Prices
|
SERVICES |
COST |
ADDITIONAL EXPENSES |
|
Registration of generic medicinal product |
From 32000 $ |
State duty 10’000 $ Prove-out of methods of analysis in laboratory center From 1000 $ Pre-clinical trials From 12'000 $ Clinical trials From 60’000 $ Translation and notarial certification and other expenses
|
|
Registration of original medicinal product |
From 48000 $ |
State duty 10’000 $ Prove-out of methods of analysis in laboratory center From 1500 $ Pre-clinical trials From 20'000 $ Clinical trials From 150'000 $ Translation and notarial certification and other expenses
|
|
Registration of medicinal product permitted for medical use in the Russian Federation for more than twenty years |
From 20000 $ |
State duty 1000 $ Pre-clinical trials From 5000 $ Translation and notarial certification and other expenses
|
|
Organization and follow up of preclinical trials of medicinal product |
From 7500 $ |
|
|
Organization and follow up of clinical trials of medicinal product |
From 80000 $ |
|
|
Confirmation of state registration of medicinal product |
From 11000 $ |
State duty 3000 $ Translation and notarial certification and other expenses
|
|
Entering a pharmaceutical substance in the State Register of Medical Remedies |
From 27000 |
State duty 3000 $ Prove-out of methods of analysis in laboratory center From 1000 $ Translation and notarial certification and other expenses
|
|
Introducing amendments to registration dossier Not subject to the expert examination |
From 3500 $ |
State duty 200 $ (since 2015) Translation and notarial certification and other expenses
|
|
Introducing amendments to registration dossier
Subject to the expert examination |
From 11000 $ |
State duty 2500 $
|
|
Importation of samples and standards for clinical trials and medicinal product quality assessment |
From 2500 $ |
|
|
Registration/re-registration of selling price limit for medicinal product |
From 5000 $ |
|
|
Preliminary evaluation of registration dossier |
400 $ |
|
|
Provision of any information on registered medicinal products and pharmaceutical substances, information on analogues present in the market, or lack thereof. |
From 3500 $ |
|