Documents submitted for registration of medicines in the Republic of Uzbekistan




Part 1. Administrative Documents
1.1
Copies of certificates (notarized)
1.2
General information
1.2.1
A copy of the Certificate of Pharmaceutical product (СРР) or a certificate of registration (registration certificate) of a medicinal product in country-manufacturer
1.2.2
* GMP certificate
1.2.3
Certificates confirming registration in other countries
1.3
Brief description of the medicinal product, labeling and instructions for medical use
1.3.1
Summary of product characteristics (SmPC)
1.3.2
Labels
1.3.3
A copy of the instructions for use of the medicinal product approved in country-manufacturer in Russian, and project of instructions for use in the state and Russian languages
1.3.4
Colored packaging models on paper and electronic media in a scale of 1:1
1.4
The normative document of the medicinal product (when extension of the period of registration, a copy of the approved normative document), as well as an explanatory note to the normative document
1.5
Detailed description of pharmacovigilance and risk management system during medical use of product
1.5.1
Document confirming presence of qualified person responsible for pharmacovigilance for collection and registration of adverse reactions, detected on the territory of Republic of Uzbekistan
1.5.2
Periodic safety update report (PSUR)
1.6
Information on the possible environmental hazards
1.6.1
Information on the presence of genetically modified organisms (GMOs) in the composition of a medicinal product
Part 2. Chemical, pharmaceutical and biological information on medicinal products that contain chemical and / or biological active substances
2.1
Content
2.2
Introduction
2.2.S
The active substance(s) (for medicinal products that contain more than one active substance, the information is provided in full for each drug substance)
2.2.S.1
General information:
2.2.S.1.1
Name
2.2.S.1.2
Structure
2.2.S.1.3
General properties
2.2.S.2
Manufacture of active substance(s)
2.2.S.2.1
Manufacturer(s) information
2.2.S.2.2
Description of manufacturing process and process control
2.2.S.2.3
Control of raw materials used in the technological process
2.2.S.2.4
Control of critical steps and intermediates
2.2.S.2.5
Process validation and/or evaluation
2.2.S.2.6
Manufacturing process development
2.2.S.3
Characteristics of the active substance(s)
2.2.S.3.1
Elucidation of structure and other characteristics
2.2.S.3.2
Impurities
2.2.S.4
Control of drug substance(s)
2.2.S.4.1
Specification
2.2.S.4.2
Analytical procedures
2.2.S.4.3
Validation of Analytical Procedures
2.2.S.4.4
Batch Analyses
2.2.S.4.5
Justification of Specification
2.2.S.5
Reference Standards or Materials
2.2.S.6
Container closure system
2.2.S.7
Stability
2.2.S.7.1
Stability Summary and Conclusions
2.2.S.7.2
Post-approval stability protocol and stability commitment
2.2.S.7.3
Stability Data
2.2.P
Finished medicinal product
2.2.P.1
Description and composition of the medicinal product
2.2.P.2
Pharmaceutical development
2.2.P.2.1
Components of the medicinal product
2.2.P.2.1.1
Active substance(s)
2.2.P.2.1.2
Excipients
2.2.P.2.2
Medicinal product
2.2.P.2.2.1
Formulation Development
2.2.P.2.2.2
Overages
2.2.P.2.2.3
Physicochemical and biological properties
2.2.P.2.3
Manufacturing process development
2.2.P.2.4
Container closure system
2.2.P.2.5
Microbiological attributes
2.2.P.2.6
Compatibility
2.2.P.3
Manufacture
2.2.P.3.1
Manufacturer(s)
2.2.P.3.2
Batch formula
2.2.P.3.3
Description of manufacturing process and process control
2.2.P.3.4
Controls of critical steps and intermediates
2.2.P.3.5
Process validation and/or evaluation
2.2.P.4
Control of excipients
2.2.P.4.1
Specifications
2.2.P.4.2
Analytical procedures
2.2.P.4.3
Validation of analytical procedures
2.2.P.4.4
Justification of specification
2.2.P.4.5
Excipients of human or animal origin (TSE procedure)
2.2.P.4.6
Novel excipients
2.2.P.5
Control of medicinal product:
2.2.P.5.1
Specification(s)
2.2.P.5.2
Analytical procedures
2.2.P.5.3
Validation of analytical procedures
2.2.P.5.4
Batch analyses
2.2.P.5.5
Characterisation of impurities
2.2.P.5.6
Justification of specification(s)
2.2.P.6
Reference standards or materials
2.2.P.7
Container closure system
2.2.P.8
Stability:
2.2.P.8.1
Stability summary and conclusion
2.2.P.8.2
Post-approval stability protocol and stability commitment
2.2.P.8.3
Stability data
2.2.A
Appendices
2.2.A.1
Technical means and equipment
2.2.A.2
Adventitious agents safety evaluation
2.2.A.3
Novel excipients
3.2.R
Regional information
Part 3. Reports on pre-clinical studies
3.1
Content
3.2
Nonclinical Study Reports
3.2.1
Pharmacology
3.2.1.1
Pharmacodynamics
3.2.2
Pharmacokinetics
3.2.3
Toxicology
3.2.3.1
Single-dose toxicity
3.2.3.2
Repeat-dose toxicity
3.2.3.3
Genotoxicity
3.2.3.4
Carcinogenicity (large trials; short or medium duration trials)
3.2.3.5
Reproductive and ontogenetic toxicity
3.2.3.6
Local tolerance (local irritative effect, allergenic action)
3.2.3.7
Other toxicity studies
3.3
Literature references
Part 4. Reports on clinical studies
4.1
Content
4.2
Listing of clinical studies
4.3
Clinical study reports
4.3.1
Reports of biopharmaceutic studies
4.3.2
Reports of studies pertinent to pharmacokinetics using human biomaterials
4.3.3
Reports of human pharmacokinetic studies
4.3.4
Reports of human pharmacodynamic studies
4.3.5
Reports of efficacy and safety studies
4.3.6
Reports of post-marketing experience
4.3.7
Case report forms and individual patient listings
4.4
Literature references

