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CFDA modify some clauses such as the "Administrative Measures for Drug Operation License"
Release time: 2017-11-23 & nbsp & nbsp & nbsp Source: Anonymous

    November 21,CFDA's official website announced the "Decision on Modifying Part of the Regulations"。The decision aims to implement the State Council to deepen the simplified administration and decentralization、Binding of Dalvation Pipe、Requirements for optimizing service reform,CFDA reform involving administrative approval system、Relevant regulations such as commercial system reforms,The specific modification content is as follows:
 
I. "Administrative Measures for Drug Management License"
 
(Decree No. 6 of the State Food and Drug Administration on February 4, 2004)
 
(1) In Article 8 (1), & ldquo; 2. The approved certification documents issued by the industrial and commercial administrative department & rdquo; modify it to & ldquo; 2.。
 
(2) In Article 9 of Article 9 (Paragraph 4, Items & LDQUO; 2. The approved certification documents issued by the industrial and commercial administrative department & rdquo; modify it to & ldquo; 2.。
 
(3) Add one,As 34: & ldquo; The drug business license electronic certificate produced by the food and drug supervision and management department is the same legal effect & rdquo;。
 
2. "Administrative Measures for Internet Drug Information Service"
 
(July 8, 2004 State Food and Drug Administration Order No. 9 announced)
 
Article 13 (1) of the business license (the new enterprise business license (new enterprise provides the name pre Stake Sports Bettingstake online sports betting-checking notice and related materials issued by the industrial and commercial administrative department) & rdquo; modify it to & ldquo; ;。
 
3, "Measures for the Supervision and Management of Drug Production"
 
(August 5, 2004, Order of the State Food and Drug Administration No. 14)
 
(1) Article 5 and 3 & ldquo; The name of the proposed enterprise name issued by the industrial and commercial administrative department will be approved in advance,Production address and registered address、Enterprise type、Legal representative or head of corporate & rdquo; modify to & ldquo; enterprise business license,Production address and registered address、Enterprise type、Legal representative or head of the enterprise & rdquo;。
 
(2) Article 28 of the first, & ldquo; injection、Biological products (excluding vaccine products、Blood Products) and Inter -provincial、Autonomous Region、Pharmaceutical commissioned production application,It is revised to & ldquo;,、Autonomous Region、The food and drug supervision and management department of the municipality directly under the Central Government is responsible for accepting and approval & rdquo;。
 
(3) Delete Article 29.
 
(4) Article 30 to Article 29,and will & ldquo among them;、Autonomous Region、Municipal (Food) stake betting appDrug Supervision and Administration Department proposes to apply & rdquo; modify it to & ldquo;、Autonomous Region、The food and drug supervision and management department of the municipality directly under the Central Government shall apply & rdquo;。
 
(5) Add one,As Article 59: & LDQUO; Drug production license electronic certificate produced by the food and drug supervision and management department is the same legal effect & rdquo;。
 
Fourth, "Measures for the Supervision and Management of Medical Device Production"
 
(July 30, 2014, the State Food and Drug Administration Order No. 7 announced)
 
(1) Article 8 of the first item & ldquo; business license、Copy of the organization code certificate & rdquo; modify to & ldquo; business license copy & rdquo;。
 
(2) Article 30, paragraph 2 (2 2 (2nd (2) of the commissioner and the trustee business license and organization code certificate & rdquo; modify it to & ldquo; & rdquo;。
 
(3) Article 32, paragraph 1 (1) of the first item & ldquo;、Copy of the organization code certificate & rdquo; modified to & ldquo; Copy of the commissioner and the trustee's business license & rdquo;。
 
(4) Add one,As Article 72: & LDQUO; Medical Device Production Licensing Electronic Certificate and Printed Medical Device Production stake betting appLicense of the Food and stake betting appDrug Supervision and Administration Department have the same legal effect & rdquo;。
 
