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

27.10.2015

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Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbHwww.ages.at

AGES-Gespräch eSubmission - eAF - eServices

ein Überblick & Ausblick

AGES Medizinmarktaufsicht

27.10.2015


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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New MAA in DCP (human) in eCTD

2013 2014 2015 2016 2017 2018


DCP and MRP in eCTDUse of NeeS and eCTD in DCP and MRP (human)

New MAA in DCP in eCTD

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, don’t 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)


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!

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71

700

8 1 70

100

200

300

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)


DCP and MRP (human) in

eCTD

All submissions in CP, DCP and MRP (vet) in VNeeS


(human) in eCTD

Use of PSUR Repository for all CAPs and NAPs

(human)

Single submission portal - combined CESP/Gatewayin CP (human)


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)


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

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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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Overview eAF usage

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Where do I find the eAFs

Option 1Notice to Applicants (Europäische 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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Upcoming changes

The next major steps in eAF development

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www.ages.at

Important Documents

www.ages.at

Q&A

www.ages.at

User Guides (human/veterinary)

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www.ages.at

Technical Guide

• Purpose and technical rules

• Description of all eAFs

• MAA (human)

• MAA (veterinary)

• Variation

• Renewal

www.ages.at

Benchmark response times

www.ages.at

Release Notes

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www.ages.at

Working with eAFs

Dynamic behaviour:

Content of the application forms may appear/disappear, depending on your input

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www.ages.at

A lot of new functions

• Fast navigation

• Catalogues

• Add/Remove section

• Calendar

• Populate data in section

• Validation

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Fast navigation

Navigating via hyperlinks

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Catalogues

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Add/Remove section

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www.ages.at

Calendar

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www.ages.at

Populate data in section

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Validation

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www.ages.at

A glimpse at what the formslook like

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Deleting sections

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Since AGES plans to extract data from the xml of the eAFs please make sure

you delete all fields before unticking sections in the forms,

www.ages.at

eAF Term Request Process –user perspective

(day 0)

MAH fills in request form and emails request to [email protected]

Term request evaluation process

(+5 day)

MDMS Service desk informs MAH of term to be used

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* In the term request form there are

detailed instructions on what information

is required to apply for changes in each

list.

www.ages.at

eAF Term Request Form

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• Standard word form

• Multiple terms can be requested at one time

• 2. Product and application details

• 3. Missing substances and excipients

• 4. Missing terms for other drop downs

• Indication of which eAF list it relates to

• Indication of required details

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www.ages.at

Confirm security warning

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www.ages.at

Importing data into eAFs

• eAFs can import data via Data Exchange Standard DES

• Templates

• Export from IT system

• Information available here

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www.ages.at

Please sign / lock the eAF

Click into the signature area

and follow instructions in PDF

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Source: http://esubmission.ema.europa.eu/eaf/docs/eAF%20Question%20and%20Answers%20-%20update.pdf

Needs to be reviewed –focuses on

CAPs

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www.ages.at 40

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. With this step a further milestone of the HMA/EMA eSubmission roadmap

(http://esubmission.ema.europa.eu/tiges/cmbdocumentation.html) will be achieved.

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. The eAFs for centralized procedures were already successfully

introduced on 1st of July 2015.

As mentioned above the mandatory use of electronic application forms includes national

procedures (initial, variation, renewal).

A user manual and Q&A document was created. These documents can be found here:

http://esubmission.ema.europa.eu/eaf/

Further information on the implementation phase is also available under

http://www.basg.gv.at/eservices/elektronisches-antragsformblatt-eaf/

eAF – mandatory from 1st ofJanuary 2016

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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


Pharos-User-Group

Dipl. Ing. Georg NeuwirtherMEA – Head of IT

Vienna, 27.10.2015

27.10.2015

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www.ages.at

Externe Nutzergruppe

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Nutzergruppe

• Sammeln von begründeten Anforderungen aus der Industrie

• Abstimmen (Machbares identifizieren) und Priorisieren dieser Anforderungen

• Einbringen der priorisierten und beschriebenen Anforderungen in die Nutzergruppe

• Industrieseitige Bestätigung von Anforderungen auf Basis der mit der Industrie und AGES MEA abgestimmten Anforderungen

• Organisation des Tests von IT-Umsetzungen• Industrieseitige Bestätigung der IT-

Umsetzung

www.ages.at

Externe Nutzergruppe

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Aktuelle Mitglieder der externen Nutzergruppe

• Michael Sander, PHARMIG ([email protected]) • Hildegard Kyriazopoulos, Fa. Bayer

