AGES Gespr¤ch IT Projekt PHAROS AGENDA 2 Thema Vortragender Agenda Neuwirther Presentation...

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  • sterreichische Agentur fr Gesundheit und Ernhrungssicherheit GmbH www.ages.at

    AGES Gesprch IT Projekt PHAROS

    AGES Medizinmarktaufsicht

    09.09.2014

  • www.ages.at

    AGENDA

    2

    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 Durchfhrungsverordnung 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

    4

    Nutzergruppe

    Sammeln von begrndeten Anforderungen aus der Industrie Abstimmen (Machbares identifizieren) und Priorisieren dieser

    Anforderungen Einbringen der priorisierten und beschriebenen Anforderungen

    in die Nutzergruppe Industrieseitige Besttigung von Anforderungen auf Basis der

    mit der Industrie und AGES MEA abgestimmten Anforderungen

    Organisation des Tests von IT-Umsetzungen Industrieseitige Besttigung 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 Schiefermller, KWIZDA (v.schiefermueller@kwizda.at) Industrieseitige Organisation: Michael Sander MEA-Ansprechperson: Georg Neuwirther

    http://ratiopharm.at/http://fresenius-kabi.at/http://fresenius-kabi.at/http://fresenius-kabi.at/http://sandoz.com/http://novartis.com/mailto:michael.sander@pharmig.atmailto:v.schiefermueller@kwizda.at

  • 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

    6

  • www.ages.at

    External user administration

    7

    Used for automatic mails only

  • www.ages.at

    eService laufende Anbringen ongoing procedures

    8

  • www.ages.at

    eService laufende Anbringen ongoing procedures

    9

  • www.ages.at

    eService abgeschlossene Anbringen closed procedures

    10

  • www.ages.at

    Austrian medicinal product index

    11

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

    search for synonyms

  • www.ages.at

    Values for supply status

    12

  • www.ages.at

    Auto suggest for substances

    13

  • 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

  • 15

    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 (=Bevollmchtiger whrend des Verfahrens)

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

    How to make sure to see a procedure on the eService

  • 16

    - 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.

  • 17

    New application:

    Where to enter the roles in the Application Form

    Please make sure to

    include company name

  • 18

    New application cont.:

    Where to enter the roles in the Application Form cont.

  • 19

    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

  • 20

    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

  • 21

    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

  • 22

    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

  • 23

    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:

    - rtfs are not transferred to eService Abgeschlossene Verfahren and the product index.

    Upload of documents

  • 24

    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 hinzufgen

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

    Upload of documents cont.

  • 25

    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.

  • 26

    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:

  • 27

    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 hinzufgen functionality as described above for FI, GI and KE, and only then click Absenden)

    Best Practice for documents:

  • 28

    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.:

  • 29

    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

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