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.


You can download this scheme:


Download in DOCX (WORD) format:

downloads: 2

Download as PDF:

downloads: 2




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...


Read more

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...;

Read more

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...;


Read more



up
down