([email protected])• Birgit Hirschbichler, Fresenius-Kabi

([email protected])• Michael Obereigner, Ratiopharm

([email protected])• Verena Schiefermüller, MSD,

([email protected])• Julia Slaje, Sandoz ([email protected])

Industrieseitige Organisation: Michael SanderMEA-Ansprechperson: Georg Neuwirther

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• positive feedback for the eService “Authorization and Lifecycle-Management”

• Questions and change requests were discussed – please find next part of the presentation

Results Meeting 2015/09/24

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www.ages.at

Mag. Beate Gasser

AGES-Gespräch eSubmission - eAF - eServices

Vienna, 27.10.2015

News and Best Practice for eServices and Austrian Medicines Index

www.ages.at 47

What is the meaning of the envelope symbol:

- visible: at least 1 new communication from MEA that hasn‘t been answered yet, i.e. no document has been uploaded as reply by the applicant/MAH

- Not visible: all communications have been answered

Communications and Envelope-Symbol

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One procedure under Current Applications

has at least one open communicaton

Click on procedure number

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The MAH/applicant may enter a status for this comunication:

Geschlossen, in Bearbeitung bzw. Offen. (Closed, in process,

open). This status is not visible for MEA, it is for internal

processing only

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To answer mark line and click „Response“ under „Edit“

CAVE: Do not choose „Voluntary response“, otherwise

the envelope sign won‘t disappear!

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Upload document(s) to the respective product with

the respective document type, check on confirmation

page and send

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In this example there were 2 open communications.

Since only one was answered the envelope is still there

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Answer second communication as well �

envelope is gone

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In the application the finished communications

including the documents are visible (for viewing

the documents click on arrow on the left side)

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Entering e-mail addresses for notifications for all applications of an organization:

- The administrator of an organisation may enter e-mail addresses at the organisation level. These addresses will receive e-mails for all applications where this organisationhas been listed in the AF/eAF as Applicant, MAH, Authorised organisation during the procedure or Authorised organisation after the authorisation procedure

At the start of the procedure in PHAROS, new additional claim and closure of procedure

FAQ will be published soon

Automatic e-mail notifications

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CAVE: This funcionality is only available for proceduresstarted in the system from 26.11.2014 on! � Should

be less and less of a problem

Multiple addresses entered with „;“

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CAVE: If an organisation (with exactly this organisation ID) is not listed as

- MAH

- Applicant

- Authorised organisation during the procedure

- Authorised organisation after the authorisation procedure

in the AF/eAF, the automatic notification won‘t work even though the e-mail addresses are entered on the organisation file.


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E-mail addresses for specific procedures additionally or instead of the addresses on the organisation level:

Edit in eService in the current applications:


Mark procedure and click on „Edit email addresses

for notifications“ under „Edit“

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Add address. Multiple addresses underneath

each other with „Enter“

CAVE: Also only available for procedures that

were started in the system from 26.11.2014 on!

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Austrian Medicines Index:

- English Homepage links directly to english Medicines Index Search now

- The Name „Austrian Federal Office for Safety in Health Care“ now links to the Homepage, too (previously only the coat of arms was linked)

eService:

- Finished communications are also visible in the current applications now

- Official certificates (decision letters) also under completed applications now

- Document types were restricted to the ones really needed

- Plus a few improvements for Vet: AntibiotikaMengenströme

Overview of changes implemented in 2014

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Full screen functionality:

Useful tips

Procedure type and classification are normally cut

off, changing the width of the column helps a bit,

scrolling is possible. Tip: Click on Full screen

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Useful tips

Functionalities like Edit also available here

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Mouse-Over in column Name

Useful tips

With Mouse-Over all product names in a Grouping are visible– unfortunately only for a very short time � will be extended!

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Visibility is defined by role:

- Ongoing procedures can be seen by

o (future) MAH (=Zulassungsinhaber)

o Applicant (=Anbringer)

o Company authorised for communication during the procedure (=Bevollmächtigter während des Verfahrens)

o Company authorised for communication after marketing authorisation (=Bevollmächtigter nach dem Zulassungsverfahren)

How to make sure to see a procedure on the eService

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- Closed procedures can be seen by

o MAH

o Company authorised for communication after marketing authorisation

�product-specific rights for companies other than the

MAH can be achieved by being added as Company authorised for communication after marketing authorisation

How to make sure to see a procedure on the eService cont.

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New application:

Where to enter the roles in the Application Form

Please make sure to

include company name

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New application cont.:

Where to enter the roles in the Application Form cont.