5. "Measures for the Supervision and Management of Medical Device Management"
 
(July 30, 2014, Order of the State Food and Drug Administration No. 8 announced)
 
(1) Article 8 of the first item & ldquo; business license and organization code certificate copy & rdquo; modify to & ldquo; copy of the business license & rdquo;。
 
(2) Add one,As 166: & ldquo; The medical device business license electronic certificate produced by the food and drug supervision and management department is the same legal effect & rdquo;。
 
6、"Administrative Measures for the Import and Export and Export and Export and Export and Export and Export of Protein Assimilation Preparations"
 
(September 28, 2014, the State Food and Drug Administration of the State Food and Drug Administration of Customs General Administration of the State Sports General Administration No. 9)
 
(1) Article 4, 4, Item 4 & ldquo; "Pharmaceutical Business License" of the imported unit、"Business Corporate Business License"、"Import and Export Enterprise Qualification Certificate" (or "Registration Form for Foreign Trade Operators")、Copy of "Organizational Code Certificate"; Drug production enterprises import the materials and preparation intermediates required by the enterprise (including domestic packaging preparations),shall be submitted to the "Drug Production License"、"Business Corporate Business License"、"Organization Certificate Certificate" copy & rdquo; modified to & ldquo; "Drug Operation License"、"Business Corporate Business License"、"Import and Export Enterprise Qualification Certificate" (or "Registration Form for Foreign Trade Operators");,shall be submitted to the "Drug Production License"、Copy of "Business License of Enterprise Legal Person" & rdquo;。
 
(2) Article 5 of Article 5 & ldquo;,You also need to provide a copy of the commissioned agency agreement and the "Business License of the Enterprise Legal Person"、"Import and Export Enterprise Qualification Certificate" (or "Registration Form for Foreign Trade Operators")、"Organization Certificate Certificate" copy & rdquo; modify to & ldquo;,You also need to provide a copy of the commissioned agency agreement and the "Business License of the Enterprise Legal Person"、"Import and Export Enterprise Qualification Certificate" (or "Registration Form for Foreign Trade Operators")。
 
(3) Article 15 (3) Item 6 & ldquo; "Enterprise Legal Business License"、"Import and Export Enterprise Qualification Certificate" (or "Registration Form for Foreign Trade Operators")、"Organization Certificate Certificate" copy & rdquo; modified to & ldquo; "Enterprise Legal Business License"、"Import and Export Enterprise Qualification Certificate" (or "Registration Form for Foreign Trade Operators")。
 
Seven, "Administrative Measures for Food Production License"
 
(August 31, 2015, the State Food and Drug Administration Order No. 16 No. 16)
 
Add one,As Article 62: & ldquo; Food production license electronic certificate produced by the food and drug supervision and management department is the same legal effect & rdquo;。
 
stake sports betting app8. "Measures for the stake online sports bettingManagement of Food Management"
 
(August 31, 2015, the State Food and Drug Administration Order No. 17 announced)
 
Add one,As 56: & ldquo; The food business license electronic certificate produced by the food and drug supervision and management department is the same legal effect & rdquo;。
 
In addition,The "Administrative Measures for Drug Management License", "Administrative Measures for Internet Drug Information Services", "Measures for the Supervision and Management of Drug Production" & LDQUO; (Food) Drug Supervision and Management Department & RDQUO; (Food) stake betting appDrug Supervision and Administration Institution & RDQUO; & ldquo; (Food) Drug Supervision and Administration (Institution) & rdquo; & ldquo; (Food) Drug Administration & rdquo; and other expressions unified modification to & ldquo; food and drug supervision and management department & rdquo;,Modify the State Food and Drug Administration & rdquo; modify it to & ldquo; State Food and Drug Administration & rdquo;,Modify & ldquo; Modify the Provincial Drug Inspection Institute & RDQUO;,Modify & ldquo; Chinese Pharmaceutical Biological Products Institute & RDQUO;。