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 ([email protected])
• Birgit Hirschbichler, Fresenius-Kabi ([email protected]) • Julia Slaje, Sandoz ([email protected]) • Susanne Grimm-Bursch, Novartis ([email protected]) • Michael Sander, PHARMIG ([email protected]) • Verena Schiefermüller, KWIZDA ([email protected]) 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
Austrian medicinal product index
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News: • New field „Supply Status“ • Autosuggest search for Active Substance incl.
search for synonyms
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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•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
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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 ([email protected] ) 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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• 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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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