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Renewal:


Same as 2.4.3 in New Application=

Company authorised for communication

after marketing authorisation

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Variation:


Same as 2.4.3 in New

Application=

Company authorised for

communication

after marketing

authorisation

If different from MAH or in

case of

Grouping/Worksharing: Will

be added as Applicant

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Ongoing procedures:

- As soon as the procedures have been started in PHAROS and the roles have been entered. Lifecycle procedures: MAH and Company authorised for communication after marketing authorisation are added automatically at creation of procedure.

Closed procedures:

- Set by default to last 3 months

�might be necessary to change filter to more

than 3

Visibility of procedures

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There was the wish to see the current expert/assessor working on a procedure (sometimes it isn‘t according to the allocation scheme) in order to be able to contact this person by telephone

- Responsibility according to the allocation scheme (http://www.basg.gv.at/en/about-us/contact-us/). Sometimes somebody else takes over a procedure to make the best use of available resources � faster processing

Topics from user group

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Visibility of procedures: There was a problem because one user still had an account according to the old address of that organisation.

- Administrators should keep user rights up to date.

- Generally please check addresses that are used in the AF/eAFvery closely. AF/eAF is the leading source of information. If there is a different spelling than on the organisation file it could cause visibility problems until the duplicate check at MEA has been done. Or if the organisation moves: Please check with us first whether we will issue a new organisation ID. In that case a new organisation account and a switch of all the users is necessary.

- Variations for MAH-name/address change should be submitted promptly for all products.


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Request to upload more than one document at a time

- It will be evaluated what is technically possible: User-Interface, drag & drop

Limit of number of documents that can be uploaded (even one after the other): In one case only 6 documents could be uploaded

- There is no limit, should the situation arise please contact http://www.basg.gv.at/eservices/

It‘s not clear in which cases/procedures FI/GI/KE have to be uploaded per procedure or per strength

- In general it‘s always per strength (facilitates processing at MEA), rules for acceptability of combined FIs or GIs see Homepage and QRD Stylistic matters. FAQ will be published


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Chat functionality was requested: Short message concerning a procedure without the need to upload a document.

- A chat functionality and related processes are not feasible, to many info lines would block the Worklist and hinder the workflow

In the procedure in the e-Service only one name is visible in the column „Name“, not all concerned products. All products are only visible in the Mouse-over but this disappears very quickly.

- Mouse over-time will be extended (will also be evaluated for the comment next to the claim), increasing the width of the column is possible, full-screen option is available


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Column Classification is only filled in in procedures of MR/DC products, should also be filled in in national procedures

- This should be the case: The classification also has to be entered in national procedures

Negative outcome of a variation: In PHAROS the procedure is listed under the completed applications with the completion date like all the others. Completion does not specify a positive or negative outcome, it only means that the national implementation is completed.

- It will be evaluated whether it is possible to display the CTS status in the completed applications.


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The name of the product should be mentioned in the subject of the automatic e-mail-notification at the completion of a procedure (currently it‘s only the procedure number). Important for national procedures.

- It will be evaluated whether the procedure number in the automatic e-mail-notification can be linked to the procedure in the eService or whether the name should be included in the mail

Official notifications are sent via HPC, but are also in eService

- The official notification sent via HPC is legally binding. The display of the notification in the eService is an additional service


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How can a communication be opened for a completed application? Procedures of MR/DC products are sometimes closed too early.

- E-mail with the procedure number to the respective functional e-mail-address, e.g. [email protected] or to the respective expert listed in the allocation scheme � Re-

Submission procedure is created by MEA in which the documents can be uploaded.

- Should only be exceptional cases.


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Please combine outer and inner Mock-Ups for one strength in one document already at upload �

facilitates processing.

The same for the labelling.

Upload of FI/GI/KE for IAs and IBs at the eService additionally to the submission via CESP/CD/DVD is appreciated.

