| | Pharmaceutical products |
| Name
of documents | Original
medical products | Generics | Pharmaceutical
substances (API) | Medical
immunobiological products | Medicinal
vegetative raw material | Homoeopathist
products |
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 |
| Part I The general documentation | | | | | | |
1A | The administrative data | | | | | | |
1 | The application under the authorized form (hard
copy and soft copy) | + | + | + | + | + | + |
2 | The inventory - the acceptance report - transfers
of documents of the registration file | + | + | + | + | + | + |
3 | The certificate on a pharmaceutical (medical)
product according to recommendations of WHO ; The certificate on registration in the country of
the manufacturer or a copy of the registration certificate in the country -
manufacturer (notarized copy); The certificate of conformity to requirements GMP
(certified); The
certificate resolving free sale (export) (certified | + | + | + | + | + | + |
4 | The license for pharmaceutical activity (notarized
copy); | + | + | + | + | + | + |
5 | The appendix to the license (for vegetative raw
material - the sanction to preparation) | + | + | + | - | + | + |
6 | Copies of registration certificates in CIS
countries and other countries (notarized copy); | + | + | + | + | + | + |
7 | The certificates of Raw materials (the analytical
passport also for API) | + | + | + | - | + | - |
8 | Certificate of Finished product (the analytical passport) of 3 batches | + | + | + | + | + | + |
9 | The document about safety of substances of an animal
origin, the information on absence (BSE/TSE) | + | + | + | - | - | - |
10 | Copy of the registration / Re-registration
certificate of Republic Uzbekistan (at a re-registration) | + | + | + | + | + | + |
1B | Summary
characteristic of a medical product (SPC) in English and Russian | + | + | + | + | + | + |
1 | The instruction on clinical trials in English and
Russian languages (soft and hard copies) | + | + | + | + | + | + |
2 | Instruction for medical use in Russian (soft and
hard copies) | + | + | + | + | + | + |
3 | Artworks in CDR format | + | + | + | + | + | + |
4 | Specification of package materials | + | + | + | + | + | + |
5 | Copy of Patent or other document for pharmaceutical
product’s security | + | - | - | + | - | + |
1C | Conclusions of experts concerning chemical,
pharmaceutical, microbiological, pharmacological, toxicological and clinical
given (the resume of the basic properties of a preparation) for Microbiologic -
diagnostic efficiency (sensitivity, specificity) | + | + | + | + | - | - |
| Part II The chemical,
pharmaceutical and biological documentation | | | | | | |
2 | The contents | + | + | + | + | + | + |
2A | Qualitative
and quantitative structure of pharmaceutical product (Detailed composition
and usage of components) | + | + | + | + | + | + |
2B | 1. Information
about product manufacturing: 1)
Manufacturing formula 2)
manufacturing description 3) The
control over manufacture 4)
validation productions 2. The project of the normative document | + | + | + | + | + | + |
2C | Techniques
of the control of initial substances with the appendix of certificates of
analyses | + | + | - | + | + (for collec.) | + |
2D | Techniques of the analysis of intermediate products | + | + | + | + | - | - |
2E | The specification of a medical product, technique
of quality assurance and them validation (except
for Pharmacopeia techniques) (in Russian and-or in English languages) | + | + | + | + | + | + |
2F | The data on stability not less than on 3 batches in
natural conditions at long-term storage (in Russian and-or in English
languages) | + | + | + | + | + | + |
2G | The data on probable danger to an environment to
preparations which contain genetically changed organisms | + | + | + | + | - | - |
2H | Other additional information confirming efficiency,
safety and quality | + | + | + | + | + | + |
| Part III The pharmacological and toxicological documentation | | | | | | |
3 | The contents | + | + | + | + | + | + |
3A | Toxicity
at unitary introduction and introduction of repeated dozes (sharp, subacute and
chronic toxicity) | + | - | - | + | + (for new) | + (for new) |
3B | Influence on reproductive function. The data on teratogenicity,
gonadotoxic and
embryotoxity | + | - | - | - | + (for new) | - |
3C | Data on
mytagenicity | + | - | - | - | + for new)) | - |
3D | Data on
carcinogenicity | + | - | - | - | + for new)) | - |
3E | Specific
action, general pharmacology (for МИБП -
reaktogenicity, specific activity) | + | - | - | + | + for new)) | - |
3F | Pharmacokinetics (absorption, distribution, a
metabolism, allocation) | + | - | - | - | - | - |
3G | The data on bioequivalence (for generics) | - | + | - | + | - | - |
3H | *Data about
place-irritating action
immunogenicity for
vaccines | + | - | - | + | + for new)) | - |
3I | Drug dependence | + | - | - | - | - | - |
3J | Antigencity | + | - | - | - | - | - |
| Part IV The clinical documentation |
|
|
|
| |
|
IV | The contents | + |
| + | + |
+
| + |
IVA | The data on clinical pharmacology
(pharmacokinetics) (for in vivo the data on epidemiological, clinical, immunological efficiency) | + | + | - | + | + for new)) | - |
IVB | Results of clinical tests, scientific publications,
reports | + | + | - | + | + for new) | + |
IVC | Other additional information confirming efficiency,
safety and quality, re-registration the data on clinical efficiency
and safety | + | + | - | + | +
| + |
