R4BP 3.9 key users testing Introduction 4-5 May 2017 Roberto Gilioli R4BP 3 and SPC editor Product Manager European Chemicals Agency

Key users testing of R4BP 3 Objectives: Get familiar with the new features of R4BP 3.9 Test the usability Provide early feedback Preview R4BP 3.10 Now you can transfer only assets

Overview Agenda and scope of the testing How to perform the testing and report feedback New features in R4BP 3.10

Agenda 1

Introduction to the testing exercise Agenda   4 May 2017 09:30 -11:00 Introduction to the testing exercise 11:00 - 11:20 Coffee break 11:20 – 13:00 Testing of the tool 13:00 – 14:00 Lunch break 14:00 – 15:30 Testing of the tool (cont’d) 15:30 - 15:45 15:45 – 17:30 5 May 2017 09:30 – 11.00 New features in R4BP 3.10 11:20 – 12:00 Q&A session on R4BP 3.10 12:00 – 12:30 Wrap up 12:30 END Now you can transfer only assets

Scope of the testing 1

Main features in R4BP 3.9 New case types, for industry and MSCAs Extension of grouped submissions (new asset types or new cases) Synchronisation of evaluation types in renewals Better display of reference and concerned cases in MR search results Process flow improvements: more flexibility Now you can transfer only assets

Detailed description of the test scenarios

New case types Amendment of notification (SN-ADC) Cancellation of notification (SN-CCL) Extension of change of participant to RP assets (PA-CHG) Review of Active Substance Approval (AS-REV) (3.10) Now you can transfer only assets

Workflow: Amendment of Notification (SN-ADC) COM Evaluation Evaluate & decide MSCA ECHA IND

Workflow: Cancellation of Notification (SN-CCL) COM Evaluation Evaluate & decide MSCA ECHA IND

SN-ADC and SN-CCL new cases Now you can transfer only assets

Workflow: Review of active substance (AS-REV ) COM Decision Collect Comments Public consultation MSCA ECHA IND ECHA Opinion

Workflow: Participants Change (PA-CHG) COM Business Rules Check RP asset update MSCA ECHA IND Evaluate & decide

PA-CHG for RP asset participants Now you can transfer only assets

Process flow enhancements

Case withdrawal Possibility for applicants to withdraw from a case Now you can transfer only assets

Trigger a case transfer Transferring case owner and/or perspective asset owner Now you can transfer only assets

Accept a case transfer The second Legal Entity has to accept Now you can transfer only assets

Nomination for Review Programme cases Now available also for Review programme notifications Now you can transfer only assets

Improved search and display

Improved search and display… Search for Products and Active Substances Now you can transfer only assets

…with multi-select options Now you can transfer only assets

Improved communication

Automatic notification to cMS when rMS closes the case Now you can transfer only assets

Quickly select all MSs in a MR case Now you can transfer only assets

How to perform the testing and report feedback 1

Testing environment (Trasys) Trasys testing environment will be used today Instructions on how to access are available in your laptop Customised data are available for testing Now you can transfer only assets Feedback form to be filled in!

Features tested in the previous session 1

New case types Amendment of active substance in Annex I (AN-CHG) Essential Use Derogation (DE-APP) Notification of unexpected or adverse effect for Union authorization (UE-NOT) Now you can transfer only assets

Workflow: Amendment of active substance in Annex I (AN-CHG) (1-5 or 6) COM Business Rules Check Evaluate Validate Resubmit MSCA ECHA IND Decision Accept Opinion

Workflow: Notification of unexpected or adverse effect for UA (UE-NOT) COM Evaluation Evaluate & decide MSCA ECHA IND

Workflow: Essential use derogation (DE-APP) COM Decision Collect Comments Public consultation MSCA ECHA IND

Grouping Extension of grouped submissions for ADC Add NA asset in grouped applications linked by mutual recognition (NA-RNL, ADC, MIC, MAC) Now you can transfer only assets

1. Select grouped ADC At the bottom of the industry “New Applications” list

2. Search for assets Assets of different types can be included in the search

3. Confirm selection

4. Check selected assets

5. Assign contact details Same contact details can be assigned to all assets in one go by clicking “Apply to all”

6. Browse SPCs for upload All SPCs relevant for upload can be browsed and uploaded in the upper section

7. Assign SPCs to relevant assets

8. Upload SPCs and confirm selection 2 1

9. Bulk upload other files

Add a new case in a grouped application (ADC, RNL, MIC, MAC) Open a reference case in progress: “Create new case” available to add cases to the group

Select the case to be added

Synchronisation Synchronise the type of evaluation between rMS and cMS (full or light). To test this: Create 2 NA assets (1 reference and 1 concerned linked by MR) Launch a grouped renewal Select full evaluation for the reference Check that the concerned has “light evaluation” disabled Now you can transfer only assets

Improved display New display of search of reference and concerned cases in mutual recognitions Reference case displayed with an icon in the case search list New column to display evaluating Member State in the task list of applicant interface Now you can transfer only assets

Identify reference and concerned cases

Icon for the reference case

Evaluating MS in the task list

Process flow improvements and increased flexibility Possible to extend deadline for resubmission Permitted to initiate a NA-BBP with NA-MRS as reference case Removal of mandatory file upload in the field available on MEV/VAL/EVL task items Now you can transfer only assets

Extend resubmission deadline

New features in R4BP 3.10 1

Main features in R4BP 3.10 Revised and synchronised workflow for NA-APP and NA-MRP Allowed to apply for Mutual recognition of a same biocidal product Possible to provide information post approval of an active substance Redefinition of Active substance Better communication system Now you can transfer only assets

NA-APP, NA-MRP synchronisation Now you can transfer only assets

Identified issues How to implement the disagreement scenario What happens to a late applicant What happens if NA-APP is rejected during the process Should the rMS finish first to enable the other cMS to complete the authorisation What happens to the MR in disagreement Now you can transfer only assets

Mutual recognition of same biocidal products Possibility currently prevented by the “triplet” rule (same Legal Entity, market, product UUID) A solution will be found, possibly relaxing the rule Mutual recognition of SBPs will be possible, but other options as well: multiple NAs in same market; multiple MRs in same market; multiple SAs multiple UAs Now you can transfer only assets

Redefinition of Active Substances R4BP 3.10 will enable the redefinition of a substance during MS evaluation and ECHA peer review (for review programme cases) It has to be triggered by the evaluating competent authority Provision of information may happen via IUCLID files “Old” substances may be placed in the list to invite for notification, in belonging to the Review Programme Now you can transfer only assets

Post decision/approval submission of information on active substances Provision of information required from the applicant after the Commission decision will be possible Normally required 6 months before the approval of the substance To be triggered by the applicant Possible to submit information via IUCLID file Now you can transfer only assets

Improved communications management Better interface and display Sent and received messages retrieved in the same list More filters to search (i.e. subject, topic, number, related trade and product name, etc.) Possibility to classify messages as archived Now you can transfer only assets

Other features More informative error messages Case owners to send communications to MSCA directly Save an application before submission (for grouped submissions) More fields exportable in excel from search results Few more case types (i.e. cancellation of Active substances, collection of annual fee for UA, …) Now you can transfer only assets

Thank you! roberto.gilioli@echa.europa.eu