Planning tool for requesting timeslots expanded to more procedures
The planning tool firms can use to reserve a timeslot for requesting assessment procedures is being expanded. From now on, the tool is not only available for decentralized procedures, but also for a number of other procedures.
The planning tool has been available via the MEB website for a number of years to request time slots for decentralized procedures (DCPs), in which the Netherlands is a reference member state (NL=RMS DCPs). The MEB has received positive feedback on the tool and there is also European interest in the tool.
Procedure planning thru this system works well. Companies know when they will be able submit their applications and when MEB capacity is available for the assessments. The planning tool helps the MEB to properly plan the required capacity. In addition, potential problems surrounding the file can be identified earlier on in the process. For example, issues concerning the status determination, legal basis or proposed indications. This allows the MEB to discuss these issues with the applicant. This helps improve the validation of the application.
Timeslots for more procedures
As of today, the options for planning procedures have been expanded. Time slots can now be requested for the following procedures:
- Decentralized procedure with the Netherlands serving as reference member state: DCP (NL=RMS)
- DCP line extension (NL=RMS)
- Mutual recognition procedure with the Netherlands serving as the reference member state: MRP (NL=RMS)
- MRP Repeat-Use with the Netherlands as reference member satte: RUP (NL=RMS)
- (Re-)consultation procedure for a medical device
- National registration application (except duplex)
- National scientific advice
- Parallel request
Applicants can book the time slots for human procedures (including herbal and homeopathic medicines).
The MEB makes time slots available per procedure, per month and per department. This planning tool helps the MEB to optimize the available capacity.
Timeslots can be booked here. Before requesting a time slot, applicants have to complete the corresponding form, which contains a number of administrative details. The form has to be uploaded to the request for a timeslot. The forms can be found here on the MEB website.
Eventually the MEB will only process procedures if a time slot has been requested in advance. This is already the case for applications for DCP’s. The timeframe in which reservation of timeslots will become obligatory, will be communicate in due time.