Notes:
• Participating in the manufacturing process, the documents specified inparagraphs 1.3.2 and 1.3.4 are submitted for all participants of manufacture.
* Submission of a GMP certificate with a copy of the results of the last inspection is mandatory only for foreign manufacturers.
• The documents indicated in the list are required taking into account the origin, properties, features of the way of obtaining/production of medicines.
• In the event that parts of the documents are not presented in the appropriate section, the reason should be indicated.
• For registration of medicinal matters (substances) the documents specifiedin paragraphs 1.2.2, 1.3.2, 1.3.4, 1.4, 1.5, 1.6, 2.2.S.1, 2.2.S.2 (2.2.S.2.1-2.2.S.2.3), 2.2.S.3, 2.2.S.4, 2.2.S.5, 2.2.S.6, 2.2.S.7 (2.2.S.7.1-2.2.S.7.2) are submitted.
• When the Certificate of Conformity of the European Pharmacopoeia (CEP) is provided, the documents specified inparagraphs 2.2.S.2-2.2.S.3.2 and 2.2.S.7-2.2.S.7.3 are not required. The validity of the CEP certificate is checked by the responsible employee in the electronic database of the European Directorate for Quality of Medicines and Health.
• Applications for renewal of the registration certificate must contain the data described inparts 1, 2.
• Applications for generic medicinal products should contain the data described inparts 1, 2, together with data showing bioavailability and bioequivalence with the original medicinal product, provided that the latter is not a biological medicinal product.
• Registration documents of medicinal plant raw materials should contain the data ofparts 1 and 2.
• Regarding the nomenclature of medicinal plant raw materials, it is necessary to indicate the binomial scientific name of the plant (genus, species, variation and author) and chemotype (if necessary), plant parts, plant substance definition, other names (synonyms indicated in another pharmacopeia).
• For medicinal products of animal origin,the following additional information should be provided in part 2:

• data on the species, age, ration and geographic region of origin of animals from which raw materials are obtained;
• data on the nature (category) of the tissue from which the raw material for the production of the medicinal product is derived, in terms of its danger regarding content of prions;
• technological scheme for processing raw materials with an indication of extractants, temperature conditions, etc.;
• control methods of the raw materials.

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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 additions and amendments of the...

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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 the applicant on the...

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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 independent experts;
- decides on the use of the medicines without clinical trials in the...

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