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201510 AGES Gespräch v06a · PDF fileSingle submission portal-combined CESP/Gateway in CP (human) Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH Electronic

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Text of 201510 AGES Gespräch v06a · PDF fileSingle submission portal-combined CESP/Gateway in CP...

27.10.2015

1

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!

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10

20

30

40

50

60

Jan Feb Mrz Apr Mai Jun Jul Aug Sep Okt

eCTD

NeeS

www.ages.at 5

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

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100

200

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400

500

600

700

800

Juli - human August -human

September -human

eAF non-compliant

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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

www.ages.at 11

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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www.ages.at 13

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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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

27.10.2015

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www.ages.at

Important Documents

www.ag