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Questionnaire for preparing a commercial proposal for bringing into compliance with the requirements of the Union
1. General information
Your company name
Trade name of the medicinal product
INN or group name
*
Dosage form
*
Dosages planned for transfer to the EAEU
*
Packaging (SKU) planned for transfer to the EAEU
*
Type of medicinal product
*
Original
Generic
Biosimilar
Hybrid
Well-established use
Unknown at the moment
Other
Category of medicinal product
*
Chemical
Biological
Radiopharmaceutical
Homeopathic
Herbal
Other
Is the medicinal product orphan?
*
Yes
No
Unknown at the moment
Is the medicinal product high-tech?
*
Gene therapy, somatic cell-based, or tissue-engineered product
Yes
No
Unknown at the moment
Do you need help developing a regulatory strategy?
*
Yes
No
Other
2. Geographic presence
Reference member state
*
Armenia
Belarus
Kazakhstan
Kyrgyzstan
Russia
Unknown at the moment
Concerned member state
*
Armenia
Belarus
Kazakhstan
Kyrgyzstan
Russia
Unknown at the moment
Other
n which EAEU member states is there a valid national registration for this medicinal product?
*
Armenia
Belarus
Kazakhstan
Kyrgyzstan
Russia
Specify the trade name for each valid national registration
*
Has an application for EAEU upgrade been previously submitted in any EAEU member state?
*
Yes
No
3. Manufacturing
In which country is the production site (sites) located?
*
Does the manufacturer have a valid GMP certificate issued according to the national requirements of an EAEU member state or EAEU requirements?
*
Yes
No
4. Studies
Are there results of your own preclinical studies available?
*
Yes
No
Other
Are there results of clinical studies conducted in the territory of one of the EAEU member states?
*
Yes
No
Other
Do you need help in conducting PIL readability testing?
*
Yes
No
5. Electronic dossier
Do you need help in forming an electronic dossier in XML format?
*
Yes
No
Требуется ли помощь для подачи электронного досье в регуляторный орган референтного государства?
*
Yes
No
Do you need help in submitting the electronic dossier to the regulatory authority of the reference member state?
*
Yes
No
6. Other
Is it necessary to submit variations to the registration dossier simultaneously with EAEU upgrade?
*
Yes
No
Unknown at the moment
Is assistance required in forming Module 1?
*
Yes
No
Is assistance required in writing SmPC/PIL?
*
Yes
No
Is assistance required in writing/reviewing scientific reviews for Module 2?
*
Yes
No
Is assistance required in forming Module 3?
*
Yes
No
Is assistance required in preparing the quality Normative Document (ND)?
*
Yes
No
Is assistance required in developing/reviewing pharmacovigilance documents?
*
Yes
No
Desired deadline for forming the dossier for submission
Additional conditions and requests
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Your name
*
Email
*
Phone number
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