Electronic World. Mag. Beate Gasser LCM/REUR. AGES Gespräch Wien, Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH

Transcription

1 Electronic World Mag. Beate Gasser LCM/REUR AGES Gespräch Wien, Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH

2 Topics PHAROS: The new system at MEA - New features in eservices MEA-recommended electronic tools: - eaf and CESP: Important issues and latest developments ASMF Assessment Report Repository: An outlook 2

3 PHAROS: How has it changed the way LCM works No more paper electronic workflow only Everything is a procedure Tasks in Worklist Time line management via worklist Direct connection to european system CTS 3

4 Workflow example: New application 4

5 Worklist Task Upload of PI to eservice Date appears in this column End of Procedure date PI concerned yes or no 5

6 Data fields according to eaf eaf data can be imported into PHAROS no more typing in data again that have already been typed in by somebody saves time and minimises mistakes RDM conformity Data quality: More and more detailed data are held better product management 6

7 eservices: New features in December release Marketing data: External users can enter the data themselves again Overview of active medicinal products (for MAHs and person/company authorised for communication after authorisation) Finished procedures (default finished in the past 3 months, can be changed) with PI texts in word Open procedures: New columns european procedure nr. and classification/content of procedure Confirmation page and after upload 7

8 Open procedures 8

9 Overview of products 9

10 Marketing data

11 Marketing data cont.

12 Marketing data cont.

13 Marketing data cont. See the whole table

14 Closed procedures with PI texts

15 Common issues with eservices How can I limit which procedures can be viewed by a consultant? - Don t register consultant employees as members of MAH/applicant company oconsultant company should rather be included in application form as applicant (AF declaration and signature page) or company authorised for communication before or after authorisation (AF or 2.4.3) in new applications, o AF Name and address of contact in Renewals and Variations (please add consultant company name; will be entered as company authorised for communication after authorisation in PHAROS) o and/or applicant in AF Variation - Consultant company will be used in PHAROS in above mentioned roles, not a particular person 15

16 Common issues with eservices cont. I want to upload PI texts for a procedure but it isn t visible in the eservice. What should I do? - A procedure is made visible in the eservice during validation. For IAs and IBs national translations should be submitted already with the variation dossier. It would be an additional step to come back a few days later to submit the texts via eservice. So for IA and IB it is best to submit the texts as working documents with the dossier. - For submission of translations after New Applications, Renewals, Type II and for IBs that underwent text changes during the procedure please register at the eservice in the national step at the latest.

17 eaf: Where to get it 2/index_en.htm Volume 2B: Link to esubmission Website for all kinds of eafs: New Application, Renewal and Variation 17

18 EMA esubmission Website 18

19 Forms Frequent revisions according to user requests 19

20 User documents Q&A, request for terms 20

21 Q&A: Problems? There is help Q.7. Where can I find guidance for completing the eaf? - If you encounter an issue with a specific field, please refer to the Known Issues in the Release Notes for the specific form. These may be found on the eaf pages of the EMA s esubmission website. New issues may be raised via eaf service desk (eaf@ema.europa.eu). - In case of any further technical queries, please contact us at: eaf@ema.europa.eu You can also report problems and suggestions with the eaf to MEA: - Mag. Alexander Ertl - DI Georg Neuwirther 21

22 Missing terms Q.19 & 20: Missing terms in drop-down lists (substance, pharmaceutical form etc.) can be requested: - your request to eaf@ema.europa.eu A provisional term is added within 5 working days 22

23 Re-use data for further strengths Q.25: The data can exported to e.g. the desktop as xml and then be imported into the next form for another strength with the import xml functionality. 23

24 eaf for New Applications, Variations and Renewals MEA suggestion: Start with Variation and Renewal eafs: Fewer fields New field in MAA and Variation AF: EU (or national) ASMF number (see slides later in presentation) 24

25 eaf: Next steps process defects and pending change requests Goal is to have a stable version for the eaf to be able to promote the usage of the eaf --- Q1/2014 Define vision for the future: Possible Common Application Service replacing eafs and CESP (data now entered in AFs could be entered directly into a common from in the system + submission of the dossier) 25

26 No more paper please Please use CESP or CD s/dvd s Scanning paper is time consuming and structure can be lost/impaired 26

27 CESP ZIPs: Not all formats allowed: - Please note that the only zip / compression formats that have been tested on the system are outlined below. Zip files created with other software packages should not be uploaded through the CESP system as it can create issues when delivering submissions to agencies. Tested Software is as follows: WinZip Microsoft Compressed file format Don t re-use CESP numbers Take care that only the right and complete dossier is in the transfer folder for submission 27

28 CESP: Common issues 28

29 CESP support 29

30 How to submit documentation electronically Reminder: and are expected to be disabled by CESP eservice Zulassung/Lifecycle ASP DVD/CD EudraLink Procedure Start (dossier) preferred no possible no Responses (parts of dossier) preferred no possible no Communication concerning european procedures (except national phase) Communication concerning national procedures Submission of national product information texts (FI/GI/KE) preferred possible possible possible possible preferred possible possible possible preferred possible possible 30

31 ASMF Assessment Report Repository AT significantly involved in development of worksharing procedure and repository Pilot phase starts December 2013, will last 1 year Objective: Avoid unnecessary duplication of assessment and optimise the consistency of the assessment process by sharing the assessment reports among the Competent Authorities 31

32 Pilot phase Step-wise approach: Only intended to include new ASMFs, submitted in Centralised or Decentralised procedure only. New ASMF is defined as an ASMF that has not been previously assessed by a Competent Authority as part of a Centralised, Decentralised or Mutual Recognition new marketing authorisation or variation application - it is accepted that a new ASMF may have been assessed as part of a national application. 32

33 Before the CAP/DCP ASMF Holder requests EU/ASMF number (mandatory info: procedure number of procedure that will most likely be submitted first) from respective Competent Authority. CA issues number in the repository (the system assigns the numbers sequentially in order of request) EU/ASMF/XXXXX/YYY XXXXX is the reference number of the ASMF. YYY: Assessment report number for the version of the ASMF. Sequentially assigned by the ASMF holder, applies to the entire ASMF regardless of whether the AP and/or RP of the ASMF has been updated. 33

34 EU/ASMF reference number CA communicates number to ASMF holder ASMF holder communicates number to all applicants The EU/ASMF reference number should then be used in all correspondence and documentation relating to the version of the ASMF (MA or MAV application forms, Letter of Access (Annex 2, CHMP/QWP/227/02 Rev. 3), Submission Details Form (Annex 3, CHMP/QWP/227/02 Rev. 3) etc 34

35 Assessment stages 1&2 Repository can determine parent procedure (i.e the one in which the AR is due first) since the time tables are available in the system. CA of parent procedure loads up AR Clock Stop: Possible that parent procedure has to be switched Ideally the same CA stays the lead in the second stage If not: System indicates which procedure should take over switch possible, other CA adds to AR of first CA 35

36 Questions and Discussion! 36

37 Thanks for your attention! 37