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

2. 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
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3. Overview Agenda and scope of the testing
How to perform the testing and report feedback
New features in R4BP 3.10

4. Agenda 1

5. Introduction to the testing exercise
Agenda
4 May 2017
09:30 -11:00
Introduction to the testing exercise
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: :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
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6. Scope of the testing 1

7. 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
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8. Detailed description of the test scenarios

9. 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)
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10. Workflow: Amendment of Notification (SN-ADC)
COM
Evaluation
Evaluate & decide
MSCA
ECHA
IND

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

12. SN-ADC and SN-CCL new cases
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13. Workflow: Review of active substance (AS-REV )
COM
Decision
Collect Comments
Public consultation
MSCA
ECHA
IND
ECHA Opinion

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

15. PA-CHG for RP asset participants
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16. Process flow enhancements

17. Case withdrawal Possibility for applicants to withdraw from a case
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18. Trigger a case transfer
Transferring case owner and/or perspective asset owner
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19. Accept a case transfer The second Legal Entity has to accept
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20. Nomination for Review Programme cases
Now available also for Review programme notifications
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21. Improved search and display

22. Improved search and display…
Search for Products and Active Substances
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23. …with multi-select options
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24. Improved communication

25. Automatic notification to cMS when rMS closes the case
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26. Quickly select all MSs in a MR case
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27. How to perform the testing and report feedback1

28. 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
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Feedback form to be filled in!

29. Features tested in the previous session1

30. 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)
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31. 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

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

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

34. Grouping Extension of grouped submissions for ADC
Add NA asset in grouped applications linked by mutual recognition (NA-RNL, ADC, MIC, MAC)
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35. 1. Select grouped ADC
At the bottom of the industry “New Applications” list

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

37. 3. Confirm selection

38. 4. Check selected assets

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

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

41. 7. Assign SPCs to relevant assets

42. 8. Upload SPCs and confirm selection2 1

43. 9. Bulk upload other files

44. 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

45. Select the case to be added

46. 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
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47. 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
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48. Identify reference and concerned cases

49. Icon for the reference case

50. Evaluating MS in the task list

51. 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
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52. Extend resubmission deadline

53. New features in R4BP 3.10 1

54. 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
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55. NA-APP, NA-MRP synchronisation
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56. 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
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57. 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
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58. 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
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59. 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
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60. 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
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61. 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, …)
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62. Thank you!