Algorithm for registration of medicinal products in the Republic of Uzbekistan
 Applicant
 Uploading documents into the electronic system and making payment
 Primary examination
Evaluation of the completeness and reliability of documents
30 days
Making a decision to conduct a pharmaceutical GMP inspection
 Submitting a request to the «Center for Good Practices»
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 Submitting a request to the applicant to correct the deficiencies
45 days
The documents are incorrectly completed and/or not submitted in full
 The documents are completed correctly and submitted in full
 Sending samples to laboratories
 Laboratory tests
75 days
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Documents not provided
 Deadline for correcting deficiencies
90 days
 Submitting a request for deficiencies in documents
When eliminating deficiencies
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 Formation of the final report of the Scientific Commission
In the absence of defects
90 days
Clinical trials
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Specialized expertise Evaluation of documents by scientific commissions
Generic - bioequivalence of the original
Clinical Study Reports Examination
Conducting a pharmaceutical inspection, generating a report:
 Making a decision to reject an application
 Discussion of the conclusions of the Scientific Commission in the Presidiums of the Committees
 Submission of the Presidiums' recommendations to the Expert Council
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Formation of the Presidiums' recommendation on registration / refusal of registration
15 days
 Registration decision
Decision to refuse registration
 Submission of registration certificate
 Expert Council
Consideration of recommendations of Scientific Commissions and Committees and decision-making |
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See also other state duties:
State duty for registration of medicines in the Republic of Uzbekistan
State duty for registration of medical devices and medical equipment in the Republic of Uzbekistan
State duty for registration of dietary supplements in the Republic of Uzbekistan
State duty for registration of food additives in the Republic of Uzbekistan
State duty for registration of cosmetics, chemicals, biological agents and materials, polymers and plastics in the Republic of Uzbekistan
State duty for registration of veterinary medicines and feed additives in the Republic of Uzbekistan
State duty for registration of medical devices and medical equipment in the Republic of Uzbekistan
State duty for registration of dietary supplements in the Republic of Uzbekistan
State duty for registration of food additives in the Republic of Uzbekistan
State duty for registration of cosmetics, chemicals, biological agents and materials, polymers and plastics in the Republic of Uzbekistan
State duty for registration of veterinary medicines and feed additives in the Republic of Uzbekistan
See also other products:
Medicines
Medical devices and Medical Equipment
Dietary Supplements
Food Additives
Cosmetics, Chemicals, Biological Agents and Materials, Polymers and Plastics
Veterinary Medicines
Medical devices and Medical Equipment
Dietary Supplements
Food Additives
Cosmetics, Chemicals, Biological Agents and Materials, Polymers and Plastics
Veterinary Medicines
See also:
Required Documents for the State Registration of Medicinal Products in the Republic of Uzbekistan
Documents required for state registration of medical devices and medical equipment in the Republic of Uzbekistan
Documents required for state registration of dietary supplements in the Republic of Uzbekistan
Documents required for state registration of food additives in the Republic of Uzbekistan
Documents required for state registration of cosmetics, chemicals, biological agents and materials, polymers and plastics in the Republic of Uzbekistan
Documents required for state registration of veterinary products in the Republic of Uzbekistan
Documents required for state registration of medical devices and medical equipment in the Republic of Uzbekistan
Documents required for state registration of dietary supplements in the Republic of Uzbekistan
Documents required for state registration of food additives in the Republic of Uzbekistan
Documents required for state registration of cosmetics, chemicals, biological agents and materials, polymers and plastics in the Republic of Uzbekistan
Documents required for state registration of veterinary products in the Republic of Uzbekistan
See also:
List of foreign organizations whose results in terms of registration of medical equipment, medical devices and their components are recognized in the Republic of Uzbekistan from June 1, 2021
List of countries and international organizations whose results of registration of medicines are recognized in the Republic of Uzbekistan
List of countries and international organizations whose results of registration of medicines are recognized in the Republic of Uzbekistan
See also departments:
Registration Department
Pharmacological Committee
Pharmacopoeial Committee
Committee on New Medical Technology (CNMT)
Laboratory for quality control and standardization of medicines
Laboratory of vaccines, serous drugs and microbiological research
Laboratory for quality control of medical devices and medical equipment
Laboratory of Pharmacotoxicological Research
Department of Pharmacovigilance (PV Dept)
Department for the implementation of special digital markings
Quality Management Systems Certification Body
Reference Pricing Department
Pharmacological Committee
Pharmacopoeial Committee
Committee on New Medical Technology (CNMT)
Laboratory for quality control and standardization of medicines
Laboratory of vaccines, serous drugs and microbiological research
Laboratory for quality control of medical devices and medical equipment
Laboratory of Pharmacotoxicological Research
Department of Pharmacovigilance (PV Dept)
Department for the implementation of special digital markings
Quality Management Systems Certification Body
Reference Pricing Department