Structure of the registration dossier in Ukraine:

1. Structure of the dossier for new registration:

• Structure of the dossier in “simple” format ;
• Structure of the dossier in CTD format ;

2. Structure of the dossier for renewal of registration.

 1. Structure of the dossier for new registration.

In accordance with valid legislation in Ukraine simultaneously two types of the registration dossier are acceptable for submission to the State Pharmacological Centre of Ministry of Health of Ukraine for state registration: “simple” (also called “simplified” or “old”) and CTD (Common Technical Documentation ) formats.

Below you will find the structure of the every format.

Structure of Registration Dossier

Full registration dossier consists of four parts:

Part I. Summary of dossier

I A. Administrative data

•  Table of contents of registration dossier

•  Application form

•  Samples of the medicinal product (sample in final immediate (interior) and secondary (outer) packages. If not available – a sample in final immediate (inside) package without final labeling shall be submitted. In this case a sample in final immediate (inside) and secondary (outer) packages should be given additionally as soon as it is available. Further on, for approval of methods of quality control of the medicinal product the additional samples, reference substances with batch certificate, including date of production, shelf life and storage conditions, could be requested.

•  Quality certificate for three production batches of the medicinal product or one certificate for one produced batch with obligations to present certificates for two other batches as soon as they are available (any certificate shall be submitted for each declared manufacturing site).

I B. Summary of product characteristics, labelling and package leaflet/insert.

I B1. Summary of product characteristics.

I B2. Proposals for samples/mock-ups of packaging, labelling, package leaflet/insert.

I_B3. Copy of summary of product characteristics already approved in applicant/manufacturer-country.

I C. Expert reports.

I C 1. Expert report on chemical, pharmaceutical and biological documentation.

I C 2. Expert report on pharmaco-toxicological documentation.

I C 3. Expert report on clinical documentation.

Part II. Chemical, pharmaceutical and biological documentation.

Table of contents.

II A.. Composition.

II A 1. Formula of the medicinal product.

II A 2. Container (short description).

II A 3. Clinical trial formula

II A 4. Development pharmaceutics

II B. Method of preparation (flow-chart of technological process or draft of technological regulations)

II B 1. Manufacturing formula

II B 2. Manufacturing process

II B 3. Process validation

II C.Control methods of starting materials*

II C 1. Active substance*

II C 1.1. Specifications and standard tests*

II C 1.2. Scientific data*

II C 1.2.1. Nomenclature*

II C 1.2.2. Description*

II C 1.2.3. Manufacture*

II C 1.2.4. In-process control of quality*

II C 1.2.5. Development chemistry*

II C 1.2.6 Impurities*

II C 1.2.7. Batch testing*

II C 2. Auxiliary substances (excipients)

II C 2.1 Specifications and approved methods of quality control

II C 2.2 Scientific information

II C 3. Packaging material (immediate/outer package)

II C 3.1 Specifications and approved methods of quality control

II C 3.2 Scientific information

II D. Methods of quality control of intermediate products (if necessary)

II E. Methods of quality control of the finished medicinal product

II E.1. Specifications and approved methods of quality control

II E 1.1. Specifications and approved methods of in-process control, specific standards

II E 1.2. Methods of quality control

II E 1.2.1. Methods for identification and quantitative expression of active substance (-s)

II E 1.2.2. Identification and expression of excipient (-s)

II E 2. Scientific information

II E 2.1 Validation of analytical methods and comments, standards (working standards)

II E 2.2. Batch analysis

II F. Stability

II F 1. Methods of stability testing of active substance (-s)

II F 2. Methods of stability testing of finished medicinal product

II G. Bioavaialability/bioequivalence. Refer to appropriate sections of Part IV, if necessary

II H. Data related to the environment risk for products containing genetically modified organisms (GMO)

II Q. Other information

Part III. Pharmacological and toxicological documentation

Table of contents

III A. Single dose toxicity and repeated dose toxicity

III A. 1. Single dose toxicity

III A 2. Repeated dose toxicity

III B. Reproductive function (fertility and general performance of reproductive function)

III C. Data on embryo toxicity and teratogeneity

III D. Mutagenic potential

III E. Carcinogenic potential

III F Pharmacodynamics

III F.1. Pharmacodynamic effects with respect to proposed indications

III F.2. General pharmacodynamics

III F.3. Drug interactions

III G. Pharmacokinetics

III G.1. Pharmacokinetics after a single dose

III G.2. Pharmacokinetics after repeated administration

III G.3. Distribution in intact (normal) and pregnant animals

III G.4 Biotransformation

III H. Local tolerance

III Q. Other information (alergenicity data etc.)

