eaf version 1.20 Update

Transcription

1 eaf version 1.20 Update Ing. Sonja Königshofer, DI Georg Neuwirther AGES-Gespräch "Implementierung der EU-Telematikstrategie in Österreich und aktuelle Informationen zu IDMP/SPOR - 29/11/2016 Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH

2 When to use an eaf? eafs have to be used: - Marketing authorisation application according to 7a, 9a, 9b, 9c, 9d, 10 Abs. 1(1), 10 Abs. 1 (2), 10 Abs. 9, 10a, 10b, 11, 11a and 12 AMG (Austrian Medicinal Products Act) - Renewal applications according to 20 AMG - Variations according to Variation Regulation (EC) No. 1234/2008 For all other applications the forms published on the BASG webpage have to be used: - Application for parallel import license according to 10c AMG - Variations according to 24 AMG - transfer of MA according to 25 AMG - withdrawal of MA according to 23 AMG 2

3 percentage Use of eafs in AT 30% percentage of procedures with no (defect) eaf 25% 25% 20% 19% 15% 10% 9% 5% 0% 6% 5% 4% 4% 5% 3% 4% 3% 3% 1% 0% 1% 1% 2% 2% 2% 1% 2% 2% 1% 1% 0% 1% 0% 0% 0% 0% 1% 1% 1% 1% 1% 1% 1% 0% 0% 0% 0% week (2016) 3

4 eaf documents avaliable at EMA Link: 4

5 eaf Guideance at MEA Link: 5

6 eaf Guideance at MEA /2 German language 6

7 News about eaf variation Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH 7

8 eaf-variation- updates Main change in version of the eaf Variation is in section 2 Products concerned by this application - New layout - Annexes have been integrated into the eaf - Footnote for detailed information about strengths in complex compositions, e.g. multi-strain vaccines 8

9 eaf Variation section 2 9

10 eaf Variation section 2 guidance 10

11 eaf Renewal usage information Button Add all should be used in section Concerned member state only In all other sections please use button Add selected 11

12 Findings at MEA Scanned PDFs instead of intelligent eafs - received eaf is a printed and scanned pdf and does not contain the xml data anymore - eaf importation fails - request for resubmission of the eaf containing xml data prior start of the procedure eaf problem concerning Do you have a separate admin and manufacturer address? in section 2.4 eaf MAA or section 2 eaf Renewal - Was initially answered with Yes but then changed to No. -!!!! Information on the admin site still remains in the form, but is not visible - request for resubmission as differences between Pharos and eaf occurs 12

13 Questions and answers Validation issues are marked in the eaf. Can I close/submit it nevertheless? - Yes. Resubmission will be requested, if information is incomplete. Can I submit more than one strength per Marketing Authorisation application and renewal application? - No, except centralised procedures - see als Q30 in document Questions and Answers A worksharing procedure concerns many products. Can I use an annex instead of section 2 of the Variation eaf? - In this context an annex is allowed. - Nevertheless AT prefers the use of section 2. 13

14 Questions and answers /2 A worksharing procedure concerns pure national products. How to fill in the variation procedure number/variation number? - Select National Authorisation in MRP/DCP in section 1 - Keep it selected as long as you enter data in section 2. - Afterwards deselect National Authorisation in MRP/DCP, variation procedure number/variation number remain visible. The eaf has been updated during procedure. Should I upload the corrected form via eservices? - Recommended, but not mandatory. Anyway the updated eaf has to be part of the closing sequence. - AT=CMS Variations: If the variation number has been corrected or the procedure has been upgraded, please inform us via to basgcms@ages.at. This will speed up national closing procedures. 14

15 Importing concerned products Entering concerned products got much easier in the last eaf-release but there is still place for improvement - especially extended functionality for uploading concerned products into the eaf-variation instead of typing in. This extension will be discussed at the eaf maintenance group DI Georg Neuwirther 15

16 Opportunity It s technical possible to import data into the eaf Electronic parsing of the XML to add products from textfile Please contact georg.neuwirther@ages.at in case your IT would like to support such a scenario eafcompatible XML Import XML into eaf RIM DI Georg Neuwirther 16

17 Upcoming Releases EMA plans 2-3 releases in 2017 Release 1: Q o bug fixing release o no DES -change expected Release 2, 3: scope not yet defined 17