Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH www.ages.at

AGES Gespräch IT Projekt PHAROS

AGES Medizinmarktaufsicht

09.09.2014

www.ages.at

AGENDA

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Thema Vortragender

Agenda Neuwirther

Presentation External Usergroup PHAROS Neuwirther

eService ASP & ASP Register - New Functions - Tips und Tricks

Gasser

CESP – lessons learned Neuwirther

Info: eSubmission Roadmap EMA Neuwirther

Info: Antibiotika Mengenstromverordnung Neuwirther

Info: Versandhandelsapotheken Durchführungsverordnung Neuwirther

Fragen und Diskussion Neuwirther

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

Dipl. Ing. Georg Neuwirther MEA – Head of IT

Vienna, 09.09.2014

Externe Nutzergruppe

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

Aktuelle Mitglieder der externen Nutzergruppe • Michael Obereigner, Ratiopharm (mobereigner@ratiopharm.at)

• Birgit Hirschbichler, Fresenius-Kabi (birgit.hirschbichler@fresenius-kabi.at) • Julia Slaje, Sandoz (julia.slaje@sandoz.com) • Susanne Grimm-Bursch, Novartis (susanne.grimm-bursch@novartis.com) • Michael Sander, PHARMIG (michael.sander@pharmig.at) • Verena Schiefermüller, KWIZDA (v.schiefermueller@kwizda.at) Industrieseitige Organisation: Michael Sander MEA-Ansprechperson: Georg Neuwirther

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

MSc. Beate Gasser LCM/REGA

eServices New Features in November Release

Vienna, 09.09.2014

New Features in November Release

www.ages.at

Improvements

„ … would like to know when new documents arrive ..“

„ … not efficient to check whether the procedure is available in the e-service …”

“ … would like to be notified when my procedure was finished by AGES ...”

Improvement

Organizations can set up a general notification email-adresses

Procedures can get specific notification email-addresses

see next slides for more …

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www.ages.at

External user administration

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Used for automatic mails only

www.ages.at

eService – „laufende Anbringen“ – ongoing procedures

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www.ages.at

eService – „laufende Anbringen“ – ongoing procedures

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www.ages.at

eService – „abgeschlossene Anbringen“ – closed procedures

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www.ages.at

Austrian medicinal product index

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News: • New field „Supply Status“ • Autosuggest search for Active Substance incl.

search for synonyms

www.ages.at

Values for supply status

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www.ages.at

Auto suggest for substances

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

MSc. Beate Gasser LCM/REGA

eServices Tips and Tricks

Vienna, 09.09.2014

eServices Tips and Tricks –

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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 (=Bevollmächtiger während des Verfahrens)

o Company authorised for communication after marketing authorisation (=Bevollmächtiger 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:

Where to enter the roles in the Application Form cont.

Same as 2.4.3 in New Application=

Company authorised for communication

after marketing authorisation

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•Variation:

Where to enter the roles in the Application Form cont.

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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•New Application, Renewal, Type II:

- eService after end of procedure on European level

•Type IA/IB:

- Working documents on CD/DVD/ in CESP submission

- Possibility to upload texts to PHAROS (much appreciated by AGES) as soon as procedure is started. Improvement after November 2014 release of PHAROS due to notification email

- Change during IB procedure: upload new texts via eService after end of procedure on European level

Preferred submission routes for product information texts

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•Correct document type is important:

- Only document types „Fachinformation“, „Gebrauchsinformation“ and „Kennzeichnung“ will trigger alarm „texts have arrived“ internally

•Wrong document type such as „Summary of PI-changes“ or „Sonstige“ will also not be transferred to „Abgeschlossene Verfahren“ as final texts

•doc or docx only:

- rtf‘s are not transferred to eService „Abgeschlossene Verfahren“ and the product index.

Upload of documents

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•Only one document per document type

- 1) Choose product(s) („Betrachtungsobjekt“)

- 2) Choose document type, e.g. „Fachinformation“ (FI, Austrian SmPC)

- 3) Choose document via „Durchsuchen“-button

- 4) Click „Dokument hinzufügen“

- Repeat for „Gebrauchsinformation“ (GI, Austrian PL) and one more time for „Kennzeichnung“ (KE, Austrian Labelling)

Upload of documents cont.

