Table Of Contents (TOC) for REPUBLIC OF UZBEKISTAN

NOTE: ALL DOCUMENTS SHOULD BE IN TWO COPIES

LIST

Document’s which is necessary for registration question about registration epicene of medicine in the republic of Uzbekistan.

The application letter about registration on company letterhead

 Application for registration

Certificate of registration of preparation in country manufacturing and in other country’s and NIS (New independence states) countries (original or signed copy) if your product registered somewhere in and NIS countries.

Direction for medicine using in English (Russian)

Standard documentation using during quality control of preparation in Russian and in language of original.

Certificate of quality confirming matter substances of functioning matters  (GMP).

Copies of certificate about registration of preparation of company guarantee in the republic of Uzbekistan (Quality Certificate)

Data’s of using medicines in clinic under other medical fields.

Specimens of drug for three times analysis and substances of functioning drug.

Specimen and description of packing

Necessary present documents should be notarized and signed

Appendix 1

Central Administrative Board

On Quality of Drugs and Medial Facilities

under the Ministry of Public Health

of the Republic of Uzbekistan

This is certify to advise you that company­­­­­­­­­­­­­­­­­ ________________________________wishes    to register in the Republic of Uzbekistan a drug (substance) produced by Company under the name _________________________________________________________­­­­­­_______ in pharmaceutical dosage form_______________________________________________

The present drug (Substance) is registered______________________________________

(to name number date of registration)

The following enclosed to this letter:

Application for registration of the preparation in the Republic of Uzbekistan – two copies

Registration documentation  - two copies

Specimens of preparation for three times analysis and substances of functioning mother

Specific reagents necessary for test.

Signature                                                                                 Company’s Seal

APPLICATION FOR REGISTRATION

1.Company Applicant, Country.

2.Manufacturing Company, Country.

3.Name of the preparation.

4.International Non-proprietary name.

5.Main synonyms of the preparation.

6.Composition of the preparation.

7.Medicinal Form.

8.Dosage of the preparation.

9.Administration  (Oral, Injectable etc., )

10.Main Indications for Administration.

11.Storage terms and Requirements.

                        Standard Package.

Toc for republic of uzbekistan, toc formate for dossier