The Ministry of Health has adjusted the regulations for issuing permits for the import and export of biomaterials for clinical trials (CT) to Russia. The order was published on the portal of legal regulations.
According to the document, the period for issuing relevant permits has been reduced from ten to five days.
At the same time, the list of documents submitted for obtaining permission has been expanded. In particular, the applicant will now be required to attach data on the clinical trial, indicate the date of its conduct, as well as the name of the state and organization in which it is planned to use the biomaterial, the purpose of its import (or export).
The order also appeared options for the provision of services. Which option is needed, the applicant will indicate when filling out the questionnaire: this may be the issuance of a permit, information about a previously issued or refusal to issue it, or to correct errors in the document. If the applicant only needs information about the previous application, then such a service will be provided within one business day.
The formats for obtaining the results of the provision of public services have also been expanded. Now, in addition to the One Window information system and the public services portal, conclusions can be obtained through a personal account in the GRLS. In addition, it is established that the multifunctional center does not have the right to refuse to accept documents and information necessary for the provision of public services.
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