|Full registration dossier consists of four parts|
Part I. Summary of dossier
I A. Administrative data
Table of contents of registration dossier
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, labeling and package leaflet/insert.
I B1 Summary of product characteristics.
I B2 Proposals for samples/mockups of packaging, labeling, package leaflet/insert.
I B3 Copy of summary of product characteristics already approved in applicant/manufacturer-country.
І С Reports of independent experts.
I C1 Expert report on chemical, pharmaceutical and biological documentation.
I C2 Expert report on pharmaco-toxicological documentation.
I C3 Expert report on clinical documentation.
Part II. Chemical, pharmaceutical and biological documentation.
Table of contents.
II A Composition.
II A1 Formula of the medicinal product.
II A2. Container (short description).
II A3 Clinical trial formula
II A4 Development pharmaceutics
II B Method of preparation (flow-chart of technological process or draft of technological regulations)
II B1 Manufacturing formula
II B2 Manufacturing process
II B3 Process validation
II C Control methods of starting materials*
II C1 Active substance*
II C1.1 Specifications and standard tests*
II C1.2 Scientific data*
II C1.2.1 Nomenclature*
II C1.2.2 Description*
II C1.2.3 Manufacture*
II C1.2.4 In-process control of quality*
II C1.2.5 Development chemistry*
II C1.2.6 Impurities*
II C1.2.7 Batch testing*
II C2 Auxiliary substances (excipients)
II C2.1 Specifications and approved methods of quality control
II C2.2 Scientific information
II C3 Packaging material (immediate/outer package)
II C3.1 Specifications and approved methods of quality control
II C3.2 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 E1 Specifications and approved methods of quality control
II E1.1 Specifications and approved methods of in-process control, specific standards
II E1.2 Methods of quality control
II E1.2.1 Methods for identification and quantitative expression of active substance (-s)
II E1.2.2 Identification and expression of excipient (-s)
II E2 Scientific information
II E2.1 Validation of analytical methods and comments, standards (working standards)
II E2.2 Batch analysis
II F Stability
II F1 Methods of stability testing of active substance (-s)
II F2 Methods of stability testing of finished medicinal product
II G Bioavailability/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 A1 Single dose toxicity
III A2 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 F1 Pharmacodynamic effects with respect to proposed indications
III F2 General pharmacodynamics
III F3 Drug interactions
III G Pharmacokinetics
III G1 Pharmacokinetics after a single dose
III G2 Pharmacokinetics after repeated administration
III G3 Distribution in intact (normal) and pregnant animals
III G4 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 A1 Pharmacodynamics
IV A2 Pharmacokinetics
IV B Clinical experience
IV B1 Clinical trials
IV B2 Post-registration experience (if available)
IV B3 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).
*Minimum of information to be given in Part II C1.
|Registration of medicinal products|