N E O P A S S

Contact information: e-mail:uzbekistanian@mail.ru Web site: www.neopass.uz

LIST OF DOCUMENTS FOR REGISTRATION PHARMACEUTICAL PRODUCT IN REPUBLIC OF UZBEKISTAN

1) Letter for Registration;

2) Application form;

3) GMP;

4) COPP;

5) Manufacturing License;

6) Registration Certificates (if available);

7) General information about Pharmaceutical product;

8) Pharmacological report;

9) Data of pharmcoakinetics of the pharmaceutical and/or its bioequivalency;

10) Toxicology report (acute, subacute and chronic toxicology);

11) Specific activity report related to the following side effects

(carcinogenic effects, birth defects, allergic, skin irritations);

12) Data of clinical trials;

13) Instruction for Medical use;

14) Qualitative and Quantitative form (Batch size information and components);

15) Specifications of Raw Material (s);

16) Specification of Finished Product and Methods;

17) Certificates for Raw materials;

18) Certificates for Finished products (3 Batches);

19) Stability Data (3 Batches);

20) Specification of Packaging Materials;

21) Artwork of Packages (Corel Draw 12);

22) Samples of the pharmaceutical products in the proposed packaging form;

23) WS;

NB: All copies of Certificates should be notarized; Abbreviations: GMP - Good Manufacturing Practice Certificate; COPP - Certificate of Pharmaceutical Product; FSC - Free Sale Certificate;

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N E O P A S S

Contact information: e-mail:uzbekistanian@mail.ru Web site: www.neopass.uz

LIST OF DOCUMENTS FOR RE-REGISTRATION PHARMACEUTICAL PRODUCT IN REPUBLIC OF UZBEKISTAN

1) Letter for Registration;

2) Application form;

3) GMP;

4) COPP;

5) Manufacturing License;

6) Copy of Registration Certificate of Uzbekistan;

7) Registration Certificates (if available);

8) General information about Pharmaceutical product;

9) Pharmacological report;

10) Data of pharmacokinetics of the pharmaceutical and/or its bioequivalency

11) Toxicology report (acute, subacute and chronic toxicology);

12) Specific activity report related to the following side effects

(carcinogenic effects, birth defects, allergic, skin irritations);

13) Data of clinical trials;

14) Instruction for Medical use;

15) Qualitative and Quantitative form (Batch size information and components);

16) Specifications of Raw Material (s);

17) Specification of Finished Product and Methods;

18) Certificates for Raw materials;

19) Certificates for Finished products (3 Batches);

20) Stability Data (3 Batches);

21) Specification of Packaging Materials;

22) Artwork of Packages (Corel Draw 12);

23) Samples of the pharmaceutical products in the proposed packaging form;

24) WS;

NB: All copies of Certificates should be notarized;If any changes in Specification of Finished Product, Components - points 23 and 24 should be submitted for analyses;

Abbreviations: GMP - Good Manufacturing Practice Certificate; COPP - Certificate of Pharmaceutical Product; FSC - Free Sale Certificate;

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N E O P A S S

Contact information: e-mail:uzbekistanian@mail.ru Web site: www.neopass.uz

LIST OF DOCUMENTS FOR REGISTRATION SUBSTANCE IN REPUBLIC OF UZBEKISTAN

1) Letter for Registration;

2) Application form;

3) GMP;

4) FSC;

5) Manufacturing License;

6) Registration Certificates ( from Manufacturer’s country and others);

7) Methods for analyses used in quality control;

8)

9) Samples for analyses;

Certificates (from Manufacturer);

NB: All copies of Certificates should be notarized; Abbreviations: GMP - Good Manufacturing Practice Certificate; FSC - Free Sale Certificate;

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