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Questionnaire for preparing a commercial proposal for a new medicinal product registration
1. General information
Your company name
Trade name of the medicinal product
INN or group name
*
Dosage form
*
Dosage
*
Packaging (SKUs) planned for registration
*
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
Planned dispensing procedure in the reference member state
*
Rx
Over-the-counter
Hospital use
Unknown at the moment
Other
Do you need assistance in selecting/verifying the trade name?
*
Yes
No
Do you need help in 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
In which EAEU member states does this medicinal product have a valid national registration?
*
Nowhere
Armenia
Belarus
Kazakhstan
Kyrgyzstan
Russia
Has an application for registration of this medicinal product been previously submitted in any EAEU member state?
*
Yes
No
3. Manufacturing
In which country is the manufacturing site(s) 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 preclinical study results available?
*
Yes
No
Not required
Other
Are clinical study results available from studies conducted in one of the EAEU member states?
*
Yes
No
Not required
Other
Is assistance required in conducting PIL readability testing?
*
Yes
No
Is assistance required in aprobation analytical procedures?
*
Yes
No
5. Electronic dossier
Is assistance required for creating an electronic dossier in XML format?
*
Yes
No
Is assistance required for submitting the electronic dossier to the regulatory authority of the reference member state?
*
Yes
No
Is assistance required for submitting the electronic dossier to the regulatory authority of the concerned member state?
*
Yes
No
6. Other
Is assistance required in preparing Module 1?
*
Yes
No
Is assistance required in writing the SmPC/PIL?
*
Yes
No
Is assistance required in writing/reviewing scientific overviews for Module 2?
*
Yes
No
Is assistance required in preparing 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 dossier preparation for submission
Additional conditions and requests
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Your name
*
Email
*
Phone number
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