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RUSSIA |
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Authority |
MOH and Social Development |
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website |
http://www.mzsrrf.ru/ http://www.mednet.ru/main/ |
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if any |
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DOSSIER REQUIRMENTS |
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Chapter I: Administrative documents. Page No#
1.0 Cover letter -------------------------------------------------------------
1.1 Product information
1.1.1 SmPC, labeling and packing leaflet -------------------------
1.1.2 Mock – up ---------------------------------------------------------
1.1.3 Specimen --------------------------------------------------------
Chapter II: Description of Pharmaceutical properties
Composition -----------------------------------------------------
Raw material Specifications and STP------------------------
Raw material Certificate of Analysis-------------------------
2.3 Packing material Specifications and STP--------------------
Chapter III: Manufacturing data
Manufacturing License-----------------------------------------
Manufacturing Process overview-----------------------------
Control of manufacturing process steps and intermediate
Product------------------------------------------------------------
Validation and qualification of the process ----------------
3.4 Material balance ------------------------------------------------
Chapter IV: Quality control data
Draft of normative Document (Based on manufacturers
Analytical documentation , but made according to Russian
standards)----------------------------------------------------------
Finished product specification , STP , Analytical method
validation --------------------------------------------------------
Artwork of packing labels (cartons, blisters, vials etc…)
4.3 Stability data using submitted packing material -----------
4.4 Reference standards, Samples of the product for the
Pharmaceutical examination, packing material------------
Chapter V: Pre –clinical documentation
Summary on pre-clinical trails carried out -----------------
Reports about performed trail --------------------------------
Pharmacology –result confirming that product is
Pharmacologically active-------------------------------------
pharmacokinetics – absorption, distribution, Metabolism, excretion, interactions with other pharmaceutical Products------------------------------------------------------------
Toxicology – general toxicity, specific toxicity---------------
List of literature used---------------------------------------------
Chapter VI: Clinical documentation
Bioequivalence study report-------------------------------------
Toc for russia, toc formate for dossier
