Registration of dietary supplement and biologically active additives (BAA) in Uzbekistan
List of documents submitted for state registration of biologically active additives (BAA) in the Republic of Uzbekistan


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:

  • for BAA containing living organisms – description indicating the genus, type of strain in Latin, information about the depositing (passport or certificate);
  • for BAA containing animal ingredients – a document confirming prion safety;
  • for BAA containing blood components – a document confirming transmissible safety;
  • for BAA containing parts of plants – their botanical name is indicated, including in Latin, pharmacopeia articles and (or) state standards (if any) are additionally presented.

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:

Registration of medicines in Uzbekistan
Registration of medical device and medical equipment in Uzbekistan
Registration of food additives and food supplements in Uzbekistan
Registration of cosmetics and perfumes, chemical substances, biological agents and materials, polymer and plastic materials in Uzbekistan
Registration of veterinary medicinal products, medicines, drugs and feed additives in Uzbekistan




Pharmacopoeia Committee

Tasks 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...


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Department of Registration

Tasks 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...;

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Pharmacological Committee

Tasks 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...;


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