Please ensure that the application contains all the required information as a significant percentage of the grounds for objection that have been raised have resulted from the failure to supply the necessary data within the 60 day time period allowed by the Regulations.
The application is sent to expert assessors. If further information is required during the course of the clinical investigation assessment, a letter will be sent to the manufacturer. The MHRA has a maximum of 60 days to reach a decision. The clock does not stop when additional information is requested.
If the UK Competent Authority raises grounds for objection, it will notify other EU Competent Authorities and the European Commission of the decision and grounds for objection. The applicant may re-submit revised documentation, provided the reason for refusal of the original application has been addressed.
Further details are available on the MHRA website.
When will I get approval?
The MHRA has a maximum of 60 days to reach a decision. Information on current timelines are reported on the MHRA website.