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Questionnaire for preparing a commercial proposal for a dossier documents review
Your company name
Trade name of the medicinal product
INN or group name
*
Dosage form
*
Dosage
*
For what purpose are the documents prepared for review?
*
New registration
EAEU upgrade
Renewals
Variations
Response to a request
Other
In which countries is submission planned?
*
Armenia
Belarus
Kazakhstan
Kyrgyzstan
Russia
Other
Your expectations from documents review
Desired deadline for documents review
Which documents need to be reviewed?
*
Cover letter
Administrative documents (Module 1)
Package leaflet and/or SmPC
Justification of the medicinal product type (generic, hybrid, well-established use, etc.)
Pharmacovigilance documents
Резюме по качеству (Модуль 2)
Quality summary (Module 2)
Non-clinical overview (Module 2)
Clinical overview (Module 2)
Quality normative document
Non-clinical study reports (Module 4)
Clinical study reports (Module 5)
Other
Additional conditions and requests
Upload files
Выберите или перетащите файл
Файл не более 10 МБ
How can we contact you?
Your name
*
Email
*
Phone number
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