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Uzbekistan drug registration,Uzbekistan Pharmaceutical registration,Pharmaceutical products in Republic ofUzbekistan,Pharmaceutical re-registration in Uzbekistan,The list of the registration documents necessary for a registration / re-registration Pharma
来源: | 作者:pmt93305e | 发布时间: 2018-11-15 | 77 次浏览 | 分享到:

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.

 

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