Our company can perform:
– preparation of drug samples for evaluation during state registration,
– writing sections 2,4-2,7 of the registration dossier,
– amending the already submitted documents,
– advising on the preparation of the dossier,
– if necessary, to finalize the documents.
At the time of submitting an application for state authorization of a medicinal product to the Ministry of Health of Russia, the registration dossier must contain the following documents:
- Certificate of compliance of the foreign manufacturer’s production with the rules of good manufacturing practice (GMP certificate) (pre-authorization procedure)
- Report on a clinical trial conducted in the Russian Federation (in case clinical trial in the Russian Federation is required for this medicinal product) (the categories of medicinal products for which clinical trials in Russia are not required are listed in the legislation) (Pre-registration procedure)
- Dossier collected according to CTD format (pre-registration procedure)
- Samples of one batch of the drug must be prepared for submission for quality review(pre-registration procedure)
Please read the Order of July 12, 2017 No.409n
On approval of the Procedure for the formation of the registration dossier for a medicinal product and the requirements for the documents in it, requirements for the amount of information provided as part of the registration dossier for certain types of medicinal products for medical use and procedure for submission of documents that form the registration dossier for a medicinal product for medical use for the purpose of its state registration