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Questionnaire for preparing a commercial proposal for introducing a medicinal product into civil circulation in the Russian Federation
Your company name
Trade name of the medicinal product
INN or group name
*
Dosage form
*
Dosage
*
In which country is the manufacturing site (sites) located?
*
Is the medicinal product already registered in the Russian Federation?
*
Yes
No
What specific support for introduction into civil circulation (CC) do you need?
*
Development of all necessary powers of attorney/agreements between the Marketing Authorization Holder, Importer and/or Manufacturer in Russian and/or English
Development and agreement with the Manufacturer of the template of the certificate of analysis/conformity in English, as well as preparation of the template translation into Russian or preparation of a bilingual certificate
Development of a template confirmation for introduction into CC, signed by the person responsible for introduction into CC
Conclusion of an agreement with the laboratory
Creation of personal accounts in the AIS Roszdravnadzor and/or "Honest Sign", training in working with these accounts
Processing the calculation of necessary materials at the request of the laboratory
Assistance in ordering and importing necessary materials at the request of the Roszdravnadzor laboratory
Submission of all necessary materials to the laboratory
Full technical support during the introduction into civil circulation of the first imported batch of the medicinal product
Other
Do you need a service for regular introduction of batches of the medicinal product into civil circulation?
*
Yes
No
Unknown at the moment
Additional conditions and requests
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Your name
*
Email
*
Phone number
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