Registration of dietary supplement and biologically active additives (BAA) in Uzbekistan
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1 |
Application of established form. |
2 |
Power of Attorney from the manufacturer (authorized to submit documents and obtain a Registration Certificate addressed to Applicant (if the applicant is not a manufacturer)). |
3 |
The samples of BAA in the amount necessary for toxico-hygienic assessment. |
4 |
The sample of consumer packaging of BAA or its project in the State and Russian languages. |
5 |
The document on the full ingredient composition of BAA indicating recommendations for use and contraindications (instructions for use). |
6 |
Materials for evaluating the effectiveness of the claimed properties of BAA indicating the organization that conducted these studies. |
7 |
For BAA produced in the Republic of Uzbekistan, additional normative documents is provided (organization standards, processing instructions and formulation). |
8 |
For imported BAA, a safety certificate or registration certificate of the manufacturing country (if any) is additionally presented:
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9 |
If necessary, presentation by the manufacturer of clinical trials of BAA. |
10 |
Scientific justification for the expiration dates claimed by the manufacturer. |
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See also:
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Pharmacopoeia CommitteeTasks of the Pharmacopoeia Committee:- examination of normative documents for medicines subject to registration and extension of the term of registration; - systematic revision of normative documents for medicines with a view to improving their quality and improving the methods of control; - examination and preparation for approval of additions and amendments of the... Read more |
Department of RegistrationTasks of the Registration Department:- after the adoption of the application for registration, conducts the initial (preliminary) examination of the application and attached registration documents and samples of medicines, medical devices and medical equipment; - conducts appropriate correspondence with the applicant on the... Read more |
Pharmacological CommitteeTasks of the Pharmacological Committee:- conducts examination of administrative, pharmacological, toxicological and clinical parts of registration documents of pharmacological and (or) medicinal products; - conducts examines and re-examines documents of pharmacological and (or) medicinal products with the involvement of independent experts; - decides on the use of the medicines without clinical trials in the... Read more |