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Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbHwww.basg.gv.at
Austria as RMS –Success Factors
Mag. Veronika PisazkaAGES MEA (Austrian Medicines and Medical Devices Agency)
AGES-Gespräch: Austria as RMS
Vienna, 03.10.2013
www.basg.gv.at 2
Overview
• Slot Booking System
• Presubmission Phase
• Case Management
• Validation Phase− Assistant Documents
− Target Timelines
− Validation Phase Management in AT
• Clock-Stop Phase− Assistant Documents
− Target Timelines
− Clock-Stop Phase Management in AT
− Outlook
• RMS-Transfer
www.basg.gv.at
Slot Booking System –Assistant Document/Link
•CMD(h):“Information on national timeslot booking systems and recommendations for requests to act as RMS” (March 2012), http://www.hma.eu/92.html
•AGES MEA websitehttp://www.basg.gv.at/en/medicines/authorisation/mrpdcp/ages-slots/
www.basg.gv.at
Slot Booking System
For DCPs:�Availability-matrix published on the Agency‘s website
�Long-term planning („request windows“ twice a year)
�Short-term planning (requests can be placed any time)
For MRPs/RUPs/Line Extension Procedures:�Requests can be placed anytime
AT‘s mailing address for the presubmission-phase: [email protected]
www.basg.gv.at
Pre-Submission Phase/Request for Additional Information
Applicants will be contacted via e-mail 1 quarter before the intended submission slot.
� Allocation of procedure number(s)
� Submission date
� Quality issues for clarification (active substance documentation, impurities, availability of stability data, deviations from guidelines, …)
� Clinical issues for clarification (clinical study / bioequivalence study, …)
If any major questions arise, these matters can be discussed at a meeting.
www.basg.gv.at
AT=RMSCase Management
One Case Manager per procedure:
� One single contact person for applicants
� Smooth communication between applicant, assessor(s) and CMS(s)
� Overview of the procedure
� Proactive supervision of sensitive procedurephases (e.g. validation phase, clock-stop phase,…)
www.basg.gv.at
Validation Phase -Assistant Documents (1)
CMD(h):“Member state agreement upon conditions under which the RMS can start MRP/DCP (July 2013)”, http://www.hma.eu/91.html
www.basg.gv.at
Validation Phase -Target Timelines
Day -14:
Receipt of the application (DCP) and the RMS assessment (MRP/RUP).
Day -7:
RMS notifies the CMSs who have not completed the Communication and Tracking System (CTS).
Day 0:
Start of the procedure.
www.basg.gv.at
Validation Phase -Experience
0%
5%
10%
15%
20%
25%
30%
35%
Experienced Lengths of Validation Phases (AT=RMS)(procedures submitted 2010-2013)
Experienced Lengths of Validation Phases(AT=RMS)
www.basg.gv.at
Validation Phase -Streamlining the Validation Period
RMS empowerment to start a procedure by dividing the raised issues into
�validation issues (incomplete dossier, missing or incorrect paid fees, data exclusivity period for the reference medicinal product has not expired,…)
− no procedure start
�non-validation issues (missing mock-ups, missing samples, the CMS has not notified the RMS within the foreseen automatic validation period,…)
� procedure start
www.basg.gv.at
Submission of Responses to Non-Validation Issues During the Procedure
MRP/RUP:
All pending non-validation issues have to be solved/fulfilled by Day 30 at the latest.
DCP:
All pending non-validation issues have to be solved/fulfilled by Day 50 at the latest.
� The applicant is asked to confirm in their day 60 response (MRP) or day 106 response (DCP) that all non-validation issues have been solved/fulfilled.