MEA wish list

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www.ages.at

Problem with Marketing Authorisation Transfers: The old procedures could only be seen by the old MAH –The identification of the MAH will work via the „Grundakt“ so that the current/new MAH sees the old procedures

New document type in eService: „Application for conditional approval“� instead of FI/GI/KE please

upload this document (F_Z130) if a conditional approval is requested (e-mail to [email protected] not necessary anymore)� will trigger the workflow in the same way

as FI/GI/KE

Planned changes

Austrian Agency for Health and Food Safety www.ages.at

Mag. Alexander Ertl

CESPlessons learned

CESP – Confirmation Mails

What the confirmation mails tell you:

• 1st mail confirms successful upload to CESP

• 2nd mail is sent, when the transfer to the selected agency starts

No confirmation, that AGES received your complete submission

Since 11/2014 AGES sends notification emails, as soon as a new procedure is started and displayed in the e-Service portal

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CESP – Delivery File

Never rename your submission

•Do

CESP_Submission_12345.xml

•Don’t

CESP_Submission_12345 (Arzneimittel 2014-064719 Seq 0170).xml

�in the latter AGES receives data, but no information that it was transmitted

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CESP – Submission Number

• CESP number is required for tracking submissions

- To find out whether or not a submission was sent to AGES

• Never re-use CESP numbers

- Even if you have issues with a submission, resubmit the data by using a new CESP number

- It is highly recommended to use the comments in the new submission to indicate, that the same submission was also sent with the old submission (CESP number where the problems appeared).

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A Submission CESP_Submission_Nummer.xml has been uploaded to your Agency.

Details of your Submission:First Name : MaxSurname : MustermannEmail : [email protected] Number : 00430000000Company Name : FirmennameProcedure Number : UK/H/0000/003/IA/92Comments : Zusatzinformationen

Number: UK/H/0000/003/IA/92Department Type: Human MedicinesRegulatory Activity Type : Variation Type IA Sub Activity ID: H001Sub Activity Detail: Not ApplicableProcedure Type : MRPSubmission Type : NeeSChecksum : Agency Reference Numbers : Products : Technically Validated : trueValidation Tool : Lorenz eValidatorOther Validation Tool : NA ZIP File Format: true Other Zip File Format: Microsoft Compressed Folders

CESP – the perfect submission

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CESP – Comments

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Details of your Submission:First Name : MaxSurname : MustermannEmail : [email protected] Number : 00430000000Company Name : FirmennameProcedure Number : UK/H/0000…Comments : Zusatzinformationen

Number: UK/H/0000Department Type: Veterinary MedicinesRegulatory Activity Type : Intitial Marketing Authorisation ApplicationSub Activity ID: H001Sub Activity Detail: Not ApplicableProcedure Type : MRPSubmission Type : NeeSChecksum : Agency Reference Numbers : Products : Technically Validated : trueValidation Tool : Lorenz eValidatorOther Validation Tool : NA ZIP File Format: true Other Zip File Format: Microsoft Compressed Folders


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• Comments

- „Response“ – Please declare in comments that the current submission is a response, that helps in the correct processing of the submission

- If possible please also indicate the “AGES-Verfahrensnummer”

- Important additional information e.g.

o Product name;

o As mentioned above, the old CESP submission number if you experienced technical issues

o Also indicate if you are submitting related data via more than one submission. Please list the associated CESP numbers

o Please also indicate any deviations from the standard submission procedure


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• Department Type

- Humane Medicines, Veterinary Medicines

• Regulatory Activity Type

- Variation Type IA, IB etc. Periodic Safety Update Report (PSUR), Development Safety Update Reports (DSUR), Active Substance Master File (ASMF), Transfer of a marketing authorisation….

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Details of your Submission:First Name : MaxSurname : MustermannEmail : [email protected] Number : 00430000000Company Name : FirmennameProcedure Number : UK/H/0000….Comments : Zusatzinformationen

Number: UK/H/0000/003/IA/92Department Type: Human MedicinesRegulatory Activity Type : Variation Type IA Sub Activity ID: H001Sub Activity Detail: Not ApplicableProcedure Type : MRPSubmission Type : NeeSChecksum : Agency Reference Numbers : Products : Technically Validated : trueValidation Tool : Lorenz eValidatorOther Validation Tool : NA ZIP File Format: true Other Zip File Format: Microsoft Compressed Folders


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• Procedure Number

- European procedure number

- MR/DC MA number

- PSUSA Number, ASMF Number

- For purely national authorisations Grundzahl(Automator)

• Procedure Type

- MRP, DCP, national

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CESP AGES recommendations for a

quick processing of groupings

UK/H/1234/001/IA/007 � CESP 1234

UK/H/1234/002/IA/007 � CESP 1238

UK/H/1234/003/IA/007 � CESP 1245

UK/H/1234/001-003/IA/007 � 1 CESP Number

• Please submit all products in one CESP transfer. It is hard and extremely time consuming do identify the associated parts of submissions afterwards.

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• If it is impossible to send all required information please send a list of the associated CESP numbers to [email protected] or use the comments field to do so

CESP – Zipping submissions

• Only zip the first level of your submission!

- Never zip subfolders!

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Questions/Discussion

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