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N E O P A S S
Contact information: e-mail:[email protected] 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:[email protected] 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:[email protected] 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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