www.basg.gv.at
Validation Phase -Assistant Documents (2)
CMD(h):
“Additional Data requested for New Applications in the Mutual Recognition and Decentralised Procedures” (July 2013), http://www.hma.eu/91.html
�AT: NO additional data requested
�Please note: Croatia as new member state in the EU(-> CMDh ad Hoc Group on Validation Issues/National Requirements)
AT‘s mailing address during the procedure: [email protected]
www.basg.gv.at
Validation Phase –Assistant Documents (3)
CMD(h):“Requirements on submissions (number and format) for New Applications within MRP, DCP or National procedures” (August 2013), http://www.hma.eu/277.html
In AT application submission via CD/DVD or CESP:� Application form on CD/DVD
� Valid submission via CESP (http://cesp.hma.eu/Home), otherwise documents may be illegible
� NO signed documents
� NO additional paper version
� National portal can NOT be used
� Email/Eudralink is NOT accepted instead of the CD/DVD
www.basg.gv.at
AT = RMSValidation Phase Management
The RMS Case Manager ensures:
� Prompt validation check of submittedapplications and feedback to the applicant
� Prompt update of the CTS
� Active supervision of the validation phase byinforming the applicant of any deficiencies notified by the CMS(s)
� Active notification of the CMS who have not completed the CTS record (“day -7 e-mail”)
� Close contact between RMS, applicant and CMS(s)
www.basg.gv.at
Advice for Applicants (1)
� Availability during the whole validation period
(Case: 26 days after last dossier submission still unresolved validationissues from the RMS and several CMSs, contact person on vacationwith no access to e-mails from day 27 until day 41.)
� Dispatch list
(The validation period is starting when all CMSs have received the application (for DCP) or both application and RMS assessment (for MRP/RUP).)
www.basg.gv.at
Advice for Applicants (2)
� Close contact between applicant and RMS
(e-mails should be sent in cc to Case Manager and/[email protected] )
(Case: MRP, 17 CMS, last dossier submission on day „-14“, CMS validation e-mails were sent directly to MAH, despite several RMS e-mails no feedback from MAH to RMS, procedure started 98 days after last dossier submission.)
www.basg.gv.at
Clock-Stop Phase –Assistant Document / Target Timelines
CMD(h):“Decentralised Procedure, Member States’ Standard Operating Procedure (SOP)”, http://www.hma.eu/92.html
Day 105: The RMS stops the clock if no consensus is reached that the product isapprovable.
3 months: Submission of draft responses to RMS, followed by feedback from theRMS and submission of final responses (from applicant and ASMF holder) to RMS and CMS(s).
Extension:The clock-stop period can be extended by 3 more months.
www.basg.gv.at
Clock-Stop Phase –Experience
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
Experienced Lengths of Clock-Stop Phases (AT=RMS)(DCPs submitted 2010-2013 and positively approved)
Experienced Lengths of Clock-StopPhases (AT=RMS)
www.basg.gv.at
AT=RMSClock-Stop Management
The RMS Case Manager ensures:
� Timely initiation of the clock-stop period in consultation with the applicant.
� Reminder e-mail to applicant after 2 months.
� Prompt forwarding of draft responses fromapplicant and feedback from assessor(s).
� Restart asap after submission of final responsesfrom applicant and ASMF holder and receipt ofdispatch list(s).
www.basg.gv.at
Advice for Applicants (3)
� Immediate information in case of delays
(Case: 3 months clock-stop, 3 times extension for one more month: 3+1+1+1, submission of draft responses after 6 months.)
� Close contact with ASMF holder
(Case: ASMF holder applied for extension of the clock-stop periodwithout informing the applicant.)
� Submission of draft responses as a singlesubmission
www.basg.gv.at
Outlook
•CMD(h) initiative to improve the operatingprocedures for the DCP – predictability of the clock-stop phase.
•Concurrent AT is working on the implementation ofthis new/enhanced approach.
•News will be communicated asap (via AGES BASG website/newsletter/…?).
www.basg.gv.at
Early Finalised DCPs with AT=RMS
69%
58%
31%
42%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2012 (Jan.-Jul.) 2013
early closed DCPs
timely closed DCPs
www.basg.gv.at
RMS Transfer –Assistant Documents
• CMD(h):„CMDh procedural advice on changing the RMS” (December 2011), http://www.hma.eu/90.html
• AGES MEA website:http://www.basg.gv.at/en/medicines/authorisation/mrpdcp/rms-transfer/
www.basg.gv.at
RMS Transfer –From Another Member State to AT
Completed request form „Request Change of RMS“ should be sent to [email protected]
� The reason(s) for changing the RMS.
� Information, if the current RMS has agreed to the RMS change.
� Information, if all pending procedures have been finalised.
� If the product is part of a bulk of procedures, the relevant MRP numbers.
� The Concerned Member States (CMSs).
Allocation of a new procedure number by AGES MEA.
www.basg.gv.at
RMS-Transfer –Experience
13
19 19
0
2
4
6
8
10
12
14
16
18
20
2011 2012 (Jan.-Sept.) 2013
RMS transfers to AT
RMS transfers to AT
Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbHwww.basg.gv.at
Thank you for your attention!
