1. R4BP 3.10 and SPC editor key users testing
Introduction to the new features
25 September 2017
Roberto Gilioli
European Chemicals Agency

2. Overview Agenda of the day Objectives and scope of the testing
Perform the testing and report feedback
Items for implementation in 2018

3. Agenda of the day 1

4. Introduction to the testing exercise
Agenda
25 September 2017
09:30 – 10:30
Introduction to the testing exercise
10:30 – 10:45
Coffee break
10:45 – 13:00
Testing of R4BP 3.10 beta
13:00 – 14:00
Lunch break
14:00 – 15:30
15:30 – 15:45
15:45 – 17:00
New features for 2018 and wrap up
17:00
END
After-hour plans
18:00 - …
Informal get-together
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5. Objectives and scope of the testing1

6. Objectives Get familiar with the new features of R4BP 3.10
Test the usability
Provide early feedback
Discuss the scope of R4BP 3 development in 2018
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7. Main features in R4BP 3.10 User interface improvements
Communication improvements
Mutual recognition of same biocidal products
Synchronisation of NA-APP and NA-MRP
Redefinition of active substance
Submission of information post approval of active substance
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8. User interface improvements

9. Relation diagram

10. More features of the diagram
Clicking on any rectangle or circle will open in a new tab the corresponding case or asset details.
The case type is reported in each rectangle
Circle's border is dotted: the asset is a family member
Label of a circle not bold: the current user cannot access the asset details
No case type number in the circle: it is migrated!

11. Enhanced case and assets details export
Fields exported in worksheet:
Dossier UUID
Evaluating authority Submission date
Case status
Completed on
Target Asset number
Implementing regulation decision
Decision date
Case owner name
Asset owner name
Case number
Product/Substance name
Trade name(s)
Active substances
Product type(s)
BAS number
EC number
CAS number
IUPAC name
Case type

12. Search cases/assets also by company name

13. New filter criteria
Assets generated from NA-MRS, NA-MRP, NA-BBP and NA-BBS

14. More multi-select fields
For cases and assets

15. Calendar selection for reply by date
No more counting of days…

16. Additional improvements
Possible to select multiple PTs per single use in the SPC editor
Improved message for SPC format error
Fixed the Invalid XML SPC error when pasting text with special characters in the editor
No more automatic message sent to applicant when a case is resumed by ECHA

17. Improved communication

18. Better search and… archive!

19. Case owners can initiate a communication with evaluating CAs

20. Process flow enhancements

21. Mutual recognition of SBP
professional & public uses
professional & public uses
public uses (25 ppm) MR MR
SBP
public uses (25 ppm)
professional & public uses
public uses (25 ppm)
MAC MR

22. Mutual recognition of SBP
professional & public uses
professional & public uses
public uses (25 ppm) MR
NOW PERMITTED! MR
SBP
public uses (25 ppm)
professional & public uses
public uses (25 ppm)
MAC MR

23. One LE can hold more than one NA (SBP) per product per market area
As a consequence are allowed:
Multiple Mutual recognitions of SBP in the same market where the reference product already holds a Mutual recognition
Multiple NA (SA, UA) in the same market for the same product
Multiple MR having the same reference NA
Multiple SA or UA (or both) for the same product

24. Synchronisation of NA-APP and NA-MRP
Agreement scenario

25. Synchronisation of NA-APP and NA-MRP
Disagreement scenario

26. Synchronisation of NA-APP and NA-MRP
New task items

27. Synchronisation features
"Evaluate and draft PAR & SPC(s)“ (EVP) by rMS has to be concluded within 365 days.
"Agree on SPC" (ASP) must be concluded within 90 days.
If cMS does not respond in 90 days, silent agreement is assumed!
rMS should grant authorisation first!

28. Streamlined notifications (SN-NOT)
Notify one or more members of a family in one wizard
Notify one or more single products in one wizard

29. New SPC “component” for upload

30. Select assets 2 1 3

31. Redefinition of an active substance

32. Within the Review Programme
Supported:
One substance redefined in another one
One substance redefined in more than one substances
Many substances redefined in one substance

33. Change (correct) Active substance

34. Additional features
Scientific data update after active substance is approved (AS-UPD), (AN-UPD) – To Be Completed
The evaluation timer for CAs in SA-APP after provision of further documentation by the applicant is restarted and set to 90 days
Automation of ECHA processes
Increased capability for data corrections

35. How to perform the testing and report feedback1

36. 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!

37. Plans for 2018

38. Features to be implemented in 2018
New case types
Article 95 list amendments
Active Substance cancellations
Grouped NA-MIC and NA-MAC process synchronisation
Workflow enhancements
Support amendments or cancellations of markets where Union Authorisations are applicable
Union Authorisation in EEA countries
Enhancement of efficiency of internal ECHA processing of dossiers

39. Features to be implemented in 2018
User interface improvements:
Further enhancement of the search functionality, (remember filter, search for reference MR, etc.)
More information on the case available on process steps details (i.e. AS already applied for)
Allow amendments of actions done by mistake
Communication enhancements: further flexibility to the messaging system (cc feature)
Improvements to the SPC editor “compare” feature
“Find and replace” text in the SPC editor

40. Features to be implemented in 2018
Performance improvements
Preparations for Brexit:
Possibility to transfer reference case responsibility from one MS to another.
Content check in applications (e.g. flag applications for Annex I of Active substances not eligible)
Further improve error messages and alerts from the system

41. Thank you!