1、Application form for DrugReRegistretion 进口药品再注册申请表格Application form for DrugRe-Registretion 进口药品再注册申请表格 State Food and Drug Administration Drug Re-Registration Application -for Foreign Applicants Entry Number: Acceptance No:StatementWe guarantee: 1This application complies with laws and regulations
2、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 infringi
3、ng any others rights. Any methods and data is results of research and the drug tests conducted on the drugs; 2The 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:
4、Application Items1The Application for: Import application 2 Registration category: Chinese traditional medicine nature product chemical drug therapeutic Biological product Biological product for prevention pharmaceutics adjuvant invitro diagnostics administrated with drugsDrugs Information3 Generic
5、Name: 4 English / Latin name: 5 Chinese Phonetic Alphabet: 6 Chemical Name: 7 Trade Names: 8 Product category: non- product: drug substance: Chinese traditional drug materials new medicinal parts from Chinese traditional drug materials API active pharmaceutical parts intermediate of the drug product
6、 accessories others Product: dosage form from china pharmacopeia dosage form excluded in china pharmacopeia Special dosage form9 Strength: 10 Other accepted or submitted preparation and Strength at the same time: 11 Packaging: immediate packing material: Packaging size: 12 Date of Expiration: 36 mon
7、ths13 Prescriptions (Including Prescription Volume):API/material in TCM( Tradizionale chinese medicine): Accessories: 14 Indications or Attending Functions: indication category: 15 Whether apply supplementary items concurrently:16 Initial approved registration contents and relevant information: Init
8、ial IDL No: Approved date: Expiry date of IDL: Drug specification No.:17 Approved information of previous supplementary application: No.Acceptance No.Approval No.Approved events18 Times for Applications: First time application multi-times application the times applicationWithdrew before, date_ reaso
9、n: _ not approved, date_ reason: _The Applicant and Commissioned Research Institutions19. 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:
10、 E-mail: Legal Representative (Signatures): (Department Official Seal) Month Day, Year20. 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:
11、E-mail: Legal Representative (Signatures): (Department Official Seal) Month Day, Year21 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: Te
12、l: Fax: E-mail: Legal Representative (Signatures): (Department Official Seal) Month Day, Year22 Institutions 4 (Registration Agency of Imported Drugs):This agency is responsible for payment Chinese Name: English Name: Organization Code: Legal Representative: Position: Registered Address: Zip Code: C
13、ontact Address: Zip Code: Head of an Application for Registration: Position: Contact: Position: Phone : Fax : E-mail: phone: Legal Representative (Signatures): (Department Official Seal) Month Day, Year 23 Items list for this application:AuthoritiesAfter reviewed, the table is in line with the form with the request.Authorities: Reviewer (Signatures) Date:
