Check list for registration of Pharmaceutical product in Kyrgyzstan by healthcare ministry

 

List of documents for registration of original medicinal product in Kyrgyzstan

According to the national registration procedure

	MODULE 1.
	ADMINISTRATIVE INFORMATION
No.	Name of documents	Mandatory documents	Documents in the absence of which the mark “not applicable” is made or an explanation is attached	Documents provided if available
1.0.	Cover letter (free form)	there is  No
1.1.	Content	there is  No
1.2.	General documentation
1.2.1.	Certificate  to register the drug	there is  No
1.2.2.	Document confirming the payment of expert works and (or) payment of the registration fee (fee) in the case and the procedure established in accordance with the legislation of the State - a member of the Eurasian Economic Union, carrying out registration * (upon acceptance of the registration dossier, the availability is not checked in accordance with clause 20 of the PPKR No. 4 05 of 28.08.2018)
1.2.3.	To opium of a certificate for a medicinal product (certified in accordance with the established procedure) in accordance with the format recommended by WHO, issued by the authorized body of the manufacturing country. In the absence of such a certificate, a document confirming registration in the manufacturing country and (or) in the country holding the registration certificate for the medicinal product (certified in accordance with the established procedure) is submitted (in the presence of) Note: it is allowed to provide a copy of the certificate for the medicinal product (certified in accordance with the established procedure) in accordance with the format recommended by WHO, issued by the authorized body of the country of manufacture or the exporting country			there is No
1.2.4.	translation into Russian and a duly certified copy of the expert report issued by the authorized body when registering a medicinal product in the manufacturing country or in the country that holds the registration certificate (in the presence of)			there is  No
1.2.5.	Conclusion (recommendation) of the authorized body (authorized organization) states - members of the Eurasian Economic Union on the basis of prior scientific advice regarding the medicinal product in the State - a member of the Eurasian Economic Union (in the presence of)			there is  No
1.2.6.	RECOMMENDATIONS Expert Committee for Medicinal Products under the Eurasian Economic Commission on the results of the preliminary scientific advice regarding the medicinal product (if available)			there is  No
1.3.	General characteristics of the medicinal product, instructions for medical use (leaflet), labeling:
1.3.1.	Project general product characteristics for medical use instructions (package insert), compiled in accordance with the acts of the Eurasian Economic Union in Russian	draft instructions for medical use (leaflet), drawn up in accordance with the requirements of Appendix No. 3 (PP KR No. 405) in Russian, in paper and electronic versions there is    No
1.3.2.	Markets of primary (internal) and secondary (consumer), intermediate packaging, drawn up in accordance with the Requirements of acts of the bodies of the Eurasian Economic Union in Russian. Intermediate packaging, labels, stickers layouts are provided subject to availability	there is        No		Intermediate packaging, labels, stickers layouts   there is    No
1.3.3.	Performan user testing of the text on the package leaflet (leaflet) (in the presence of)			there is  No
1.3.4.	Product holder of the registration certificate copy of the general characteristics of the drug from the date of the last revision of the instructions for medical use (leaflet), approved by the competent authority of the country of production and (or) the custodian of the country of registration certificate and (or) other countries with well regulated pharmaceutical the market where the medicinal product is registered (if available)			there is  No
1.4.	Information on the regulatory status of the medicinal product in other countries (if available)			there is  No
1.4.1.	The list of countries in which the medicinal product was submitted for registration, registered, was refused registration, or its circulation on the market of these countries was suspended, indicating the name of the medicinal product, the number and date of the registration certificate, its validity period or the date of the decision to refuse registration, suspension of registration certificates, the information provided must be certified by the holder of the marketing authorization			there is  No
1.5.	Quality documents:
1.5.1.	With certificate compliance with Article Pharmacopoeia of the Eurasian Economic Union or the European Pharmacopoeia for BSE or document issued authorized bodies of veterinary supervision of the country of origin of raw materials in the case of using pharmaceutical substances of animal origin (if applicable)		Provided only if pharmaceutical substances of animal origin are used in the manufacture of the medicinal product. If such substances are not used, a letter of confirmation from the applicant that this requirement is not applicable to the declared medicinal product must be included in the documents of the registration dossier. there is  No
1.5.2.	Master file active isomer holder pharmaceutical substance with the obligation to report all changes to the manufacturer of the medicinal product and the authorized body of a member state of the Eurasian Economic Union before any significant changes are made to the master file of the pharmaceutical substance (notarized copy of the letter signed by the authorized person for quality with translation) Note: a guarantee is allowed on the provision of a document within 90 calendar days	there is  No
1.5.3.	A letter confirming the consent of the holder of the master file of a pharmaceutical substance to the submission of documents of the closed part of the master file for a pharmaceutical substance at the request of the authorized body of a member state of the Eurasian Economic Union Note: a guarantee is allowed on the provision of a document within 90 calendar days	there is  No
1.5.4.	To opium of the certificate of compliance of the pharmaceutical substance with the requirements of the European Pharmacopoeia ( if available)			there is  No
1.5.5.	Product certificate for the plasma master file issued by the authorized body of the manufacturing country (in the presence of)			there is  No
1.5.6.	By opium certificate for vaccine antigen master file, issued by the competent authority of the country of manufacture (in the presence of)			there is  No
1.6.	Production documents:
1.6.1.	A duly certified copy of a valid document confirming the compliance of the manufacturer (production site) of the medicinal product applied for registration with the requirements of the Rules of Good Manufacturing Practice of the Eurasian Economic Union, approved by the Eurasian Economic Commission, issued by the authorized body of the member state . Copies of valid documents, certified in accordance with the established procedure , confirming the compliance of the manufacturer with the requirements of good manufacturing practice, issued by the authorized bodies of the country (countries) in which the production site is located (production sites at different stages of production), and (or) another authorized body, and, if available, submit website address of the register of certificates of compliance with the requirements of good manufacturing practice (for example, EudraGMP ) issued by the authorized body on the Internet Note: in case of applications for medicines manufactured in the EAEU member states, the following is provided: - the above document or - valid documents confirming the compliance of the production site (production sites) that produces the finished dosage form and issues quality control of the medicinal product with the requirements of good manufacturing practice, issued to the manufacturer of the medicinal product by the authorized body of the country - manufacturer of the medicinal product or - a copy of the report on the results of the last inspection of the production site (production sites at the production stages) carried out by the authorized body of the country of manufacture and (or) another authorized body within the last 3 years.	there is  No
1.6.2.	W averennye in the prescribed manner a copy of a valid permit (license) for production (including annexes), issued by the competent authority of the country in which there is a production site (production sites at different stages of production)	Only for medicinal products manufactured in countries where licensing of medicinal products manufacturing is adopted separately from the assessment of compliance with the Good Manufacturing Practice ( GMP ) there is    No	If the legislation of the country of manufacture of the medicinal product has adopted the assessment of compliance with the Rules of Good Manufacturing Practice ( GMP ) as a form of licensing, the applicant's confirmation letter must be included in the documents of the registration dossier, explaining that this requirement is not applicable to the declared medicinal product. there is  No
1.6.3.	W averennye in the prescribed manner a copy of the inspection of the production site reports (production sites at different stages of production) for compliance with good manufacturing practice, carried out (spent) by the authority of the country of the manufacturer or other authorized body for the last 3 years from the date of application, with the plan and post-inspection corrective action report (CAPA) (in the presence of)			there is  No
1.6.4.	A duly certified copy of the contract (agreement) between the marketing authorization holder and the manufacturer on compliance issues good manufacturing practice requirements, if the marketing authorization holder is not involved in the production of the medicinal product (in the presence of)			there is  No
1.6.5.	W averennaya in the prescribed manner a copy of the contract (agreement) between the contract and the production site by the manufacturer on compliance with the requirements of Good Manufacturing P raktiki, when the whole process, or one of the stages of drug production is contracted production site (if applicable)		Provided only if, during the production of a medicinal product, the entire process or one of the stages of production of a medicinal product is carried out at a contract manufacturing site there is    No
1.6.6.	From the knowledge of any regulatory measures taken by the authorized body that carried out the inspection within the last 3 years based on the results of inspections (from the date of filing the application) in relation to the declared production site (in the presence of)			there is  No
1.6.7.	P ismo authorized person on the quality of conformity conditions of production declared for the registration of the drug requirements of the Rules of Good Manufacturing Practices of the Eurasian Economic Union, approved by the Eurasian Economic Commission, including in respect of the raw materials for each production site, used in the manufacturing process of the drug and active pharmaceutical substances, including sites where quality control and process control are carried out production. The letter must be signed by an authorized person for quality and certified by the manufacturer's seal (stamp), if necessary, with translation into Russian	there is  No
1.6.8.	From the management of complaints regarding the quality of medicinal products produced at the production site of the medicinal product applied for registration over the last 3 years (if applicable)		Provided if there have been complaints regarding the quality of medicinal products produced at the production site of the medicinal product applied for registration over the past 3 years. If there have been no complaints, an appropriate confirmation letter must be included in the registration dossier documents there is    No
1.6.9.	With announced at carrying out pharmaceutical inspection for compliance with Good Manufacturing Practice of the Eurasian Economic union approved by the Eurasian Economic Commission	Consent is provided by a confirmation letter (in any form) there is  No
1.6.10.	W averennaya applicant a copy of the main file (a master file) production site (production sites) (if applicable)		Provided only if the legislation in the countries of manufacture of the medicinal product adopted the compilation of the main dossier (master file) of the production site (production sites). If not applicable, the applicant's confirmation letter must be included in the documents of the registration dossier, explaining that this requirement is not applicable to the declared medicinal product. there is    No
1.6.11.	From hema stages of production with an indication of all production sites involved in the production of a medicinal product and active pharmaceutical ingredient, including quality control issuing	Either a separate scheme is provided, or a link (in a separate page) to the corresponding section of the module, which includes this scheme there is  No
1.7.	Information about specialists
1.7.1	And Info (short summary) about the specialist who prepared a quality resume	there is  No
1.7.2.	And Info (short summary) about the specialist who prepared a summary of preclinical data	there is  No
1.7.3.	And Info (short summary) about the specialist who prepared a clinical summary	there is  No
1.8.	Specific requirements for different types of applications:
1.8.1.	P ismo holder of the registration certificate of the supplementary trade name of the drug (if applicable)		there is  No
1.8.2.	A Document of Clinical Trials (if applicable)		Either separate documents are provided, or a link (in a separate page) to the corresponding section of the module, which includes these documents. If not applicable, the applicant's confirmation letter must be included in the documents of the registration dossier, explaining that this requirement is not applicable to the declared medicinal product. there is    No
1.8.3.	T ABLE with a list of clinical trials ( if applicable)		Either a separate table or a link (in a separate page) to the corresponding section of the module, where the data is included, is provided. If not applicable, the applicant's confirmation letter must be included in the documents of the registration dossier , explaining that this requirement is not applicable to the declared medicinal product. there is    No
1.8.4.	P ismo holder of the registration certificate of compliance of clinical trials applied for registration of the drug requirements The rules of good clinical practice in the Eurasian Economic Union, have confirmed by the Eurasian Economic Commission Note: or the requirements of good clinical practice, equivalent to the requirements of the Union (or not lower), as well as the principles of the Declaration of Helsinki of the World Medical Association "Ethical principles of medical research with human participation as a research subject."	there is  No
1.9.	Applicant's documents on the assessment of the potential hazard to the environment (in the presence of):			there is    No
1.9.1.	N ismo applicant that the preparations contain genetically modified organisms or derived from them (if applicable)		If not applicable, the applicant's confirmation letter must be included in the documents of the registration dossier , explaining that this requirement is not applicable to the declared medicinal product. there is    No
1.10.	Information regarding the applicant's pharmacovigilance in a member state of the Eurasian Economic Union	there is    No
1.10.1.	M aster file of the pharmacovigilance system of the marketing authorization holder in accordance with the good pharmacovigilance practice of the Eurasian Economic Union or a brief description of the pharmacovigilance system of the marketing authorization holder	there is  No
1.10.2.	A written confirmation that the holder of the registration certificate has at his disposal a qualified person responsible for pharmacovigilance in the territory of a member state of the Eurasian Economic Union	there is  No
1.10.3.	P lan risk management on a drug applied for registration in accordance with the requirements of the Rules of Good Practice pharmacovigilance Eurasian Economic Union, approved by the Eurasian Economic Commission (if applicable)		If not applicable, the applicant's confirmation letter must be included in the documents of the registration dossier , explaining that this requirement is not applicable to the declared medicinal product. there is    No
1.10.4.	D Document, duly certified, confirming the presence of interaction, ensuring the proper implementation of a number of legal entities of all the duties of the holder of the registration certificate (if applicable)		If not applicable, the applicant's confirmation letter must be included in the documents of the registration dossier, explaining that this requirement is not applicable to the declared medicinal product. there is    No
1.11.	Copies of documents confirming the registration of the trademark (in the presence of)			there is    No
	UNIT 2.
	SUMMARY OF GENERAL TECHNICAL DOCUMENT
2.1.	Content of _______ modules 2 - 5
2.2.	Introduction to DTD
2.3.	General summary of quality
2.4.	Review of preclinical data
2.5.	Clinical data review
2.6.	Preclinical study summary
2.6.1.	Summary of pharmacological data in text format
2.6.2.	Summary of pharmacological data in tabular form
2.6.3.	Summary of Pharmacokinetic Data in Text Format
2.6.4.	Summary of pharmacokinetic data in tabular form
2.6.5.	Summary of toxicological data in text format
2.6.6.	Summary of toxicological data in tabular format
2.7.	Clinical summary
2.7.1.	Summary of biopharmaceutical research and related analytical methods
2.7.2.	Clinical Pharmacology Research Summary
2.7.3.	Clinical efficacy summary
2.7.4.	Clinical Safety Summary
2.7.5.	Copies of used literary sources
2.7.6.	Brief overview of individual studies
	MODULE 3.
	QUALITY
3.1.	Module 3 content
3.2.	Basic information
3.2.S.	Active pharmaceutical substance (API), for medicinal products containing several active (active) substances, information is provided in full regarding each of them **
3.2.S.1.	General information regarding raw materials and raw materials **
3.2.S.1.1.	Information on the name of the API **
3.2.S.1.2.	API structure **
3.2.S.1.3.	General properties of API **
3.2.S.2.	API manufacturing process
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 raw materials
3.2.S.2.4.	Control of critical stages and intermediate products
3.2.S.2.5.	Validation of the production process and / or its assessment
3.2.S.2.6.	Manufacturing process development
3.2.S.3.	Description of API characteristics **
3.2.S.3.1.	Confirmation of structure and other characteristics
3.2.S.3.2.	Impurities **
3.2.S.4.	API quality control **
3.2.S.4.1.	Specification**
3.2.S.4.2.	Analytical methods **
3.2.S.4.3.	Validation of analytical procedures
3.2.S.4.4.	Batch analyzes (batch analysis results) **
3.2.S.4.5.	Rationale for the specification
3.2.S.5.	Standard samples or materials
3.2.S.6.	Packaging (capping) system **
3.2.S.7.	Stability**
3.2.S.7.1.	Summary of stability tests and conclusion on stability **
3.2.S.7.2.	Post-marketing stability testing program and stability commitments **
3.2.S.7.3.	Stability test data **
3.2.R.	Medicinal product
3.2.P.1.	Description and composition of the medicinal product
3.2.Р.2.	Pharmaceutical development
3.2.Р.2.1.	Components of the medicinal product
3.2.Р.2.1.1.	Active pharmaceutical ingredient
3.2.Р.2.1.2.	Excipients
3.2.Р.2.2.	Medicinal product
3.2.Р.2.2.1.	Dosage form development
3.2.Р.2.2.2.	Production surpluses
3.2.Р.2.2.3.	Physicochemical and biological properties
3.2.Р.2.3.	Manufacturing process development
3.2.Р.2.4.	Packaging (capping) system
3.2.Р.2.5.	Microbiological characteristics
3.2.Р.2.6.	Compatibility
3.2.Р.3.	Medicinal product manufacturing process
3.2.Р.3.1.	Manufacturers
3.2.Р.3.2.	Composition per batch (production recipe)
3.2.Р.3.3.	Description of the production process and its control
3.2.Р.3.4.	Control of critical stages and intermediate products
3.2.Р.3.5.	Validation of the production process and / or its assessment
3.2.Р.4.	Quality control of excipients
3.2.Р.4.1.	Specifications
3.2.Р.4.2.	Analytical techniques
3.2.Р.4.3.	Validation of analytical procedures
3.2.Р.4.4.	Rationale for specifications
3.2.Р.4.5.	Excipients of human and animal origin
3.2.Р.4.6.	New excipients
3.2.Р.5.	Quality control of the medicinal product
3.2.Р.5.1.	Specifications
3.2.Р.5.2.	Analytical techniques. Draft quality regulatory document prepared in accordance with the recommendations approved by the Eurasian Economic Commission ***	Draft normative document on quality, prepared in accordance with Appendix 2 of the PP KR No. 405
3.2.Р.5.3.	Validation of analytical procedures
3.2.Р.5.4.	Batch Analysis Results
3.2.Р.5.5.	Characterization of impurities
3.2.Р.5.6.	Rationale for specifications
3.2.Р.6.	Standard samples and materials
3.2.Р.7.	Packaging (capping) system
3.2.Р.8.	Drug stability
3.2.Р.8.1.	Summary of stability tests and stability report **
3.2.Р.8.2.	Post-marketing stability testing program
3.2.Р.8.3.	Stability test data
3.2.A.	Supplements
3.2.A.1.	Industrial premises and equipment
3.2.A.2.	Safety assessment with respect to foreign agents
3.2.A.3.	New excipients
3.2.R.	Regional information
3.3.	Copies of used literary sources
	MODULE 4.
	PRE-CLINICAL (NON-CLINICAL) STUDY REPORTS
4.1.	Module 4 content
4.2.	Research reports (if applicable)
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 drug interactions
4.2.2.	Pharmacokinetics
4.2.2.1.	Analytical methodologies and validation reports
4.2.2.2.	Absorption
4.2.2.3.	Distribution
4.2.2.4.	Metabolism
4.2.2.5.	Excretion (excretion)
4.2.2.6.	Pharmacokinetic drug interactions
4.2.2.7.	Other pharmacokinetic studies
4.2.3.	Toxicology
4.2.3.1.	Single dose toxicity
4.2.3.2.	Repeated dose toxicity
4.2.3.3.	Genotoxicity
4.2.3.4.	Carcinogenicity
4.2.3.5.	Reproductive and ontogenetic toxicity: fertility and early embryonic development, embryo - fetal development, prenatal and postnatal development; studies in immature offspring with follow-up
4.2.3.6.	Local tolerance
4.2.3.7.	Other toxicological studies: antigenicity , immunotoxicity , studies of the mechanism of action,
4.3.	Copies of used literary sources
	MODULE 5.
	REPORTS ABOUT CLINICAL STUDIES
5.1.	Module 5 content
5.2.	List of all clinical studies (trials) in the form of tables
5.3.	Clinical trials (trials) reports
5.3.1.	Biopharmaceutical Research Reports
5.3.2.	Pharmacokinetic Study Reports Using Human Biomaterials
5.3.3.	Human Pharmacokinetic Study Reports
5.3.4.	Human Pharmacodynamic Study Reports
5.3.5.	Efficacy and Safety Study Reports
5.3.6.	Post-registration experience reports
5.3.7.	Individual registration cards and patient lists
5.4.	Copies of used literary sources