As of 1 July 2025 it will be mandatory to use the MEB planning tool to reserve a time slot for submitting an application for assessment procedures.
The Medicines Evaluation Board (MEB) has a planning tool available for several years already for requesting time slots for decentralised procedures (DCPs) in which the Netherlands acts as the Reference Member State (NL=RMS DCPs). The MEB has received positive feedback on the tool (for human medicinal products).
For over a year now, the tool has also been available for several other types of applications. Up to now, use of the planning tool for these procedures has been optional.
The planning process using this expanded planning tool has proven to be effective. Companies are successfully using the tool for the additional procedures. They know when to submit their applications and when the MEB has assessment capacity available.
The planning tool helps the MEB to efficiently allocate the necessary capacity. It also allows potential issues regarding a dossier to be identified earlier – for example, concerning legal status of supply, legal basis, or proposed indications. This allows the MEB to discuss these issues with the applicant at an early stage, which benefits the validation of the application.
Mandatory Use of the Planning Tool from 1 July
Use of the planning tool for decentralised procedures (NL=RMS DCPs) was already mandatory. From 1 July onwards, the planning tool will also be mandatory for the other procedures listed below.
From 1 July, always request a time slot in advance for the following procedures:
- Decentralised procedure with the Netherlands as Reference Member State: DCP (NL=RMS)
- DCP line extension (NL=RMS)
- Mutual Recognition Procedure with the Netherlands as Reference Member State: MRP (NL=RMS)
- Repeat-Use Procedure with the Netherlands as Reference Member State: RUP (NL=RMS
- (Re-)consultation procedure for a medical device
- National marketing authorisation application (except duplex applications)
- National scientific advice
- Parallel import marketing authorisation application
After 1 July the MEB will only process above procedures if a time slot has been requested and allocated in advance.
The MEB will make time slots available per procedure, per month, and per department. Time slots can be booked using the planning tool. Before requesting a time slot, please complete the corresponding form with administrative details. Attach this form to your time slot request. The forms are available on the CBG website.
Applicants can book time slots for human procedures (including herbal and homeopathic medicinal products).
Excerpt from the official page. The original is authoritative.