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Registration of medicinal products in Uzbekistan

Documents required for state registration of medicines in the Republic of Uzbekistan

Section 1 General Documents
1.1	An application in accordance with Appendix 5 to the Regulation on the Procedure for State Registration of Medicines. When the application is submitted through a representative, a document confirming the authority of the representative (power of attorney).
1.2	Proof of payment.
1.3	For foreign manufacturers, a registration certificate issued by authorized bodies, international or foreign organizations and/or a certificate of pharmaceutical product (CPP) in the form in accordance with the WHO recommendations. If the submitted CPP indicates that the medicine is not registered in the country of manufacture, it is necessary to provide a notarized or apostille-certified registration certificate in other countries.
1.4	General description of the medicine in Uzbek: scope of application, circulation in other foreign countries, including information on the cessation of circulation in these countries and the presence of side effects.
1.5	Information on the storage of prions of substances derived from animal raw materials used in the production of the medicine.
1.6	Labels for primary (internal) and secondary (consumer) and intermediate packaging in Uzbek (but may also be provided in other languages). Layouts of intermediate packaging, labels, stickers (if available). For medicines registered under the recognition principle, it is allowed to label such medicines in the language of the manufacturing for other foreign countries. The labeling of the medicine packaging shall be clear, understandable, easily visible and indelible, in a well-readable font, and shall be maintained throughout the entire shelf life of the medicine
1.7	Color mock-ups of the consumer packaging, label, sticker of the medicine.
1.8	A draft of the general description of the medicine, instructions for use and package leaflet in the Uzbek language. The applicant may additionally submit a draft of the general description of the medicine, instructions for use and package leaflet in another language. Draft summary of the summary of product characteristics and instructions for use of the generic and biosimilar medicine, consistent with the current summary of product characteristics and instructions for use of the patent (reference) medicine, and a comparison table for compliance (except for differences in information on the manufacturer, shelf life, composition of excipients, and differences in bioavailability or pharmacokinetic parameters).
1.9	Documents related to the quality of the medicine: a copy of the certificate of compliance of the medicinal substance with the requirements of the European Pharmacopoeia (if available); a letter of consent of the holder of the master file of the medicinal substance to provide the closed part of this master file based on the Center’s request; the draft manufacturer’s pharmacopoeial monograph of the medicine; explanatory letter to the draft manufacturer’s pharmacopoeial monograph of the medicine; the current manufacturer’s pharmacopoeial monograph of the medicine when extending the validity period of the certificate.
1.10	Manufacturing documents: certificate of compliance with the requirements of the national standard of the Republic of Uzbekistan «Good Manufacturing Practices GMP» (if available); certificate of compliance with the requirements of the standard «Good Manufacturing Practices GMP» and a report on the results of the last inspection (for foreign manufacturers); License issued for the production of medicines.
1.11	For medicines to be registered on the basis of technology transfer: quality assurance agreement concluded by the parties for the implementation of transfer technology; technology transfer program; the report of the holder of the technology transfer on the implementation of the transfer.
1.12	For contract manufacturers — a contract for the manufacture of registered medicines without changing the technologies within the resources of the local pharmaceutical organization.
1.13	Information on the presence of genetically modified organisms or its extraction from them in the medicine.
1.14	Documents on the implementation of the pharmacovigilance system in the Republic of Uzbekistan: master file of the pharmacovigilance system prepared in accordance with the requirements of the national standard «Good Pharmacovigilance Practices – GVP»*; information about a person with a degree in medicine or pharmacy/pharmacology appropriate qualifications in pharmacovigilance (certificate), who is responsible for fulfilling pharmacovigilance requirements in the Republic of Uzbekistan; risk management plan for medicines submitted for registration based on the requirements of the national standard «Good Pharmacovigilance Practice — GVP»; when extending the validity period of the certificate or making amendments and additions to the registration documents – a periodic report prepared in accordance with the requirements of the national standard «Good Pharmacovigilance Practice — GVP».
1.15	A protection document (certificate, patent and annex thereto) confirming the intellectual property rights (trademarks and industrial designs) used in medicines, or an agreement on their use, or a conclusion of an authorized body in the field of intellectual property on the trade name and design of the medicine..
Section 2 Common Technical Documents
2.1	2–5 – table of contents
2.2	Introduction to CTD (Common Technical Documents)
2.3.S	Medicinal substance
2.3.S.1	General information
2.3.S.2	Production
2.3.S.3	Verification of the structure and other characteristics of the substance*
