DCP/MRP/RUP Slots

BASG as RMS

Please find below information about our available slots.

BASG 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.gvat.

Last updated: 25.09.2020
Quarter CHEM VETE HERB BIOL
4/2020 done free resources done free resources done free resources clear no resources available
1/2021 done free resources done free resources done free resources done free resources
2/2021 done free resources done free resources done free resources done free resources
3/2021 done free resources done free resources done free resources done free resources
4/2021 done free resources done free resources done free resources done free resources
done free resources
clear no resources available

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 rmsbasg.gvat. The CMD(h) request form can be found in the Downloads section or on 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 found in the Downloads section.

Furthermore, there is the possibility to submit a slot request (including the request form) via the eServices; see the User Manual for Marketing Authorisation and Lifecycle Management of Medicines in the guidance section (Presubmission DCP/MRP/RUP).

For general information on the authorisation of veterinary medicinal products please refer to the CMD(v) website.

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 rmsbasg.gvat.

For the application of MR and Repeat-Use Procedures for human medicinal products, completed CMD(h) request forms need to be sent to rmsbasg.gvat. The CMD(h) request form can be found in the Downloads section or on 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.gvat. The request form can be found in the Downloads section.

For general information on the authorisation of veterinary medicinal products please refer to the CMD(v) website.

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 rmsbasg.gvat 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.

Downloads

For further information please contact

Human and Veterinary Medicinal Products: rmsbasg.gvat

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

Tel. national: 050 555-36666

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

Email: hotline.euregulatorybasg.gvat

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