Application form for Drug Registretion 進(jìn)口藥品注冊(cè)申請(qǐng)表格

1、 State Food and Drug Administration Drug 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 Admin

2、istration 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

3、; 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: 2 Application for: 3 Registration category: 4 Supplemental applicatio

4、n for:Drugs Information5 Generic Name: 6 Generic Name Source: 7 English / Latin name: 8 Chinese Phonetic Alphabet: 9 Chemical Name: 10 Other Name: 11 Trade Names: 12 Product category: 13 Strength: 14 Other accepted or submitted preparation and Strength at the same time: 15 Packaging: 16 Date of Expi

5、ration: 36 months17 Prescriptions (Including Prescription Volume): Accessories:18 Materials /Accessories SourceSerial NumberMaterials /Accessories NameApproval No/Registration No/Accepted NoManufacturerImplementation Standards1234567819 Chinese Medicinal Materials Standard: 20 Drugs Standard: Self-m

6、ade standard Source: Other standard: 21 Indications or Attending Functions: Relevant Conditions22 Patents: Patent Ownership Statement: We state that: the application does not cause patent infringement. 23 Whether or not involved in the management of special drugs or ingredients: 24 Variety Protectio

7、n of Chinese Medicine: 25 Monitoring Time With Same Variety of New Drugs: 26 Times for Applications: The Applicant and Commissioned Research Institutions27. Institutions 1 (Foreign Pharmaceutical Companies):Chinese Name: English Name: Legal Representative: Position: Registered Address: Country or Re

8、gion: 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 Re

9、gion: Head of An Application for Registration: Positions: Tel: Fax: E-mail: Legal Representative (Signatures): (Department Official Seal) Month Day, Year29 Institutions 3 (Foreign Imported Drugs Packaging Factory): Nothing 30 Institutions 3 (Registration Agency of Imported Drugs):This agency is resp

10、onsible for payment Chinese Name: English Name: Organization Code: Legal Representative: Position: Registered Address: Zip Code: Contact 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 31 Commissioned Research Institutions:32 Declaration:material