2.3.S.4	Control of the medicinal substance
2.3.S.5	Standard samples or materials
2.3.S.6	Container Closure System
2.3.S.7	Stability
2.3.P	Medicinal product
2.3.P.1	Description and composition of the medicine
2.3.P.2	Pharmaceutical development
2.3.P.3	Production
2.3.P.4	Control of excipients
2.3.Р.5	Control of the medicinal product
2.3.Р.6	Standard samples or materials
2.3.Р.7	Container Closure System
2.3.Р.8	Stability
2.3.А	Annexes
2.3.А.1	Facilities and equipment
2.3.А.2	Safety assessment of foreign substances
2.3.А.3	Excipients
2.3.R	Regional information
2.4	Review of preclinical studies
2.5	Review of clinical data
2.6	Summary of preclinical studies (written and tabular summaries)
2.7	Summary of clinical study reviews (written and tabular summaries)
Section 3 Information determining the quality of the medicine
3.1	Content of Section 3
3.2	Basic information
3.2.S	Medicine (for medicines that contain more than one active substance, information shall be provided in full for each medicinal substance)
3.2.S.1	General information
3.2.S.1.1	Name
3.2.S.1.2	Structure*
3.2.S.1.3	General properties
3.2.S.2	Production
3.2.S.2.1	Manufacturer
3.2.S.2.2	Description of the production process and its control
3.2.S.2.3	Control of starting materials
3.2.S.2.4	Control of critical stages and intermediate products
3.2.S.2.5	Process validation and/or assessment
3.2.S.2.6	Development of the production process
3.2.S.3	Defining properties
3.2.S.3.1	Verification of the structure and other characteristics of the substance*
3.2.S.3.2	Impurities (foreign substances)
3.2.S.4	Control of the medicinal substance
3.2.S.4.1	Specification
3.2.S.4.2	Analytical test methods
3.2.S.4.3	Validation of analytical test methods
3.2.S.4.4	Series tests (results of series tests)
3.2.S.4.5	Justification of specification
3.2.S.5	Standard samples or substances
3.2.S.6	Container Closure System
3.2.S.7	Stability
3.2.S.7.1	Information and conclusions on stability tests
3.2.S.7.2	Statement of Post-Registration Sustainability
3.2.S.7.3	Research and Sustainability Commitments
3.2.P	Medicinal product
3.2.P.1	Description and composition of the medicinal product
3.2.P.2	Pharmaceutical development
3.2.P.2.1	Constituents of the medicinal product
3.2.P.2.1.1	Medicinal substance
3.2.P.2.1.2	Excipients
3.2.P.2.2	Medicinal product
3.2.P.3.2.1	Development of a dosage form
3.2.P.3.2.2	Surplus products in production
3.2.P.3.2.3	Physicochemical and biological properties
3.2.P.2.3	Development of the manufacturing process
3.2.P.2.4	Container Closure System
3.2.P.2.5	Microbiological characteristics
3.2.P.2.6	Compatibility
3.2.P.3	Production
3.2.P.3.1	Manufacturer(s)
3.2.P.3.2	Batch formulation (manufacturing formula)
3.2.P.3.3	Classification of the production process and process control
3.2.P.3.4	Control of critical stages and intermediate products
3.2.P.3.5	Process validation and/or assessment
3.2.P.4	Control of excipients
3.2.P.4.1	Specifications
3.2.P.4.2	Analytical test methods
3.2.P.4.3	Validation of analytical test methods
3.2.P.4.4	Justification of specifications
3.2.P.4.5	Excipients of human and animal origin
3.2.P.4.6	New excipients
3.2.P.5	Control of the medicinal product
3.2.P.5.1	Specification(s)
3.2.P.5.2	Analytical test methods
3.2.P.5.3	Validation of analytical test methods
3.2.P.5.4	Batch test results
3.2.P.5.5	Description of impurities (foreign substances)
3.2.P.5.6	Justification of Specification(s)
3.2.P.6	Standard samples or materials
3.2.P.7	Container Closure System
3.2.P.8	Stability
3.2.P.8.1	Stability summary and conclusion
3.2.P.8.2	Post-registration stability study report and stability commitments
3.2.P.8.3	Stability data
3.2.A	Supplements
3.2.A.1	Facilities and equipment
3.2.A.2	Safety assessment regarding foreign agents
3.2.A.3	Excipients
3.2.R	Regional information
3.3	References (where applicable)
Section 4 Information on preclinical studies
4.1	Contents of Section 4
4.2	Research reports
4.2.1	Pharmacology
4.2.1.1	Primary pharmacodynamics*
4.2.1.2	Secondary pharmacodynamics*
4.2.1.3	Pharmacological safety
4.2.1.4	Pharmacodynamic interaction of medicinal substances*
4.2.2	Pharmacokinetics
4.2.2.1	Reports on analytical methods and validation (in case of separate reports)*
4.2.2.2	Absorption
4.2.2.3	Distribution
4.2.2.4	Metabolism
4.2.2.5	Removal*
4.2.2.6	Pharmacokinetic drug interactions (preclinical)*
4.2.2.7	Other pharmacokinetic studies*
4.2.3	Toxicology
4.2.3.1	Single dose toxicity (by animal species, route)
4.2.3.2	Repeated dose toxicity (by animal species, route, duration, including justified toxicokinetic evaluation)*
4.2.3.3	Genotoxicity (In vitro, In vivo, including based toxicokinetic evaluation)
4.2.3.4	Carcinogenicity (short-, medium- and long-term studies)*
4.2.3.5	Reproductive and ontogenetic toxicity (fertility and early embryonic development, embryofetal development, prenatal and postnatal development, offspring (juveniles) dosing and/or studies included in the subsequent evaluation)
4.2.3.6	Local tolerance
4.2.3.7	Other toxicological studies (if available): antigenicity, immunotoxicity, mechanism of action studies, drug dependence, metabolites, foreign substances, etc.*
4.3	List or copies of references used
Section 5 Information on clinical studies
5.1	Contents of Section 5
5.2	A tabular list of all clinical studies
5.3	Reports on clinical studies
5.3.1	Reports on biopharmaceutical studies
5.3.2	Reports of studies concerning pharmacokinetics when using human biomaterial*
5.3.3	Reports of pharmacokinetic (PK) studies conducted in humans*
5.3.4	Reports of pharmacodynamic (PD) studies conducted in humans*
5.3.5	Reports on efficacy and safety studies
5.3.6	Post-registration experience reports
5.3.7	Individual registration forms and patient lists
5.4	References

