents: Have Chinese patent: chemical compound patent; formulation patent; process patent; other patent; Patent No.: _ Patentee: _Patent licensing/Publication date _ Have foreign patent Patent No.: _ Patentee: _Patent licensing/Publication date _Patent Ownership Statement: _We state that: the application does not cause patent infringement. 24 Variety Protection of Chinese Medicine: Variety Protection of Chinese Medicine expiry date:25 Monitoring Time With Same Variety of New Drugs: Expiry date: _ 26 Times for Applications: First time application multi-times application the times applicationWithdrew before, date_ reason: _not approved, date_ reason: _The Applicant and Commissioned Research Institutions27. Institutions 1 (Foreign Pharmaceutical Companies):Chinese Name: English Name: Legal Representative: Position: Registered Address: Country or Region: Head of An Application for Registration: Positions: Tel: Fax: E-mail: Legal Representative (Signatures): (Department Official Seal) Month Day, Year28. Institutions 2 (Imported Drugs Production Plant): Chinese Name: English Name: Legal Representative: Position: Registered Address: Country or Region: Head of An Application for Registration: Positions: Tel: Fax: E-mail: Legal Representative (Signatures): (Department Official Seal) Month Day, Year29 Institutions 3 (Imported Drugs Foreign Packaging Factory):Chinese Name: English Name: Legal Representative: Position: Registered Address: Country or Region: Head of An Application for Registration: Positions: Tel: Fax: E-mail: Legal Representative (Signatures): (Department Official Seal) Month Day, Year30 Institutions 4 (Imported Drugs sub- Packaging Factory): Chinese Name: English Name: Organization code:Pharmaceutical production license No.:Legal Representative: Position: Registered Address: zip code:Postal address: zip code:Head of An Appli