Technical update 19 of December 2016 EU-CEG Technical update 19 of December 2016 1

Agenda Accounts / Submissions in production – figures Applet java from ETRUSTEX GUI phasing out Data quality – main issue New submission type options Domibus version in acceptance 3.2 (feedback from industry) EUCEG Support – stats and situation Open questions

Accounts in production - figures Period 08 September 28 of October 15 of December N° of accounts created 648 946 1739 E-ETRUSTEX web interface users 444 674 1359 System-to-system users (AS4 access point)   204 272 380 AS4 active users (Successful submission + encryption) 2 6 13 3

Submissions in production - figures Period 08 September 28 of October 15 of December > 2month N° of industries submitting in production 41 127 522 +395 Tobacco products 378 2436 21612 + 19176 E-cigarette products 1562 3888 73613 + 69725 Total number of products 1940 6324 95225 + 88901 Total number of submissions treated by the system 6653 29808  308198  + 278390 4

Daily new products 20/11/2016

Total number of products

Data quality : main issue 1. Incorrectly adding a new presentation (national market) Based on the feedback given by the MS we found that a lot of industries have made a mistake by incorrectly adding a presentation to an existing product. How it has been done :

Data quality : main issue How they should do : 2. Attachments Some of the submitters re-submit systematically the attachments each time they are making correction to an existing product. If there is NO change on the files the identifier must be used in the submission in order to avoid the resubmission of the files.

Applet java from ETRUSTEX GUI phasing out For security reason the java applet used in ETRUSTEX GUI to encrypt and send the data to EUCEG will no longer be supported. Possible solutions to replace the ETRUSTEX GUI Provide a module to encrypt and send the data to EUCEG directly from the XML creator. Provide a module to encrypt the data in the XML creator and develop a web interface to send the data and follow the submission status. Next action Feasibility and impact Analysis of the 2 possible solutions – in progress

Current submission types Submission types currently active: New product (1) Substantial modification (2) Correction (7)  Submission type 7 (correction) is currently used in a wider sense (i.a. adding/removing product presentations, changing product information, annual sales update…)

Submission types New submission type options The following proposition is under evaluation. Submission leading to a 'new product' Submission type Description New product (existing :type 1) Submission of a new product (i.a. novel product / first-time submission to EU-CEG) Substantial modification (existing type 2) Existing submission is modified in a way that changes the product characteristics substantially (e.g. change in composition of ingredients) Relates to changes at level of product and/or presentation 11

Submission types Changes at the level of the 'product' Submission type Description Correction (existing type 7 -> meaning will change) Minor modification of existing submission at product level Minor changes Spelling mistakes Administrative update … Ingredient fluctuations New type : Under evaluation Reporting of minor fluctuations across product batches; submission of actual quantities of ingredients 12

Submission types Changes at the level of the 'product presentation' Description Add presentation New type : Under evaluation Adding a new presentation to an existing product submission New national market Additional presentation (e.g. package units/type) … Remove presentation Removal of an existing presentation Withdrawal of national market Removal of other presentations (e.g. package units/type) Update presentation Modifications (non-substantial) of an existing presentation Sales data Reporting of annual sales volume of the product per Member State 13

New submission type options Next actions Impact Analysis on the existing process Quality assessment and impact Analysis on the data already submitted (feedback from MS) Submission type 7 (correction) will remain for the moment the submission type to send any types of update (including the annual sales)

EDELIVERY Domibus 3.2.1 Installed in acceptance since 01/12/2016 Any problem should be reported to the support mailbox with subject "Domibus 3.2.1 acceptance - issue" We performed internal testing and we did not find any technical issue Your feedback is important to install this new version in production Foreseen installation in production January 2017 Downtime around 1 hour Compatible with domibus 3.1.1

EDELIVERY Domibus 3.2.1 This version includes important improvements we suggest that you install this version too. For more information related to the content of the version 3.2.1 (and 3.2) please check the CEF Digital website. https://ec.europa.eu/cefdigital/wiki/display/CEFDIGITAL/Domibus+-+releases For technical help to install this version please contact the CEF EDELIVERY support team (CEF-EDELIVERY-SUPPORT@ec.europa.eu)

EU-CEG next steps for 2017 Data quality follow-up Solution for applet java phasing out XML Creator business rules Performance issue New submission types

Current releases for all the components EUCEG gateway 1.3.1 (27/10/2016) XML Creator 1.1.3 (27/06/2016) XSD 1.0.1 (07/06/2016) EDELIVERY v3.1.1 (03/06/2016) https://ec.europa.eu/cefdigital/wiki/display/CEFDIGITAL/Domibus+-+releases 18

EUCEG Support – stats and situation 19

Questions ?