27.10.2015
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sterreichische Agentur fr Gesundheit und Ernhrungssicherheit GmbHwww.ages.at
AGES-Gesprch eSubmission - eAF - eServices
ein berblick & Ausblick
AGES Medizinmarktaufsicht
27.10.2015
sterreichische Agentur fr Gesundheit und Ernhrungssicherheit GmbHwww.ages.at
HMA/EMA E-SUBMISSION ROADMAP - STATUS
Georg NeuwirtherMEA - Head of IT
Vienna, 27.10.2015
www.ages.at
eSubmission Roadmap(reflecting final adopted version 1.0 dated 141107)
eSubmission Roadmap Timelines
2013 2014 2015 2016 2017 2018
Use of eAF in all procedures (human and vet)
Single Submission Portal
with integration of eAF
for all submissions
(human and vet)
Use of VNeeS in CP, DCP and MRP (vet)
All submissions in CP,
DCP and MRP (human) in
eCTD
Ongoing/optional
Mandatory
Use of eCTD v.4
CESP (human and vet)
eGateway (CP)
(human and vet)eGateway (CP, human)
NCA use of Common Repository for all CP submissions
(human)
All submissions in CP, DCP and MRP (vet) in VNeeS
NCA use of Common Repository for CP submissions
(human)
Single submission portal - combined CESP/Gatewayin all other procedures (human and vet)
Use of NeeS and eCTD in DCP and MRP (human)
in CP
New MAA in DCP (human) in eCTD
All submissions in MRP (human)
New MAA in DCP and MRP
(human) in eCTD
All other in CP and all
MRP submissions (vet)
New MAA in CP and DCP (vet)
in VNeeS
All other MRP submissions
(human)
eAF in all procedures (human and vet)
All submissions in CP (human) in eCTD
Use of PSUR Repository for all CAPs and NAPs
(human)
Use of PSUR Repository for CAPs
and NAPs (human)
draft
eSub
Roadmap
NCA &
industry
survey
eSub
Roadmap
Adoption
Single submission portal - combined CESP/Gatewayin CP (human)
in all other procedures
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www.ages.at 4
New MAA in DCP (human) in eCTD
2013 2014 2015 2016 2017 2018
All submissions in CP,
DCP and MRP in eCTDUse of NeeS and eCTD in DCP and MRP (human)
New MAA in DCP in eCTD
MRP
New MAA in DCP and MRP
in eCTD
All other MRP submissions
All submissions in CP in eCTD (human)
No major concerns about this milestone of the roadmap!
0
10
20
30
40
50
60
Jan Feb Mrz Apr Mai Jun Jul Aug Sep Okt
eCTD
NeeS
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Common Repository mandatory since 1st of July 2015
2013 2014 2015 2016 2017 2018
New process of submitting CAPs via Common Repository works well Only a few number of documents will be submitted via CESP
Please, dont send CAPs dossiers vis CESP anymore.
Please find Q&As under following link
NCA use of Common Repository for all CP submissions
(human)
NCA use of Common Repository for CP submissions
(human)
www.ages.at
Status eAF
62013 2014 2015 2016 2017 2018
Use of eAF
Fully functional
single submission portal
for all submissions (human
& vet)
CESP (human & vet)
eGateway (CP)
(human and vet)eGateway (CP, human)
Single submission portal - combined CESP/Gateway
in MRP/DCP
in CP
(Mandatory for CP-human, optional for other procedures)
eAF in all procedures
Successful start of compulsory usage of the eAF for Centralized Procedures (all types, hum&vet) Transition period ended on the 1st of September; applicants will be
requested to send eAFs only if other formats are received!
