Are you planning to submit an application involving the Netherlands or seeking advice from the Dutch Medicines Evaluation Board (MEB)? Then keep reading, because this post will give you valuable information.
For several years, the MEB has used a planning tool for applicants intending to submit a Decentralised Procedure with the Netherlands acting as the Reference Member State. This tool allows applicants to request a time slot based on the planned submission date of their Marketing Authorisation Application.
For over a year now, MEB has been offering this tool for various other types of applications as well. Up until now, this tool could be used by applicants on a voluntary basis.
The planning tool benefits both the applicant and the MEB, it cuts both ways. The applicant can schedule their submission in line with the MEB’s capacity, allowing them to better align their own planning and timelines. On the other side, the planning tool enables the MEB to allocate the required capacity more efficiently. An added advantage is that the MEB can identify potential issues at an earlier stage which may result in a shorter validation period of the application.
Therefore, the MEB has decided to make the use of the planning tool mandatory starting 1 July. From that date onward, applicants must always request a time slot 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 the 1 July the, MEB will no longer consider applications for which no time slots have been requested.
Do you need help completing the Timeslot Request Form or looking for regulatory assistance? Please feel free to contact us at [email protected] and we will be happy to help you.