III R. Assessment of the environmental risk potential/ecotoxicity (not resulting from GMO)

Part IV. Clinical documentation

Table of contents

IV A. Clinical pharmacology

IV A..1. Pharmacodynamics

IV A..2. Pharmacokinetics

IV B. Clinical experience

IV B.1. Clinical trials

IV B.2. Post-registration experience (if available)

IV B.3. Published and unpublished experience

IV Q. Other information

If some parts of documentation are not included to the materials, the reason should be indicated in an appropriate place under corresponding (appropriate) heading.

For medicinal products of animal origin in Part II C.1. the following additional information should be presented:

•  species, age and diet of animals used as raw stock;

•  nature (category) of tissue taken as raw stock for production of medicinal product pertinent to its safety for prions;

•  flow-chart of stock processing with indication of extragents, temperature regimen etc.;

•  control tests of output raw stock including methods for detection of prions in finished product (if any).

State registration of medicinal products, medicines, pharmaceutical products in Ukraine. Marketing authorization of medications, remedies, pharma products. Regulatory affairs legislation of health and medical products. Ukraine, Kiev, Cratia Ltd. State registration of healthcare products, medicines, pharmaceuticals. Dossier on medicinal product (CTD format). State registration of vitamin, herbal, pharma, generic products in Ukraine. Ukraine, Kiev, Cratia Ltd.

Structure of Registration Dossier (Download as MS WORD)

(format of common technical document – CTD)

Full registration dossier consists of 5 modules:

Module 1. Administrative information:

• Application form;

Comment: common Application; we will translate it and prepare in accordance with the specific of the Application (generic/original, type of Application and so on);

• Comprehensive table of contents;

Comment: we will prepare it by ourselves;

• Suggested summary of product characteristics for Ukraine;

Comment: we will translate it and prepare instruction/leaflet;

• Labeling;

Comment: we will prepare the text that should be presented on the package or we can edit Corel Draw or PDF files;

• Package leaflet/insert;

Comment: it is not necessary, you can send SmPC only;  

1.3.4. Mockups and samples of finished product in localized package design (if samples of trade packages are not available – a sample in final immediate (inside) package without final labeling shall be submitted. In this case a sample in final immediate (inside) and secondary (outer) packages should be given additionally as soon as it is available. Further on, for approval of methods of quality control of the medicinal product additional samples, reference substances with batch certificate including date of production, shelf life and storage conditions could be requested;

Comment: import of the samples will be initiated only after submission of the dossier;

• Summary of product characteristics approved in manufacturer/applicant country

• Information on experts:  

1.4.1. Information on quality expert

1.4.2. Information on pre-clinical expert

1.4.3. Information on clinical expert

• Certificates:

- GMP certificate;

- Manufacturing license;

- Certificate of pharmaceutical product

Comment: preferable, but not necessary;  

- Certificate of registration in manufacturer’s country;

• Overseas regulatory status:

- List of countries where the product is registered (or submitted for registration) with mentioned date of first registration;

- Copies of the registration certificate from mentioned countries;

Comment: preferable, but not necessary;  

• Environmental risk;

Module 2. Summary of CTD

2.1. Table of contents of modules 2.3.4.5

2.2 Introduction to CTD

2.3 General summary on quality

2.4 Review of preclinical data

2.5 Review of clinical data

2.6 Summary of pre-clinical data

2.6.1. Summary of pharmacological data in text format

2.6.2. Summary of pharmacological data in tabular format

2.6.3. Summary of pharmacokinetics data in text format

2.6.4. Summary of pharmacokinetics data in tabular format

2.6.5. Summary of toxicological data in text format

2.6.6. Summary of toxicological data in tabular format

2.7. Summary of clinical data

2.7.1. Summary of biopharmaceutical studies and related analytical methods

2.7.2. Summary of clinical pharmacology studies

2.7.3. Summary of clinical efficacy

2.7.4. Summary of clinical safety

2.7.5. Copies of used literature sources

2.7.6. Short reviews of individual trials

Module 3. Quality

3.1. Table of contents

3.2. Relevant data

3.2.S. Medicinal substance (for medicinal products containing more than one medicinal substance an information should be given in full with respect to each of them)*

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. Manufacture*

3.2.S.2.1. Manufacturer*

3.2.S.2.2. Description of manufacturing process and its control*

3.2.S.2.3. Control of materials

3.2.S.2.4. Control of critical stages and intermediate products

3.2.S.2.5. Process validation and/or its assessment

3.2.S. 2.6. Development of manufacturing process

3.2.S.3. Characteristics*

3.2.S.3.1. Demonstration of structure and other characteristics

3.2.S.3.2. Impurities*

3.2.S.4. Control of medicinal substance*

3.2.S.4.1. Specification*

3.2.S.4.2. Analytical methods

3.2.S.4.3. Validation of analytical methods

3.2.S.4.4. Batch analysis*

3.2.S.4.5. Substantiation 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. Summary on stability and conclusions*

