海关联盟cutr认证|俄罗斯测试认证中心TEST CERT LTD
gost@gost.org.cn                  021-36411293

俄罗斯标准-测试认证中心 "Стандарт-Тест"

海关联盟授权代码:RA.RU.11AB24 

上海卡卢加机电设备检测中心


新闻中心

Uzbekistan drug registration,Uzbekistan Pharmaceutical registration,Pharmaceutical products in Republic ofUzbekistan
来源: | 作者:pmt579fb4 | 发布时间: 2018-11-15 | 2301 次浏览 | 分享到:
The list of the registration documents necessary for a registration / re-registration Pharmaceutical products in Republic ofUzbekistan

The list of the registration documents necessary for a registration / re-registration Pharmaceutical products in Republic ofUzbekistan

 

 

 

 

 

Pharmaceutical products

 

 

Name  of documents

Original  medical products

Generics

Pharmaceutical  substances (API)

Medical  immunobiological products

 

Medicinal  vegetative raw material

 

Homoeopathist  products

 

1

2

3

4

5

6

7

8

 

Part I

The general documentation

 

 

 

 

 

 

 

1A

The administrative data

 

 

 

 

 

 

 

1

The application under the authorized form (hard  copy and soft copy)

 

+

+

+

+

+

+

2

The inventory - the acceptance report - transfers  of documents of the registration file

 

+

+

+

+

+

+

3

 

The certificate on a pharmaceutical (medical)  product according to recommendations of WHO ;

The certificate on registration in the country of  the manufacturer or a copy of the registration certificate in the country -  manufacturer

(notarized copy);

The certificate of conformity to requirements GMP  (certified);

The  certificate resolving free sale (export) (certified

+

+

+

+

+

+

4

The license for pharmaceutical activity (notarized  copy);

 

+

+

+

+

+

+

5

The appendix to the license (for vegetative raw  material - the sanction to preparation)

 

 

+

+

+

-

+

+

6

Copies of registration certificates in CIS  countries and other countries (notarized copy);

 

 

+

+

+

+

+

+

7

The certificates of Raw materials (the analytical  passport also for API)

 

+

+

+

-

+

-

8

Certificate of Finished product  (the analytical passport) of 3 batches

 

+

+

+

+

+

+

9

The document about safety of substances of an animal  origin, the information on absence (BSE/TSE)

 

+

+

+

-

-

-

10

Copy of the registration / Re-registration  certificate of Republic Uzbekistan (at a re-registration)

 

+

+

+

+

+

+

1B

Summary  characteristic of a medical product (SPC) in English and Russian

+

+

+

+

+

+

1

The instruction on clinical trials in English and  Russian languages (soft and hard copies)

 

+

+

+

+

+

+

2

Instruction for medical use in Russian (soft and  hard copies)

 

+

+

+

+

+

+

3

Artworks in CDR format

 

+

+

+

+

+

+

4

Specification of package materials

 

+

+

+

+

+

+

5

Copy of Patent or other document for pharmaceutical  product’s security

 

+

-

-

+

-

+

1C

Conclusions of experts concerning chemical,  pharmaceutical, microbiological, pharmacological, toxicological and clinical  given (the resume of the basic properties of a preparation) for Microbiologic -  diagnostic efficiency (sensitivity, specificity)

 

+

+

+

+

-

-

 

Part II

The chemical,  pharmaceutical and biological documentation

 

 

 

 

 

 

 

2

The contents

 

+

+

+

+

+

+

2A

Qualitative  and quantitative structure of pharmaceutical product (Detailed composition  and usage of components)

+

+

+

+

+

+

2B

1.  Information  about product manufacturing:

1)   Manufacturing formula

2)   manufacturing description

3)  The  control over manufacture

4)   validation productions

2. The project of the normative document

 

+

+

+

+

+

+

2C

Techniques  of the control of initial substances with the appendix of certificates of  analyses

+

+

-

+

+

(for collec.)

+

2D

Techniques of the analysis of intermediate products

 

+

+

+

+

-

-

2E

The specification of a medical product, technique  of quality assurance and them validation  (except  for Pharmacopeia techniques) (in Russian and-or in English languages)

 

+

+

+

+

+

+

2F

The data on stability not less than on 3 batches in  natural conditions at long-term storage (in Russian and-or in English  languages)

 

+

+

+

+

+

+

2G

The data on probable danger to an environment to  preparations which contain genetically changed organisms

 

+

+

+

+

-

-

2H

Other additional information confirming efficiency,  safety and quality

 

+

+

+

+

+

+

 

Part III

The pharmacological and toxicological documentation

 

 

 

 

 

 

3

The contents

 

+

+

+

+

+

+

3A

Toxicity  at unitary introduction and introduction of repeated dozes (sharp, subacute and  chronic toxicity)

+

-

-

+

+

(for new)

+

(for new)

3B

Influence on reproductive function. The data on teratogenicity,  gonadotoxic and  embryotoxity

 

+

-

-

-

+

(for new)

-

3C

Data on  mytagenicity

+

-

-

-

+

for new))

-

3D

Data on  carcinogenicity

+

-

-

-

+

for new))

-

3E

Specific  action, general pharmacology (for МИБП -  reaktogenicity, specific activity)

+

-

-

+

+

for new))

-

3F

Pharmacokinetics (absorption, distribution, a  metabolism, allocation)

 

+

-

-

-

-

-

3G

The data on bioequivalence (for generics)

 

 

 

 

 

-

+

-

+

-

-

3H

*Data about  place-irritating action  immunogenicity for  vaccines

+

-

-

+

+

for new))

-

3I

Drug dependence

 

+

-

-

-

-

-

3J

Antigencity

 

+

-

-

-

-

-

 

Part IV

The clinical documentation

 

 

IV

The contents

 

+

+

+

+

+

IVA

The data on clinical pharmacology  (pharmacokinetics) (for in vivo the data on epidemiological, clinical, immunological efficiency)

 

+

+

-

+

+

for new))

-

IVB

Results of clinical tests, scientific publications,  reports

 

+

+

-

+

+

for new)

+

IVC

Other additional information confirming efficiency,  safety and quality, re-registration the data on clinical efficiency  and safety

 

+

+

-

+

+

+

 

The *-documents specified in the list and-or other not specified documents are required or dependences on features of an origin, properties, a way of reception / manufacture and regulation in the country of manufacture of a medical product are not required;

** - documents are given only by factories - manufacturers;

*** - documents are given only by factories - manufacturers of CIS countries;

The documents which are not having designations are obligatory for all applicants.

 


联系我们:上海经合工业设备检测有限公司/俄罗斯EAC认证机构中国代表处


021-36411223  021-36411293

邮件:gost@gost.org.cn    gost-r@163.com

skype:gostchina

微信:18621862553

www.gost.org.cn  

                         

  微信号 扫一扫联系我               公众号 扫一扫                企业微信