DCP/MRP/RUP Slots

AGES MEA as RMS

Please find below information about our available slots.

  

AGES MEA will accept to act as RMS for as many submissions as possible within the limitation of its assessment resources. The routine of allocating time slots for DC procedures allows better scheduling of applications and optimisation of the use of the assessor resources.  

DCP: Routine of allocating time slots

Please see below an availability-matrix showing available resources in the different assessor groups. The specific topics of the assessor groups are listed accordingly.

 

Slot-requests and -bookings can be placed at any time according to the availabilities as indicated in the below matrix.

Short-term available slots:

Due to late cancellations/postponements slots may become available at short notice. If you are interested in a short-term slot, please contact us via rmsbasg.gv.at.

Last updated: 28.6.2019
free resources free resources
no resources available no resources available
CHEM VETE HERB BIOL
3. Quarter 2019 free resources free resources free resources free resources
4. Quarter 2019 free resources free resources free resources free resources
1. Quarter 2020 free resources free resources free resources free resources
2. Quarter 2020 free resources free resources free resources free resources
3. Quarter 2020 free resources free resources free resources free resources

 

CHEM:
Chemical medicinal products
 
VETE:
Veterinary medicinal products

 

HERB: 
Herbal medicinal products

 

BIOL:
Biological medicinal products

  

Yellow boxes indicate resources are still available, grey boxes indicate that we will not be able to handle an application within the stipulated time table for the DCP.

 

For the application of time slots for human medicinal products, completed CMD(h) request forms need to be sent to rms@basg.gv.at. The CMD(h) request form can be downloaded from below or the CMD(h) website.

For the application of time slots for veterinary medicinal products, completed request forms F_Z84 need to be sent to rmsbasg.gvat. The request form can be downloaded from below.


We will send an email of acceptance or refusal of a slot based on the decision of the particular groups of assessors to the contact person mentioned on the request form as soon as possible.

MRP/Repeat-Use/Line Extensions

For Line Extension Procedures requests can be placed anytime via email  directly to rms@basg.gv.at .

For the application of MR and Repeat-Use Procedures for human medicinal products, completed CMD(h) request forms need to be sent to rms@basg.gv.at. The CMD(h) request form can be downloaded from below or the CMD(h) website.

For the application of MR and Repeat-Use Procedures for veterinary medicinal products, completed request forms F_Z85 need to be sent to rmsbasg.gv.at. The request form can be downloaded from below.

General notes following the allocation of slots

To prepare the scheduled procedures, we will contact you via email in the quarter before the intended submission slot.

 

Applicants cannot change the active substance/therapeutic group or the time slot agreed by themselves. Applicants are advised to inform us via rms@basg.gv.at as early as possible if an agreed application cannot be submitted in due course to the slot agreed. Not meeting the agreed time slot without consultation with AGES MEA can lead to the loss of the slot and a new one needs to be requested.

For further information please contact

Human and Veterinary Medicinal Products: rms@basg.gv.at

 

For general requests concerning DC- and MR-procedures please contact AGES MEA via:

 

Tel. national: 050 555-36666

Tel. international: +43 (0)50 555-36666

Email: hotline.euregulatory@basg.gv.at

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Created: 27.04.2009 | Page last modified: 04.07.2019

© Austrian Federal Office for Safety in Health Care
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