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•Choose more than one product only in the case of combined FI or GI

•For the purpose of sending product information texts never use the + button

•Do not upload responses (validation phase or later during the procedure) via eService for European procedures. Consolidated dossier via CESP or CD/DVD after validation phase and after End of Procedure is very much appreciated

Upload of documents cont.

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•Title of FI/GI/KE documents: No technical constraints but still helpful for assessors:

- MRP-Nr. or GRZ

- FI or GI or KE

- Productname

- Date

- Clean or marked

- and please do not change the title (except for the date) later during text discussion

Best Practice for documents:

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•Grouping/Worksharing:

- When uploading product information texts for more than one product please make sure that the correct texts are linked to the respective product

•Product information texts for one product:

- Please send all texts for this product at once (using the „Dokument hinzufügen“ functionality as described above for FI, GI and KE, and only then click „Absenden“)

Best Practice for documents:

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•Text discussions:

- Please make sure to continue with the (latest) AGES version. Final version without header and footer

•National procedures:

- In case of parallel procedures (e.g. Renewal and Variation) please upload new versions to ongoing procedure as soon as texts have been finalised in the other procedure.

Best Practice for documents cont.:

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• FAQs http://www.basg.gv.at/ages-medizinmarktaufsicht-eservices/faq-fuer-eservices/

Where to turn to in case of technical problems

Or mail to

basg-eservices@ages.at

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•See „Zuteilungsschema“

- http://www.basg.gv.at/arzneimittel/faq/zuteilungsschema/

Where to turn to in case of other problems

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

Dipl. Ing. Georg Neuwirther MEA - Head of IT

Vienna, 09.09.2014

CESP lessons learned

CESP – die Bestätigungsmails

Wichtig sind die Bestätigungsmails:

• Die erste Mail erfolgt bei erfolgreichem Upload der Unterlagen an CESP

• Die zweite Mail erfolgt wenn die Daten durch CESP an die AGES übertragen werden

ACHTUNG: Dies bedeutet nicht, dass die Daten vollständig übertragen wurden!!!!!

Ab November erhält man notification emails, sobald Verfahren im e-Service verfügbar , d.h. submission ist auch erfolgreich angekommen

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CESP – Delivery File

Hier ist es wichtig diese nicht umzubenennen:

•Richtig

CESP_Submission_12345.xml

•Falsch

CESP_Submission_12345 (Arzneimittel 2014-064719 Seq 0170).xml

Hier langt der Ordner am Laufwerk ein, jedoch keine Bestätigungsmail an die AGES

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CESP – Die perfekte Einreichung

• nur in erster Ebene zippen!

- BITTE KEINE ZIPs in Subverzeichnissen

• jede CESP-Submission-Nummer nur einmal verwenden

- Bei Problemen nicht die alte CESP Nummer verwenden, sondern unbedingt eine neue.

- Wichtig ist in den Kommentaren auf die alte Nummer hinzuweisen (am besten kurze Schilderung des Problems)

• Bei Problemen

- Sollte etwas schief gehen bei der Einreichung ist das Befüllen des Kommentarfelds das Um und Auf. So können unnötige Verzögerungen vermieden werden.

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CESP – Die perfekte Einreichung

• Procedure Number

- 1. Europäische Verfahrensnummer

- 2. MR/DC oder Zulassungsnummer

• Umgang mit Responses bei laufenden Verfahren

- „Response“ - bitte extra vermerken im Kommentarfeld, damit kein neues Verfahren im e-service angelegt wird!

- Bitte MEA-Verfahrensnummer angeben

- Je ausführlicher im Kommentarfeld die Erklärung, desto effizienter die Bearbeitung

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CESP AGES - Wunsch bei Groupings

für schnelle Bearbeitung

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 Nummer

• Bitte unbedingt alle Produkte zu einer Variation gestaffelt mit einer

CESP_Submission hochladen (da sonst nur sehr schwer und mit viel Zeit zuordenbar)

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• Wenn sie die Einreichung mittels nur einer CESP-Nummer nicht realisieren lässt, ist es besonders bei nationalen Anträgen und Groupings wichtig in einer gesonderten Email (cesp@ages.at ) alle zusammengehörigen CESP-Nummern zu dem Verfahren zu nennen!

