Страница 1 из 2
Questionnaire for preparing a commercial proposal for a medicinal product renewal
Your company name
Trade name of the medicinal product
*
Dosage form
*
Reference member state
*
Armenia
Belarus
Kazakhstan
Kyrgyzstan
Russia
In which concerned member state is the medicinal product registered?
*
Armenia
Belarus
Kazakhstan
Kyrgyzstan
Russia
Is the medicinal product recognized as orphan in any EAEU member state?
*
Yes
No
Does the medicinal product have post-registration obligations?
*
Yes
No
Has an application for renewal of this medicinal product been submitted previously?
*
Yes
No
Is there currently an active registration procedure for variations in any EAEU member state, or is one planned?
*
Yes
No
Other
Is it necessary to submit variations to the registration dossier simultaneously with renewal?
*
Yes
No
Unknown at the moment
Other
Does the manufacturer have a valid GMP certificate issued according to the national requirements of an EAEU member state or EAEU requirements?
*
Yes
No
Do you need assistance in developing/reviewing pharmacovigilance documents?
*
Yes
No
Do you need assistance in writing/reviewing scientific reviews for Module 2?
*
Yes
No
Unknown at the moment
Other
Do you need assistance in preparing the electronic dossier in XML format?
*
Yes
No
Do you need assistance in submitting the electronic dossier to the regulatory authority of the reference member state?
*
Yes
No
Do you need assistance in submitting the electronic dossier to the regulatory authority of the concerned member state?
*
Yes
No
Not applicable
Desired deadline for dossier preparation for submission
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
By clicking "Send", you agree with the terms of
the personal data processing policy
Send