Notes:

For registration under the recognition principle, the above-listed documents are required (with the exception of the current master files of the medicinal substances used in the manufacture of the medicine).
Foreign applicants may submit sections 2 to 5 of the registration documents in English or Russian.
Foreign applicants may submit clauses 1.5, 1.9, 1.11, 1.13, 1.14 of section 1 of the registration documents in English or Russian.
When extending the validity period of the certificate, the documents listed in sections 1–3 shall be submitted.
Applications for generic medicines shall include the documents listed in Sections 1 to 3, as well as reports confirming the bioavailability and bioequivalence of the medicine specified in the application against the reference (patent) medicine in humans, with the exception of biosimilar medicines.
The approved report of clinical studies, approved study report, regulatory authority’s permission to conduct the study (if available), the approval of the ethics committee, a copy of sponsor’s liability insurance contract in case of harm to the life and health of the study subject, chromatograms (when bioequivalence studies are submitted), copies of agreements between the sponsor of the clinical study and the research center (contract research organization) (if necessary after removing confidential information).
Reports confirming the bioequivalence carried out by the biowaiver method can be submitted for medicines containing a medicinal substance belonging to the І and ІІІ biopharmaceutical classification system.
In cases where the certificate of conformity to the European Pharmacopoeia (EPCC) is submitted, it is allowed not to provide the documents listed in paragraph 3.2.Ѕ.
The authenticity of the EPCC shall be checked by the responsible employee from the electronic database of the European Directorate for the Quality of Medicines and Healthcare.
* The documents specified in these paragraphs are not required for the registration of biotechnology medicines produced on the basis of cell technology.
When registering biotechnology medicines produced on the basis of cell technology obtained as a result of processing human cells without significant changes, it is necessary to be guided by the documents specified in Section 1, paragraphs 2.3.P.5, 2.3.P.8, 2.5.6, 2.5.7, 2.7.3.1, 2.7.4.6, 2.7.5 of Section 2, paragraphs 3.2.P.2.2.1, 3.2.P.3.1, 3.2.P.3.2, 3.2.P.3.3, 3.2.P.3.4, 3.2.P.5.1, 3.2.P.5.2, 3.2.P.5.6, 3.2.P.8.3, 3.2.A.3 of Section 3, paragraphs 5.2., 5.3.6, 5.4 of Section 5, as well as instructions for use for the indicated method of medical care using biotechnology medicines produced on the basis of cell technology obtained as a result of processing human cells without significant changes.
If, due to the characteristics of the medicine, some of the required documents or the information contained therein are missing, the applicant has the right to submit an official letter justifying this situation (a reasoned explanatory letter).

Registration of medicinal products in Uzbekistan

Documents required for state registration of medicines in the Republic of Uzbekistan

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