151
71
700
8 1 70
100
200
300
400
500
600
700
800
Juli - human August -human
September -human
eAF non-compliant
4
8
18
6
2 2
0
5
10
15
20
Juli - veterinary August -veterinary
September -veterinary
eAF
non-compliant
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New MAA in CP and DCP (vet) in VNeeS
2013 2014 2015 2016 2017 2018
Use of VNeeS in CP, DCP and MRP (vet) All submissions in CP, DCP and MRP in VNeeSAll other CP submissions
and all MRP submissions
New MAA in CP and DCP in
VNeeS
New version of guideline available
Guideline on eSubmissions for Veterinary Products - version 2.3 (March 2015) Please note: Effective from 1.10.2015 only
VNeeS Checker (Version 2.3) October 2015 National Agency for Veterinary Medicinal Products in France (Anses -
ANMV)
Federal Agency for Medicines and Health Products in Belgium (FAGG-AFMPS)
In discussion: Validation by RMS
www.ages.at 8
Setting up project structure for the Single Submission Portal (replacing the eAF in 2018)
and IMDP/SPOR preparations have started
Next steps
2013 2014 2015 2016 2017 2018
Single Submission Portal
with integration of eAF
for all submissions
(human and vet)
All submissions in CP,
DCP and MRP (human) in
eCTD
All submissions in CP, DCP and MRP (vet) in VNeeS
New MAA in DCP and MRP
(human) in eCTD
Use of PSUR Repository for all CAPs and NAPs
(human)
Single submission portal - combined CESP/Gatewayin CP (human)
sterreichische Agentur fr Gesundheit und Ernhrungssicherheit GmbHwww.ages.at
Electronic Application Form eAF:
eAF becoming mandatory for European and national procedures from 1st of January 2016
Alexander Ertl
Georg Neuwirther
27.10.2015
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www.ages.at
Status eAF
102013 2014 2015 2016 2017 2018
Use of eAF
Fully functional
single submission portal
for all submissions (human
& vet)
CESP (human & vet)
eGateway (CP)
(human and vet)eGateway (CP, human)
Single submission portal - combined CESP/Gateway
in MRP/DCP
in CP
(Mandatory for CP-human, optional for other procedures)
eAF in all procedures
Successful start of compulsory usage of the eAF for Centralized Procedures (all types, hum&vet) Transition period ended on the 1st of September; applicants will be
requested to send eAFs only if other formats are received!
151
71
700
8 1 70
100
200
300
400
500
600
700
800
Juli - human August -human
September -human
eAF non-compliant
4
8
18
6
2 2
0
5
10
15
20
Juli - veterinary August -veterinary
September -veterinary
eAF
non-compliant
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Release Planpublished here: http://esubmission.ema.europa.eu/eaf/index.html
Excerpt of Release Plan(status 10.10.2015)
Release Plan of eAFs
Milestone Date
Publication of eAF V 01.19 03/11/15
Replacement eAF V 01.18 by 01.19 30/11/15
Publication of eAF V 01.20 08/03/16
Replacement eAF V 01.19 by 01.20 04/04/16
Please be sure to process the current version
www.ages.at 12
From 1 January 2016, the use of electronic application forms (eAF) for MRP/DCP and national procedures (human and veterinary) will be mandatory within electronic submissions (more information: http://esubmission.ema.europa.eu/tiges/cmbdocumentation.html)
The currently used application forms in Word format published by the European Commission will no longer be available and only the latest version of the electronic application form will be used for all EU procedures, including CP, MRP/DCP and national procedures.
eAF mandatory from 1st of January 2016
27.10.2015
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As mentioned above the mandatory use of electronic application forms includes national procedures (initial, variation, renewal).
- BASG will provide a german user manual for support:
A Word form will be provided for variations of registered medicinal products (24 AMG)
eAF in national procedures
www.ages.at
What to do at applicants level(key steps)?
Check IT infrastructure (Adobe Version 10 or above) Check / ensure online connectivity with EUTCT terms (search for
substances) - see screenshot
Offer internal trainings about the usage of eAF Same content different functionality
Update internal guidelines! Create eAF templates
Implement automatized data import (using DES)
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sterreichische Agentur fr Gesundheit und Ernhrungssicherheit GmbHwww.ages.at
Overview eAF usage
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27.10.2015
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www.ages.at
Where do I find the eAFs
Option 1Notice to Applicants (Europische Kommission)http://ec.europa.eu/health/documents/eudralex/vol-2
Option 2eSubmission Homepage (EMA)http://esubmission.ema.europa.eu/eaf/index.html
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www.ages.at
Current Version
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www.ages.at
Upcoming changes
The next major steps in eAF development
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www.ages.at
Important Documents
www.ag