CESP – Die Nummer

•Die CESP Nummer ist sehr wichtig, va. Bei Nachfragen oder Troubleshooting

- Um Auskunft über CESP Einreichungen zu erteilen, benötigen die AGES Mitarbeiter die CESP Nummer als Suchkriterium.

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

Dipl. Ing. Georg Neuwirther MEA - Head of IT

Vienna, 09.09.2014

Info: eSubmission Roadmap

EMA

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“.. In support of administrative, regulatory and scientific activities related to medicinal product regulatory applications the main objectives of the eSubmission Roadmap are:

• Consistent, efficient, effective and secured electronic handling (submission, reception, validation, processing and distribution) of regulatory information for all procedures throughout the life cycle of medicinal products (One process).

• Fully electronic processing without paper or any physical media.

• Implementation of a single electronic exchange message for submission of regulatory information for medicinal products, in line with international standards.

• One single entry point for submission of applications to all authorities.

• Identical regulatory information made available to all authorities

… “

The eSubmission Vision

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Objectives – draft!

Area Vision Objectives

Submission format

Single electronic exchange message for submission of regulatory information for medicinal products

Streamline life cycle management of submissions

Submission media

Fully electronic processing of submissions

Eliminate all physical media (paper, CD/DVD) and other electronic messaging systems

Eliminate wet signed paper submitted with electronic submissions and minimize/eliminate the need of any kind of signatures

Submission transfer mechanism

One single entry point for secure electronic submission of applications to all authorities for downloading or for automatic transfer to the national systems.

Eliminate all physical media (paper, CD/DVD)

Implement single electronic submission forms

One single portal for all applications providing a shared service to create application forms online or to upload application data and supported, wherever possible, by controlled vocabularies and master data and considering the ISO message standards (IDMP and future RPS) achieved by a stepwise approach

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Objectives – draft!

Area Vision Objectives

Content requirements

Identical regulatory information available to all authorities

Agreed handling of eSubmission for national specific documents and regulatory activities.

Content format

Consistent electronic handling of regulatory information

Reduce data inconsistency by implementing full systematic use of controlled terminology

Automate the extraction of structured information into databases

Processes across the Network

Consistent validation of eSubmissions

Efficient and secure electronic handling of regulatory information

Common approach to technical validation

Validation by EMA/RMS

Implement common repository for remote access to dossiers for review and download dealing with all procedure types

eSubmission Roadmap – draft!

(reflecting final version 1.0 dated 140721)

eSubmission Roadmap Timelines

2013 2014 2015 2016 2017 2018

Use of eAF

Fully functional

single submission portal

for all submissions (human

& vet)

Use of VNeeS in CP, DCP and MRP (vet)

All submissions in CP,

DCP and MRP in eCTD

draft

eSub

Roadmap

NCA &

industry

survey

Ongoing/optional

Mandatory

eSub

Roadmap

Adoption Use of eCTD v.4

CESP (human & 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 in VNeeS

NCA use of Common Repository for CP submissions

(human)

Single submission portal - combined CESP/Gateway

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

in MRP/DCP

in CP

(Mandatory for CP-human, optional for other procedures)

New MAA in DCP in eCTD

MRP

New MAA in DCP and MRP

in eCTD

All other CP submissions

and all MRP submissions

New MAA in CP and DCP in

VNeeS

All other MRP submissions

eAF in all procedures

All submissions in CP in eCTD (human)

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Endorsement by EU Telematics Management Board, October 2014

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• waiting for endorsement

• communication and information to industry

• legal changes to “Einreichverordnung” if necessary

• …

Next steps

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

Dipl. Ing. Georg Neuwirther MEA - Head of IT

Vienna, 09.09.2014

Info: Antiobiotika-Mengenstrom-

Verordnung

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Information: Antiobiotika-Mengenstrom-Verordnung

Start der Übergangsfrist zur Meldungsabgabe: 2015

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Information: Antiobiotika-Mengenstrom-Verordnung

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Link to website

http://www.basg.gv.at/ages-medizinmarktaufsicht-eservices/veterinaer-antibiotika-mengenstromanalyse/

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

Dipl. Ing. Georg Neuwirther MEA - Head of IT

Vienna, 09.09.2014

Info: Versandhandel

Durchführungsverordnung

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•Local Contact Point:

- Andreas Krassnig

- Georg Neuwirther

Information: Versandhandel Durchführungsverordnung

www.ages.at

Beantwortung offener Fragen

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