Dutch Agency MEB expands options for Planning Tool for requesting time slots
Until recently the planning tool on the website of the Medicines Evaluation Board (MEB) was available for requesting time slots for decentralized procedures (DCPs), in which the Netherlands is a reference member state (NL=RMS). The MEB received positive feedback on their tool and there is also interest from other European Health Agencies.
The planning tool helps MEB to plan the required capacity. Moreover, potential problems before the application can be identified earlier on in the process. This allows MEB to discuss initial concerns with the applicant. This may improve the validation of the application.
The MEB is now expanding the options for planning certain procedures. As of 16 January 2024, time slots can now also be requested for the following procedures:
- Mutual Recognition Procedure (MRP) with the Netherlands serving as RMS
- MRP Repeat-Use with the Netherlands as RMS
- (Re-)consultation procedure for a medical device
- National registration application (except duplex)
- National scientific advice
- Parallel request
Note that applicants can book the time slots for human procedures only (including herbal and homeopathic medicines).
Time slots are made available per procedure, per month and per department which helps the MEB to optimize the available capacity. Time slots can be booked in the planning tool on the MEB website. Before requesting a time slot, applicants have to complete a corresponding form, which contains a number of administrative details. The form has to be uploaded to the request for a timeslot. The required forms can be reached via the MEB website too.
Eventually, the MEB will only process procedures if a time slot has been requested in advance which is already the case for DCP applications. The timeframe in which reservation of time slots will become obligatory will be communicated in due time by MEB.
If you are planning to submit one of the above-mentioned procedures in the near future you may already make use of this planning tool and corresponding forms. Starodub can guide you through this process. For more information please contact us via the Contact form.