The government has simplified licensing for biomedical cell products manufacturers. Applications can be submitted through Gosuslugi (the state services portal) with the use of an electronic signature, and the term of consideration of the application has been reduced to five working days.
The corresponding resolution was published on the legal information portal, and the document will enter into force on September 1, 2023. Amendments have been made to the Regulation on Licensing of Biomedical Cell Products Manufacturing Activities, approved in October 2018.
Along with traditional on-site inspections to check the license applicant’s compliance, there is now an opportunity to arrange the check remotely, using audio or video conferencing, photo and/or video shooting. It is no longer necessary to submit documents confirming the availability of a license for production facilities, the necessary technical means and equipment: now it is enough to sent their numbers and details. In addition, conditions are being established for the involvement of experts in the assessment.
Now applications have to be considered within five working days, whereas before the decision the waiting time was up to sixteen working days. But if the license applicant wants to operate in a restricted-access territory, the consideration of their application may take up to 20 working days. A review of an application for amendments to the entry in the register of licenses also takes up to 20 working days.
It is planned to further simplify the regulations on BMCP products licensing.
