Structure of dossier in simplified format

LS 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, 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).

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

See also:

registr Registration of medicinal products