Questions and answers about the timeslot tool

Slots for the months ahead will be made available periodically (on the first working day in January, May and September). For instance, slots for January through April 202x+1 will be made available in January 202x. The MEB may also decide to make a slot that was cancelled available again. It is therefore recommended to periodically check the planning tool to see if a timeslot is available in the desired month. The MEB does not have a reserve list.

The MEB will notify the applicant whether the timeslot is accepted or denied within three weeks.  

No, the application dossier is validated upon the actual submission. Its outcome determines whether the application can be initiated.  

An agreed month of submission can only be changed in consultation with the MEB. To do so, the MEB must be contacted by email at least two months before the agreed date of submission. You will find the needed contact details below, divided in PT-groups. See our page about the planningtool for more information. 
If you are unable to submit your application within the month agreed and nothing has been agreed on moving the timeslot, the allocated timeslot will be cancelled and a new timeslot must be requested.

Contact details

FT1: M. van Teijlingen (m.v.teijlingen@cbg-meb.nl)
FT2: E.C. Bojtor (ec.bojtor@cbg-meb.nl) 
FT3: L. Veth-Tello (l.veth@cbg-meb.nl)
FT4: W.J. van Brussel (wj.v.brussel@cbg-meb.nl)
CIM: M. van de Wetering (m.vd.wetering@cbg-meb.nl) of C. Klaassen (cm.klaassen@cbg-meb.nl)
Herbal medicine and homeopathy: M. Zwaan (mc.zwaan@cbg-meb.nl)

Yes, the MEB must be informed by email as soon as possible of a timeslot being cancelled. You will find the needed contact details below, divided in PT-groups. See our page about the planningtool for more information. 

Contact details

FT1: M. van Teijlingen (m.v.teijlingen@cbg-meb.nl)
FT2: E.C. Bojtor (ec.bojtor@cbg-meb.nl) 
FT3: L. Veth-Tello (l.veth@cbg-meb.nl)
FT4: W.J. van Brussel (wj.v.brussel@cbg-meb.nl)
CIM: M. van de Wetering (m.vd.wetering@cbg-meb.nl) of C. Klaassen (cm.klaassen@cbg-meb.nl)
Herbal medicines and homeopathy: B. Kroes (bh.kroes@cbg-meb.nl)

No. There are no costs associated with reserving a timeslot, just as no costs are charged when a timeslot is cancelled.  

No, it cannot.

Parallel applications are processed by the Case Management and Implementation Unit (CIM). For a parallel application, a slot must be applied for with CIM.  

A timeslot must only be requested for a regular Repeat Use procedure. No timeslot needs to be requested for a Zero Day Repeat Use procedure. Its submission can be coordinated with the MEB outside the planning tool. Please contact the case manager of the relevant medicinal product.

Having a timeslot for an RUP/MRP means that the form Request to the MEB to act as a reference Member State on behalf of the Netherlands in the mutual recognition procedure (MRP/RUP) can be submitted in the month of the timeslot via CESP, along with an accompanying letter. The MEB will then start preparing the MRP/RUP assessment report. See our page about the Mutual Recognition Procedure (MRP) for more information. It will then be determined in coordination with the MEB when the dossier can be submitted to the CMSs.

An NL=RMS MRP timeslot can only be applied for if there is certainty that the national application will be completed successfully.
For a national application, this means that an NL=RMS MRP timeslot can only be applied for if any compelling concerns in the national application procedure have been addressed.
If the national application is a duplex, an NL=RMS MRP timeslot can be applied for once the duplex application has been submitted.
It is recommended to always first contact the MEB to coordinate the planning if no marketing authorisation has been granted for the product for which an NL=RMS MRP application is sought.

You cannot apply for an NL=RMS RUP timeslot until the second round has started (Day 106) and there is certainty that the DCP application will be completed positively. We recommend first contacting the DCP case manager to coordinate the planning.

Upon receipt of the form Request to the MEB to act on behalf of the Netherlands as reference member state in the mutual recognition procedure (MRP/RUP) together with a submission letter, an MRP number will be assigned. See our page about the MRP for more information.

A few months before submission of the application file, a DCP number can be requested. You can contact the MEB for this. The necessary contact details can be found in the confirmation e-mail that the requested timeslot has been assigned to you.

Having a timeslot means that the request for advice can be submitted in the relevant month. The timeslot does not mean that the meeting in which an oral advice is given will take place in that month or that the advice will be sent at such time. See our page about Scientific and regulatory advice for more information.