3.2.S.7.2. Report on post-registration stability study and stability associated obligations*

3.2.S.7.3 Stability data*

3.2.P. Medicinal product

3.2.P.1. Description and composition of the medicinal product

3.2.P.2. Development pharmaceutics

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.2.2.1. Development of composition

3.2.P.2.2.2. Overages

3.2.P.2.2.3. Physical and chemical, and biological properties

3.2.P.2.3. Development of 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. Manufacture

3.2.P.3.1. Manufacturer (-s)

3.2.P.3.2. Composition for batch

3.2.P.3.3. Description of manufacturing 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 its assessment

3.2.P.4.Control of excipients

3.2.P.4.1. Specifications

3.2.P.4.2. Analytical methods

3.2.P.4.3. Validation of analytical methods

3.2.P.4.4. Substantiation 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 medicinal product

3.2.P.5.1. Specification (-s)

3.2.P.5.2. Analytical methods

3.2.P.5.3. Validation of analytical methods

3.2.P.5.4. Batch analysis

3.2.P.5.5. Characteristics of impurities

3.2.P.5.6. Substantiation of specification (-s)

3.2.P.6. Standard samples and substances

3.2.P.7. Container/closure system

3.2.P.8. Stability

3.2.P.8.1. Summary and conclusions on stability

3.2.P.8.2. Report on post-registration stability study and stability associated obligations*

3.2.P.8.3. Stability data

3.2.A. Amendments

3.2.A.1. Technical devices and facilities

3.2.A.2. Safety assessment of foreign microorganisms

3.2.A.3. New excipients

3.2.R. Regional information

3.3. Copies of used literature sources

State registration of medicinal products, medicines, pharmaceutical products in Ukraine. Marketing authorization of medications, remedies, pharma products. Regulatory affairs legislation of health and medical products. Ukraine, Kiev, Cratia Ltd. State registration of healthcare products, medicines, pharmaceuticals. Dossier on medicinal product (CTD format). State registration of vitamin, herbal, pharma, generic products in Ukraine. Ukraine, Kiev, Cratia Ltd.

Module 4. Reports on preclinical trials

4.1. Table of contents

4.2.1. Pharmacology

4.2.1.1. Primary pharmacodynamics

4.2.1.2. Secondary pharmacodynamics

4.2.1.3. Safety pharmacology

4.2.1.4. Pharmacodynamic drug interactions

4.2.2. Pharmacokinetics

4.2.2.1. Analytical methods and their validation report

4.2.2.2. Absorption

4.2.2.3. Distribution

4.2.2.4. Metabolism

4.2.2.5. Excretion

4.2.2.6. Pharmacokinetic drug interactions (pre-clinical)

4.2.2.7. Other pharmacokinetic studies

4.2.3. Toxicology

4.2.3.1. Toxicity after a single dose administration

4.2.3.2. Toxicity after repeated administration

4.2.3.3. Genotoxicity

4.2.3.4. Carcinogenicity

•  Reproductive and ontogenetic toxicity

•  Local tolerance

•  Other toxicity studies

•  Copies of used literature sources

Module 5. Report on clinical trials

5.1. Table of contents

5.2. List of all clinical trials in tables

5.3. Report of clinical trials

5.3.1. Reports on biopharmaceutical studies

5.3.2. Reports on studies related to pharmacokinetics studies with use of human biomaterials

5.3.3. Reports on pharmacokinetic studies in human beings

5.3.4. Reports on pharmacodynamic studies in human beings

5.3.5. Reports on efficacy and safety studies

5.3.6.Reports on post-registration experience

5.3.7. Samples of individual registration forms and individual lists of patients.

5.4. Copies of used literature sources

If some parts of documentation are not included to the materials, the reason should be indicated in appropriate place under corresponding (appropriate) heading.

For medicinal products of animal origin in section 3.2.S. the following additional information should be presented:

•  data on species, age, diet of animals used as raw stock;

•  data on nature (category) of tissue taken as raw stock for production of medicinal product pertinent to its safety for prions;

•  flow-chart of stock processing with indication of extragents, temperature regimen etc.;

•  control tests of final stock including methods for detections of prions in final product (if any).

Note: strcutre of the CTD format is based on Rules governing medicinal product in the European Union, NTA, vol. 2B-CTD, 2001 (if other versions had been used, please, specify).

* Minimum of information to be given in Part II C1.

* Minimum of information which should be given in section 3.2.S.